RULE 070.00.98-006 - Section II - Board of Pharmacy Regulations

RULE 070.00.98-006. Section II - Board of Pharmacy Regulations

SECTION II BOARD OF PHARMACY REGULATIONS

01 -GENERAL OPERATIONS

01-00-0001 -DESCRIPTION OF THE BOARD

The Arkansas State Board of Pharmacy shall consist of six pharmacist members as provided by Arkansas Code 17-92-201(a)(1) and 17-92-201(d) plus a consumer member and a senior citizen consumer member as provided by Arkansas Code 17-92-201(a)(2). The qualifications, powers, and duties of the Board shall be those enumerated by the provisions of A.C.A. 17-92-201 through 17-92-208. (10/9/80, amended 6/20/91).

01-00-0002 -LOCATION OF BOARD OFFICES

The office of the Arkansas State Board of Pharmacy shall be located at 101 East Capitol, Suite 218, Little Rock, Arkansas. All communications thereto may be addressed to Arkansas State Board of Pharmacy, 101 East Capitol, Suite 218, Little Rock, AR 72201. (10/9/89).

01-00-0003 -REQUESTS FOR INFORMATION

Any person or persons seeking information respecting the Arkansas State Board of Pharmacy or desiring to submit complaints or charges thereto or make request thereof shall do so by filing with the Board an instrument in writing, signed by the writer and containing a return address. Communications need not be typed but should be legible. (10/9/80).

01-00-0004 -LICENSEES GOVERNED BY PHARMACY PRACTICE ACT

Except wherein items of practice and procedure are specifically set out in these Regulations, the practice and procedure before the Arkansas State Board of Pharmacy shall be governed by the provisions of the Pharmacy Practice Act. (10/9/80).

01-00-0005 -CERTIFICATES OF LICENSURE--EXPIRATION

AH certificates of licensure issued by the Arkansas State Board of Pharmacy shall expire on the 31st day of December, following the date of issuance of the same. Every licensed pharmacist engaged in the active practice of pharmacy shall pay to the Board of Pharmacy annually, between January 1st and January 31st a minimum renewal fee as defined in Regulation 01-00-0007. If the renewal fee for any pharmacist certificate be unpaid by the first day of February of any year, the holder that if the renewal be unpaid by April 1st of any year, such certificate shall be null and void, and the thereof must pay a penalty as defined in Regulation 01-00-0007 for each month thereafter, provided, holder thereof must be reinstated as a licensed pharmacist by satisfying the State Board of Pharmacy that he is of the same moral character and temperate habits as was required at the time of the original registration, and satisfy the Board of Pharmacy that he is competent and qualified to compound and fill prescriptions, and must pay a reinstatement fee as defined in Regulation 01-00-0007 for each delinquent year up to a maximum as defined in regulation 58 plus the current year's renewal fee.10/09/80 (Revised 10/14/81, Act of 1985, 6/20/91, and 8/23/96).

01-00-0006 -BOARD OF PHARMACY MEETING REQUIREMENTS

The Arkansas State Board of Pharmacy shall meet the second Tuesday in February, the second Tuesday in June, and the second Tuesday in October of each year-unless changed and announced in advance by the Board of Pharmacy. Examination of candidates for licensure to practice pharmacy shall be on dates, time, and place as determined by the Board of Pharmacy. 10/09/80 (Revised 6/20/91)

01-00-0007 -FEES CHARGED BY THE BOARD OF PHARMACY

The fees charged by the Arkansas State Board of Pharmacy for the various examinations, permits, licenses, certificates, and books issued by the board shall be as follows:

(1) The fee for examination to become a licensed pharmacist shall be twenty-five dollars ($25.00) plus the actual cost of the examination;

(2) The fee for a license as a licensed pharmacist from another state by reciprocity (license transfer) shall be two-hundred dollars ($200.00);

(3) The fee for the initial license and renewal of a license as a licensed pharmacist shall be seventy-five dollars ($75.00);

(4) The fee for issuance of a permit for the first time to operate a pharmacy or drugstore shall be three-hundred dollars ($300.00); the fee for annual renewal of a permit to operate a pharmacy or drugstore shall be one-hundred fifty dollars ($150.00);

(5) When there is a change of ownership, a new permit must be obtained, and the fee shall be one-hundred fifty dollars ($150.00);

(6) The fee for issuance of a permit for the first time to operate an out-of-state pharmacy or drugstore shall be three hundred dollars ($300.00). The fee for annual renewal of a permit to operate an out-of-state pharmacy or drugstore shall be one hundred fifty dollars ($150.00). When there is a change in ownership in an out-of-state pharmacy or dug store, a new permit must be obtained, and the fee shall be one hundred fifty dollars ($150.00);

(7) The fee for a certificate as a licensed pharmacist shall be ten dollars ($10.00);

(8) The fee for certifying grades in connection with an application for reciprocity (license transfer) shall be ten dollars ($10.00);

(9) The fee for issuance of, and annual renewal of, a license as a wholesale dealer under the Arkansas Prophylactic Law, ? § 20-63-101 et seq., shall be thirty-five dollars ($35.00);

(10) The fee for issuance of a hospital pharmaceutical service permit shall be three-hundred dollars ($300.00), and the fee for the annual renewal of a hospital pharmaceutical service permit shall be one hundred fifty dollars ($150.). When there is a change of ownership of a hospital pharmacy, a new permit must be obtained and the fee shall be $150.00;

(11) The fee for issuance of, and the annual renewal of, an institutional pharmaceutical services permit shall be thirty-five dollars ($35.00);

(12) The fee for issuance of, the annual renewal of, and the reinstatement of a nursing home pharmacy consultant permit shall be thirty-five dollars ($35.00);

(13) The fee for intern registration shall be fifteen dollars ($15.00) per year;

(14) The fee for change of pharmacist in charge of any pharmacy, or change of consultant pharmacist in charge of any institution shall be thirty-five dollars ($35.00);

(15) The fee for reinstatement of a pharmacist licensure shall be seventy-five dollars ($75.00) for each delinquent year up to a maximum of three-hundred dollars ($300.00);

(16) The fee for the Board of Pharmacy law book shall be twenty-five dollars ($25.00) except to interns on initial licensure, and applicants for reciprocity, on a one-time basis. A copy of each edition as revised shall be provided free to each pharmacy permit holder;

(17) The fee for a change of location inspection shall be one-hundred dollars ($100.00);

(18) The penalty for late payment of renewal of any permit, license, registration or certificate shall be twenty dollars ($20.00) per month beginning the first day of the second month after expiration, provided that if the renewal is not paid by the first day of the fourth month after expiration, the license shall be null and void;

(19) The fee for issuance of a Wholesale Distributor of Legend Drugs and/or Controlled Substances permit shall be three-hundred dollars ($300.00), and annual renewal shall be one-hundred fifty dollars ($150.00), provided that if the renewal is unpaid by December 31, of any year, the permit will expire. When there is a change in ownership of a wholesale distributor of legend drugs and/or controlled substances, a new permit must be obtained and the fee shall be one hundred fifty dollars ($150.00);

(20) The fee for issuance of a permit to sell, rent, offer to sell, or rent directly to patients in this state any home medical equipment, legend devices, and/or medical gas shall be two-hundred fifty dollars ($250), and annual renewal fee or change ownership fee shall be one-hundred twenty-five dollars ($125);

(21) The fee for issuance of a temporary permit for pharmacist on active duty in a branch of the armed forces shall be $25 and shall be administered as defined in regulation # 02-03-0001.

(22) The registration fee for a pharmacy technician (pharmacist assistant) certified and/or registered shall be thirty-five ($35.00) The reinstatement fee for a pharmacist's assistant certified and/or registered shall be thirty-five dollars ($35.00) per year and shall not exceed one hundred forty dollars ($140.00);

(23) The fee for registration as a preceptor shall be $20 every two years and shall expire on June 1 every other year.

All fees for examination for license shall be payable with the application and shall not be subject to refund. All other fees are only refundable if it is determined that there has been an overpayment. 8/23/96 (Revised 6/19/97)

02 -PHARMACISTS

02-00: GENERAL REQUIREMENTS FOR PHARMACISTS

02-00-0002 -CHANGES IN EMPLOYEMENT

Whenever any Licensed Pharmacist shall change his place of employment for any reason, it shall be the duty of the former and current employer and said Licensed Pharmacist to notify the State Board of Pharmacy in writing of such change within five days after such change of employment. The said notification must be by letter and must contain the new place of employment of the Licensed Pharmacist, his licensure number, and his renewal number. (10/9/80, amended 10/14/81).

02-00-0003 -REPLACEMENT OF PHARMACIST'S CERTIFICATE

Any licensed Pharmacist whose certificate has been lost or destroyed may procure a duplicate from the Arkansas State Board of Pharmacy by filing an affidavit that said certificate has been lost or destroyed, upon payment of a fee as defined in Regulation 01-00-0007. (10/9/80 amended 8/23/96)

02-00-0004 -PRACTICE AFTER INACTIVITY WHEN RECIPROCATING OR REINSTATING A LICENSE

To be reinstated and immediately practice without supervision, the pharmacist's license shall not have lapsed more than two calendar years.

To be reciprocated and immediately practice without supervision, the pharmacist shall have practiced the profession of pharmacy, as defined by law, and in a licensed facility at least 40 hours per year in the previous two calendar years.

If these criteria are not met, the pharmacist must:

1. Prior to resuming the unsupervised practice of pharmacy, practice 40 hours under direct pharmacist supervision of an Arkansas licensed pharmacist for each year or part of year out of practice. This time under supervision shall not exceed 240 hours.

2. Cause the supervising pharmacist to document, in writing to the Board, that the pharmacist has completed the designated number of hours of supervised practice.

3. Meet with a Board representative in a practice situation so that the Board representative, by observation, questioning, and other methods as required, can assure the pharmacist is able to competently practice pharmacy. (10/12/93)

02-00-0005 -ARMED FORCES CERTIFICATES

Any person serving in the armed forces within the State of Arkansas, who is a Licensed Pharmacist in another state, may obtain a temporary permit to practice pharmacy in the State of Arkansas by furnishing certified proof of his registration from the Board of Pharmacy in his state of original registration, and the payment of a fee as defined in Regulation 01-00-0007. This permit shall entitle the holder thereof to practice in any store where an Arkansas Licensed Pharmacist is on duty a minimum of 40 hours per week. The permit must be renewed at each succeeding meeting of the Board. (10/09/80 amended 8/23/96).

02-01: INTERNSHIP/CLERKSHIP

02-01-0001 -INTERNSHIP REQUIRED

Hereafter no extern, intern, or student of a pharmacy school shall be granted authority from this Board to practice pharmacy in Arkansas and serve any internship period in Arkansas unless he is licensed with the Arkansas State Board of Pharmacy and pays an intern licensure fee as defined in regulation. The application for licensure as an intern will be furnished by the Arkansas State Board of Pharmacy. (Amended 6/23/96).

02-01-0002 -BOARD OF PHARMACY REGULATES INTERNSHIP PROGRAM

The Board of Pharmacy is charged with regulating the internship program made to which reference is made in the Arkansas Code ? § 17-92-301. The Arkansas State Board of Pharmacy recognizes that in order to properly fulfill its obligation to the profession of pharmacy and general welfare and protection of the public health that it must implement and supervise an internship program in the State of Arkansas.

From time to time, as is required to establish a viable internship program, the Board will establish, publish, and disseminate criteria establishing requirements And standards necessary for qualifications for licensure under Arkansas Code ? § 17 92-305, ? § 17-92-307, and Regulation 02-01-0002.

Hereafter, every applicant for licensure by examination in Arkansas must have 2,000 hours of acceptable internship training obtained after beginning the professional college curriculum. Up to 1,500 hours of the required 2,000 may be obtained in a training program as part of school curriculum.

02-01-0003 -DEFINITIONS

A. LICENSED INTERN: A person licensed by the Arkansas State Board of Pharmacy, as a licensed Intern, and who is a student accepted by and enrolled as a student in the University of Arkansas College of Pharmacy or a student enrolled in an approved College of Pharmacy outside of Arkansas.

(1) Extern--An intern prior to graduation or a graduate who has taken and failed the Board Exam.

(2) Graduate Intern-An intern who has graduated or completed requirements for examination as set forth in Regulation 02-02-0001 A.

B. GRADUATION: Certification from a Board-approved College of Pharmacy that the student has fulfilled all requirements for graduation or has completed all foreign pharmacist requirements as set forth in Regulation 02-02-0001 A.

C. SUPERVISION: Shall mean that, in a pharmacy where experience is being obtained, a certified Preceptor or Alternate Preceptor supervises the practical experience with both personal and physical supervision, and actually giving instruction to the Intern obtaining the experience during the entire period of such experience.

D. LIMITED SUPERVISION: The pharmacist in a Class A pharmacy supervising a Graduate Intern is within voice or telephone contact.

E. CLASS A PHARMACY: A pharmacy which has obtained at least 85 on its last Board inspection, and has a pharmacy permit with a pharmacist on duty at least 40 hours per week.

02-01-0004 -REQUIREMENTS FOR INTERNSHIP TRAINING

A. Any extern or intern receiving internship training practice or experience in the State of Arkansas must be licensed as an intern with the Arkansas State Board of Pharmacy. No credit for internship training will be allowed prior to licensure as an intern. The intern licensure application can be obtained from the office of the Board of Pharmacy. There is a fee as defined in Regulation 01-00-0007 for licensure as an intern.

B. All students accepted by and enrolled as a student in the University of Arkansas College of Pharmacy shall be licensed as an intern.

All students enrolled in Colleges of Pharmacy outside Arkansas shall license as an intern in Arkansas prior to any participation in the practice of Pharmacy as defined in ? § 17-92-101, ? § 17-92-301, and ? § 17-92-307.

Provided that any licensed intern shall not participate in the practice of Pharmacy as defined in ? § 17-92-101, ? § 17-92-301, and ? § 17-92-307, until said Intern has successfully completed the first professional year on a 2-3 or 2-4 program of study or the second professional year on a 1 -4 program of study in a school or college of pharmacy approved by the Arkansas Board of Pharmacy. The intern license remains valid as long as the intern maintains active student status in a Board-approved College of Pharmacy and for one year (12 calendar months) after graduation from a College of Pharmacy or completion of foreign pharmacist requirements as set forth in Regulation 02-02-0001 A. At this time, the intern license becomes void. The graduate intern may not practice pharmacy until approval by the Board of Pharmacy has been granted and another license as an intern in Arkansas has been granted.

C. The certificate of licensure as a "licensed" intern must be displayed in the drugstore or pharmacy in which the intern is being trained. Licensed interns shall not be left in sole charge of the prescription department at any time. Violation of this regulation may effect a cancellation of any and all internship toward licensure that may be accrued by the pharmacy intern, and the revocation of the Preceptor's certificate.

D. For each pharmacy setting where an intern practices pharmacy, the intern shall complete and file with the Board of Pharmacy office, prior to any practice, a "Training Plan" that is signed by the Preceptor pharmacist or supervising pharmacist (in the case of a graduate intern) for that particular work situation. Such Training Plan shall expire on May 1 of each year. At no time may a Preceptor supervise more than one licensed intern.

E. Participation in a School or College of Pharmacy curriculum extern or clerkship program, approved by the Board of Pharmacy, will be credited week for week training.

F. The Arkansas State Board of Pharmacy examination will be offered upon graduation and proof of participation in an approved extern clerkship program in a school curriculum, or proof of completion of foreign pharmacist requirements as set forth in Regulation 02-02-0001 A.

G. After proving eligibility to sit for the Board Examination, the candidate may practice pharmacy in the State of Arkansas under limited supervision in a Class A pharmacy. Failure to make a passing grade on the examination will reduce the applicant to extern status for further training under the personal and physical supervision of an assigned Preceptor or Alternate Preceptor.

H. After presenting proof of 2,000 hours of practical experience or training under Arkansas Board of Pharmacy approved conditions, the intern may be designated as a candidate suitable for full licensure if other conditions have been met. Affidavits of one-year training must be submitted to the Board of Pharmacy for full licensure, and can be obtained from the Board of Pharmacy office.

Before permitting a student to participate in any way in the practice of Pharmacy, the Preceptor must assure:

A. The Preceptor is licensed.

B. The Intern is currently licensed.

C. The intern has filed a current Training Plan. Reg. 27,4.) (Revised 6/22/84,4/07/89, 6/20/91, and 4/10/92)

02-01-0005 -RULES APPLYING TO PRECEPTORS WHO TRAIN INTERNS

The Arkansas internship training program requires that a pharmacist, who has been duly certified by the Arkansas State Board of Pharmacy, may serve as preceptor or alternate for an intern or extern.

The following requirements must be met to be certified by the State Board of Pharmacy for serving as a Preceptor or Alternate:

1. Be an Arkansas Licensed Pharmacist licensed for not less than two years and having been actively engaged in the practice of Pharmacy for not less than two years immediately preceding the application. One can be certified as an alternate without the two years practice.

2. Be a full-time pharmacist in a pharmacy which currently holds a Class A rating indicated by the Inspection Sheet for pharmacies as outlined by the State Board of Pharmacy.

3. For the initial application as preceptor or alternate preceptor, the applicant must satisfactorily complete a test on requirements and responsibilities of a preceptor or alternate preceptor as developed and administered by the Board of Pharmacy or its representatives.

4. Have a pharmacy library (latest edition) which meets or exceeds the requirements of the "Inspection Sheet" for pharmacies.

5. At least one preceptor from the internship site shall be a member of an appropriate national pharmaceutical organization. All preceptors and alternates shall be a member of at least one professional state organization.

6. Must have not been convicted for any violation of Arkansas Code ? § 17-92-311, unless the Board officially grants exception.

7. Must have attended at least one professional meeting during the previous calendar year.

8. Must agree to give immediate personal and direct physical supervision to assigned intern. A preceptor or alternate cannot supervise more than one intern at any specified time.

9. Renewal as a Preceptor or Alternate will be required every two years by executive application and paying a fee as defined in Regulation 01-00-0007.

02-01-0006 -PENALTY FOR VIOLATION

Violation of any of the rules and requirements set forth in section "02-01" Above may cause the Preceptor or Alternate to lose his certification as such, and may also cause the intern to suffer loss of internship training credit. 10/09/80 (Revised 2/17/8 2/12/86, 2/10/87, 6/20/91, and 8/23/96).

02-01-0007 -ACCREDITED PHARMACY DEGREE PROGRAM

An accredited pharmacy degree program shall be any program which meets at least the Minimum standards established for a recognized Bachelor of Science program by the American Council on Pharmaceutical Education.

At the October Board meeting each year, the Board of Pharmacy shall adopt a specific list (by name) of approved colleges.

Until the list is revised, the existing list shall remain valid. 6/25/83

02-02: EXAMINATION

02-02-0001 -REQUISITES FOR EXAMINATION

Before being admitted to the State Board of Pharmacy Examination, each applicant must have the following requisites:

A. Satisfactory proof of graduation and receipt of the first professional undergraduate degree from a college of pharmacy which has been approved by the Board of Pharmacy; or satisfactory proof of graduation from a foreign college of pharmacy, completion of a transcript verification program, successful completion of a college of pharmacy equivalency exam program equivalent to graduation from a Board of Pharmacy approved College of Pharmacy, and a minimum score of 550 on the Test of English as a Foreign Language (TOEFL) within two years of the completion of the college of pharmacy equivalency exam.

B. Applicants will apply to the Board of Pharmacy for an application blank which must be completed and returned to the Board of Pharmacy office together with the fee as defined in Regulation 01-00-0007 plus cost of the exam as determined by the Board. The application must be received no later than the date designated by the Board for receipt of applications.

C. Each application must be accompanied by a recent 3" X 2" picture and a physical description stating age, height, weight, color of hair, eyes, and complexion of the applicant.

D.

i.

The examination will be held at a site and at a time or during a time Period designated by the Board of Pharmacy, and each applicant will be notified in advance.

ii. Upon the receipt, by the Board of Pharmacy, of (1) certification of the requirements as defined in section A. of this regulation, and (2) an application for examination for licensure such applicant may practice pharmacy as a graduate intern, pursuant to Regulation # 02-01-0002, in the State of Arkansas temporarily until the occurrence of the first of the following events:

a. failure to take the exam at the designated time for the individual applicant; provided, however, the Board may grant a similar temporary privilege to practice pharmacy as a graduate intern subject to the same terms and conditions herein in the event the applicant is reasonably unable, due to circumstances beyond the applicant's control, to take the examination at the first designated time for the individual applicant;

b. failure to receive a passing grade on the examination at the first designated time for the individual applicant;

c. the expiration of 12 calendar months following the applicant's graduation date from a college of pharmacy or completion of foreign pharmacist requirements as set forth in Regulation 02-02-0001(A).

iii. The granting of status as a graduate intern, shall in no way entitle the recipient thereof to any rights of tenure of permanent license and is purely discretionary and gratuity by the Board.

E. The test or tests shall be graded and reported, and a reported score of 75 or above is considered passing.

F. No person except members of the Board of Pharmacy or the authorized representatives will be permitted to enter the testing site during the course of examination.

G. The applicant must make a score of 70% on the jurisprudence exam prior to making application for licensure as a pharmacist in the state of Arkansas. 10/09/80 (Revised 1/14/81, 6/22/84, 6/13/85, 6/20/91, and 2/11/97)

02-02-0002 -SCORE TRANSFER

The Arkansas State Board of Pharmacy participates in the National Association of Boards of Pharmacy Score Transfer Program. The Score Transfer Program requires the applicant, or test candidate, to submit a NABPLEX Score Transfer Form either before the administration date of NABPLEX or within seven days after the examination and fulfill other state requirements for licensure in the state to which the scores are transferred for licensure by examination it that state. Score transfer Forms will be available, upon request, from the Board of Pharmacy office.

If a candidate takes NABPLEX in another participating state, properly transfers the score to Arkansas, and completes other requirements for licensure, Arkansas will license the applicant by the examination process.

The Arkansas Board will provide information related to states participating, NABP fees, and Arkansas fees. 6/20/91

02-03: RECIPROCITY

02-03-0001 -REQUIREMENTS FOR RECIPROCITY

Hereafter, no Temporary License shall be granted a reciprocity applicant until the Preliminary application has been received and approved by the National Association of Boards of Pharmacy and the applicant has submitted the application to the Board Office, paid the reciprocity fee, supplied a copy of the applicant's birth certificate, submitted proof of required continuing education, and supplied a current photograph of the applicant. The Temporary License shall expire at the next meeting of the Board of Pharmacy after the issuance of the Temporary License, he/she must cease practicing pharmacy in the State of Arkansas until reciprocity has been granted by the Arkansas State Board of Pharmacy.

Before issuing a Temporary Registration, the Board Member must personally talk to the applicant and ascertain that he/she has passed the Arkansas Jurisprudence Exam.

One is not eligible for an Arkansas license by reciprocity until he has been licensed six months in his/her state of original licensure by examination. Any practice in Arkansas, within this six month period, must be as an intern and under the requirements set out in this criteria (unless consideration is made by the Board of Pharmacy and an exception is approved). The application for reciprocity will become null and void, if it has not been completed in one year from the date of receipt in the Board of Pharmacy Office. 10/09/80 (Revised 4/07/89 and 4/10/92, 2/10/97)

02-04: DEFINING UNPROFESSIONAL OR DISHONORABLE CONDUCT:

02-04-0001 Preamble:

In defining "unprofessional conduct," the definitions of professional conduct and a pharmacist's duty should be determined. Professional conduct may be defined as complying with all the laws and regulations that apply to a given professional activity.

A pharmacist's duty means the practicing pharmacist has a general duty to qualify himself by attaining and maintaining an acceptable level of professional competence and by using such skill and precaution in the preparation, compounding, dispensing, labeling and distribution of drugs and medical devices whether on prescription or not, so as to prevent injury or death to all who are exposed to his professional services; and if the pharmacist is an owner, operator, or director of a pharmacy, he has an additional duty to employ only qualified persons and such other duties as are incidental to the operation of a mercantile business establishment.

