RULE 070.00.96-005 - Reg. 59 - Fees

RULE 070.00.96-005. Reg. 59 - Fees

REGULATION 59 : FEES.

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 fifty dollars ($50.00);

(4) The fee for issuance of a permit for the first time to operate a pharmacy or drugstore shall be two-hundred dollars ($200.00);

(5) The fee for annual renewal of a permit to operate a pharmacy or drugstore shall be one-hundred dollars ($100.00);

(6) When there is a change of ownership, a new permit must be obtained, and the fee shall be one-hundred dollars ($100.00);

(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 twenty-five dollars ($25.00);

(10) The fee for issuance of, and the annual renewal of, a hospital pharmaceutical service permit shall be one-hundred dollars ($100.00). The permit shall expire on December 31 of each year;

(11) The fee for issuance of, and the annual renewal of, an institutional pharmaceutical services permit shall be twenty dollars ($20.00). The permit shall expire on December 31 of each year;

(12) The fee for issuance of, and the annual renewal of, a nursing home pharmacy consultant permit shall be twenty dollars ($20.00). The permit shall expire on December 31 of each year;

(13) The fee for intern licensure shall be twenty dollars ($20.00);

(14) The fee for change of pharmacist in charge of any pharmacy, or change of consultant pharmacist in charge of any institution shall be twenty-five dollars ($25.00);

(15) The fee for reinstatement of a pharmacist licensure shall be fifty dollars ($50.00) for each delinquent year up to a maximum of two-hundred dollars ($200.00) plus the fee for the current year's license;

(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 a pharmacist, pharmacy, wholesaler distributor of legend drugs and/or controlled substances, supplier of medical equipment, legend devices, and/or medical gas, hospital pharmacy, institutional and nursing home consultant permits shall be twenty dollars ($20.00) per month from February 1, provided that if the renewal is unpaid by April 1 of any year, the license shall be null and void;

(19) The fee for issuance of a Wholesale Distributer of Legend Drugs and/or Controlled Substances permit shall be two-hundred dollars ($200.00), and annual renewal shall be one-hundred dollars ($100.00), provided that if the renewal is unpaid by December 31, of any year, the permit will expire. Penalties for late payment are defined in section 18 of this regulation;

(20) The fee for issuance of a permit to operate as a supplier of medical equipment, legend devices, and/or medical gas shall be two-hundred dollars ($200), and annual renewal shall be one-hundred dollars ($100), provided that, if the renewal is unpaid by December 31 of any year, the permit will expire. Penalties for late payment are defined in section 18 of this regulation;

(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 13.

(22) The registration fee for a pharmacy technician (pharmacist assistant) shall be $25.

(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.

5. 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 59 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).

10. 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 59. (10/9/80)

13. 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 59. 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

20. All 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 59. If the renewal fee for any pharmacist certificate be unpaid by the first day of February of any year, the holder thereof must pay a penalty as defined in regulation 59 for each month thereafter, provided, that if the renewal be unpaid by April 1st of any year, such certificate shall be null and void, and the 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 59 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, and 6/20/91)

26. 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 59. The application for licensure as an intern will be furnished by the Arkansas State Board of Pharmacy.

27. The Board of Pharmacy is charged with regulating the internship program made reference to 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 27.

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.

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 12 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 12 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.

(1) 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 59 for licensure as an intern.

(2) 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 12 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.

(3) 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.

(4) 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.

(5) 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.

(6) 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 12 A.

(7) 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.

(8) 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.b.) (Revised 6/22/84, 4/07/89, 6/20/91, and 4/10/92)

RULES APPLYING TO PRECEPTORS

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 or national 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 59.

Violation of any of the rules and requirements set forth 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 2/17/82, 12/12/86, 2/10/87, and 6/20/91)

29. 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 all 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 59. The inventory shall be made on the day the new owner takes charge of the pharmacy.

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.

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.

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)

41. 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 59.

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 #48 (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 #48 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)

42. WOLESALE DRUG DISTRIBUTORS REGULATION

A. 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 I 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.

a.

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.