02-04-0002 Definition:

Unprofessional or dishonorable conduct by a pharmacist shall mean, among other things, but not limited to:

1. Violation of any provision of the pharmacy act.

2. Violation of the Board of Pharmacy Regulations.

3. Violation of the Drug and Cosmetic act.

4. Violation of the Controlled Substances Act.

5. Failure of a pharmacist to conduct himself professionally in conformity with all applicable federal, state, and municipal laws and regulations in his relationship with the public, other health care professions, and fellow pharmacists.

6. Failure to keep his pharmacy and/or area of professional practice clean, orderly, maintained and secured for the proper performance of his professional duties.

7. Acquiring prescription stock from unlicensed sources or buying or selling legend drugs in violation of local, state, or federal law.

8. Personal participation in the sale of alcoholic beverages while "on duty" as a pharmacist. (Exempts pharmacies selling alcoholic beverages before 6/85.)

9. Failure to hold to the strictest confidences all knowledge concerning patrons, their prescriptions, and other confidence entrusted or acquired by him; divulging in the interest of the patron, only by proper release forms, or where required for proper compliance with legal authority.

10. Participation in a plan or agreement which compromises the quality or extent of professional services, or facilities at the expense of the public health and welfare.

11. Participation in any plan, agreement, or arrangement which eliminates or Detrimentally affects the traditional relationship of physician, patient, pharmacist, and the patient's freedom of choice of professional services.

12. The distribution, promotion, or advertising of premiums, rebates, coupons, amounts off, etc., on prescription drugs unless the offer is given to all patients purchasing prescriptions in the same time period. *Senior Citizen discounts shall not be considered a violation of this section.

13. The solicitation of prescription business by providing prescribers with prescription blanks with the name of any licensed pharmacy or pharmacy printed thereon.

14. Violation of Regulations and Procedures governing payment to pharmacies for pharmaceutical services for eligible Public Assistance recipients and/or other third party payment programs.

15. The provision of medication carts, printing and maintenance of the data base to produce the doctor's order sheet or medication administration record, consultation and related services by provider pharmacists to long-term care facilities free of charge or obviously below cost.

16. Falsifying contracts or agreements for legend drug purchases or violation of such contracts.

17. Providing invalid or insufficient checks in payment for licenses or renewals.

18. Receiving a score of 70 or below on two consecutive Board of Pharmacy inspections. The inspection is Based on the Board of Pharmacy inspection form which is available on request.

19. Dishonorable conduct shall include, without limitation, conduct involving moral turpitude, fraud, dishonesty, or otherwise demonstrating lack of good moral character, whether or not said conduct involves the practice of pharmacy. 10/09/80 (Revised 4/07/89, 6/07/90, and 4/10/92)

02-05: BOARD ACTIONS

02-05-0001 -EMERGENCY SUSPENSION

The Arkansas Administrative Procedures ACA * 25-15-211(c) states:

"If the agency finds that public health, safety, or welfare imperatively requires emergency action, and incorporates a finding to that effect in its order, summary suspension of a license may be ordered pending proceedings for revocation or other action, which proceedings shall be promptly instituted and determined."

Where the Executive Director of the Board of Pharmacy believes that the above condition exists, he shall call an emergency meeting with proper notifications of involved parties and media. Proper notifications shall be consistent with the Arkansas Administrative Procedures Act. This emergency meeting may be via a conference telephone call to a quorum of Board members.

The Executive Director of the Board of Pharmacy shall introduce evidence why he/she thinks an emergency exists and that a violation of the Pharmacy licensing law or regulation has occurred. The Board shall determine whether the license should be summarily suspended. A hearing shall be scheduled promptly for which notice shall be given pursuant to ACA * 17-92-313. If immediate action is requested, this hearing shall be within 14 days from the final Board decision. (10/12/88)

02-06: CONTINUING EDUCATION FOR PHARMACISTS

02-06-0001 -ESTABLISHING AN ARKANSAS TRIPARTITE COMMITTEE ON CONTINUING PHARMACY EDUCATION

Arkansas Tripartite Committee on Continuing Pharmacy Education:

A. The Arkansas Tripartite Committee on Continuing Pharmacy Education, hereinafter referred to as the Committee, is established to maintain professional competence through continuing education. The Committee shall consist of the Executive Director of the Arkansas State Board of Pharmacy, the Dean of the University of Arkansas College of Pharmacy, and the Executive Vice President of the Arkansas Pharmacists Association or the designated representatives of these individuals.

B. The general areas of responsibility for the Committee shall be following:

1. Plan and coordinate continuing education opportunities.

2. Promote research in continuing pharmacy education.

3. Develop information and record systems, pertaining to the participation of pharmacists licensed in the state of Arkansas, in continuing education.

4. Make recommendations to the Arkansas State Board of Pharmacy concerning Continuing Education Regulations.

C. The Committee will meet periodically review and recommend changes in the criteria by which the continuing education will be approved and to accomplish the above responsibilities.

D. The Executive Director of the Board of Pharmacy will carry out approval of continuing education according to the guidelines below.

E. The Executive Director of the Board of Pharmacy will act as Chairman of the Committee.

02-06-0002 -ACCREDITATION GUIDELINES:

A. GUIDELINES

1. The Continuing Education Unit (CEU) shall be the basis for accreditation of offerings within the state. 1 CEU is defined as 1 contact hour.

2. The Board of Pharmacy will accredit Intrastate and interstate C.E. offerings that have been reviewed by an appropriate national agency.

3. Continuing Education programs shall be accredited for the total length of the program.

4. Credit shall not be allowed for:

a. "Banquet" meetings with no educational program.

b. Unstructured demonstrations.

c. Unstructured questions and answers session.

5. Credit (hour for hour) shall be allowed for:

a. Speakers.

b. Panels.

c. Structured discussions, workshops, and demonstrations.

d. Structured questions and answers sessions.

6. Keynote speakers and topics will be accredited on an individual basis.

7. The Committee reserves the right for members or designees to review programs in operation.

B. ACCREDITATION MECHANISM

1. Members of the Committee shall be responsible for reviewing and recommending changes in the criteria for the accreditation of C.E. offerings.

2. In the temporary absence of a designated Committee member, a designated representative may review and offer recommendations for establishing and reviewing the criteria for the accreditation of C.E. offerings.

3. The Executive Director of the Board of Pharmacy shall review all programs within 10 days of receipt of request for accreditation.

4. All requests for accreditation must be received, in writing, in the Board of Pharmacy office at least 15 days before the offering is to occur.

C. REQUIREMENTS FOR ACCREDITATION

1. The organization shall have completed the appropriate program requirements. (See D below.)

2. The organization shall have the proper personnel to plan and produce educational programs.

3. The organization and personnel presenting the offering shall be qualified in the area of the presentation.

4. The organization shall provide the proper administrative facilities, provide the proper physical facilities, and have the financial resources for the production of educational programs.

D. PROGRAM CRITERIA FOR ACCREDITATION

1. The program criteria shall be appropriate to meet the needs of the pharmacist.

2. Beginning and ending times for each section of "Live" programs must be indicated.

3. A description of the program content shall accompany the request for accreditation and must be evaluated prior to its presentation.

4. The program description, which is presented for accreditation, shall have a statement of objectives and goals.

5. The program outline shall indicate how performance and effectiveness by the pharmacist will be measured.

a. Live programs in themselves; shall be acceptable for accreditation.

b. Audiovisual and correspondence programs shall require a live moderator or testing procedure.

6. The program shall allow the pharmacist a method to evaluate the presentation.

7. The program shall demonstrate a quality educational process.

a. Appropriate handout materials will be used with live presentations and correspondence courses.

b. Appropriate audiovisual materials will be used with audiovisual presentations and correspondence courses when necessary.

8. The program administrator shall present accreditation certificates to pharmacists, who satisfy requirements of the program. The application for approval shall specify how the accreditation certificates will be presented to participants.

9. The Executive Director of the Board of Pharmacy must approve changes in the date, starting time, or duration, of the program being presented, if said changes are made after initial accreditation.

10. Changes in speakers are acceptable if the quality of the program being presented is not diminished.

11. The Executive Director of the Board of Pharmacy must receive any changes in topics to be presented at least seven (7) days before the program is to be presented.

12. The organization presenting a C.E. program must provide reasonable notification to potential participants of any changes in, date, time, or duration of the program; changes in speakers; or changes in topics to be presented.

E. Programs sponsored and conducted by local pharmacists associations, will be accredited provided that the programs meet the criteria outlined in Section II C & D of these guidelines in addition to the following procedures.

1. The program shall be structured and shall be offered to all pharmacists who are members of the local association.

2. Each program shall be a minimum of one hour in length.

3. The local pharmacists association shall provide a method of registration and verification of attendance as outlined in II. D. above.

02-06-0003--lMPLEMENT1ON OF PHARMACY CONTINUING EDUCATION

A. The Board of Pharmacy adopts the accreditation guidelines set out by the Arkansas Tripartite Committee on Continuing Pharmacy Education for establishment of acceptable continuing education.

B. Thirty (30) hours of Continuing Education are required for the two (2)-year period 1997-1998. Effective January 1, 1999 the Board establishes the following Continuing Education (CE) requirements:

1. 15 hours of C.E. each calendar year.

2. A minimum of nine (9) of the fifteen (15) C.E. hours must be live contact hours as defined by the Committee. A minimum of six (6) of the nine (9) live contact hours must be concerning drug therapy or patient management. No more than six (6) hours of Continuing Education-in any year-may be obtained by attending any government Board Meeting; attending any Association Board Meeting; or answering questions from periodicals, audiotapes, videotapes, cable television, computer assisted instruction, or monographs.

C. The Arkansas State Board of Pharmacy will accept C.E. credits, approved by State Boards of Pharmacy in other states, toward licensure as a pharmacist in Arkansas provided that there is a reciprocal arrangement and that the requirements of III.B. are met.

D. Pharmacists are required to retain certificates of participation in Continuing Education for a period of two years and to certify completion of the required C.E., on a form furnished by the Board of Pharmacy with the annual license renewal forms. The pharmacist must present certificates of participation to any representative of the Board of Pharmacy if requested to do so.

E. Pharmacists who wish to retain their license, but do not want to meet the annual Continuing Education requirements, may go on inactive pharmacist status for an indefinite period. To reestablish active status and return to practice in Arkansas, a pharmacist must acquire half of the continuing education hours missed plus the continuing education hours for the current licensure year up to 60 hours. If the pharmacist has been on inactive status with regard to C.E. for two (2) calendar years or more and has not been actively practicing pharmacy in another state, said pharmacist shall also comply with all requirements in Regulation 53.

F. A licensed pharmacist may satisfy the continuing education requirement, as described in item III. B., by completing one or more programs in disease state management that has been approved by the Executive Director of the Arkansas State Board of Pharmacy. The program must document, by examination, the possession of related competency expectations adopted by the Arkansas State Board of Pharmacy. Said program would satisfy the continuing education requirement for the year in which the program is completed and the following year.

G. A licensed pharmacist, who has satisfactorily completed a Board of Pharmaceutical Specialties certification and received approval by the Board of Pharmacy, may receive credit for continuing education for the year in which the program is completed and the following year. 10/09/80 (Revised 4/07/89, 04/30/93 and 6/98)

03 - PHARMACY TECHNICIANS

03-00 -PHARMACY TECHNICIANS-REGISTRATION/PERMIT REQUIRED

03-00-0001 -DEFINITIONS:

A. PHARMACY TECHNICIAN: This term refers to those individuals identified as Pharmacist Assistants in Arkansas Code ? § 17-92-801. Pharmacy Technicians are those pharmacy personnel, exclusive of pharmacy interns, who are regular paid employees of the pharmacy or hospital and assist the pharmacist in pharmaceutical services.

B. SUPERVISION: Supervision means that the responsible pharmacist must be physically present to observe, direct, and supervise the pharmacy technician at all times when the pharmacy technician performs acts specified in this regulation. The supervising pharmacist is totally and absolutely responsible for the actions of the pharmacy technician.

03-00-0002 -REGISTRATION REQUIRED

A. A pharmacy technician shall register annually with the Board of Pharmacy on a form approved by the Board; and said registration shall expire on December 31 of each year.

B. The registration fee for a pharmacy technician shall be defined in Regulation 01-00-0007.

C. The Board will issue a permit for the pharmacy technician applicable to a specified pharmacy location; said permit cannot be transferred to any other pharmacy location. The permit shall be prominently displayed for public perusal in said pharmacy.

D. Prior to a person beginning work as a pharmacy technician the pharmacy technician shall submit an application to the Board office which shall issue a certificate of registration to the pharmacy technician and a permit for the pharmacy technician to work at the pharmacy designated on the application.

E. When a pharmacy technician leaves the employment of a pharmacy, the pharmacist-in-charge shall notify the Board, in writing, within fourteen (14) days thereof.

F. Any concurrent or subsequent employment at a pharmacy other than the pharmacy identified on the current permit, issued by the Board of Pharmacy, the pharmacist in charge of the pharmacy where the pharmacy technician will be working must notify the Board of pharmacy, in writing, of the exact date when the pharmacy technician will begin working. The pharmacy technician shall not work at that location until a permit has been received from the Board of Pharmacy for that pharmacy location.

G. A pharmacy technician shall identify himself as such in any telephone conversation regarding the functions of a pharmacy technician while on duty in the pharmacy.

H. If the pharmacy technician is suspected to have or evidence exists that a pharmacy technician may have violated any law or regulation regarding the practice of pharmacy, legend drugs or controlled substances, the pharmacist-in-charge shall notify the Board, in writing, within ten days or immediately if any danger to the public health or safety may exist. Any other pharmacist, whether or not practicing in the same pharmacy, who has such knowledge or suspicion, shall notify the Board in a like manner.

I.

(1) The Board may, after notice and hearing, suspend or revoke the permit of a pharmacy technician upon a finding of the following:

(a) Violation of this regulation.

(b) Violation of any law or regulation regarding the practice of pharmacy.

(c) Violation of any law or regulation related to legend drugs or controlled substances.

(2) The Board shall follow the same procedures for hearings for pharmacy technicians as applicable to hearings for pharmacists as set forth in A.C.A. ? § 17-92-101 et seq. and Board Regulations.

03-00-0003 -A PHARMACY TECHNICIAN SHALL:

A. Conduct himself professionally in conformity with all applicable federal, state, and municipal laws and regulations in his relationship with the public, health care professions, and pharmacists.

B. Hold to the strictest confidences all knowledge concerning patrons, their prescriptions, and other confidence entrusted or acquired by him; divulging in the interest of the patron, only by proper release forms, or where required for proper compliance with legal authority.

C. Provide valid and sufficient checks in payment for licenses or renewals.

03-00-0004 -QUALIFICATIONS

A. A high school graduate or a recognized graduate equivalency degree (G.E.D.).

B. Of good moral character and temperate habits.

C. If the pharmacy technician has a past record of alcohol or drug addiction or past record of violation of any law related to controlled substances, employment must be prior approved by the Board of Pharmacy.

D. Be a paid employee of a pharmacy.

03-00-0005 -TASKS, RESPONSIBILITIES, AND DUTIES OF THE PHARMACY TECHNICIAN

A pharmacy technician may assist the pharmacist in performing the following specific tasks in accordance with specified Policy and Procedures covering the areas described in this section. If the pharmacy technician performs any other task that is defined as the practice of pharmacy, it will be considered a violation.

A. Approved tasks:

(1) Placing, packing, pouring, or putting in a container for dispensing, sale, distribution, transfer possession of, vending, or barter any drug, medicine, poison, or chemical which, under the laws of the United States or the State of Arkansas, may be sold or dispensed only on the prescription of a practitioner authorized by law to prescribe drugs, medicines, poisons, or chemicals. This shall also include the adding of water for reconstitution of oral antibiotic liquids.

(2) Placing in or affixing upon any container described in Section IV(A) (1) of this Regulation a label required to be placed upon drugs, medicines, poisons, or chemicals sold or dispensed upon prescription of a practitioner authorized by law to prescribe those drugs, medicines, poisons, or chemicals.

(3) Selecting, taking from, and replacing upon shelves in the prescription department of a pharmacy or apothecary drugs, medicines, chemicals, or poisons which are required by the law of the United States or the State of Arkansas to be sold or dispensed only on prescription of a practitioner authorized by law to prescribe them.

(4) In a manual system - preparing, typing, or writing labels to be placed or affixed on any container described in ACA ? § 17-92-101(14) (A), which a label is required to be placed upon drugs, medicines, poisons, or chemicals sold or dispensed upon prescription of a practitioner authorized by law to prescribe those drugs, medicines, poisons, or chemicals.

In a computer system - a pharmacy technician may enter Information into the pharmacy computer. The pharmacy technician shall not make any judgement decisions which could affect patient care. The final verification of prescription information, entered into the computer, shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry.

(5) A pharmacy technician may obtain prescriber authorization for prescription refills provided that nothing about the prescription is changed.

(6) Prepackaging and labeling of multi-dose and unit-dose packages of medication. The pharmacist must establish the procedures, including selection of containers, labels and lot numbers, and must check the finished task.

(7) Dose picking for unit dose cart fill for a hospital or for a nursing home patient.

(8) Nursing unit checks in a hospital or nursing home: Pharmacy technicians may check nursing units for proper medication storage and other related floor stock medication issues. Any related medication storage problems or concerns shall be documented and initialed by a pharmacist.

(9) Patient and medication records.

The recording of patient or medication information in manual or electronic system for later validation by the pharmacist may be performed by pharmacy technicians.

(10) The pharmacy technician shall not make any judgement decisions which could effect patient care.

B. Additional tasks which can be performed in a Hospital setting:

(1) Bulk reconstitution of prefabricated non-injectable medication

(2) Bulk compounding. This category may include such items as sterile bulk solutions for small-volume injectables, sterile irrigating solutions, products prepared in relatively large volume for internal or external use by patients, and reagents or other products for the pharmacy or other departments of a hospital.

(3) Preparation of parenteral products.

a. The pharmacy technician must follow guidelines established by the pharmacist as directed in Section V of this regulation.

b. Pharmacy technicians may (1) perform functions involving reconstitution of single or multiple dosage units that are to be administered to a given patient as a unit and (2) perform functions involving the addition of one manufacturer's single dose or multiple unit doses of the same product to another manufacturer's prepared unit to be administered to a patient. Pharmacy technicians shall not add multiple ingredients in preparing parenteral products but may draw up or prepare the ingredients. The pharmacist must check the preparations and make the final addition.

03-00-0006 -DUTIES OF THE PHARMACIST IN THE USE OF PHARMACY TECHNICIANS

A. A pharmacy which utilizes a pharmacy technician to enter information into the pharmacy computer must develop and keep, on file at the pharmacy, written policy and procedures which describe the procedures by which the supervising pharmacist verifies the accuracy, validity, and appropriateness of the filled prescription or medication order. Written procedures for training and utilization of pharmacy technicians in the use of parenteral products and the check required of the pharmacy technicians must be included in the procedures if the pharmacy technician is performing these tasks.

B. The pharmacist shall include, in the Policy and Procedure Manual, the specific scope of responsibilities for pharmacy technicians or procedures delegated to pharmacy technicians.

C. The duties of pharmacy technicians in the preparation or processing of medication shall be accomplished under the immediate and direct supervision of the pharmacist who assumes the responsibility. The final check and verification of the medication dispensed shall be the responsibility of the pharmacist. The pharmacist is totally responsible for all aspects of the data and data entry.

D. The supervising pharmacist shall assure that the pharmacy technician maintains confidentiality of all patient records.

03-00-0007 -PHARMACIST TO PHARMACY TECHNICIAN RATIO:

A. Retail Pharmacy Setting:

(1) A pharmacy, with one pharmacist on duty, may utilize two pharmacy technicians to assist the pharmacist. Beyond two pharmacists, the maximum number of technicians at any given time is limited to a number equal to the number of pharmacists on duty in the pharmacy at that specific time with a limit of four (4) pharmacy technicians.

(2) While supervising one or two technician(s) the pharmacist shall not also supervise more than one student intern. A Graduate intern will not affect the ratio.

B. Hospital Setting:

(1) Pharmacy technicians used in assisting the pharmacist in pharmaceutical services for inpatients of the hospital shall be permitted to perform under direct supervision of a licensed pharmacist within the following conditions:

a. The number of supportive personnel employed by the Pharmacy Department shall not exceed a ratio of one pharmacy technician directly involved in medication distribution to each pharmacist on staff. The one to one ratio is governed by the number of employees and is not shift dependent. If the pharmacist in charge desires to use more than a one to one ratio on a certain shift, the hospital pharmacist in charge shall notify the Board of Pharmacy that the ratio on that shift exceeds one to one and include a brief summary of the duties now performed by the pharmacist with emphasis on counseling, quality assurance, drug utilization evaluation, education, and MD/RN interactions, etc.

The ratio shall not exceed two pharmacy technicians to one pharmacist on any one shift. This ratio shall not include pharmacy interns counted as either supportive personnel or pharmacists. Also excluded from the count of supportive personnel are those persons whose functions are not related to the preparation or distribution of medication. Such persons include clerks, secretaries, messengers, and delivery personnel. (8/23/96).

04 -PHARMACY

04-00: GENERAL REGULATIONS REGARDING PHARMACIES

04-00-0001 -EQUIPMENT SPECIFICATIONS

Minimum prescription equipment specifications as authorized by the Arkansas State Board of Pharmacy are:

1. Graduates capable of measuring from .1ml to at least 120ml.

2. Mortars and pestles-at least one (porcelain or glass).

3. Hot and cold running water in prescription department.

4. Spatulas.

5. Ointment slab or ointment papers.

6. Exempt narcotic record book.

7. Class III Balance and Weights.

8. Equipment for Labeling.

9. Pharmacy Library-Each pharmacy shall have:

(a) available for use by the pharmacist and use by the patient either current drug information manuals, or computer capability of printing current drug information for the pharmacist and patient drug information and monographs for patients, (i.e: The U.S.P. Dl 3 Book Set including "Drug Information for the Healthcare Professional" {2 Volumes} and "Advice for the Patient" {1 Volume}); or "Drug Facts and Comparisons" and "Patient Drug Facts")

(b) other pharmacy reference books and periodicals necessary for effective pharmacy practice. EXCEPTIONS: Pharmacies meeting the requirements of Regulation 04-02-0100 or Regulation 07-02-0001 shall be exempted from requirements of this Regulation when not applicable. (10/09/80) (Revised 6/25/83, 4/07/89, 6/07/90, and 8/20/97)

04-00-0002 -TIME REQUIRMENTS FOR PHARMACIST ON DUTY

All drugstores or pharmacies must have on duty an Arkansas Licensed Pharmacist a minimum of 40 hours per week. The said 40 hours per week must be served by a single person and cannot be met by a combination of weekly hours of two or more pharmacists with less than 40 hours each. 10/09/80 (Revised 10/14/81, and 6/20/91)

04-00-0002 -VENDING MACHINES

The sale of any legend drugs or medicines, by means of a coin operated vending machine is expressly prohibited. (10/09/80)

04-00-0003 -REUSE OF DRUGS PROHIBITED

The reuse of returned portions of a prescription drug for human consumption is prohibited whether dispensed by order of a prescription or otherwise. (10/09/80)

04-00-0004 -PICK UP STATIONS

No person, firm, or business establishment shall offer to the public, in any manner, their services as a "pick-up-station" or intermediary for the purpose of having prescriptions filled or delivered, whether for profit of gratuitously. Nor may the owner of any Pharmacy or Drug Store authorize any person, firm, or business establishment to act for them in this manner-provided however, intermediary delivery stations after approval by the Board may be operated in community owned an/or sponsored Clinics in which a physician is in attendance at least one day per week and located in an area where pharmaceutical services are unavailable within ten miles of the Clinic provided the filled prescriptions are delivered to a designated representative of the pharmacist filling the prescription. 10.09/80 (Revised 2/17/82)

04-00-0005 -EMERGENCY PHARMACY SERVICES:

Any pharmacy providing prescription drugs to one or more patients in a nursing home or other institution shall provide emergency prescription services for those patients and shall provide information to the nursing home or institution indicating how the pharmacists can be reached after pharmacy hours.

All pharmacies (other than hospital and institutional) who do not provide emergency drug services for non-institutionalized patients shall post a sign at least 8?½ by 11" with letters of at least inch stating "This pharmacy will not provide emergency prescription drugs when the pharmacy is closed." 6/25/83

04-01: PHARMACY PERMIT FEES

04-01-0001 -PERMIT FEES

Any person, corporation or partnership operating a pharmacy in this state desiring to continue such operation must pay a fee for a permit as established by law and/or regulation. If said fee is not paid on or before February 1st of any year, a penalty as defined in Regulation 01-00-0007 shall be levied for each month the pharmacy permit fee is delinquent. If said permit fee is unpaid by April 1st of any year, the licensed pharmacy shall be expunged from the records of the State Board of Pharmacy, and the owner and/or pharmacist in charge thereof shall, within thirty days, remove all drug signs and legally dispose of all prescription legend drugs. (10/9/80, amended 6/13/85, amended 6/20/91 & 8/23/96).

04-02: REGULATIONS REGARDING RETAIL PHARMACIES

04-02-4001 -APPLICATIONS FOR PHARMACY PERMITS

Licensed pharmacy permits will be considered by the Board staff upon written application in such forms as may be adopted by the Board. The permit will be issued in the name of the licensed pharmacist who shall be directly responsible to the Board of Pharmacy for the operation of the prescription department.

04-02-0002 -REQUIREMENTS FOR A NEW PHARMACY PERMIT

Applications for pharmacy permits other than annual renewal of existing permits, will be reviewed by the Board of Pharmacy Staff. Provided that no pharmacy may open for business within 30 days of submission of original application. Applications for a pharmacy permit for a new pharmacy must have the name and license number of the pharmacist in charge at the time of submission and cannot be altered except by submission of an application for change of pharmacist in charge and the fee as defined in Regulation 01-00-0007. The pharmacist in charge of the new pharmacy application cannot be the pharmacist in charge of another pharmacy at the time submission of the new pharmacy application. If a post office box is used as the address for the pharmacy, the actual street address must also be included on the application. The Executive Director may require that a representative of the ownership and pharmacist in charge appear before the Board of Pharmacy to finalize the application. After review by the Board of Pharmacy Staff, an "Inspection Request Form" will be sent to the address given as that of the ownership of the pharmacy making application. The inspection request form must be received in the Board of Pharmacy office at least one week before the facility will be ready for inspection. Upon approval of the inspection of the physical facility by the Board of Pharmacy Inspector, the Executive Director will complete the final approval of the application and the permit number will be issued.

04-02-0003 -LEASED OPERATIONS-PHARMACY IS A DEPARTMENT OF ANOTHER BUSINESS

A. In any building, firm, or place of business where the pharmacy is a leased operation, and/or in situations where the pharmacist in charge does not own a substantial part of the business and is not manager of the total operation, and/or where the pharmacy is a department in a larger business that is not a drugstore or pharmacy, the prescription department shall be completely separated from the remainder of the building by some type of partition and said department shall be arranged and constructed so that the public will not have access to any legend drugs or medicine.

B. The prescription area or department of any pharmacy, firm or place of business must be constructed so that it may be locked to prevent unauthorized persons from entering it in the absence of a licensed pharmacist, (or other authorized prescription personnel.)

C. A copy of the signed lease must be submitted with the application of the original permit, and at such other times as the original lease is changed or renewed.

04-02-0004 -NECESSARY EQUIPMENT REQUIRED

No pharmacy permit shall be issued or continued for the conduct of a pharmacy or drugstore unless the premises are equipped with the necessary appliances for maintenance of proper sanitation and kept in a clean, sanitary and orderly manner.

04-02-0005 -PHARMACIST IN CHARGE

A. Pharmacists, employed and in charge of pharmacies or drugstores, are required to notify the Board of Pharmacy and surrender for cancellation the permit issued in their names immediately upon the termination of such employment. It shall be the duty of the owner of such pharmacies or drugstores to immediately notify the Board upon the termination of employment of licensed pharmacists and to cause the surrender of permit as indicated. The further operation of the pharmacy or drugstore in the absence of a replacement and the issuance of a new permit is forbidden by law and each day so operated will be considered a separate offense.

B. When a licensed pharmacist in whose name a permit has been issued leaves the employment of such pharmacy or drugstore, he will be held responsible for proper notification to the Board of Pharmacy of such termination of his services within five days in addition to providing the Board of Pharmacy with an inventory of controlled drugs as defined in Regulation 04-02-0008. Neglect on his part to so notify the Board and to provide said inventory will operate to prevent his securing a permit to take charge or operate another pharmacy or drugstore at a subsequent date.

C. When the licensed pharmacist in whose name a permit has been issued to a pharmacy for any reason ceases to be actually the person who has responsible supervision over said pharmacy or drugstore the permit becomes void, and must be surrendered to the Board before a duplicate will be issued to said pharmacy. Where there is merely a change of licensed pharmacist one replacing the other as the pharmacist in charge, a duplicate permit will be issued upon proper application and payment of a fee as defined in Regulation 01-00-0007.

D. No pharmacy permit shall be issued to any drugstore or pharmacy when the licensed pharmacist in charge of the prescription department is not on duty in that pharmacy a minimum of 40 hours per week. A pharmacist in charge of a retail pharmacy may act as a consultant or part-time pharmacist.

E. The pharmacist in charge is responsible for the security and accountability of all drugs, legend and/or controlled, stored in said pharmacy and is responsible for the validity and legality of all prescriptions upon which drugs are dispensed . in said drugstore or pharmacy. Dispensing of drugs classified as controlled drugs under any of the schedules classifying drugs under either state or federal law governing controlled substances is the primary responsibility of the Pharmacist in Charge and is also the responsibility of such other pharmacist, interns or students as may have dispensed said drugs. In the event of a shortage of said drugs revealed by an accountability inventory of either federal or state agencies, the Pharmacist in Charge shall be held primarily responsible for such shortage and shall be subject to disciplinary action by the State Board of Pharmacy. Any other pharmacists, interns, or students causing or aiding or abetting the said unlawful shortage of said drugs shall also be subject to disciplinary action by the State Board of Pharmacy.

F. Any pharmacist, when making his or her initial application to be licensed as Pharmacist in Charge, must satisfactorily complete a test on the requirements and responsibilities of a Pharmacist in Charge. The test shall be developed and administered by the Board of Pharmacy or its representatives.

G. The Pharmacist in Charge named on any licensed pharmacy permit or pharmacist on call as designated by the Pharmacist in Charge, shall have immediate access to the pharmacy at all times and if requested by Board of Pharmacy Inspectors he/she shall show satisfactory proof of access.

04-02-0006 -PERMIT REQUIRED

The permit licenses the pharmacy or drugstore to which it is issued and is not transferable. It is issued on the application of the owner and the licensed pharmacist in charge, on the sworn statement that it will be conducted in accordance with the provisions of law.

A. Pharmacies or drugstores opening for business must first secure a permit and be licensed with the Board of Pharmacy before they may lawfully conduct a pharmacy or drugstore. A fee of as defined in Regulation 01-00-0007 is charged for issuing such original permit. AH pharmacies or drugstores must register with the Board annually and secure an annual permit and pay a Renewal fee as defined in Regulation 01-00-0007.

B. Permits must be posted in a conspicuous place. This requirement is not met when a permit is locked in a safe, placed in a desk drawer, or otherwise hidden away.

C. No pharmacy may open for business, nor may it be inspected for the purpose of obtaining a permit, prior to the approval by the Board.

04-02-0007 -CHANGE OF OWNERSHIP

A. Upon a change of ownership of a pharmacy as set out herein, a new permit shall be secured by the new owner(s). The new owner(s) can continue operation of the pharmacy for fourteen (14) days after the effective date of the change of ownership; after the said fourteen (14) day period, the permit issued to the prior owner shall be void and same shall be surrendered to the Executive Director of the Board of Pharmacy.

B. A change of ownership of a pharmacy occurs under, but is not limited to the following circumstances:

1. A change of ownership of a pharmacy, owned by a SOLE PROPRIETOR, is deemed to have occurred when:

a. The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy-which ever occurs first.

b. The proprietor enters into a partnership with another individual or business entity.

2. A change of ownership of a pharmacy, owned by a PARTNERSHIP, is deemed to have occurred when:

a. There is an addition or deletion of one or more partners in a partnership to which a pharmacy license has been issued.

b. The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy-which ever occurs first.

3. A change of ownership of a pharmacy, owned by a CORPORATION, is deemed to have occurred when:

a. An individual or business acquires or disposes of twenty percent (20%) or more of the corporation's outstanding shares of voting stock. (This shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over the counter market); or

b. The corporation merges with another business or corporation; (The corporation owning the pharmacy is required to notify the Arkansas State Board of Pharmacy if a change of ownership or merger occurs within the parent corporation of the corporation which owns the pharmacy); or

c. The corporation's charter expires or is forfeited; or

d. The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy-which ever occurs first.

The responsibility to assure compliance with this regulation rests both with the pharmacist and with the pharmacy owner if they are not the same. 10/09/80 (Revised 2/17/82, 6/13/85, 2/10/87,4/07/89, 6/20/91, and 6/23/96)

04-02-0008 -INVENTORY REQUIRED

A. When there is a change of pharmacy permit for a change of ownership of the pharmacy and the pharmacist in charge is changed, an inventory of ail drugs now or hereafter classified as Schedule 2, 3, 4, or 5, drugs under either Federal or State Statutes shall be made by the Pharmacist in Charge and a copy of that inventory signed by the Pharmacist in Charge shall be submitted with the application for change of ownership and the fee for change of ownership as defined in Regulation 01-00-0007. The inventory shall be made on the day the new owner takes charge of the pharmacy.

B. When there is a change of pharmacy permit for a change of pharmacist in charge, an inventory of all drugs now or hereafter classified as Schedule 2, 3, 4, or 5, drugs under either Federal or State Statutes will be made by the exiting pharmacist in charge and a copy of that inventory signed by said pharmacist shall be furnished to the Arkansas State Board of Pharmacy within seven days after the pharmacist's last day to work at the pharmacy and a copy left with the Controlled Substance Records of the Pharmacy. The new Pharmacist in Charge as his first action in the pharmacy shall also inventory all drugs now or hereafter classified as Schedule 2, 3, 4, or 5, drugs under Federal or State Statutes and a copy of that inventory signed by the new Pharmacist in Charge shall be provided to the Arkansas State Board of Pharmacy with the application to change the pharmacy permit's Pharmacist in Charge.

C. It is acceptable and preferable if the inventory is made jointly by both pharmacists, signed by both pharmacists, and supplied to the Arkansas State Board of Pharmacy with the application for change of Pharmacist in Charge.

D. Both copies of said inventory (exiting pharmacist and new pharmacist) must be received by the Board before a new permit will be issued. 10/09/83 (Revised 6/25/80 and 6/20/96)

04-02-0009 -OWNER'S RESPONSIBILITY- PHARMACIST IS LICENSED

No owner or owners of a drugstore, apothecary, pharmacy, etc., should allow any of its employees to profess to the public in any manner that they are a licensed pharmacist when they are not licensed. (10/9/80, amended (6/20/91).

04-02-0010 -REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD KEEPING SYSTEMS IN PHARMACIES HOLDING PHARMACY PERMITS

A. These regulations shall be construed, if possible, so as not to be violative of or in conflict with any federal regulation or requirement and if any part hereof is held invalid because of such conflict such invalidity shall not affect other provisions or applications of these regulations which can be given effect without the invalid provisions and to this end, the provisions of these regulations are declared severable. In any event D.E.A. permission to use Electronic Data Processing record keeping systems must be obtained.

B. The Arkansas State Board of Pharmacy must approve system prior to implementation.

C. Input of drug information into system may be performed only by a pharmacist or pharmacy technician under the supervision of a pharmacist. The final verification of prescription information, into the computer, shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry. Any judgmental decision concerning patient utilization of drugs must be performed by a pharmacist.

D. The original prescription order must be numbered, dated, initialed or signed by dispensing pharmacist at the time of the first filling of the prescription order and filed according to regulation.

E. Any electronic data processing system must be capable of the following:

1. Must provide on-line retrieval (CRT or hard copy) of original prescription order information.

This shall include, but not be limited to, the following:

a. Original prescription order number, date filled; full name and address of patient; name, address and DEA number (if applicable) of practitioner.

b. Trade name (or generic name and manufacturer's name), strength, dosage form and quantity of drug dispensed.

c. Number of authorized refills or, if not refutable, it must be so indicated.

2. Must provide on-line retrieval (CRT or hard copy) of refill history of each prescription order to include in addition to information in parts a and b, subsection 1 above, but not limited to the following:

a. Initials or code designation of dispensing pharmacist for each refill.

b. Date refilled.

c. Number of authorized refills remaining.

3. Daily Hard Copy

A. Must provide daily hard copy printout of each day's prescription order activity to include but not limited to the following:

a. Date of record.

b. Prescription order number, patient's name, name of drug, quantity dispensed and dosage form of drug, practitioner's name and DEA number (if applicable), and dispensing pharmacist's designation or initials on each prescription.

c. Above record shall be verified and signed by each pharmacist each day who has filled or refilled one or more prescriptions.

The signature should appear at the end of the printout and it signifies that the pharmacist has reviewed the printout and accepts the responsibility for any prescription with his or her designation or initials on it.

d. Daily log may be replaced by monthly log containing same information. This information must be maintained at pharmacy for a period of two years.

e. Any pharmacy employing a computerized system must have above printout in its possession in 48 hours.

f. Any electronic data processing system must also assure strict confidentiality of patient records.

g. All required information must be entered on the records of all prescription orders filled at the pharmacy including non-refillable prescriptions.

h. Must be capable of producing a patient profile (CRT or hard copy) indicating all drugs being taken and dates of refills for the patient.

i. A pharmacy shall make arrangements with supplier of data processing services or materials to assure continuing adequate and complete prescription orders and dispensing records. If for any reason the relationship with said supplier terminates, the pharmacy shall assure the continuity of records.

j. Registrants holding a Hospital Pharmaceutical Services Permit shall comply with Regulation No. 04-02-0010 "Regulating the use of electronic data processing in lieu of present record keeping systems in Hospital Pharmacies holding Hospital Pharmacy Permits."

In lieu of signing a daily hard copy printout, the pharmacist in charge of the pharmacy may maintain a bound log book in which an individual pharmacist involved in such dispensing may sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed by him and is correct as shown. The log should identify the time of day at which the pharmacist started filling prescriptions and the time of day at which the pharmacist stopped filling prescriptions. Said log book shall be maintained, by the pharmacist in charge or his successor, in the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized prescription. The pharmacy must still provide a daily hard copy printout of each day's prescription order activity as described in 33. E. 3. (A) above.

4. Must be capable of providing a refill-by-refill audit trail for any specific strength and dosage form of any drug in the system to contain but not limited to the following:

a. Practitioner's name.

b. Name and address of patient .

c. Name of drug (must include manufacturer's name if generic name used).

d. Quantity dispensed on original and each refill.

e. Prescription order number.

f. Initials or code designation of dispensing pharmacist on original and each refill.

g. Date of original and each refill.

h. Above printout must be made available within 48 hours after authorized request.

5. If the pharmacy closes, the pharmacist in charge, at the date of closing, shall store said records and within 14 days of closing shall notify the Board of Pharmacy where said records are located. A hard copy printout of any daily log(s) shall be produced and made available to the Board on its request and to any other person authorized by law to examine or receive copies of prescription records.

6. In event of computer breakdown (down time), the pharmacy must have an approved auxiliary record keeping system. This system must contain all necessary information to insure prompt data entry into system as soon as computer is available. 10/09/80 (Revised 6/19/97)

04-02-0100 -NUCLEAR PHARMACY

The practice of nuclear pharmacy is hereby recognized as a specialty of pharmacy practice regulated by the Arkansas State Board of Pharmacy. As such, the following rules are included to address those areas specific or unique to this specialty practice. These regulations are intended to supplement the regulations of other state and federal agencies.

I. Definitions:

A. "Authentication of Product History"-Identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.

B. "Nuclear Pharmacy"-A pharmacy which provides radiopharmaceutical services, and shall be licensed by the Arkansas State Board of Pharmacy.

C. "Practice of Nuclear Pharmacy"-A patient-oriented service that embodies the scientific knowledge and professional judgement required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.

D. "Qualified Nuclear Pharmacist"-A pharmacist who holds a current license issued by the Board of Pharmacy, and who is certified as a Nuclear Pharmacist by a Certification Board recognized by the Arkansas State Board of Pharmacy, or satisfies each of the following requirements:

1. Meets minimal standards of training for status as an authorized user of radioactive material, as specified by the Arkansas Department of Health, Division of Radiation Control and Emergency Management of the Nuclear Regulatory Commission.

2. Has successfully completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a College of Pharmacy approved by the Arkansas State Board of Pharmacy, or other training program recognized by the Arkansas State Board of Pharmacy, with the minimum 200 hours apportioned as follows:

a. Radiation Physics and Instrumentation

b. Radiation Protection

c. Mathematics pertaining to the use and measurement of radioactivity

d. Radiation Biology

e. Radiopharmaceutical Chemistry

3. Has attained a minimum of 500 hours of clinical/practical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in, but not limited to, the following areas:

a. Procuring radioactive materials

b. Compounding radiopharmaceuticals

c. Performing routine quality control procedures

d. Dispensing radiopharmaceuticals

e. Distributing radiopharmaceuticals

f. Implementing basic radiation protection procedures

g. Consulting and educating the nuclear medicine community, pharmacists, other health professionals, and the general public.

4. Has submitted an affidavit of experience and training to the Board of Pharmacy.

E. "Quality Assurance Procedures"-All activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies.

F. "Quality Control Testing"-The performance of chemical, biological and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.

G. "Radiopharmaceutical"-Any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but which does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term also includes any biological product, which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

H. "Radiopharmaceutical Services"-The procurement, storage, handling, compounding, preparation, labeling, quality control testing, dispensing, distribution, transfer, record keeping, and disposal of radiochemicals, radiopharmaceuticals, and ancillary drugs, and also includes quality assurance procedures, radiological health activities, and consulting activities associated with the use of radiopharmaceuticals, health physics, and any other activities required for provision of pharmaceutical care.

II. General Requirements for Pharmacies Providing Radiopharmaceutical Services

A. A permit to operate a nuclear pharmacy, providing radiopharmaceutical services, shall only be issued to a facility employing a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs shall be under the direct supervision of a qualified nuclear pharmacist, who shall be in personal attendance when the nuclear pharmacy is open for business. The pharmacist-in-charge shall be responsible for all operations of the nuclear pharmacy.

B. The permit to operate a nuclear pharmacy is effective only so long as the nuclear pharmacy also holds a current Arkansas Department of Health or Nuclear Regulatory Commission license.

C. Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided. All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas: radiopharmaceutica! preparation/dispensing area; radioactive material shipping/receiving area; radioactive material storage area; and radioactive waste decay area. The application for a permit to operate a nuclear pharmacy shall include detailed floor plans and no material change may be made without the permission of the Board.

D. The nuclear pharmacy professional service area shall be secured from unauthorized personnel and must be totally enclosed and lockable.

E. Nuclear pharmacies shall maintain records of acquisition, inventory and disposition of all radioactive materials in accordance with Board and Arkansas Department of Health or Nuclear Regulatory Commission statutes and regulations.

F. Nuclear pharmacies shall compound and dispense radiopharmaceuticals in accordance with accepted standards of radiopharmaceutical quality assurance. The Board of Pharmacy recognizes that the preparation of radiopharmaceuticals involves the compounding skills of the nuclear pharmacist to assure that the final drug product meets accepted professional standards.

G. A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Arkansas Department of Health or Nuclear Regulatory Commission to possess, use, and administer such drug. Radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.

H. A nuclear pharmacy, upon receipt of an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing, or recorded in a data processing system, which writing or record shall contain at least the following:

1. the name of the institution and prescriber, or prescriber's agent;

2. the date of dispensing and the calibration time of the radiopharmaceutical;

3. the name of the procedure;

4. the name of the radiopharmaceutical;

5. the dose or quantity of the radiopharmaceutical;

6. the serial number assigned to the order for the radiopharmaceutical;

7. any specific instructions;

8. the initials of the person who dispensed the order.

Orders for routine diagnostic radiopharmaceuticals, which have been previously established by the nuclear pharmacist with the physician, may be taken by a pharmacy technician and entered into the computer. The nuclear pharmacist shall verify the label with the written order. However, whenever an order is for a therapeutic or blood-product radiopharmaceutical, the prescription order must be received by a nuclear pharmacist and the patient's name must be obtained and recorded prior to dispensing.

I. The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

1. the name and address of the pharmacy;

2. the name of the prescriber;

3. the date of dispensing;

4. the serial number assigned to the order for the radiopharmaceutical;

5. the standard radiation symbol;

6. the words "Caution Radioactive Material";

7. the name of the procedure;

8. the radionuclide and chemical form;

9. the amount of radioactivity and the calibration date and time;

10. if a liquid, the volume;

11. if a solid, the number of items or weight;

12. if a gas, the number of ampoules or vials;

13. molybdenum 99 content to USP limits; and

14. the name of the patient or the words "Per Physician's Order" in the absence of a patient name. The requirements of this sub-section shall be met when the name of the patient is readily retrievable from the physician upon demand.

When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label prior to dispensing.

J. The immediate inner container label of a radiopharmaceutical to be dispensed shall be labeled with:

1. the standard radiation symbol;

2. the words "Caution Radioactive Material";

3. the identity of the radionuclide;

4. the chemical form;

5. the name of the procedure; and

6. serial number of the radiopharmaceutical.

I. When a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application (IND), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, a copy of the Institutional Review Board approval form (or letter), and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

J. Each nuclear pharmacy shall have a current copy of state and applicable federal regulations governing the safe storage, handling, use, dispensing, transport, and disposal of radiopharmaceuticals.

III. MINIMUM EQUIPMENT:

The professional area of the pharmacy shall have the following equipment:

A. Radionuclide Dose Calibrator;

B. Refrigerator;

C. Single or multiple channel scintillation counter with well-type Nal(Tl) or Ge(Li) detector;

D. Radiochemical fume hood and filter system with suitable air sampling equipment;

E. At least two GM survey meters (including one high-range meter);

F. Microscope and hemacytometer;

G. Supplies to perform quality assurance testing;

H. Syringe and vial radiation shields;

I. Lead-shielded drawing station;

J. Decontamination supplies;

K. Supplies to perform quality assurance testing;

L. Lead transport shields for syringes and vials; and

M. D.O.T. approved USA Type A, 7A approved transport containers and other labels and supplies for shipping radioactive materials. (10/14/98)

04-04: OUT OF STATE PHARMACIES

04-04-0001 -OUT OF STATE PHARMACY REGULATION

Out-of-State Pharmacies shall comply with the following qualifications to be and remain licensed in Arkansas by the Board.

1.

A. The pharmacy holds a current license in good standing in the state(s) in which it is located.

B. Each pharmacist dispensing drugs into Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he practices if that state has standards of licensure at least equivalent to those of Arkansas.

2. A pharmacist licensed in Arkansas or by the state where he practices having standards of licensure at least equivalent to Arkansas standards shall be named in the application as the pharmacy's contact person for communications by the Board.

A. That pharmacist will be responsible for receiving and maintaining publications distributed by the Board.

B. If at anytime the pharmacist so designated shall leave the employment of the pharmacy or be absent from the pharmacy in excess of 14 consecutive calendar days, the pharmacy shall promptly notify the Board and designate another pharmacist to perform this function.

3. The Out-of-State Pharmacy shall apply for licensure and renewal on forms approved by the Board. The Board may require such information as reasonably necessary to carry out the provisions of A.C.A. ? § 17-92-401, including, without limitation, the name, address and position of each officer and director of a corporation or of the owners if the pharmacy is not a corporation.