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

c. 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. Intracompany sales:

b. 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;

c. 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;

d. 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;

e. 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 LICENSED VETERINARIAN."

B. 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.

C. 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 59. 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 59.

b. All permits issued under this section shall expire on December 31, of each year. A penalty, as defined in regulation 59, will be charged, provided that if the renewal is unpaid by April 1, of any year, the license shall be null and void.

3. Each permit issued hereunder shall be displayed by the holder thereof in a conspicuous place.

D. WHOLESALE DISTRIBUTORS-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.

E. MINIMUM 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 wholesale distributor, each such location shall be licensed by the Arkansas Board of Pharmacy.

3. Changes in any information on the application for Iicensure shall be submitted to the Arkansas Board of Pharmacy within 30 days after such change.

F. MINIMUM QUALIFICATIONS.

1. The Arkansas Board of Pharmacy will consider the following factors in determining eligibility for Iicensure 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 lo 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.

2. 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.

G. 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.

H. 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. All 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.

3. 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 notadversely 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. Examinations 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 transferor, 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.

I. 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.

J. 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.

K. 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.

L. 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.

M. APPLICABILITY.

Nothing in this regulation shall apply to the sale of chemicals or poisons for use for nonmedical 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.

N. 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)

REGULATION 57

57. Medical Equipment, Legend Devices, and/or Medical Gas Regulation

I. 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;

(l) 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.

II. 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 59. 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 59.

(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 59. 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.

III. 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. AH 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)

5. 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 59shall 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).

10. 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 59.(10/9/80)

13. 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 59. 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

20. All 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 59. If the renewal fee for any pharmacist certificate be unpaid by the first day of February of any year, the holder thereof must pay a penalty as defined in regulation 59 for each month thereafter, provided, that if the renewal be unpaid by April 1st of any year, such certificate shall be null and void, and the 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 59 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, and 6/20/91)

26. 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 Iicensure fee as defined in regulation 59. The application for Iicensure as an intern will be furnished by the Arkansas State Board of Pharmacy.

27. The Board of Pharmacy is charged with regulating the internship program made reference to 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 27.

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.

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 12 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 12 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.

(1) 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 59 for licensure as an intern.

(2) 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, § 517-92-301. 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 12 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.

(3) 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.

(4) 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.

(5) 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.

(6) 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 12 A.

(7) 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.

(8) 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.b.) (Revised 6/22/84, 4/07/89, 6/20/91, and 4/10/92)

RULES APPLYING TO PRECEPTORS

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 or national 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 59.

Violation of any of the rules and requirements set forth 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 2/17/82, 12/12/86, 2/10/87, and 6/20/91)

29. 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 all 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 59. The inventory shall be made on the day the new owner takes charge of the pharmacy.

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.

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.

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)

41. 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 59.

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 #48 (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 #48 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)

42. WHOLESALE DRUG DISTRIBUTORS REGULATION

A. 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 I 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.

a.

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.

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

c. 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. Intracompany sales:

b. 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;

c. 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;

d. 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;

e. 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 LICENSED VETERINARIAN."

B. 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.

C. 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 59. 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 59.

b. All permits issued under this section shall expire on December 31, of each year, a penalty as defined in regulation 59 will be charged, provided that if the renewal is unpaid by April 1, of any year, the license shall be null and void.

3. Each permit issued hereunder shall be displayed by the holder thereof in a conspicuous place.

D. WHOLESALE DISTRIBUTORS-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.

E. MINIMUM 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 wholesale 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.

F. 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.

2. 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.

G. 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.

H. 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. All 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.

3. 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 notadversely 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 transferor, 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.

e. 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.

I. 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.

J. 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.

K. 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.

L. 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.

M. APPLICABILITY.

Nothing in this regulation shall apply to the sale of chemicals or poisons for use for nonniedical 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.

N. 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)

REGULATION 57

57. Medical Equipment, Legend Devices, and/or Medical Gas Regulation

I. 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;

(l) 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.

II. 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 59. 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 59.

(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 59. 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.

III. 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)

(9/19/1996)

The following state regulations pages link to this page.