Provided, however, the Board may grant an exemption from licensing under A.C.A. ? § 17-92-401 upon application by any non-resident pharmacy which confines its dispensing activity to isolated transactions. In determining whether to grant an exemption, the Board shall consider:

(a) The number of prescriptions dispensed or reasonably expected to be dispensed into Arkansas.

(b) The number of patients served or reasonably expected to be served in Arkansas.

(c) Whether the pharmacy has promoted its services in Arkansas.

(d) Whether the pharmacy has a contract(s) with any employer(s) or organization(s) to provide pharmacy services to employees or other beneficiaries in Arkansas.

(e) Medical necessity.

(f) The effect on the health and welfare of persons in Arkansas.

(g) Any other relevant matters.

4. The pharmacy shall pay an annual license fee as defined in Regulation 01-00-0007.

5. The pharmacy shall maintain records of drugs dispensed to Arkansas addresses in such a manner so as to be readily retrievable upon request. Said records shall be made available for inspection by the Board or by Arkansas law enforcement authorities.

6. The pharmacy shall timely respond to any request for information from the Board or law enforcement authorities.

7. The pharmacy shall maintain an incoming toll free telephone number for use by Arkansas customers to be answered by a pharmacist with access to patient records. This service shall be available a minimum of 40 hours a week, six days per week during normal business hours. This telephone number plus others available for use shall be printed on each container of drugs dispensed into Arkansas. The toll free number shall have sufficient extensions to provide reasonable access to incoming callers.

8. Generic drugs shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution Act; provided, however, nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with the Arkansas Generic Substitution Act if such compliance would cause the Out-of-State Pharmacy to violate the Generic Substitution Act of the state wherein the facility of the dispensing Out-of-State Pharmacy is located.

9. The facilities and records of the pharmacy shall be subject to inspection by the Board: provided, however, the Board may accept in lieu thereof satisfactory inspection reports by the licensing entity using similar standards of the state where the pharmacy is located.

10. Each Out-of-State Pharmacy doing business in Arkansas by dispensing and delivering or causing to be delivered prescription drugs to Arkansas consumers shall designate a resident agent in Arkansas for service of process.

11. Each Out-of-State Pharmacy doing business in Arkansas shall comply with Board of Pharmacy Regulation # 09-00-0001 (Patient Information, Drug Use Evaluation, and Patient Counseling).

Nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with Board Regulation # 09-00-001 if such compliance would cause the Out-of-State Pharmacy to violate law or regulation of the state wherein the facility of the dispensing Out-of-State Pharmacy is located. 10/09/90 (Revised 04/10/92, and 6/23/96, and 8/23/96).

04-05: REGULATIONS REGARDING HOSPITAL PHARMACIES

04-05-0001 -HOSPITAL PHARMACEUTICAL SERVICES PERMIT

1. Any pharmacist practicing in an Arkansas Hospital, must so notify the Board of Pharmacy and ascertain that a Hospital Pharmaceutical Services Permit has been issued. The Hospital Pharmaceutical Services Permit shall be issued in the name of the Hospital, showing a pharmacist in charge.

2. Any hospital holding a retail pharmacy permit as of February 15,1975, upon application for renewal must separate the facilities, stocks, records, etc., in compliance with A.C.A. 17-92-403 -- 17-92-405.

All hospitals shall have adequate provisions for pharmaceutical services regarding the procurement, storage, distribution, and control of all medications. All federal and state regulations shall be complied with.

A. DEFINITIONS:

1. "Hospital Pharmacy" means the place or places in which drugs, chemicals, medicines, prescriptions, or poisons are prepared for distribution and administration for the use and/or benefit of patients in a hospital licensed by the Arkansas Department of Health.

The Hospital Pharmacy shall also mean the place or places in which drugs, chemicals, medicines, prescriptions or poisons are compounded for the dispensing to hospital employees, members of the immediate families of hospital employees, patients being discharged, and other persons in emergency situations.

Hospital Pharmacy shall also mean the provision of pharmaceutical services as defined in the Pharmacy Practice Act by a pharmacist to a patient of the hospital.

2. "Hospital Employee" means any individual employed by the hospital whose compensation for services or labor actually performed for a hospital is reflected on the payroll records of a hospital.

3. "Qualified Hospital Personnel" means persons other than Licensed Pharmacists who perform duties in conjunction with the overall hospital pharmaceutical services for inpatients.

4. "Licensed Pharmacist" means any person licensed to practice pharmacy by the Arkansas State Board of Pharmacy who provides pharmaceutical services as defined in the Pharmacy Practice Act to patients of the hospital.

5;. "Unit Dose Distribution System" is a pharmacy-coordinated method of dispensing and controlling medications in hospitals in which medication are dispensed in single unit packages for a specific patient on orders of a physician where not more than 24-hour supply of said medications is dispensed, delivered, or available to the patient.

6. Unit Dose Distribution System" is a system that meets the requirement of a "Unit Dose Distribution System," provided that up to a 72-hour supply may be sent to the floor once a week if the system has been reviewed and approved administratively by the Board of Pharmacy.

B. COMPOUNDING, DISPENSING, AND DISTRIBUTING

1. Compounding-The act of selecting, mixing, combining, measuring, counting, or otherwise preparing a drug or medication.

2. Dispensing-A function restricted to licensed pharmacists which involves the issuance of:

(a) one or more doses of a medication in containers other than the original, with such new containers being properly labeled by the dispenser as to content and/or directions for use as directed by the prescriber;

(b) medication in its original container with a pharmacy prepared label that carries to the patient the directions of the prescriber as well as other vital information;

(c) a package carrying a label prepared for nursing station use. The contents of the container may be for one patient (individual prescription) or for several patients (such as a nursing station medication container).

3. Distributing-Distributing, in the context of this regulation, refers to the movement of a medication from a central point to a nursing station medication center. The medication must be in the original labeled manufacturer's container or in a prepackaged container labeled according to Federal and State statutes and regulations, by a pharmacist or under his direct and immediate supervision.

C. ADMINISTERING

An act, restricted to nursing personnel as defined in Nurses Practice Act 43 of 1971, in which a single dose of a prescribed drug or biological is given a patient. This activity includes the removal of the dose from a previously dispensed, properly labeled container, verifying it with the prescriber's orders, giving the individual dose to the proper patient and recording the time and dose given.

D. PHARMACY AND THERAPEUTICS COMMITTEE

There is a committee of the medical staff to confer with the pharmacist in the formulation of policies, explained as follows:

1. A pharmacy and therapeutics committee (P & T Committee), composed of a least one physician, the administrator or representative, the director of nursing service or representative, and the pharmacist is established in the hospital. It represents the organizational line of communication and the liaison between the medical staff and the pharmacist.

2. The committee assists in the formation of broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, and safety procedures, and all other matters relating to drugs in hospitals.

3. The committee performs the following specific functions:

a. Serves as an advisory group to the hospital medical staff and the pharmacist on matters pertaining to the choice drugs.

b. Develops and reviews periodically a formulary or drug list for use in the hospital;

c. Establishes standards concerning the use and control of investigational drugs and research in the use of recognized drugs;

d. Evaluates clinical data concerning new drugs or preparations requested for use in the hospital;

e. Makes recommendations concerning drugs to be stocked on the nursing unit floors and emergency drug stocks;

f. Prevents unnecessary duplication in stocking drugs and drugs in combination having identical amounts of the same therapeutic ingredients.

4. The committee meets at least quarterly and reports to the medical staff by written report.

E. PHARMACY OPERATIONS

The hospital has a pharmacy directed by a licensed pharmacist. The Pharmacy is administered in accordance with accepted professional principles.

1. Pharmacy Supervision

There is a pharmacy directed by a licensed pharmacist, defined as follows:

a. The Director of Pharmacy is trained in the specialized functions of hospital pharmacy.

b. The Director of Pharmacy is responsible to the administration of the hospital and the Board of Pharmacy for developing, supervising, and coordinating all the activities of the pharmacy department and all pharmacists providing professional services in the Hospital.

c. All licensed pharmacists who provide pharmaceutical services as defined by the Pharmacy Practice Act shall practice under policies, procedures, and protocols approved by the Director of Pharmacy. These policies, procedures, and protocols shall be subject to review and approval by the Board of Pharmacy.

F. PHYSICAL FACILITIES

Facilities are provided for the storage, safeguarding, preparation, and dispensing of drugs, defined as follows:

1. Drugs are issued to floor units in accordance with approved policies and procedures.

2. Drug cabinets on the nursing units are routinely checked by the pharmacist. All floor stocks are properly controlled.

3. A careful determination of the functions of a department will regulate he space to be allocated, the equipment necessary to carry out the functions, and the number of personnel required to utilize the equipment and to render a given volume of service, as these functions relate to the frequency or intensity of each function or activity. Adequate equipment should specifically relate to services rendered and functions performed by the hospital pharmacy. Equipment lists will relate to the following services and functions:

a. Medication preparation;

b. Library reference facilities;

c. Record and office procedures;

d. Sterile product manufacturing;

e. Bulk compounding (manufacturing);

f. Product control (assay, sterility testing, etc.);

g. Product development and special formulations for medical staff.

4. Equipment and supplies necessary to the hospital pharmacy's safe, efficient and economical operation shall include but not be limited to:

a. Graduates capable of measuring from 0.1 ml. up to at least 500ml.

b. Mortars and pestles.

c. Hot and cold running water.

d. Spatulas (steel and non-metallic).

e. Funnels.

f. Stirring rods.

g. Class A balance and appropriate weights,

h. Typewriter, or other label printer.

i. Suitable apparatus for production of small-volume sterile

k. Suitable containers and labels.

I. Adequate reference library to include at least the following:

1) American Hospital Formulary Service.

2) Pharmacology text.

3) Each hospital pharmacy shall have available for personal and patient use a current copy of the U.S.P. Dl 3 book set including "Drug Information for the Healthcare Professional" (2 volumes) and "Advice for the Patient" (1 volume), or the two volume set "Facts and Comparisons" (1 volume) and "Patient Drug Facts" (1 volume).

4) Text on compatibility of parenteral products.

5) Current professional journals, such as:

(a) Drug Intelligence and Clinical Pharmacy

(b) Hospital Pharmacy.

(c) Journal of ASHP.

5. Special locked storage space is provided to meet the legal requirements for storage of controlled drugs, alcohol, and other prescribed drugs.

G. PERSONNEL

Personnel competent in their respective duties are provided in keeping with size and activity of the department, explained as follows:

1. The Director of Pharmacy is assisted by an adequate number of additional licensed pharmacists and such other personnel as the activities of the pharmacy may require to insure quality pharmaceutical services.

2. The pharmacy, depending upon the size and scope of its operations, is staffed by the following categories of personnel:

a. Chief Pharmacist (Director of Pharmacy).

b. One or more assistant chief pharmacists (Assistant Director of Pharmacy).

c. Staff pharmacists.

d. Pharmacy residents (where program has been activated).

e. Trained non-professional pharmacy helpers (qualified hospital personnel).

f. Clerical help.

H. EMERGENCY PHARMACEUTICAL SERVICES

Through the administrator of the hospital, the P & T Committee shall establish policies and procedures that include, but are not limited to the following:

1. Upon admission to the Emergency Room on an outpatient basis and when examined by the physician where medications are prescribed to be administered, a record must be kept on file in the Emergency Room admission book or a copy of the Emergency Room medication order must be kept by the pharmacist to be readily accessible, for control and other purposes, as required by these regulations.

2. If the physician wishes the patient to have medication to be taken with them from the Emergency Room Supplies, the amounts to be taken shall be sufficient to last until medication may be obtained by local pharmacies, in any case not to exceed a 48-hour supply. AH State and Federal laws must be observed concerning all records, labeling, and outpatient dispensing requirement.

3. Take home prescriptions for anti-infectives issued to patients at the time of discharge from the emergency room, filled by a pharmacist, shall be quantities consistent with the medical needs of the patient.

I. PHARMACY RECORDS AND LABELING

Records are kept of the transactions of the pharmacy and correlated with other hospital records where indicated. All medication shall be properly labeled. Such record and labeling requirements are as follows:

1. The pharmacy establishes and maintains, in cooperation with the accounting department, a satisfactory system of records and bookkeeping in accordance with the policies of the hospital for:

a. Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies, and

b. Charging patients for drugs and pharmaceutical supplies.

2. A record of procurement and dispersement of all controlled drugs is maintained in such a manner that the disposition of any particular item may be readily traced.

3. The pharmacist shall receive and provide service pursuant to the perusal of the physician's original order or a direct copy thereof, except in emergency situations wherein the pharmacist may provide service pursuant to a verbal order or to an oral or written transcription of the physician's order provided that the pharmacist shall receive and review the original or direct copy within twenty-four (24) hours of the time the service is provided.

4. A record shall be maintained by the pharmacy and stored separately from other hospital records for each patient (inpatient or outpatient) containing the name of the patient, the prescribing physician, the name and strength of drugs prescribed, the name and manufacturer (or trademark) of medication dispensed.

5. The label of each medication container prepared for administration to inpatients, shall bear the name and strength of the medication, the expiration date, and the lot and control number. The label on the medication, or the container into which the labeled medication is placed must bear the name of the patient.

6. The label of each outpatient's individual prescription medication container bears the name of the patient, prescribing physician, directions for use, the name and strength of the medication dispensed (unless directed otherwise by the physician).

J. CONTROL OF TOXIC OR DANGEROUS DRUGS

Policies are established to control the administration of toxic or dangerous drugs with specific reference to the duration of the order and the dosage, explained as follows:

1. The medical staff has established a written policy that all toxic or dangerous medications not specifically prescribed as to time or number of doses, will be automatically stopped after a reasonable time limit set by the staff.

2. The classifications ordinarily thought of as toxic or dangerous drugs are controlled sub-stances, anticoagulants, antibiotics, oxytocics, and cortisone products.

3. All deteriorated non-sterile, non-labeled or damaged medication shall be destroyed by the pharmacist, except on controlled drugs, as defined below.

a. All controlled drugs (Schedule II, 111, IV, and V) should be listed and a copy sent, along with drugs to the Arkansas Department of Health by registered mail or delivered in person for disposition.

K. DRUGS TO BE DISPENSED

Therapeutic ingredients of medications dispensed are included (or approved for inclusion) in the United States Pharmacopoeia, N.F. and U.S. Homeopathic Pharmacopoeia, or Accepted Dental Remedies (except for any drugs unfavorably evaluated therein) and drugs\ approved by provisions of the Arkansas Act 436 of 1975, or are approved for use by theP & T Committee of the hospital staff, explained as follows:

1. The pharmacist, with the advice and guidance of the P & T Committee, is responsible for specifications as to quality, quantity, and source of supply of all drugs.

2. There is available a formulary or list of drugs accepted for use in the hospital which is developed and amended at regular intervals by the P & T Committee with the cooperation of the pharmacist and the administration.

L. POLICY AND PROCEDURE MANUAL

1. A Policy and Procedure Manual pertaining to the operations of the Hospital Pharmacy with updated revisions adopted by the P. & T Committee of each hospital shall be prepared and maintained at the hospital.

2. The Policy and Procedure Manual should include at a minimum the following:

a. Provisions for procurement, storage, distribution and drug control for all aspects of pharmaceutical services in the hospital.

b. Specialized areas such as surgery, delivery, ICU and CCU units and emergency room stock and usage of medication shall be specifically outlined.

c. A system of requisitioning supplies and medications for nurses stations stock shall be in written procedural form as to limits of medications to be stocked in each nursing unit.

d. Detailed job descriptions and duties of each employee by job title working in the Pharmacy Department must be developed and made a part of these policies and procedures.

e. The Pharmacy Policy and Procedure Manual shall be subject to review and approval by the Board of Pharmacy on request from the Board.

M. EMPLOYEE PRESCRIPTION MEDICATION

1. There will be a prescription on file for all prescription drugs dispensed to hospital employees and their immediate families. These records will be kept separate from all inpatient records.

2. The only person(s) entitled to have employee prescriptions filled will be the employee listed on the hospital payroll and members of their immediate family.

N. PATIENT DISCHARGE MEDICATION

Any take-home prescription dispensed to patients at time of discharge from the hospital shall be for drugs and quantities consistent with the immediate medical needs of the patient.

O. LICENSED PHARMACIST PERSONNEL REQUIREMENTS

1. The minimum requirements for licensed pharmacists in hospitals is:

a. A general hospital, surgery and general medical care maternal

b. and general medical care hospital, chronic disease hospitals, psychiatric hospitals, and rehabilitative facilities with average annual occupied beds greater than 75, as determined by institution's patient occupancy record, shall require the services of one (1) pharmacist on the basis of 40 hours per week, with such additional pharmacists as are necessary, in the opinion of the Arkansas State Board of Pharmacy, to perform required pharmacy duties as are necessary in keeping with the size and scope of the services of the hospital pharmacy's safe, efficient, and economical operation.

c. The above classified hospitals, with average annual occupied beds less than 75, as determined by institution's patient occupancy records, shall require the services of a pharmacist such hours as, in the opinion of the Arkansas State Board of Pharmacy and the Arkansas State Board of Health, are necessary to perform required pharmacy duties in keeping with the size and scope of the services of the hospital pharmacy's safe, efficient, and economical operation,

d. Recuperative Centers, Outpatient Surgery Centers, and Infirmaries

1) If the infirmary, recuperative center or outpatient surgery center has a pharmacy department, a licensed pharmacist must be employed to administer the pharmacy in accordance with all state and federal laws regarding drugs and drug control.

2) If the infirmary, recuperative center, or outpatient surgery center does not have a pharmacy department, it has provisions for promptly and conveniently obtaining prescribed drugs and biologicals from a community or institutional pharmacy.

3) If the infirmary, recuperative center, or outpatient surgery center does not have a pharmacy department, but does maintain a supply of drugs, a licensed pharmacist shall be responsible for the control of all bulk drugs and maintain records of their receipt and disposition. The pharmacist shall dispense drugs from the drug supply, properly labeled, and make them available to appropriate nursing personnel.

4) All medication for patients shall be on individual prescription basis.

P. RESPONSIBILITY OF A PHARMACIST IN HOSPITAL PHARMACY

1. The pharmacist is responsible for the control of all medications distributed in the hospital where he practices, and for the proper provision of all pharmaceutical services.

2. The following aspects of medication distribution and pharmaceutical service are functions involving professional evaluations of judgements and may not be performed by supportive personnel:

a. Selection of the brand and supplier of medication.

b. Interpretation and certification of the medication order. This involves a number of professional responsibilities such as the determination of:

1) Accuracy and appropriateness of dose and dosage schedule.

2) Such items as possible drug interactions, medication sensitivities of the patient and chemical and therapeutic incompatibilities.

3) Accuracy of entry of medication order to patient's medication profile.

c. Final certification of the prepared medication.

Q. OPERATION OF PHARMACY DEPARTMENT WITHOUT A PHARMACIST

At no time will the hospital pharmacy be open and in operation unless a licensed pharmacist is physically present except:

a. Entrance may be obtained for emergency medication as set forth in the Pharmacy Policy and Procedure Manual when the pharmacy is closed outside its normal operation hours.

b. When the pharmacist is summoned away from the pharmacy and there are other qualified personnel left in the pharmacy, the personnel left in the pharmacy could perform only those functions authorized within this regulation.

R. THE AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS, GUIDELINES

The American Society of Health-System Pharmacists1 most recent statement on hospital drug control systems and Guidelines for Institutional Use of Controlled Substances shall be required reading by hospital pharmacists. (Revised 6/25/83, 4/7/89, 6/15/95)

04-05-0002 -MECHANICAL STORAGE AND DELIVERY

Hospitals using mechanical storage and delivery machines for Legend Drugs must secure a Hospital Pharmaceutical Services Permit, and such machines shall be stocked only by a Licensed Pharmacist under such permit. Drugs may be obtained from such machines only by a physician or registered or licensed professional nurse or student nurse, or an intern or resident physician or a licensed pharmacist acting under the prescribed rules of safety procedures as promulgated by the individual hospital or institution using said machine. Use of these machines shall not be to circumvent adequate pharmaceutical services. (Amended 8/23/96).

04-05-0003 -REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD KEEPING SYSTEMS IN HOSPITAL PHARMACIES HOLDING HOSPITAL PHARMACY PERMITS.

In accordance with the Drug Enforcement Administration's final ruling June 30,1977, which allows a pharmacy to use a data processing system as an additional manner of storing and retrieving prescription refill information for Schedule III and IV controlled substances, the following proposed regulation is submitted to regulate the use of Electric Data Processing (EDP) systems for holders of Hospital Pharmaceutical Services Permits in the State of Arkansas.

A. These regulations shall be construed, if possible, so as not to be violative of or in conflict with any federal regulation or requirement. If any part hereof is held invalid because of such conflict, such invalidity shall not affect other provisions or applications of these regulations which can be given effect without the invalid provisions of these regulations are declared severable.

B. The Arkansas State Board of Pharmacy must approve system prior to implementation.

C. Input of drug information into system may be performed by a pharmacist or supportive personnel (pharmacy technician). The final verification of prescription information, into the computer shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry. Any judgmental decision concerning patient utilization of drugs must be performed by a pharmacist.

D. Any Electronic Data Processing System must be capable of furnishing the following information:

1. Patient Medication Profile (accessible electronically on line or by hard copy.)

INTERPRETATION: The Patient Medication Profile is the basic document used by the Hospital Pharmacist to monitor a patient's medication regimen, drug compliance, drug interactions, allergies and drug usage.

a. The Patient Medication Profile must contain as a minimum the following:

Patient name, patient identification number, practitioner's name, drug name, drug strength and dosage form, number of doses issued, initials, name or identification number of pharmacist approving original order into the system, and date original order was entered into the system.

b. The Final Patient Medication Profile must be maintained by the pharmacy

E.

1. Patient Daily Medication Printout (hard copy printed daily is required).

INTERPRETATION: The Patient Daily Medication Printout is a supporting document to the Patient Medication Profile. It is printed on a daily basis and may be used to fill patient medication orders for transport to the patient care area and may serve as a daily log of all medication issued on any given day.

a. The Patient Daily Medication Printout (daily hard copy) must contain as a minimum the following: date of record, patient name, patient identification number, drug name, drug strength and dosage form and number of doses issued on that day.

b. The following additional information must appear on the Patient Daily Medication Printout if it is not shown on the Patient Medication Profile described in D.1 above; initials of the Pharmacist who checked and verified the doses issued on the Patient Daily Medication Printout.

INTERPRETATION: Since the Patient Medication Printout is a supporting document to the Patient Medication Profile, some information such as practitioner's name, initials, name or identification number of pharmacist entering the original order into the system and the date of the original order may or may not be duplicated because the information is readily retrievable from the base document.

c. The Patient Daily Medication Printout or daily log must be signed by all pharmacists filling orders, and may be replaced by a monthly log containing same information. This information must be maintained at the Pharmacy for a period of two years. INTERPRETATION: The Patient Daily Medication Printout provides a daily refill-by-refill audit trail on all drugs issued and supplements the base document, the Patient Medication profile.

In lieu of signing this daily hard copy printout, the pharmacist in charge of the hospital pharmacy may maintain a bound log book in which an individual pharmacist involved in such dispensing may sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed by him and is correct as shown.

The log should identify the time of day at which the pharmacist started filling pharmacist stopped filling prescriptions. Said log book shall be maintained, by the pharmacist in charge or his successor, in the hospital pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized prescription.

2. Assure strict confidentiality of all patient records.

3. Must be capable of receiving a hard copy printout of all the above mentioned reports within 48 hours.

4. If the hospital pharmacy closes, the pharmacist in charge, at the date of closing, shall store said records and within 14 days of closing shall notify the Board of Pharmacy where said records are located. A hard copy printout of any daily log(s) shall be produced and made available to the Board on its request and to any other person authorized by law to examine or receive copies of prescription records.

D. Hospital pharmacies who make arrangements with outside suppliers of data processing services or materials must assure themselves of continuing adequate and complete drug information data and issuing records. If for any reason the relationship with said supplier terminates, the pharmacy shall assure the continuity of records.

E. In the event of computer breakdown (down time), the pharmacy must have an auxiliary record keeping system. The backup system must contain all necessary information to insure prompt data entry into the system as soon as computer is again available.

F. Registrants holding a Hospital Pharmaceutical Service Unit Permit who fill outpatient prescriptions and who wish to utilize Electric Data Processing Equipment as a record keeping system must then comply with all the requirements of the Arkansas State Board of Pharmacy Regulation Number 33.

G. The electronic data processing systems described in this regulation are acceptable as the disposition records for all drugs, except that the actual signed disposition (proof of use) records for Schedule II Controlled Substances must be retained separate from other records for a period of two years. 10/09/80 (Revised 6/15/95, and 6/19/97)

04-06: INSTITUTIONAL PHARMACEUTICAL SERVICES PERMIT

04-06-0001 -CLASS #1 INSTUTIONAL PERMIT

A. If a pharmacy is funded primarily by state or federal funds, and/or if prescription drugs are to be purchased, maintained or dispensed by a pharmacist in a facility that purchases drugs from Arkansas State Contracts, and that facility does not meet the requirements set by the Board of Pharmacy to obtain a Licensed Pharmacy Permit, a Hospital Pharmaceutical Services Permit, or a Nursing Home Consultant's Permit, then an exception may be made to issue an Institutional Pharmaceutical Services Permit. The permit shall be issued in the name of the Licensed Pharmacist in charge.

B. A Licensed pharmacist employed or otherwise engaged to provide pharmaceutical service may have a flexible schedule of attendance in said institution, provided, however, said pharmacist must be physically present in said institution for sufficient number of hours weekly to maintain adequate supply of medications at the service area from which medications are administered, to maintain all records, to perform other pharmaceutical services authorized by law and provide adequate control and accountability of all drugs under his responsibility.

C. Medication for patients shall be on an individual prescription basis by order from a licensed Physician and the pharmacist shall dispense drugs, properly labeled to be used for patients under treatment by the facility.

D. Facilities are to be provided for the storage, safe-guarding, preparation, and dispensing of drugs. Equipment and supplies necessary to the facilities' safe and economical operation shall be provided. Special locked storage space is to be provided to meet all requirements for storage of controlled drugs, and other prescription drugs.

E. All policies and procedures related to the Institutional Pharmaceutical Services must first be approved by the Board before a permit will be issued.

F. Special floor stock or backup to meet emergency needs such as when the pharmacy is closed, will be permitted only when specifically outlined in the policies and procedures. The policies and procedures shall include:

1. lists establishing quantity limits of these emergency drugs,

2. the method of replacement,

3. maintenance of records accounting for drugs used, proper preparation and labeling by the pharmacist.

04-06-0002 -CLASS #2 INSTITUTIONAL PHARMACEUTICAL SERVICES PERMIT

A. When controlled drugs are needed for research or instruction by a licensed pharmacist and these drugs are not to be sold or dispensed on prescriptions, an Institutional Pharmaceutical Services Permit for Research or Instruction (Class #2) may be issued.

B. Total responsibility for such drugs is placed on the Licensed Pharmacist in whose name the permit is issued.

04-07: CHARITABLE CLINIC PERMIT

04-07-0001 -ISSUANCE OF CHARITABLE CLINIC PERMIT

The Arkansas State Board of Pharmacy may provide for the issuance of a Charitable Clinic Pharmacy Permit to clinics and facilities furnishing medical care and dental care to poor and underprivileged persons, in which drugs are dispensed without charge to such persons on orders or prescriptions of practitioners authorized by law to prescribe or administer said drugs and to which the requirements of a licensed pharmacist on duty for a minimum of forty (40) hours shall not apply.

04-07-0002 -PRESCRIPTIONS

All medication for patients shall be on individual prescription basis, and the pharmacist shall dispense drugs, properly labeled, and adhere to the requirements for proper storage, safeguarding, preparation and record-keeping for prescription drugs.

. 04-07-0003 -POLICIES AND PROCEDURES FOR CLINICS

All policies and procedures related to the Charitable Clinic Permit must first be approved by the Board staff before a permit will be issued to insure compliance with all existing laws and regulations.

04-07-0004 -CATEGORIES FOR PERMITS

The staff of the Board of Pharmacy is authorized to approve and issue charitable clinic permits for:

A. Clinics of the Arkansas Department of Health recognizing that medications are provided to patients in the absence of a pharmacist and that the medications dispensed in these clinics are limited to birth control medications, drugs to treat tuberculosis, and drugs to treat sexually transmitted disease treatment program.

Packaged and labeled prescription drugs shall be initialed by the pharmacist to assure accuracy and appropriateness. The prescribing practitioner or a licensed nurse may issue these pre-dispensed prescription drugs, by placing the patients name, date of issue and prescription number on the label at the time of issue to patients on order of the prescriber.

The prescription number as placed on the label of the dispensed prescription drug is to be placed with the prescribing practitioner's order in the patients medical record. The pharmacist shall monitor patients medical records to assure that medication profiles and prescription orders are maintained and utilized.

Since the pharmacist is not present when the patient receives the medication, the pharmacist shall develop protocol to assure that the patient is monitored and counseled by the prescribing practitioner or nurse consistent with the requirements of Board of Pharmacy Regulation 09-00-0001.

B. Other facilities meeting the requirements of this regulation -- provided that, if a pharmacist is not present, there shall be a limited formulary negotiated by the Executive Director and approved by the Board of Pharmacy at it's next meeting. The dispensing medication distribution provisions of 4-A of this regulation shall apply.

04-07-0005 -PHARMACIST PRESENT WHEN MEDICATION PROVIDED

Other facilities meeting the requirements of this regulation and where a pharmacist is present when medications are provided to the patient shall not be restricted to a medication formulary. (Revised 04/30/93)

05 -LONG-TERM CARE FACILITIES 1

05-00: NURSING HOME CONSULTANTS

05-00-0001 -DEFINITIONS:

1. Consultant Pharmacist in Charge

A Nursing Home Pharmacist in Charge hereinafter referred to as a Consultant pharmacist in charge is a Pharmacist who assumes the ultimate responsibility to assure adherence to all law and regulation concerning pharmacy services in the Nursing home permitted in his or her name.

The Consultant Pharmacist in Charge is required to perform a majority of the consultative services provided in the home and must assure that other consultant pharmacists assisting him or her in the home are aware of and abide by pharmacy law and regulations and policy arid procedures of the home.

2. Consultant Pharmacist

A Nursing Home Consultant Pharmacist is herein-after referred to as Consultant Pharmacist is a Pharmacist who practices as a consultant in one or more homes to assist the Consultant Pharmacist in Charge.

3. The number of residents shall be the number of patients in the home on the first day of the proceeding month.

05-00-0002 -GENERAL REQUIREMENTS:

Any pharmacist desiring to serve as a Consultant Pharmacist in Charge for a nursing home shall so notify the Board of Pharmacy and secure a Nursing Home Consultant's Permit which shall designate the home for which he or she is responsible.

Before a pharmacist is licensed as a Consultant Pharmacist or Consultant Pharmacist in Charge, he or she must certify to the Board of Pharmacy that he or she has satisfactorily completed a test on requirements developed by the Board to explain the pharmaceutical duties and responsibilities in a nursing home and that the Pharmacist has read and understands these regulations and will abide by them.

A Consultant Pharmacist in Charge shall not be issued in any instance where a full-time Consultant Pharmacist in Charge is already responsible for 1,500 or more residents, unless that pharmacist has submitted a written explanation of need and that request has been approved by the Director of the Board of Pharmacy.

In no instance shall a Consultant Pharmacist in Charge Permit be issued if the pharmacist is already responsible for more than 2,000 residents.

For renewal of a Nursing Home Consultant's Permit, it is required that, in addition to the C.E. required for all pharmacists, Consultant pharmacists must annually obtain three (3) hours of C.E. specifically relating to his/her role as a consultant in a nursing home.

05-00-0003 -RESPONSIBILITIES

The Consultant Pharmacist or Consultant Pharmacist in Charge in a nursing home is involved in drug storage, distribution and utilization in that home.

These responsibilities might be divided into five general areas.

I. Supervision of services

II. Control and accountability

III. Patient drug regiment review

IV. Labeling of drugs and biologicals and proper storage

V. Quality Assurance and Assessment Committee

I. Supervision of Services

The Pharmaceutical services are under the supervision of a qualified Consultant Pharmacist or Consultant Pharmacist in Charge who is responsible for developing, coordinating, and supervising all pharmaceutical services. The Consultant Pharmacist in charge in the contract with the home must assure that pharmacist consultation is available on a 24-hour-per-day basis. A Pharmacist (if not a full-time employee) devotes a sufficient number of hours based upon the needs of the facility, during regularly scheduled visits to carry out these responsibilities. The Consultant Pharmacist in Charge submits a written report at least quarterly to the Quality Assurance and Patient Assessment Committee on the status of the facility's pharmaceutical services and staff performance.

The Consultant Pharmacist or Consultant Pharmacist in Charge shall assist the home in developing procedures to assure provisions of emergency drugs and shall report to the Board of Pharmacy any pharmacy refusing to provide emergency drugs for the pharmacy's regular patients in the home.

The Consultant Pharmacist in Charge shall be responsible for full compliance with Federal and State laws governing legend drugs (including controlled substances).

The Consultant Pharmacist or Consultant Pharmacist in Charge should inform himself of all laws and regulations pertaining to nursing homes and should communicate with the state agencies involved with enforcement and regulation of nursing homes.

To properly perform his duties, the Consultant Pharmacist or Consultant Pharmacist in Charge shall spend sufficient time to evaluate discontinued medication, destroy unused medication, check entries in Bound Controlled Drugs Book, file the completed disposition sheets with the patient's permanent record, and make general observations at the nursing stations.

This record shall indicate the day the Consultant Pharmacist in Charge or any assisting Consultant Pharmacist visited the home, a brief statement of purpose, finding, and actions.

II. Control and Accountability of All Legend Drugs (Including Controlled Substances) Control and Accountability

The Consultant Pharmacist supervises and develops procedures for control and accountability of all drugs and biologicals throughout the facility. Only approved drugs and biologicals are used in the facility and are dispensed in compliance with Federal and State laws. Records of receipt and disposition of all controlled drugs are maintained in sufficient detail to enable an accurate reconciliation. The pharmacist determines that drug records are in order and that an account of all controlled drugs is maintained and reconciled.

A. All legend drugs must be stored in a secured location and under lock.

B. Proper records of receipt and administration of controlled drugs must be maintained for review by the pharmacist consultant.

C. All discontinued and outdated non-controlled legend drugs shall be inventoried and destroyed jointly by a designated nurse and the Consultant Pharmacist or Consultant Pharmacist in Charge with a jointly signed record kept.

D. All discontinued and outdated controlled drugs shall be jointly inventoried by a designated nurse and the Consultant Pharmacist or Consultant Pharmacist in Charge and an inventory signed by both shall be maintained for at least two (2) years.

The controlled drugs shall be sent to the Health Department by the Administrator and the Health Department receipt of drugs destroyed shall be reconciled with the nurse/pharmacist inventory by the Consultant Pharmacist in Charge.

III. Patient Drug Regimen Review

The primary responsibility of the Consultant Pharmacist or Consultant Pharmacist in Charge to the patient concerns applying his or her expertise on drugs to the patient's specific situation. To assist the Consultant Pharmacist or Consultant Pharmacist in Charge, the Department of Health and Human Services has developed INDICATORS FOR SURVEYOR ASSESSMENT OF THE PERFORMANCE OF DRUG REGIMEN REVIEWS. These shall be considered to the minimum standards for an adequate drug regimen review.

Adherence to the INDICATORS shall not be the sole criteria for considering a review to be adequate; however, failure to consider and utilize the INDICATORS shall be justification for the finding of inadequate review.

In conjunction with, or in addition to, the INDICATORS the Consultant Pharmacist or Consultant Pharmacist in Charge should routinely and systematically review each patient's chart considering:

1. Ascertains that patient history and drug utilization is being properly recorded.

2. Reviews drug usage (including O.T.C. and prescriptions).

3. Reviews patient compliance with drug regimen.

4. Reviews drug allergies or sensitivities.

5 Determines whether patient is predisposed to side effects due to disease, illness, or age.

6. Determines whether potential exists for significant drug interaction.

7. Develops procedures to monitor patient's records for signs that indicate abuse or misuse of drugs by the patient or other personnel involved.

8. Makes recommendations regarding drug therapy to the physician, nurse or other persons involved in the patient's care.

9. Assures that adequate pharmacy services are available for emergencies that might develop in the home for a specific patient.

10. Promote pharmacists' ability and knowledge to all persons involved in patient's care and to offer assistance in solving specific problems relating to patient drug regimen.

A Consultant Pharmacist or Consultant Pharmacist in Charge shall quarterly in ICF/MR facilities and monthly in nursing facilities\ review each patient's medication record, consult with the director of nursing or the patient's physician, and check orders against medication card, Kardex, and actual medication.

IV. Labeling of Drugs and Biologicals and Proper Storage

All legend drugs (including controlled substances) on the premises of a nursing home except for the emergency tray as defined by the State Board of Pharmacy, shall be stored under lock and always be in a properly labeled container as dispensed upon a prescription by the pharmacy of the patient's choice.

It is the responsibility of the Consultant Pharmacist or Consultant Pharmacist in Charge to ascertain that medications are properly labeled, properly stored, refrigerated when needed, expiration dates routinely checked, and that appropriate accessory and cautionary instructions are on all medications when required.

V. Quality Assurance and Patient Assessment Committee

1. The Consultant Pharmacist or Consultant Pharmacist in Charge shall be a member of the Quality Assurance and Patient Assessment Committee (or its equivalent) and make official reports to this Committee as often as needed to assure quality pharmaceutical care.

2. The Consultant Pharmacist in Charge shall assure that there are written policies and procedures for safe and effective drug therapy, distribution, control, and use.

3. The policies and procedures shall include and are not limited to:

(a) Stop order policies or other methods to assure appropriateness of continued drug therapy.

(b) Determine the contents of the emergency medication, but which must comply with law and regulation.

(c) Policies for the safe procurement, storage, distribution, and use of drugs and biologicals. 10/9/80 (Reg. Revised 2/17/82 & 6/25/83 & 10/12/93)

05-00-0003 -EMERGENCY KITS FOR LONGTERM CARE FACILITIES

(A) With recognition of D.E.A.'s statement of policy regarding emergency kits for long term-care facilities, the following regulation is adopted to meet D.E.A. requirements to permit controlled substances to be stored in emergency kits in long-term-care facilities in Arkansas.

REQUIREMENTS:

1. All contents of the emergency kit will be provided by one pharmacy designated by the long-term-care facility. This pharmacy must be properly registered with D.E.A.

2. The emergency kit shall be properly sealed, stored, and accessible only to authorized personnel.

3. The emergency kit contents may be administered by authorized personnel acting on order of a physician in compliance with 21 CFR 1306.11 and 21 CFR 1306.21.

4. The Board of Pharmacy will establish a standard list of drug categories to be contained in the emergency kit. The contents of the kit shall be determined by the Pharmaceutical Services Committee at the long-term care facility, and reviewed by the Executive Director of the Board of Pharmacy. Any exceptions to the established standard categories must be approved by the Board of Pharmacy. A list of contents shall be kept in the kit.

5. The facility's licensed consultant pharmacist shall be responsible for the accountability of the content of the kit and the facility's licensed consultant pharmacist shall check the kit periodically for outdated drugs, etc.

6. Legend drugs administered from the kit will be replaced within 72 hours by the designated provider pharmacy based on a prescription for the patient to whom the drugs were administered.

7. If the requirements of this regulation are violated, the violation shall be good cause to revoke, deny, or suspend permission for the facility to maintain an emergency kit.

8. Violation of this regulation shall be just cause to suspend or revoke the consulting license of the responsible pharmacist.

9. Emergency kit drugs shall be of such a nature that the absence of such drugs would detrimentally affect the health of the patient. 10/14/81 (B) Recognizing the emergency and or unanticipated need for certain legend (non-controlled) drugs to be available to nurses employed by Arkansas Licensed Home Health Agencies, an Arkansas Licensed Pharmacy may provide certain medications under the following conditions:

1. A written contract must exist between the Arkansas Licensed Home Health Agency and the Arkansas Licensed Pharmacy, and this must be available for review by the Board of Pharmacy upon request.

2. The legend drugs remain the property of and under the responsibility of the Arkansas Licensed Pharmacy.

3. All medications are administered only on physician's orders and medications administered from the nurse's supply must be recorded as a prescription by the pharmacy prior to the pharmacy's replacement of the drug in the emergency supply.

4. All medication records must be maintained as required by law, and out of date drugs must be properly destroyed by the pharmacy.

5. The emergency supply may be carried by each nurse or an emergency kit may be provided for each patient's home.

6. Careful patient planning should be a cooperative effort between the pharmacy and the nursing agency to make all medications available and this emergency supply should ONLY be used for emergency or unanticipated needs and shall NOT become a routine source or supply.

7. The following medications can be supplied by the pharmacy in sufficient but limited quantities:

Heparin Flush - Pediatric (one strength)

Heparin Flush - Adult (one strength)

Sterile Water For Injection -- small volume

Sodium Chloride For Injection -- small volume

Adrenalin (Epinephrine) Injection - ampoules only

Benadryl (Diphenhydramine) Injection - ampoules only

* Note: For Heparin, Adrenalin and Benadryl, all patients should have a precalculated dose.

* If a container is opened and partially used it is intended that any unused portion be immediately discarded.

This list can be expanded only by the Board of Pharmacy; and if expanded, notice will be provided in the Board's Newsletter.

8. The pharmacy is responsible to assure compliance with this regulation, and any abuse or misuse of the intent of this regulation shall be immediately reported to the Board of Pharmacy.

9. The pharmacy and the agency shall develop policy and procedures to address storage conditions for medications.

(Revised 10/12/93 Revised 10/14/97)

05-00-0005 -DRUG CATEGORIES FOR EMERGENCY KITS IN LONG-TERM CARE FACILITIES

The following is a list of categories of drugs which are acceptable in emergency kits in long-term care facilities in accordance with Regulation 05-00-0004(A)(4) of the Arkansas State Board of Pharmacy. In every instance where injectables are indicated, only single-dose injectables are acceptable.

ANALGESICS, CONTROLLED DRUGS

Schedule II-Injectable-

Limit: one (1)

Maximum quantity: two (2)

Schedule II, IV, or V-

Limit: three (3)

Maximum quantity: If oral: six (6) If Injectable: two (2)

ANTIBIOTICS

Oral Doses-

Limit: five (5)

Maximum quantity: five (5)

Parenteral Doses-

Limit: three

Maximum quantity: one (1)

ANTICOAGULANT

Limit: one (1)

Maximum quantity: three (3)

ANTIDIARRHEALS

Limit: one(1)

Maximum quantity: ten (10)

ANTIHISTAMINE INJECTABLES

Limit: two (2)

Maximum quantity: four (4)

ANTINAUSEANTS

Limit: three (3)

Maximum quantity: four (4)

ANTIPSYCHOTIC INJECTABLES

Limit: two (2)

Maximum quantity: four (4)

ANXIOLYTICS

Limit: one(1)

Maximum quantity: four (4)

CARDIAC LIFE SUPPORT MEDICATIONS

Injectables:

The content and quantity of injectable cardiac life support medications is to be recommended by the Pharmacy Services Committee at the Long-term Care facility and approved by the Executive Director of the Arkansas State Board of Pharmacy.

Hypertensive Crisis Oral Medications:

Limit: three (3)

Maximum quantity: eight (8)*

*When nitroglycerine sublinqual is used: quantity-1 bottle of 25 HYPOGLYCEMICS

Limit: three (3)

Maximum quantity: two (2)

INJECTABLE SEIZURE CONTROL MEDICATIONS

Limit: two (2)

Maximum quantity: four (4)

LARGE VOLUME PARENTERALS

Limit: three (3)

Maximum quantity: two (2)

POISON CONTROL

Limit: two

Maximum quantity: two (2)

06 -DISCIPLINARY PROCEDURES

06-00-0001 -PROCEDURES FOR DICIPLINARY ACTION

Before revoking the certificate of licensure of any licensed pharmacist or licensed pharmacy permit, the Board of Pharmacy shall give such person proper notice in writing to appear before such Board, at such time and place as the Board may direct, to show cause if any he has, why his certificate or permit should not be revoked. Said notice shall be signed by the Executive Director of the State Board of Pharmacy and shall set forth in clear concise language the nature of the charge against such person. Mailing a copy of such notice by registered mail, addressed to such person at his address appearing upon the records of the State Board of Pharmacy concerning the issuance of his certificate or permit or the last renewal thereof, shall be sufficient service to such notice. At such hearing, the Board shall have power to subpoena witnesses and the President or Chairman of said Board shall have the power to administer oaths and such Board shall hear evidence. If the Board finds, after such hearing, that the certificate of Iicensure or permit of such person should be revoked, the same shall be done forthwith.

07- DRUG PRODUCTS/PRESCRIPTIONS

07-00: GENERAL REGULATIONS REGARDING DRUGS/PRESCRIPTIONS

07-00-0001 -Facsimile (Fax) Prescription Drug Order-

A prescription drug order which is transmitted by an electronic device which sends an exact copy image to the receiver (pharmacy) over telephone lines.

II. Faxing Schedule II Prescriptions

A. Faxing A Schedule II For A Home Infusion And/Or I.V. Pain Therapy Patient - A prescription, written for a Schedule II narcotic substance to be compounded for the direct administration to a home infusion patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, may be transmitted directly from the prescribing practitioner, by the practitioner or the practitioner's agent, to the pharmacy by facsimile. The facsimile serves as the original written prescription. This exception does not apply to oral dose medications. (Also see Regulation # 07-04-0001)

B. Faxing A Schedule II For A Long Term Care Patient -- A prescription written for a Schedule II substance, for a resident of a long-term care facility, may be transmitted directly from the prescribing individual practitioner, by the practitioner or the practitioner's agent, to the provider pharmacy by facsimile. The facsimile serves as the original written prescription. (See also Regulation # 07-04-0001)

C. A prescription written for a Schedule II substance, for a home hospice patient may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. It must be noted on the prescription that this is a hospice patient. The facsimile serves as the original written prescription. (See Regulation # 07-04-0001)

II. Faxing From A Long Term Care Facility To A Pharmacy -- A pharmacist may accept a fax prescription from a long term care facility provided:

A. For Schedule II drugs, all requirements of a written prescription are met, including the prescriber's signature on the faxed order and it is faxed by the nurse/person the physician and the LTC facility has designated as his/her "agent" to transmit the order, and must contain the nurse/person's signature.

B. For drugs other than Schedule II, the order is faxed by the nurse/person the physician and the LTC facility has designated as his/her "agent" to transmit the order, and must contain the nurse/person's signature.

C. The pharmacist verifies the fax is from the machine in the LTC facility.

III. Faxed Prescriptions

A. A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V which is a prescription drug, or any legend drug, only pursuant to either a written prescription signed by a prescribing individual practitioner or a facsimile of a written signed prescription transmitted directly by the prescribing practitioner, or the practitioner's agent, to the pharmacy or pursuant to an oral prescription made by a prescribing individual practitioner, or the practitioner's agent, and promptly reduced to writing by the pharmacist.

B. All law and regulation applicable to oral prescription drug orders shall also apply to all facsimile orders including, but not limited to, generic substitution, maintenance of records, information required, etc.

C. A prescription order transmitted by facsimile device shall contain all prescription information required by federal and state law.

D. A pharmacist may dispense prescription orders transmitted by fax only when signed by the prescribing practitioner and transmitted from the practitioner's office or a long term care facility in compliance with all sections of this document.

E. The original fax shall be assigned the number of the prescription dispensed, and maintained in pharmacy records for at least two years.

F. The receiving fax machine must be in the prescription department of the pharmacy to protect patient/pharmacist authorized prescribing practitioner confidentiality and security.

G. Refill authorizations for prescriptions, other than Schedule II, may be transmitted using a facsimile device.

IV. Patient/Prescriber Consideration

A. No pharmacist shall enter into any agreement with a practitioner or health care facility concerning the provision of facsimile machine services or equipment which adversely affects any person's freedom to choose the pharmacy at which a prescription will be filled.

B. A pharmacy/pharmacist shall not provide a fax machine to a prescribe!*, a long term care facility, or any healthcare facility free of charge or for less than the pharmacy/pharmacist cost.

C. No agreement between a prescriber and a pharmacy shall require that prescription orders be transmitted by facsimile machine from the prescriber to only that pharmacy.

D. A pharmacy/pharmacist shall not enter into any agreement whereby the pharmacy/pharmacist pays to obtain the prescription order by fax or any electronic data transfer. (10/12/93 Amended 2/15/95, October 14,1997)

07-00-0002 -PRESCRIPTION TRANSFERS:

A. The transfer of original prescription information for a legend drug or a controlled substance listed in Schedules III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization. Transfers are subject to the following requirements:

(1) The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:

(a) Write the word "Void" on the face of the invalidated prescription.

(b) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.

(c) Record the date of the transfer and the name of the pharmacist transferring the information.

B. The pharmacist receiving the transferred prescription information shall reduce to writing the following:

(1) Write the word "transfer" on the face of the transferred prescription.

(2) Provide all information required to be on a prescription pursuant to 21 CFR 1306.05 and include:

(a) date of issuance of original prescription;

(b) original number of refills authorized on original prescription;

(c) date of original dispensing;

(d) number of valid refills remaining and date(s) and locations of previous refill(s);

(e) pharmacy's name, address, DEA registration number and prescription number from which the prescription information was transferred;

(f) name of pharmacist who transferred the prescription.

(3) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill, (a) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transfer.

07-00-0003 -SIGNING PRESCRIPTIONS

Every licensed pharmacist or intern who shall fill or refill a prescription, shall attest that he has personally filled said prescription by placing upon said prescription his signature with date thereof. 10/09/80 (Revised 10/14/81, and 6/20/91)

07-00-0004 -SECRET CODES PROHIBITED

The treatment of disease, injury or deformity by secret means or secret drugs being contrary to both the spirit and the letter of the Arkansas Medical Practices Act, and dispensing of secret medicines or drugs being contrary to both the spirit and the letter of the Arkansas Pharmacy Act and the Arkansas Food, Drug, and Cosmetic Act, hereafter no licensed pharmacist or intern shall enter into any agreement or arrangement with a physician, or other practitioner authorized by law to prescribe medicine or drugs, for the compounding and/or dispensing of secret formula or coded prescription. (10/09/80)

07-00-0005 -MAINTENANCE AND RETENTION OF DRUG RECORDS

All drug records, including but not limited to, purchase invoices, official dispensing records, prescription, and inventory records, must be kept in such a manner that all data is readily retrievable, and shall be retained as a matter of record by the pharmacist for at least two years.

At least every 12 months all prescriptions for legend drugs which are not controlled substances when refilled must be verified by the prescribing practitioner, a new prescription written, and a new prescription number assigned to the prescription. The prescription number of the updated prescription shall be recorded on the new prescription.

Provided, however, this regulation recognizes, and in no way effects, the six month and five-refill limit on controlled drug prescriptions pursuant to A.C.A. 5-64 308(c). 10/09/80 (Revised 12/12/86)

07-00-0006 -NON EQUIVALENT DRUG PRODUCT LIST

If a product is listed on the Arkansas Non-Equivalent Drug Product List and the FDA approves a competitive product as bioequivalent and publishes the products with an "A" rating in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book) Arkansas pharmacists may substitute that product consistent with law until this list is revised. Conversely, if the change is from an "A" rating to a "B" rating, the pharmacist may not substitute without the consent of the prescribing physician if the pharmacist is aware of the "B" rating.

A prescription written for any brand name drug listed can only be changed with consent of the prescribing physician. If written generically, once the pharmacist has selected a manufacturers product the physician shall be notified if another company's product is used.

Leucovorin Calcium Tablets

Levothyroxine Tablets

Phenytoin Sodium Tablets and Capsules

Quinidine Gluconate Oral

Theophyiline Capsules, Controlled Release and Tablets

Warfarin Sodium Tablets

07-00-0007 -A PHARMACIST SHALL NOT DISPENSE A GENERICALLY EQUIVALENT DRUG PRODUCT UNDER ACA * 17-92-503(a) AND (b) OF THE GENERIC SUBSTITUTION ACT IF:

A. In the case of a written prescription, on the prescription the prescriber writes in his or her own handwriting words that specify that no substitution shall be made and then also signs the prescription.

B. The prescriber, in the case of a prescription other than one in writing signed by the prescriber, expressly states at the time the prescription is given, that it is to be dispensed as communicated, and same is reduced to writing on the prescription by the pharmacist, or

C. The person for whom the drug product is prescribed indicates the prescription is to be dispensed as written or communicated. 4/07/89

07-00-0008 -ELECTRONIC PRESCRIPTION PROCESSING AND PATIENT

CONFIDENTIALITY

1. DEFINITIONS:

A. "Confidential Information" means information that is personally identifiable and, therefore, can be traced back to the patient or prescribing practitioner that is accessed or maintained by the pharmacist in the patient's records or which is communicated to the patient, as part of patient counseling, which is privileged and may be released only to the patient or prescriber or, as the patient or prescriber directs; to those practitioners, other authorized health care professionals, and other pharmacists where, in the pharmacist's professional judgement, such release is necessary to protect the patient's health and well being; and to such other persons or governmental agencies authorized by law to receive such confidential information, regardless of whether such information is in the form of paper, preserved on microfilm, or is stored on electronic media.

B. "Electronic Transmission" means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment.

C. "Prescription Drug Order" means a lawful order of a Practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

2. PATIENT CONFIDENTIALITY REQUIREMENTS:

A. Prescription information and other patient health care information shall be maintained in a manner that protects the integrity and confidentiality of such information as provided by rules of the Board.

B. The pharmacy shall provide a mechanism for patients to prevent the disclosure of any information (confidential or otherwise) about them that was obtained or collected by the pharmacist or pharmacy incidental to the delivery of Pharmaceutical Care other than as authorized by law or rules of the Board.

C. The pharmacist-in-charge shall:

(a) Establish written policies and procedures for maintaining the integrity and confidentiality of prescription information and patient health care information. All employees of the pharmacy, with access to any such information, shall be required to read, sign, and comply with the established policies and procedures.

(b) Assure that the requirements of this regulation are established and implemented.

3. MANNER OF ISSUANCE OF A PRESCRIPTION DRUG ORDER

A. A prescription drug order may be transmitted to a pharmacy by electronic transmission. If transmitted by way of electronic transmission, the prescription drug order shall be immediately reduced to a form, by the pharmacist, that may be maintained for the time required by law or rules. Persons other than those bound by a confidentiality agreement, pursuant to a consent agreement, shall not have access to pharmacy records containing personally identifiable confidential information concerning the pharmacy's patients or prescribers.

B. All prescription drug orders, communicated by way of electronic transmission shall:

(a) Be sent only to the pharmacy of the patient's choice with no intervening

(b) Person having access to the prescription drug order.

(c) Identify the transmitter's phone number for verbal confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission - as well as any other information required by Federal or State Law.

(d) Be transmitted by the authorized practitioner or his designated agent.

(e) Be deemed the original prescription drug order provided it meets the requirement of this regulation and other law or regulation.

C. All electronic equipment, for receipt of prescription drug orders communicated by way of electronic transmission, shall be maintained so as to ensure against unauthorized access. The pharmacist shall exercise professional judgement regarding the accuracy, validity, and authenticity of the prescription drug order consistent with existing Federal or State Laws or Regulations.

D. The prescribing practitioner may authorize his agent to transmit a prescription drug order, by electronic transmission, to the pharmacy -provided that the identity of the transmitting agent is included in the order.

4. PATIENT RECORDS:

A. Personally identifiable confidential information, in the patient medication record, may be released to the patient, the prescriber, other licensed practitioners then caring for the patient, another licensed pharmacist, the Board or it's representatives, or any other person duly authorized by law to receive such information. Personally identifiable confidential information, in the patient medication record, may be released to others only on written release of the patient. Personally identifiable confidential information, in the patient medication record related to identity of the prescriber, may be released only on written release of the prescriber.

5. DISCIPLINE:

A. The Board of Pharmacy may refuse to issue or renew, or may suspend, revoke, restrict the licenses or the registration of, or fine any person for divulging or revealing confidential information to a person other than as authorized by rules of the Board.

6. SECURITY:

A. To maintain the confidentiality of patient and prescriber records, the computer system shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. Once the drug has been dispensed, any alterations in prescription drug order data shall be documented -including the identification of the pharmacist responsible for the alteration.

07-01: F.D.A. APPROVAL OF DRUGS

07-01-0001 -CONTROLLED SUBSTANCES APPROVED BY F.D.A.

A. Any wholesale drug company or drug manufacturer, doing business in Arkansas pursuant to Act 173 of 1969, as amended by Act 75 of 1979 and Act 257 of 1981, shall not distribute any controlled substance and/or legend drug in the State of Arkansas, if that product requires approval by the Food and Drug Administration for marketing and distribution, and the product, in fact has not been approved for marketing and distribution by the Food and Drug Administration.

B. Violation of this regulation shall be grounds for suspension or revocation of the license of the wholesale drug or drug manufacturer's license to do business in the State of Arkansas. 10/14/81

07-01-0002 -DRUG PRODUCTS MUST HAVE NDA OR ANDA

A. In order to provide for the protection of the public health and safety, drug products which are offered for sale by, or stored at the premises of any manufacturer, distributor, wholesaler, or pharmacy located in Arkansas must have an approved new drug application (NDA) or abbreviated new drug application (ANDA) designation by the Federal Food and Drug Administration pursuant to 21 USC 355 unless they are exempt from the requirements for such a designation.

In order to protect the public health and safety, drug products offered for sale by-or stored at the premises of-a manufacturer, wholesaler, distributor, or pharmacy location in Arkansas which do not have the required NDA or ANDA, or exemption therefrom referenced in the above paragraph, are hereby declared to be contraband and subject to surrender to and destruction by the Arkansas State Health Department.

B. Whenever it is made to appear to the Board that any licensee of the Arkansas State Board of Pharmacy is in possession of a stock of drugs which are contraband as defined above, a representative of the Board shall confirm with the Federal Food Drug Administration, by telephone, that the particular drug or drugs involved do not have the requirement. Upon receipt of this confirmation, the Board shall inform the owner, or person in charge, of the contraband status of the drugs in question.

C. Retention, dispensing, promotion, or advertisement of drug products by a licensee of the Board of Pharmacy, either at their business premises or at any separate storage facility after notification of their contraband status, shall constitute a direct and immediate danger to the public health and safety and will be good and sufficient cause for the suspension or revocation of any license issued by the Board of Pharmacy for knowingly retaining, dispensing, promoting, or advertising any drug products which are contraband under this regulation.

This suspension or revocation would occur only after proper hearings are held by the Board of Pharmacy. 10/14/81 (Revised 6/20/91)

07-02: COMPOUNDING

07-02-0001 -STANDARDS FOR COMPOUNDING AND DISPENSING STERILE PARENTERAL PRODUCTS

The purpose of this regulation is to provide standards in the conduct, practices, and operations of a pharmacy compounding and/or dispensing sterile parenteral products other than manufactured units prepared ready for use.

Pharmacies and pharmacists dispensing sterile parenteral products in quantities of 48 hours or less and expiration times of 72 hours or less shall adhere to all of this regulation except section VIII which applies to pharmacies or pharmacists dispensing sterile parenteral products in quantities of more than 48 hours and/or expiration times of more than 72 hours.

Pharmacies and pharmacists dispensing sterile parenteral products shall comply with all applicable federal, state, and local law and regulation concerning pharmacy and also these additional rules:

Any pharmacist in charge who participates in or supervises the preparation and sterilization of parenteral medications shall be able to provide proof of proper knowledge and training in this specific area of practice by completing an open book test administered by the Board of Pharmacy prior to practice.

Except for those products where stability prohibits advanced compounding, all products dispensed by the pharmacy shall be in a form ready for administration, except in hospitals where medications may be provided as demanded by policies and procedures.

I. Pharmacist Requirements:

Any pharmacist in charge who performs or supervises the preparation or sterilization of parenteral medications shall:

A. Provide, in advance, written policies and procedures for all steps of compounding of intravenous admixtures or parenteral preparations.

B. Certify that all participating pharmacists have completed a documented training program.

C. Develop policies and procedures to periodically test or review the techniques of participating pharmacists to assure adherence to aseptic procedures.

II. Work Area and Equipment:

Any pharmacy dispensing sterile parenteral solutions shall meet or exceed the following requirements:

A. A specified area for compounding parenteral solutions which shall be of adequate space for compounding, labeling, dispensing, and sterile preparation of the medication.

B. This pharmacy area shall have a certified and inspected laminar air flow hood for the preparation of the sterile products which is inspected annually.

C. Pharmacies preparing parenteral cytotoxic agents, all compounding shall be conducted within a certified Class II Type A or Class II Type B vertical laminar air flow hood with bag in-bag out design. When preparing cytotoxic agents, gowns and gloves shall be worn.

D. The area shall be designed to avoid outside traffic and air flow.

E. The area shall be ventilated in a manner not interfering with laminar flow hood conditions.

F. Establish procedures for cleaning the compounding area.

III. Storage:

A. Adequate controlled room temperature storage space for all raw materials.

B. Adequate storage space for all equipment.

C. Adequate refrigerator storage space for compounded solutions, with routinely documented temperatures.

D. Adequate freezer storage space if finished products are to be frozen (e.g. reconstituted antibiotics.) There should be a procedure to routinely document temperatures.

IV. Labeling:

In addition to regular labeling requirements, the label shall include:

A. Rate of infusion.

B. Expiration date (Policies and Procedures shall address label change procedures as required by physician orders.)

C. Storage requirements or special conditions.

D. Name of ingredients.

E. Strength of ingredients.

V. Shipping:

A. Policies and procedures should assure product stability during delivery.

B. Pharmacy must assure ability to deliver products if requested.

VI. Patient Care Services:

The pharmacist in charge of the pharmacy dispensing sterile parental solutions shall provide the following or assure that they are provided prior to providing medications.

A. The pharmacist must assure that the patient is properly trained if self-administering.

B. In situations where a pharmacy or pharmacist employs a nurse to administer medications, the pharmacist in charge must:

1. Employ a Registered Nurse.

2. Assure that proper records are maintained and compliance with laws and regulations.

3. Make these records available to inspectors from appropriate agencies.

C. 24-hour service shall be assured by the pharmacy.

D. Pharmacists shall recommend and monitor clinical laboratory data as needed.

E. Side effects and potential drug interactions should be documented and reported to the physician.

F. Patient histories and therapy plans should be maintained.

VII. Destruction of Cytotoxic and Radioactive Drugs:

Any pharmacy providing cytotoxic and/or radioactive drugs shall establish procedures assuring the return and proper destruction of any unused radioactive or cytotoxic drugs.

In every instance, the pharmacist in charge should monitor the delivery, storage, and administration records of medications dispensed from his/her pharmacy.

VIII. Pharmacies dispensing sterile products in quantities of more than 48 hours and/or expiration times of more than 72 hours shall adhere to all of the above regulations and in addition shall:

A. Compound all medications in a positive airflow room.

B. Use total aseptic techniques, including gowning.

C. Provide a system for tracking each compounded product including:

1. Personnel involved in each stage of compounding;

2. Raw materials used including quantities, manufacturer, lot number, and expiration date;

3. Labeling.

D. Establishment of procedures for monitoring microbial growth.

E. Establishment of procedures for testing the techniques of pharmacists using simulated aseptic procedures and documentation thereof. 6/85

07-02-0002 -GOOD COMPOUNDING PRACTICES APPLICABLE TO ARKANSAS LICENSED PHARMACIES GOOD COMPOUNDING PRACTICES

The following Good Compounding Practices (GCPs) are meant to apply only to thecompounding of drugs by Arkansas licensed pharmacies.

A. General Provisions

The recommendations contained herein are considered to be the minimum current good compounding practices for the preparation of drug products by licensed pharmacies for dispensing and/or administration to humans or animals.

Pharmacists, engaged in the compounding of drugs, shall operate in conformance with applicable pharmacy law and regulations.

The following definitions apply to these Good Compounding Practices.

1 - Compounding The preparation, mixing, assembling, packaging, or labeling of a drug (including radiopharmaceuticals) or device (i) as the result of a Practitioner's Prescription Drug Order or initiative based on the Practitioner/patient/pharmacist relationship in the course of professional practice, or (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or Dispensing. Compounding also includes the preparation of Drugs or Devices in anticipation of Prescription Drug Orders based on routine, regularly observed prescribing patterns.

2. Manufacturing The production, preparation, propagation, conversion, or processing of a Drug or Device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance(s) or Labeling or relabeling of its container, and the promotion and marketing of such Drugs or Devices. Manufacturing also includes the preparation and promotion (other than by personal communication between pharmacist/physician/patient) of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.

3. Component Any ingredient used in the compounding of a drug product.

Based on the existence of a pharmacist/patient/ prescriber relationship and the presentation of a valid prescription, or in anticipation of Prescription Drug Orders based on routine regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug products that are commercially available in the marketplace.

Pharmacists shall first attempt to receive, store, or use drug substances for compounding that have been made in an FDA inspected facility. If unobtainable from an FDA-inspected facility or if the FDA and/or the company cannot document FDA inspection, pharmacists shall receive, store, or use drug components in compounding prescriptions that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment in the procurement of acceptable alternatives.

Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such products compounded at the pharmacy (as required by State law). The compounding of inordinate amounts of drugs in anticipation of receiving prescriptions without any historical basis is considered manufacturing.

Pharmacists shall not offer compounded drug products to other State-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.

The distribution of inordinate amounts of compounded products without a prescriber/patient/pharmacist relationship is considered manufacturing.

B. Organization and Personnel

As in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling; and the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for the proper maintenance, cleanliness, and use of all equipment used in prescription compounding practice.

All pharmacists who engage in drug compounding, shall be competent and proficient in compounding and shall maintain that proficiency through current awareness and training. Competency and proficiency in the art of compounding for all pharmacists shall be evaluated, documented, and maintained in the files of the pharmacy. Every pharmacist who engages in drug compounding must be aware of and familiar with all details of these Good Compounding Practices.

Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation.

C. Drug Compounding Facilities

Pharmacies engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile products shall be separate and distinct from the area used for the compounding of non-sterile drug products. The area(s) used for the compounding of drugs shall be maintained in a good state of repair.

Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.

Adequate lighting and ventilation shall be provided in all drug compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product. The area(s) used for the compounding of drugs shall be maintained in a clean and sanitary condition.

1. Sterile Products

f sterile (aseptic) products are being compounded, the following conditions shall be met: See Board Regulation #07-02-0001 If radiopharmaceuticals are being compounded, the following conditions shall be met: See Board Regulation # 04-02-0100

2. Special Precaution Products

If drug products with special precautions for contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of other drugs, must be utilized in order to prevent cross-contamination.

D. Equipment

Equipment used in the compounding of drug products shall be of appropriate design, appropriate capacity, and suitable located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug products shall be of suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond that desired.

Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond that desired. In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug products, cleaning, sterilization, and maintenance procedures as set forth in Board Regulation # 07-02-0001 must be followed.

Equipment and utensils used for compounding drugs must be stored in a manner to protect from contamination. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.

Automatic, mechanical, electronic, other types of equipment, and limited commercial scale manufacturing or testing equipment, may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.

It is recognized that non-pharmacists may perform any of the set-up and maintenance procedures not defined as the practice of pharmacy.

E. Control of Components and Drug Product Containers and Closures

Components, drug product containers, closures, and bagged or boxed components of drug product containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area, (e.g., floors) and inspection.

Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result. Components, drug product containers, and closures for use in the compounding of drug products shall be rotated so that the oldest stock is used first. Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug product. Drug product containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Drug product containers and closures intended for the compounding of sterile products must be handled, sterilized, stored, and in general maintained in keeping with Board Regulation # 07-02-0001. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures used in the preparation of sterile pharmaceuticals.

F. Drug Compounding Controls

There shall be written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include a listing of the components (ingredients), their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. All equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug, shall be listed. These written procedures shall be followed in the execution of the drug compounding procedure.

Components for drug product compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures. If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed in a container, and stored in another container) the new container shall be identified with the:

(a) component name

(b) lot and expiration date if available

(c) strength and concentration

(d) weight or measure

To assure the reasonable uniformity and integrity of compounded drug products, written procedures shall be established and followed that describe the tests or examinations to be conducted on the product compounded (e.g., degree of weight variation among capsules). Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug product. Such control procedures shall include, but are not limited to, the following (where appropriate):

(a) capsule weight variation;

(b) adequacy of mixing to assure uniformity and homogeneity;

(c) clarity, completeness, or pH of solutions.

Appropriate written procedures designed to prevent microbiological contamination of compounded drug products purporting to be sterile shall be established and followed. Such procedures shall include validation of any sterilization process.

G. Labeling Control of Excess Products

In the case where a quantity of a compounded drug product in excess of that to be initially dispensed in accordance with Subpart A is prepared, the excess product shall be labeled or documentation referenced with the complete list of ingredients (components), the preparation date, and the assigned beyond-use date based upon the pharmacist's professional judgment, appropriate testing, or published data. It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics (e.g., in a clean, dry place on a shelf or in the refrigerator) to ensure its strength, quality, and purity.

At the completion of the drug preparation operation, the product shall be examined by the pharmacist for correct labeling.

H. Records and Reports

Any procedures or other records required to be maintained in compliance with these Good Compounding Practices shall be retained for the same period of time as each State requires for the retention of prescription files.

All records required to be retained under these Good Compounding Practices, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection.

Records required under these Good Compounding Practices may be retained either as the original records or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. (10/12/93)

07-03: SAMPLES

07-03-0001 -DRUG SAMPLES DEFINITIONS

A. The term "Drug Sample" means a unit of a "Legend Drug" which is distributed to a practitioner by a manufacturer or a manufacturer's representative at no charge, is not intended to be sold, and is intended to promote the sale of the drug. "Drug Sample" shall not mean a drug under clinical investigations approved by the Federal Food and Drug Administration.

B. The term "Coupon" means a form which may be redeemed as part of, or all of, the cost of a prescription for a legend drug after it has been dispensed.

C. The term "Legend Drug" means a drug limited by Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act to being dispensed by or upon a medical practitioner's prescription because the drug is (a) habit forming, (b) toxic or having potential for harm, or (c) the new drug application for the drug limits its use to use under a practitioner's supervision. The product label of which is required to contain the statement "CAUTION, FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION."

Provided, however, a legend includes prescription drugs subject to the requirement of Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act which shall be exempt from Section 502(f)(1) if certain specified conditions are met.

Unprofessional conduct pursuant to Regulation # 02-04-0001 shall include the following:

1. It shall be unprofessional conduct for a licensed pharmacy, pharmacist, or pharmacy intern licensed in the state of Arkansas to sell, purchase, or trade or offer to sell, purchase, or trade any drug sample.

2. It shall be considered unprofessional conduct for any licensed pharmacy, pharmacist, or pharmacy intern licensed in the state of Arkansas to sell, purchase, trade, or counterfeit, or offer to sell, purchase, trade, or counterfeit any "coupon."

3.

a.

The possession of a "Drug Sample" by a pharmacy, pharmacist or licensed intern shall be considered unprofessional conduct unless prior approval has been obtained from the Board of Pharmacy or unless the sample was provided for personal use by the pharmacist, intern, or his family,

b. If a licensed pharmacy, pharmacist, or pharmacy intern believes that he or she has a valid reason to possess and/or distribute a "Drug Sample" free of charge, the involved pharmacist shall make a written request to the Board of Pharmacy so that the Board may review the request to assure that there is not a violation of Federal or State law or Board of Pharmacy regulation.

Upon written request stating the purpose or use of drug sample and quantity to be possessed, the Board shall approve possession of sample drugs when reasonably necessary to serve a public purpose when consistent with federal and state law. The Board may impose any conditions upon possession as determined appropriate.

The pharmacist in charge of the pharmacy where the drug samples will\ be located shall maintain same separated from other stock and in original sample packages.

No compensation shall be charged for sample drugs. 10/12/86

07-04: CONTROLLED SUBSTANCES

07-04-0001 -SCHEDULE II PRESCRIPTION DRUGS

1. Emergency Prescriptions -- In the case of an emergency situation, as defined by this regulation, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner -- provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (never more than 72 hours). Dispensing, beyond the emergency period, must be pursuant to a written prescription signed by the prescribing individual practitioner. For the purposes of authorizing an oral prescription for a controlled substance listed in Schedule II of the Arkansas Controlled Substance List, the term "emergency situation" means those situations in which the prescribing practitioner determines that:

(A) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;

(B) No appropriate alternative treatment is available (which includes the administration of a drug which is not a Schedule II), and

(C) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the pharmacist dispensing the drug prior to the dispensing.

The prescription shall be immediately reduced to writing by the pharmacist. Within seven (7) days after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The statement "Authorization for Emergency Dispensing," and the date of the oral order, must be on the face of the prescription. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the D.E.A. if the prescribing practitioner fails to deliver a written prescription-failure of the pharmacist to do so shall void the authority conferred by this regulation to dispense without a written prescription of a prescribing practitioner.

07-04-0002 -PARTIAL FILLING OF A SCHEDULE II PRESCRIPTION -

The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription).

The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

A prescription, for a Schedule II controlled substance written for a patient in a long term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist may contact the practitioner prior to partially filling\ the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record, on the prescription, whether the patient is "terminally ill" or an "LTCF patient".

For each partial filling, the dispensing pharmacist shall record, on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable), the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.

Prior to any subsequent partial filling, the pharmacist is to determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed, in all partial filling, must not exceed the total quantity prescribed. A Schedule II prescription for a patient in a LTCF or a patient with a medical diagnosis documenting a terminal illness, if partially filled, shall be totally dispensed within 60 days and dispensing cannot occur after 60 days or after the medication has been discontinued by the prescriber.

07-04-0003 -COMPUTER RECORDS FOR PARTIAL FILLING -

Information, pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness, may be maintained in a computerized system - if the system has the capability to permit:

(1) Output (display or print) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity) and listing of the partial fillings that have been dispensed under each prescription.)

(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.

(3) Retrieval of partially filled Schedule II prescription information is the same as required for Schedule III and IV prescription refill information.

The authority to dispense Schedule II prescriptions for partial quantities does not apply to other classes of patients - such as a patient with severe intractable pain who is not diagnosed as terminal.

07-04-0004 -TIME LIMIT ON A NEW SCHEDULE II PRESCRIPTION -

Prescriptions written for Schedule II controlled substances may be dispensed up to six (6) months from the date written if the pharmacist is certain of the validity of the prescription. An exception to this would be prescriptions written for a patient classified as terminally ill or a long term care facility patient and these prescriptions are valid for 60 days from date of issue and may be partially filled. (2/15/95 Amended:10/14/97)

07-04-0005 -SCHEDULE V--EXEMPT NARCOTICS

A pharmacist may sell a Schedule Five exempt product only after a personal consultation with the patient wanting to purchase the product. A determination must be made confirming that the person has a medical need for the product.

If the pharmacist has reason to believe that the patient has self medicated with a Schedule Five exempt product, for more than ten days, the sale should not be repeated without a valid explanation. If the pharmacist does not accept the explanation, the patient should be referred to a physician.

The pharmacist or pharmacy should seriously question situations where records suggest that the patient is self-medicating by buying these products more than twice in 30 days, when sales in two consecutive months total more than four or when it appears the patient makes purchases every month.

if a sale is made, the pharmacist must:

1. Make the determination to sell;

2. Assure the exempt book is kept properly and signed by the pharmacist;

3. Be able to identify the patient by personal knowledge, photo I.D., or other identification. 6/07/90

07-04-0006 -DESTRUCTION OR LOSS OF CONTROLLED DRUGS

In the event a holder of a pharmacy permit issued by the Arkansas State Board of Pharmacy Under A.C.A. 17-92-405 and Regulation # 04-05-0001 of the Regulations of the Arkansas State Board of Pharmacy has suffered:

A. A destruction in whole or in part of his stock or supply of controlled substances required to be dispensed only on the prescription of a physician, dentist or veterinarian through or by fire, storm or tornado, or

B. A loss in whole or in part of his stock or supply of controlled substances as described in (A), by theft, robbery, vandalism, riot, or unexplained disappearance, the said holder of a pharmacy permit shall submit to the Arkansas State Board of Health an inventory of Schedule 2, 3, 4, and 5 drugs described in (A).

1. lost stolen or otherwise missing

2. an inventory of Schedule 2,3,4, and 5 drugs remaining or a copy of D.E.A. form 106.

Said inventory shall be furnished by said holder within seven days of the occurrence of said loss or the discovery of loss. 10/09/83

08 : WHOLESALE DISTRIBUTION

08-00: WHOLESALE DRUG DISTRIBUTORS OF LEGEND/CONTROLLED SUBSTANCES

08-00-0001 -DEFINITIONS

As used in this Regulation, unless the context otherwise requires.

1. Board means the Arkansas State Board of Pharmacy;

2. Person includes individual, partnership, corporation, business firm and association;

3. Controlled substance means those substances, drugs, or immediate precursors listed in Schedules l through VI of the Uniform Controlled Substances Act, 5-64-101 et seq., and revised by the coordinator pursuant to his authority under 5-64-214 - 5-64-216;

4. Legend drug means a drug limited by the federal Food, Drug, and Cosmetic Act to being dispensed by or upon a medical practitioner's prescription because the drug is:

i. Habit-forming;

ii. Toxic or having potential for harm;

iii. Limited in its use to use under a practitioner's supervision by the new drug application for the drug.

a. The product label of a legend drug is required to contain the statement "CAUTION; FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION."

b. A legend drug includes prescription drugs subject to the requirement of the Federal Food, Drug, and Cosmetic Act which shall be exempt if certain specified conditions are met.

5. Prescription drug means controlled substances, legend drugs and veterinary legend drugs as defined herein.

6. Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

7. Blood component means that part of blood separated by physical or mechanical means.

8. Manufacturer means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.

9. Wholesale distribution means the distribution of prescription drugs to persons other than consumers or patients, but does not include:

a. Intra-company sales:

c. The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization or from other hospitals or health care entities that are members of such organizations:

d. The sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the federal Internal Revenue Code to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

e. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control; for the purposes of this regulation common control means the power to direct or cause the direction of the management and policies of a person or an organization whether by ownership or stock or voting rights, by contract or otherwise;

f. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug; or the dispensing of a drug pursuant to a prescription;

g. The distribution of drug samples by manufacturers' representatives or distributors' representatives; or h. The sale, purchase or trade of blood components intended for transfusion.

10. Wholesale distributor means any person engaged in wholesale distribution of prescription drugs, including but not limited to manufacturers; repackers* own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; prescription drug repackagers; physicians; dentists, veterinarians; birth control and other clinics; individuals; hospital; nursing homes and their providers; health maintenance organizations and other health care providers; and retail and hospital pharmacies that conduct wholesale distributions. A wholesale drug distributor shall not include any for-hire carrier or person or entity hired solely to transport prescription drugs.

11. Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

12. Veterinary legend drugs means drugs defined in 21 CFR 201.105 and bearing a label required to bear the cautionary statement, "CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LI CENSED VETERINARIAN."

08-00-0002 -SALES PERMIT REQUIRED.

It shall be unlawful for any person to sell or offer for sale by advertisement, circular, letter, sign, or oral solicitation or any other means any prescription drug unless the person holds and possesses a permit authorizing such sale as provided by this regulation.

08-00-0003 -WHOLESALE DISTRIBUTOR-PERMIT REQUIRED.

1. Every wholesale distributor who shall engage in the wholesale distribution of prescription drugs, to include without limitation, manufacturing in this state, shipping into this state or selling or offering to sell in this state, shall register annually with the Arkansas State Board of Pharmacy by application for a permit on a form furnished by the Board and accompanied by a fee as defined in Regulation 01-00-0007. The Board may require a separate license for each facility directly or indirectly owned or operated by the same business entity within this state, or for a parent entity with divisions, subdivisions, subsidiaries, and/or affiliate companies within this state when operations are conducted at more than one location and there exists joint ownership and control among all the entities.

2.

A. The permit may be renewed annually at a renewal permit fee as defined in Regulation 01 -00-0007.

B. AN permits issued under this section shall expire on December 31, of each year. A penalty, as defined in Regulation 01-00-0007, will be charged, provided that if the renewal is unpaid by April 1, of any year, the license shall be null and void.

3.

A. Upon a change of ownership of a wholesale distributor, as set out herein, a new permit shall be secured by the new owner(s). The new owner(s) can continue operation of the wholesale distributor for fourteen (14) days after the effective date of the change of ownership; after said fourteen (14) day period the permit issued to the prior owner shall be void and the operation of the wholesale distributor in Arkansas shall cease.

B. A change of ownership of a wholesale distributor occurs under, but is not limited to, the following circumstances:

1. A change of ownership of a wholesale distributor owned by a SOLE PROPRIETOR, is deemed to have occurred when:

a. The business is sold and the sale becomes final or the new owner assumes control of the wholesale distributor -- which ever occurs first.

b. The proprietor enters into a partnership with another individual or business entity.

2. A change of ownership of a wholesale distributor, owned by PARTNERSHIP, is deemed to have occurred when:

a. There is an addition or deletion of one or more partners in a partnership to which a wholesale distributor's license has been issued.

b. The business is sold and the sale becomes final or the new owner assumes control of the wholesale distributor -- which ever occurs first.

3. A change of ownership of a wholesale distributor, owned by a

CORPORATION, is deemed to have occurred when:

a. An individual or business acquires or disposes of twenty percent (20%) of the corporations outstanding shares of voting stock. (This shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over the counter market); or

b. The corporation merges with another business or corporation. (The corporation owning the wholesale distributor is required to notify the Arkansas State Board of Pharmacy if a change of ownership or merger occurs within the parent corporation of the corporation which owns the wholesale distributor); or

c. The corporation's charter expires or is forfeited.

d. The business is sold and the sale becomes final or the new owner assumes control of the wholesale distributor -- which ever occurs first.

4. Each permit issued hereunder shall be displayed by the holder thereof in a conspicuous place.

08-00-0004 -SHIPMENT TO CERTAIN LICENSED PROFESSIONALS.

1. All wholesale distributors must, before shipping to a recipient in this state any prescription drug as defined in this regulation, ascertain that the person to whom shipment is made is either a licensed physician licensed by the Arkansas State Medical Board, a licensed Doctor of Dentistry, a licensed Doctor of Veterinary Medicine, a licensed Doctor of Podiatry Medicine, a hospital licensed by the State Board of Health, a licensed wholesale distributor as defined in this regulation, a licensed pharmacy licensed by the Arkansas State Board of Pharmacy, or other entity authorized by law to purchase or possess prescription drugs.

2. No wholesale distributor shall ship any prescription drug to any person after receiving written notice from the board or other state or federal agency that the person no longer holds a registered pharmacy permit or is not a licensed physician, dentist, veterinarian or hospital.

08-00-0005 -MII NIMUM REQUIRED INFORMATION FOR LICENSURE.

1. The Arkansas Board of Pharmacy requires the following from each wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license:

a. The name, full business address, and telephone number of the licensee;

b. All trade or business names used by the licensee;

c. Addresses, telephone numbers, and the names of contact persons for the facility used by the license for the storage, handling, and distribution of prescription drugs;

d. The type of ownership or operation (i.e. partnership, corporation, or sole proprietorship); and

e. The name(s) of the owner and/or operator of the licensee, including:

i. If a person, the name of the person;

ii. If a partnership, the name of each partner, and the name of the partnership;

iii. If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the State of incorporation, and the name of the parent company, if any;

iv. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.

2. Where operations are conducted at more than one location by a single holesale distributor, each such location shall be licensed by the Arkansas Board of Pharmacy.

3. Changes in any information on the application for licensure shall be submitted to the Arkansas Board of Pharmacy within 30 days after such change.

08-00-0006 -MINIMUM QUALIFICATIONS.

1. The Arkansas Board of Pharmacy will consider the following factors in determining eligibility for licensure of persons who engage in the wholesale distribution of prescription drugs.

a. Any convictions of the applicant under any Federal, State, or local laws regulation to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

b. Any felony convictions of the applicant under Federal, State, or local laws;

c. The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

d. The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

e. Suspension or revocation by Federal, State, or local government of any License currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

f. Compliance with licensing requirements under previously granted licenses, if any;

g. Compliance with the requirements to maintain and/or make available to the State licensing authority or to Federal, State, or local law enforcement officials those records required to be maintained by wholesale drug distributors;

h. Any other factors or qualifications the Arkansas Board of Pharmacy considers relevant to and consistent with the public health and safety.

The Arkansas Board of Pharmacy reserves the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.

08-00-0007 -PERSONNEL

The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

08-00-0008 -MINIMUM REQUIREMENTS FOR THE STORAGE AND HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT AND MAINTENANCE OF PRESCRIPTION DRUG DISTRIBUTION RECORDS.

The following are required for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees.

1. Facilities. Ail facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed or displayed shall:

a. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operation;

b. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

c. Have a designated and clearly identified area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened;

d. Be maintained in a clean and orderly condition; and e. Be free from infestation by insects, rodents, birds, or vermin of any kind.

2. Security.

a. All facilities used for wholesale drug distribution shall be secure from unauthorized entry.

i. Access from outside the premises shall be kept to a minimum and well controlled,

ii. The outside perimeter of the premises shall be well-lighted,

iii. Entry into areas where prescription drugs are held shall be limited to authorized personnel.

b. All facilities shall be equipped with an alarm system to detect entry after hours.

c. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records. Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any in the labeling of such drugs with requirement in the current edition of an official compendium.

a. If no storage requirements are established for a prescription drug, the drug may be held at "controlled" temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

b. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.

c. The record keeping requirements in paragraph six of this section shall be followed for all stored drugs.

4. Examination of materials.

a. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

b. Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

c. The record keeping requirements in paragraph six of this section shall be followed for all incoming and outgoing prescription drugs.

5. Returned, Damaged, and Outdated Prescription Drugs.

a. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

b. Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

c. If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

d. The record keeping requirements in paragraph six of this section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

6. Record keeping.

a. Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:

i. The source of the drugs, including the name and principal address of the seller or transfer or, and the address of the location from which the drugs were shipped;

ii. The identity and quantity of the drugs received and distributed or disposed of, and

iii. The dates of receipt and distribution or other disposition of the drugs.

b. Inventories and records shall be made available for inspection and photocopying by any official authorized by the Arkansas Board of pharmacy for a period of two years following disposition of the drugs.

c. Records described in this regulation that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by any official authorized by the Arkansas Board of Pharmacy.

08-00-0009 -WRITTEN POLICIES AND PROCEDURES.

Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies and procedures the following:

A. A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.

B. A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

1. Any action initiated at the request of the Food and Drug Administration or other Federal, State, or local law enforcement of other government agency, including the Arkansas Board of Pharmacy;

2. Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

3. Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

C. A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, State, or national emergency.

D. A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two years after disposition of the outdated drug.

08-00-0010 -RESPONSIBLE PERSONS.

Wholesale drug distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

. 08-00-0011 -COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAWS.

Wholesale drug distributors shall operate in compliance with applicable Federal, State, And local laws and regulations.

Wholesale drug distributions that deal in controlled substances shall register with the appropriate State Controlled substance authority and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, local, and DEA regulations.

08-00-0012 -SALVAGING AND REPROCESSING.

Wholesale drug distributors shall be subject to the provisions of any applicable Federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including Chapter 21, parts 207,210d, 211 of the Code of Federal Regulations.

08-00-0013 -APPLICABILITY.

Nothing in this regulation shall apply to the sale of chemicals or poisons for use for non medical purposes or for uses as insecticides or biologies or medicine used for the cure, mitigation, or prevention of disease of animals or fowl or for agricultural uses which comply with the requirements of the Federal Food, Drug, and Cosmetic Act and all amendments thereto UNLESS THOSE PRODUCTS ARE PRESCRIPTION DRUGS UNDER THIS REGULATION.

08-00-0013 -INSPECTION OF PREMISES AND RECORDS.

The Board may conduct inspections upon all premises, including delivery vehicles, Purporting or appearing to be used by a person licensed under this regulation. The Board, in its discretion, may accept a satisfactory inspection by the United States Food and Drug Administration (USFDA) or a state agency of another state which the Board determines to be comparable to that made by USFDA or the Arkansas Board of Pharmacy. 6/22/84 (Revised 6/20/91, 6/23/96, and 8/23/96).

08-01: MEDICAL EQUIPMENT. LEGEND DEVICES. AND/OR MEDICAL GAS

08-01-0001 -DEFINITIONS:

(A) "Home Medical Equipment, Legend Device, and Medical Gas Supplier" means a person, business, corporation, agency, company, etc., licensed to supply home medical equipment, medical gases and/or legend devices to patients on an order from medical practitioners licensed to order, use, or administer these products and to other persons, businesses, corporations, agencies, companies, etc., licensed to supply home medical equipment, medical gases, and/or legend devices.

(B) "Home Medical Equipment Services" means the delivery, installation, maintenance, replacement, and/or instruction in the use of medical equipment, used by a sick or disabled individual, to allow the individual to be maintained in a noninstitutional environment.

(C) "Legend Device," means a device which, because of any potential for harmful effect or the method of its use, is not safe - except under the supervision of a practitioner. These devices, as approved by F.D.A., may be labeled "Caution: Federal (USA) law restricts this device to sale by or on the order of a physician."

(D)

(1) "Medical Equipment" means technologically sophisticated medical devices including but not limited to:

(a) Oxygen and oxygen delivery systems;

(b) Ventilators;

(c) Respiratory disease management devices;

(d) Electronic and computer driven wheelchairs and seating systems;

(e) Apnea monitors;

(f) Transcutaneous electrical nerve stimulator (T.E.N.S.) units;

(g) Low air loss cutaneous pressure management devices;

(h) Sequential compression devices;

(i) Neonatal home phototherapy devices;

(j) Feeding pumps;

(k) Electrically-powered hospital beds;

(I) Infusion pumps; and

(m) Patient Lifts.

(2) The term "medical equipment" does not include:

(a) medical equipment used or dispensed in the normal course of treating patients by hospitals, hospices, nursing facilities, or home health agencies;

(b) medical equipment used or dispensed by health care professionals, licensed in Arkansas - provided the professional is practicing within the scope of that professional's practice act;

(c) upper and lower extremity prosthetics and related orthotics; or

(d) canes, crutches, walkers, bathtub grab bars, standard wheelchairs, commode chairs, and bath benches.

(E) "Medical Gas" means those gases and liquid oxygen intended for human consumption.

(F) "Order" means an order issued by a licensed medical practitioner legally authorized to order medical gases and/or legend devices.

08-01-0002 -LICENSURE REQUIRED:

(A) No person or entity, subject to licensure, shall sell or rent or offer to sell or rent directly to patients in this state any home medical equipment, legend devices, and/or medical gases, unless the person or entity is licensed as required by Act 1101.

The licensure requirements of this act will apply to all companies, agencies, and other business entities that are in the business of supplying medical equipment to patients in their home and which bill the patient or the patient's insurance, Medicare, Medicaid, or other third-party payor for the rent or sale of that equipment. The application for a license shall be on a form, furnished by the Board, and shall be accompanied by payment of fee as defined in Regulation 01-00-0007. The Board shall require a separate license for each facility directly or indirectly owned or operated, within this state, by the same person or business entity within this state, or for a parent entity with divisions, subdivisions, subsidiaries, and/or affiliate companies when operations are conducted at more than one location and there exists joint ownership and control among all the entities.

(B)

(1) The annual license renewal fee is defined in Regulation 01-00-0007.

(2) All licenses issued under this act shall expire on December 31, of each calendar year.

(3) Each application for renewal of the license must be made on or before December 31 of each year. Penalties for late payment are defined in Regulation 01-00-0007. The license shall be considered null and void if the fee is not paid by April 1 of each year.

(C) Each license issued hereunder shall be displayed by the holder thereof in a conspicuous place.

08-01-0003 -STANDARDS OF PRACTICE:

(A) Written policies and procedures must be available for review and designed to meet all the following standards. Documentation of all staff training must be kept in each employee's personnel file. All local, state, and federal regulatory agency policies concerning HME and oxygen must be followed.

(1) Order Intake: A home medical equipment (HME) provider shall recognize the importance of order intake. The provider is responsible for assuring that order intake personnel are appropriately trained in the following:

(a) Identifying equipment;

(b) Determining patient/caregiver needs;

(c) Determining referral sources needs;

(d) Knowing equipment coverage criteria based on diagnosis;

(e) Responding appropriately during a medical equipment emergency;

(f) Explaining service procedures;

(g) Billing third party; and

(h) Verifying insurance.

The provider must assure that only trained order intake personnel receive referrals.

(2) Selection of Appropriate Equipment:

(a) When providing equipment services for a patient, a provider shall consider: physician orders, equipment needs of the patient, economic situation of the patient and caregiver, and requirement of any third party payor source.

(b) A provider shall recognize those items which require special fitting and evaluation, fitting of custom items shall be performed within a reasonable time frame by specially trained personnel.

(3) Delivery and Set-Up/Patient and Caregiver Education:

(a) A provider shall maintain trained personnel to coordinate order fulfillment and to schedule equipment services with timely delivery. Documentation of training will be maintained.

(b) A provider shall assure delivery personnel are appropriately trained to:

(A) Conduct an environment/equipment compatibility assessment.

(B) Appropriately and safely set up the equipment.

(C) Instruct patient and caregivers in the safe operation and client maintenance of the equipment.

(D) Recognize when additional education and/or follow-up patient compliance monitoring is appropriate.

(c) Written instructions must be provided to the patient/caregiver upon delivery and documentation of receipt of written instruction must be maintained in the patient record.

(4) Services During Use:

(a) A provider shall document that patients are advised of service hours and emergency service procedures. If equipment malfunction may threaten the customer's health, access to 24 hour per day, 365 days per year emergency service must be available for equipment maintenance or replacement.

(b) A provider shall establish a schedule at the time of the initial delivery for any appropriate follow-up HME services such as periodic maintenance, supply delivery and other related activities.

(5) Retrieval/Disinfection/Maintenance:

(a) A provider shall assure that state/federal requirements for equipment disinfection are followed including red-tagging for bio-hazards, maintaining dirty equipment isolation, equipment cleaning and disinfection areas and procedures, and appropriate staff training on hazard prevention.

(b) Cleaning and disinfection solutions must be bactericidal, tuberculocidal, and viricidal.

(c) CDC Universal precautions and OSHA regulations concerning equipment handling must be followed.

(d) Create and implement a preventative maintenance program based on manufacturers' guidelines which include appropriate record keeping. Trained staff must be utilized.

(6) Patient Record:

(a) A supplier must maintain a record for each customer when required by state or federal law or when a physician's order is required.

(b) The patient record must include an intake form and applicable physician's orders.

(c) Records should be safeguarded from loss and kept confidential.

(d) Documentation of proper patient/caregiver instruction must be maintained in the patient record.

(7) Patient Rights:

(a) The patient has the right to considerate and respectful service.

(b) The patient has the right to obtain service without regard to race, creed, national origin, sex, age, disability, diagnosis or religious affiliation.

(c) Subject to applicable law, the patient has the right to confidentiality of all information pertaining to his/her medical equipment and service. Individuals or organizations not involved in the patient's care may not have access to the information without the patient's written consent.

(d) The patient has the right to a timely response to his/her request for HME services.

(e) The patient has the right to select the HME supplier of his/her choice.

(f) The patient has the right to voice grievances without fear of termination of service or other reprisals.

(g) The patient has the right to expect reasonable continuity of service.

(h) The patient has the right to an explanation of charges for equipment and supplies.

(8) Quality Assurance:

(a) There is an ongoing continuous quality improvement program designed to monitor and evaluate quality of patient care, improvement of patient services, if applicable, and resolution of identified problems.

(b) Continuous quality improvement activities are defined in a written plan.

(c) Issues monitored should be determined by evaluating all complaints or incidents and items that are high volume, high risk or problem prone.

(9) Liability insurance coverage for products provided and operations of each licensed entity is required in the amount of at least $500,000.

(B) Prohibited Practices -- The following practices are prohibited:

(1) Patient Freedom of Choice:

(a) Participation in any plan, agreement, or arrangement which eliminates the patient's right to select a provider, licensed under this act, of their choice shall be considered a violation of this regulation.

(2) Bribes Kickbacks and Rebates:

(a) It shall be considered a violation of this regulation for anyone to knowingly and willfully offer, pay, solicit or receive any payment in return for referring an individual to another person for the furnishing, or arranging for the furnishing, of any item or service covered by this regulation. (10/13/95, amended 8/23/96).

09 - PHARMACEUTICAL CARE/PATIENT COUNSELLING

09-00: PATIENT COUNSELLING

09-00-0001 -PATIENT INFORMATION, DRUG USE EVALUATION, AND PATIENT COUNSELING.

The intent of this regulation is to improve pharmaceutical care by defining basic standards of care. Pharmacy care/ pharmaceutical care is defined as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes are:

(1) cure of disease; (2)elimination or reduction of a patient's symptomatology; (3)arresting or slowing a disease process; or (4)preventing a disease or symptomatology.

Pharmaceutical care (clinical pharmacy) involves four major functions on behalf of the patient;

(1) identifying potential and actual drug-related problems;

(2)resolving actual drug related problems;

(3)preventing potential drug-related problems; and

(4)optimizing patient therapy outcomes. It is recognized that the patient might be best served if medication is not provided.

Section I: PATIENT INFORMATION (PROFILE)

In order to effectively counsel patients, the pharmacist must, through communication with the patient or caregiver, make a reasonable effort to obtain, record, and maintain the following information for each patient. It is recognized that most of this can be obtained using "qualified pharmacy employees" and designed forms, etc.

A) Name, Address, Telephone Number;

B) Date of Birth (Age), Gender;

C) Medical History

1. Significant patient health problems known to the pharmacist.

2. Prescription drug reactions/prescription drug allergies

3. List of prescription medications and legend drug administration devices known to the pharmacist.

D) Transitory patients or situations where the pharmacy will only provide medication one time-In obtaining patient information, if the pharmacist knows or is informed by the patient that this is a one-time situation, the pharmacist may forego the above requirement to record and maintain the information.

E) Pharmacist comments

Section II: DRUG USE EVALUAT!ON-For New and Refill Prescriptions Drug use evaluation or drug utilization review includes the following activities:

A) The pharmacist shall evaluate the prescription or medication order for:

1. Reasonable dose and route of administration.

2. Reasonable directions for use.

B) The pharmacist shall evaluate medication orders and patient information for:

1. Duplication of therapy - is the patient taking same or similar medication(s).

2. Prescription drug-prescription drug interactions

3. Proper utilization (over or under utilization).

4. Known drug allergies.

Drug-Drug Contraindications as defined by the Board. (Is this medication contraindicated with another medication the patient is taking?) It is recognized that the ultimate decision to use the medication or not use the medication rests with the physician who has more complete patient information. It is the pharmacist's responsibility to monitor the patient's medication therapy in the areas addressed in this regulation and inform the physician of the suspected problem.

If a problem is suspected and the physician is informed, the pharmacist shall document the process.

Section III : PATIENT COUNSELING

* A pharmacist shall counsel the patient or caregiver "face to face" if the patient or caregiver is in the pharmacy. If not, a pharmacist shall make a reasonable effort to counsel the patient or caregiver;

* Alternative forms of patient information may be used to supplement, but not replace face to face patient counseling;

* Patient counseling, as described herein, shall also be required for outpatients of hospitals and institutions when medications are dispensed on discharge from the hospital or institution.

* Patient counseling as described in this Regulation shall not be required for inpatients of a hospital or institution where a nurse or other licensed health care professional is authorized to administer the medication. However, the pharmacist shall provide drug therapy counseling when professionally deemed to be appropriate and when medications are provided by the pharmacy, when a pharmacist is on duty and a patient is discharged from the hospital or institution.

* The pharmacist shall maintain and make available to all patients appropriate patient-oriented reference materials USP-DI or Facts and Comparisons Patient Drug Facts or an equivalent or better as determined by the Board.

* It is recognized that the ultimate decision to not provide patient counseling rests with the physician. If the physician in specific instances (blanket requests not accepted) requests that information NOT be provided to the patient and gives reason, the pharmacist should honor that request in almost all instances.

PATIENT COUNSELING shall mean the effective communication by the pharmacist of information, as defined in this act to the patient or caregiver, in order to improve therapeutic outcome by encouraging proper use of prescription medications and drug delivery devices.

1) For original prescription medication orders, (excluding renewed or updated prescriptions the patient has been recently taking) and orders for legend devices specific areas of counseling shall include:

a) Name and general description of the medication dispensed, i.e. antibiotic, antihistamine, blood pressure medicine, etc.

b) Name, general description and directions for use of drug delivery devices, i.e., insulin syringes, morphine pump, etc.

c) Explain route of administration, dosage, times of administration, and continuity of therapy;

d) Special directions for storage as deemed necessary by the pharmacist;

e) If the drug has been determined to have a significant side effect by the Board of Pharmacy, the patient shall be properly counseled to the extent deemed necessary by the pharmacist.

f) When the prescription drug dispensed has a significant side effect, if taken with OTC drugs, the pharmacist should counsel the patient about that interaction. (Example: Coumadin with Aspirin)

g) If the prescription medication is significantly affected by food or diet the pharmacist should so advise the patient. (Example: Tetracycline with milk or food)

h) The pharmacist shall inform the patient or caregiver that he/she is available to answer questions about medications or general health information.

2) Refills-On refills the pharmacist shall present the opportunity for the patient or caregiver to ask questions. However, counseling on refills is not required except when needed in the professional judgement of the pharmacist.

Section IV: DRUG INTERACTIONS-SIGNIFICANT SIDE EFFECTS

Recognizing that a pharmacist cannot be expected to recognize all possible drug interactions and also recognizing that the pharmacist and the patient does not have time to explain the numerous side effects of drugs, the pharmacy shall maintain a computer program which will identify Significant Drug Interactions (These are drugs with side effects which may be managed most effectively if the patient is aware of the specific side effect and what to do if it occurs.) The pharmacist in charge will be responsible for assuring that the computer system adequately flags and warns the pharmacist of any occurrence of significant drug interactions or significant side effects. (If a pharmacy was in business before September 1,1997, and a that time, did not have a computer system, said pharmacy may substitute Patient Drug Facts or other drug interaction manuals to reference drug interactions and side effects for effective patient counseling. This method should only be used until such time as the pharmacy acquires and adequate computer program as described in this section.)

The pharmacist will be responsible for counseling the patient on these interactions with verbal and, where appropriate, written information. (2/12/91, 2/10/98)

09-00-0002 -PRESCRIPTION ORDERS TO ADMINISTER MEDICATION AND/OR IMMUNIZATIONS

A. MEDICATIONS ADMINISTRATION ADVISORY COMMITTEE:

1. The purpose of the Medication Administration Advisory Committee shall include functioning in an advisory capacity to assist the Board with implementation and oversight of the provisions regarding medication administration authority.

2. The Medication Administration Advisory Committee shall be composed of five members, to be approved by the Governor, who have the following qualifications:

a. Two members shall be licensed physicians selected from a list of three names per position submitted jointly by the State Medical Board and the Arkansas Medical Society.

b. Two members shall be licensed pharmacists- one pharmacist shall be recommended by the Arkansas Pharmacists Association and one pharmacist shall be a member of the Arkansas State Board of Pharmacy.

c. One member shall be an advanced practice nurse holding a certificate of prescriptive authority selected from a list of three names submitted jointly by the State Nursing Board and the Arkansas Nurses Association.

d. The Board may remove any advisory committee member, after notice and hearing for incapacity, incompetence, neglect of duty, or malfeasance in office.

e. The members shall serve without compensation, but may be reimbursed to the extent special moneys are appropriated therefor for actual and necessary expenses incurred in the performance of their duties.

3. The five initial members appointed to the committee shall draw lots to determine staggered lengths of their initial terms. Successive members shall serve three (3) year terms.

B. AUTHORITY FOR PHARMACIST TO ADMINISTER MEDICATIONS/IMMUNIZATIONS:

1. Pharmacists may provide pharmaceutical care to patients over the age of eighteen (18) by administering medications or immunizations to an eligible patient upon a valid prescription order by a practitioner so authorized to prescribe such medications or immunizations. A prescription order for a medication or immunization shall constitute a unique class of prescriptions and shall apply to any person over the age of eighteen (18) desiring a medication or immunization. A prescription from a practitioner for administration, by a pharmacist, of an approved medication or immunization will be known as an "Authority to Administer."

2. An Authority to Administer, once granted, is valid for a time period not to exceed one (1) year--unless such an order is invalidated by the practitioner granting the authority.

3. An Authority to Administer is valid only for the pharmacist meeting the requirements set forth by the Arkansas State Board of Pharmacy and is not transferable.

4. Unless otherwise specifically authorized, by the Board, a person must possess the following qualifications to be qualified to accept an initial Authority to Administer order:

a. obtain and maintain a license to practice pharmacy issued by the Arkansas State Board of Pharmacy;

b. successfully complete a Board approved course of study, examination, and certification consisting of a training program that includes the current guidelines and recommendations of the Centers of Disease Control and Prevention. The Course of study should include, at a minimum:

(i) basic immunology, including the human immune response;

(ii) the mechanism of immunity, adverse effects, dose, and administration schedule of available vaccines and approved medication/immunization;

(iii) how to handle an emergency situation in the event one should arise as a result of the administration of the medication /immunization;

(iv) how to persuade patients to be immunized and options for record keeping for patients that do get immunized;

(v) how to administer subcutaneous, intradermal, and intramuscular injection; and

(vi) record keeping requirements for these medications as required by law or regulation.

c. obtain supervised instructions on the physical administration of vaccines during such course of study and certification;

d. obtain and maintain current certification in Cardiopulmonary Resuscitation (CPR) or Basic Cardiac Life Support (BCLS); and e. successfully complete the above described course of study which shall be a minimum of 20 hours and shall qualify for continuing education credits. The provider of said course of study shall provide participants a certificate of completion which shall be displayed in the pharmacy at which the pharmacist is working. A copy of said certificate shall be mailed to the Board of Pharmacy offices and placed in the pharmacist's permanent file.

5. Continuing competency for certification for Authority to Administer must be maintained. A minimum of six (6) hours of the thirty (30) hour requirement for continuing education, every two years, must be dedicated to this area of practice.

6. An Authority to Administer order shall meet the following requirements:

a. must properly identify the practitioner issuing the order;

b. must identify the medication or vaccine covered in any such order

c. must properly identify the patient to receive any medication or immunization, by name, address, age, sex, and date of administration;

d. must identify the medication or vaccine administered, site of the administration, dose administered, identity of pharmacist administering the dose; and

e. must bear the date of the original order and the date of each administration.

C. SEVEN CLASSIFICATIONS OF APPROVED MEDICATIONS FOR ADMINISTRATION

1. Immunizations

2. Vaccines

3. Allergy Medications

4. Vitamins

5. Minerals

6. Antihyperglycemics

7. Anti-nausea Medications

09-00-0003 -REQUIREMENTS FOR DIABETES SELF-MANAGEMENT TRAINING FOR PHARMACISTS

In order to be certified to provide Diabetes Self-Management Training, a pharmacist shall complete an educational program which is approved by the Arkansas State Board of Pharmacy and in compliance with the National Standards for Diabetes Self-Management Education as developed by the American Diabetes Association.

The standards for the educational program are as follows:

1. The sponsoring organization shall have a written policy that affirms education as an integral component of diabetes care.

2. The sponsoring organization shall identify and provide the educational resources required to achieve its educational objectives in terms of its target population. These resources include adequate space, personnel, budget, and instructional materials.

3. The organizational relationships, lines of authority, staffing, job descriptions, and operational policies shall be clearly defined and documented.

4. The service area shall be assessed in order to define the target population and determine appropriate allocation of personnel and resources to serve the educational needs of the target population.

5. A standing advisory committee consisting of a pharmacist, physician, nurse educator, dietitian, and individual with behavioral science expertise, a consumer, and a community representative, at a minimum shall be established to oversee the program.

6. The advisory committee shall participate in the annual planning process, including determination of target audience, program objective, participant access mechanisms, instructional methods, resource requirements (including space, personnel, budget, and materials), participant follow up mechanisms, and program evaluation.

7. Professional program staff shall have sufficient time and resources for lesson planning, instruction, documentation, evaluation, and follow-up.

8. Community resources shall be assessed periodically.

9. A coordinator shall be designated who is responsible for program planning, implementation, and evaluation.

10. Health care professionals with recent didactic and experiential preparation in diabetes clinical and educational issues shall serve as the program instructors. The staff shall include at least a nurse educator and a dietitian who collaborate routinely. Certification as a diabetes educator by the National Certification Board for Diabetes Educators is recommended.

11. Professional program staff shall obtain education about diabetes educational principles, and behavioral change strategies on a continuing basis.

12. Based on the needs of the target population, the program shall be capable of offering instruction in the following content areas:

a. Diabetes overview

b. Stress and psychosocial adjustment

c. Family involvement and social support

d. Nutrition

e. Exercise and activity

f. Medications

g. Monitoring and use of results

h. Relationship among nutrition, exercise, medication, and blood glucose levels

i. Prevention, detection, and treatment of acute complications

j. Prevention, detection, and treatment of chronic complication

k. Foot, skin, and dental care

I. Behavior change strategies, goal setting, risk factor reduction, and problem solving

m. Benefits, risks, and management options for improving glucose control

n. Preconception care, pregnancy, and gestational diabetes

o. Use of health care systems and community resources

13. The program shall use instructional methods and materials that are appropriate for the target population and the participants being served.

14. A system shall be in place to inform the target population and potential referral sources of the availability and benefits of the program.

15. The program shall be conveniently and regularly available.

16. The program shall be responsive to requests for information and referrals from consumers, health care professionals, and health care agencies.

17. An individualized assessment shall be developed and updated in collaboration with each participant. The assessment shall include relevant medical history, present health status, health service or resource utilization, risk factors, diabetes knowledge and skills, cultural influences, health beliefs and attitudes health behaviors and goals, support systems, barriers to learning, and socioeconomic factors.

18. An individualized education plan, based on the assessment, shall be developed in collaboration with each participant.

19. The participant's educational experience, including assessment, intervention, evaluation, and follow-up, shall be documented in a permanent medical or education record. There shall be documentation of collaboration and coordination among program staff and other providers.

20. The program shall offer appropriate and timely educational interventions based on periodic reassessments of health status, knowledge, skills, attitudes, goals, and self-care behaviors.

21. The advisory committee shall review program performance annually, including all components of the annual program plan and curriculum, and use the information in subsequent planning and program modification.

22. The advisory committee shall annually review and evaluate predetermined outcomes for program participants.

09-00-O004 -DRUG THERAPY MANAGEMENT BY A PHARMACIST UNDER

WRITTEN PROTOCOL OF A PHYSICIAN.

The purpose of this regulation is to provide standards for the maintenance of records of a pharmacist engaged in the provision of drug therapy management as authorized in ? § 17-92-101(14) and ? § 17-92-205(a).

(A) DEFINITIONS: The following words and terms, when used in this regulation, shall have the following meanings, unless the context clearly indicates otherwise:

(1) ACT-The Arkansas Pharmacy Practice Act

(2) BOARD - The Arkansas State Board of Pharmacy

(3) CONFIDENTIAL RECORD - any health-related record maintained by a pharmacy or pharmacist-such as a patient medication record, prescription drug order, or medication order.

(4) DRUG THERAPY MANAGEMENT -The performance of specific acts of drug therapy management delegated to a pharmacist for an individual patient by an authorized practitioner through written protocol. (Drug therapy management shall not include the selection of drug products not prescribed by the practitioner, unless the drug product is named in the practitioner initiated protocol.)

(5) WRITTEN PROTOCOL - A practitioner's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Arkansas State Medical Board under the Medical Practice Act.

(a) A written protocol must contain at a minimum the following:

(i) a statement identifying the individual practitioner authorized to prescribe drugs and responsible for the delegation of drug therapy management;

(ii) a statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management delegated by the practitioner;

(iii) a statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make which shall include:

(I) A statement of the ailments or diseases involved, drugs, and types of drug therapy management authorized; and

(II) A specific statement of the procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority;

(iv) A statement of the activities the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation shall be recorded within a reasonable time of each intervention and may be performed on the patient medication record, patient medical chart, or in a separate log book; and

(v) A statement that describes appropriate mechanisms and time schedule for the pharmacist to report to the physician monitoring the pharmacist's exercise of delegated drug therapy management and the results of the drug therapy management.

(B) A standard protocol may be used, or the attending practitioner may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the practitioner shall record, what deviations if any, from the standard protocol are ordered for that patient.

(C) Maintenance of records:

(1) Every patient record required to be kept under this regulation shall be kept by the pharmacist and be available, for at least two years from the date of such record, for inspecting and copying by the Board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.

(2) Patient records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

(a) The records maintained in the alternative system contain all of the information required on a manual record; and

(b) The data processing system is capable of producing a hard copy of the record upon the request of the Board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

(D) Written protocol:

(1) A copy of the written protocol and any patient-specific deviations from the protocol shall be maintained by the pharmacist and available for inspection by a Board Inspector upon request.

(2) Written protocols, including standard protocols, any patient specific deviations from a standard protocol, and any individual patient protocol, shall be reviewed by the practitioner and pharmacist at least annually and revised, if necessary. Such review shall be documented in the pharmacist's records. Documentation of all services provided to the patient, by the pharmacist, shall be reviewed by the physician on the schedule established in the protocol.

(3) Any protocol from a practitioner shall be maintained in the pharmacy and available for inspection by a Board Inspector upon request.

(E) Confidentiality:

(1) A pharmacist shall provide adequate security to prevent indiscriminate or unauthorized access to confidential records. If confidential health information is not transmitted directly between a pharmacy and a practitioner, but is transmitted through a data communication device, the confidential health information may not be accessed or maintained by the operator of the data communication device unless specifically authorized to obtain the confidential information by this regulation.

(2) Confidential records are privileged and may be released only to:

(a) the patient or the patient's agent;

(b) practitioners and other pharmacists when, in the pharmacist's professional judgment

(c) other persons, the Board, or other state or federal agencies authorized by law to receive such information;

(d) a law enforcement agency engaged in investigation of suspected violations of the Controlled Substances Act; or

(e) a person employed by any state agency which licenses a practitioner as defined in the Act if such person is engaged in the performance of the person's official duties.

(3) This regulation shall not affect or alter the provisions relating to the confidentiality of the physician-patient communication as specified in the Medical Practice Act.

10 ARKANSAS PHARMACY SUPPORT GROUP

10-00-0001 -SUPPORT GROUP

A. Definitions. As used in this

(1) "Board" means the Arkansas State Board of Pharmacy;

(2) "Board-approved intervenors" means persons trained in intervention and designated by the Board to implement the intervention process when necessary;

(3) "Committee" means a committee appointed by the Board to formulate and administer the impaired pharmacists program;

(4) "Impaired pharmacist" means a pharmacist who is unable to practice pharmacy with reasonable skill, competency, or safety to the public because of substance abuse;

(5) "Impaired pharmacist program" means a plan approved by the Board for intervention, treatment, and rehabilitation of an impaired pharmacist;

(6) "Intervention" means a process whereby an alleged impaired pharmacist is confronted by the Board or Board-approved intervenors who provide documentation that a problem exists and attempt to convince the pharmacist to seek evaluation and treatment;

(7) "Rehabilitation" means the process whereby an impaired pharmacist advances in an impaired pharmacists program to an optimal level of competence to practice pharmacy without endangering the public; and

(8) "Verification" means a process whereby alleged professional impairment is identified or established.

B. Administration

(1) The Board may appoint a committee to organize and administer a program that shall fulfill two functions:

(a) the program shall serve as a diversion program to which the Board may refer licensees where appropriate in lieu of or in addition to other disciplinary action; and

(b) the program shall also be a source of treatment or referral for pharmacists who, on a strictly voluntary basis, desire to avail themselves of its services.

(2) The Board may appoint a committee of five persons who are recovering pharmacists to serve three year terms with the initial members appointed to staggered terms.

(3) The Board will consider recommendations from the Arkansas Pharmacy Support Group in making these appointments and any person appointed to the Committee shall continue appointment based on continued involvement in the Pharmacy Support Group.

C. Functions. The functions of the committee shall include:

(1) evaluation of pharmacists who request participation in the program;

(2) review designation of treatment facilities and services to which pharmacists in the program may be referred;

(3) receipt and review of information relating to the participation of pharmacists in the program;

(4) assisting the pharmacists' professional association in publicizing the program; and

(5) preparation of reports for the Board.

D. Board Referral.

(1) The Board shall inform each pharmacist referred to the program by Board action of the procedures followed in the program, of the rights and responsibilities of the pharmacist in the program and of the possible consequences of noncompliance with the program.

(2) The Board shall be informed of the failure of a pharmacist to comply with any treatment provision of the program if the committee determines that the resumption of the practice of pharmacy would pose a threat to the health and safety of the public.

(3) Participation in a program under this section shall not be a defense to any disciplinary action which may be taken by the Board. Further, no provision of this section shall preclude the Board from commencing disciplinary action against a licensee who is terminated from a program pursuant to this section.

(4) The Board shall be informed when pharmacists who enter the program resume professional practice.

E. Review Activities. The Board shall review the activities of the committee. As part of this evaluation, the Board may review files of all participants in the impairment program. The Board shall also resolve complaints voiced regarding the impaired pharmacists program.

F. Civil Liability.

(1) All persons acting on behalf of the Board in the impaired pharmacists program under this section shall be considered to be acting on behalf of the Board and considered officers or employees of the state.

(2) All patient records shall be confidential and shall not be subject to public inspection except pursuant to an order of a court of competent jurisdiction. However, the records may be introduced as evidence in any relevant proceedings before the Board and shall be produced upon Board request.

G. Funding. The Board is authorized to provide up to $5,000 per year to the committee for expenses incurred in management and operation of the program. Documentation of the use of these funds shall be provided to the Board of Pharmacy for review and comment.

Expenses considered for reimbursement by the Board shall be in the areas of travel as determined by the Board, phone or other necessary communication expenses, secretarial help, postage, food when traveling out of town of residence and acting on behalf of the Pharmacy Support Group other than meetings not to exceed $13 per day, unless specifically approved by the Board, limited meeting room costs and other expenses deemed appropriate by the "committee". Meal expense may be paid without overnight stay.

It is recognized that the Board will also consider special and specific requests for expenses to cover costs related to education or ability enhancement of committee or intervenor members to improve the Group or better serve the Group. 6/20/91

11 RETAIL/WHOLESALE PROPHYLACTIC PERMITS

11-00-0001 -RETAIL/WHOLESALE PROPHYLACTIC PERMITS

Every location holding a retail/wholesale prophylactic license issued by the Board including pharmacies shall cause periodic inspection and tests of prophylactics and contraceptives in order to determine their condition and shall report damaged or inferior merchandise to the Inspector of the Board of Pharmacy.

The Inspector of the Arkansas State Board of Pharmacy shall have free access to inspect and test all prophylactics and contraceptives. And any such merchandise considered to be out-dated, not properly labeled, or inferior in any way may be disposed of and cannot be sold, in order to protect the health and welfare of the general public. 10/09/80 (Revised 6/20/91)

(11/30/1998)

The following state regulations pages link to this page.