RULE 070.00.93-002 - Reg. 9-B, Reg. 37, Reg. 52, Reg. 53, and Reg. 55

RULE 070.00.93-002. Reg. 9-B, Reg. 37, Reg. 52, Reg. 53, and Reg. 55

Amend Regulation 37

(Make existing Regulation "A." and new "B.")

Recognizing the emergency and or unanticipated need for certain legend (non-controlled) drugs to be available to nurses employed by Arkansas Licensed Home Health Agencies, an Arkansas Licensed Pharmacy may provide certain medications under the following conditions:

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

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

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

(4) All medication records must be maintained as required by law, and out of date drugs must be properly destroyed by the pharmacy.

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

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

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

Heparin Flush - Pediatric (one strength)

Heparin - Flush - Adult (one strength)

Sterile Water For Injection - small volume

Sodium Chloride For Injection - small volume

Adrenalin (Epinephxine) Injection - ampoules only

Benadryl (Diphenhydramine) injection - ampoules only

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

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

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

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

52. Facsimile (Fax) Prescription Drug Order - A prescription drug order which is transmitted by an electronic device which sends an exact copy image to the receiver (pharmacy) over telephone lines.

I. Pharmacist/Pharmacy:

A. A pharmacist may accept a facsimile prescription drug order in lieu of an oral or written prescription drug order for any drug except Schedule II drugs. However, au emergency order may be accepted by FAX as an alternative to the telephone, if all other requirements for emergency Schedule II prescriptions are met.

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

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

D. A pharmacist may dispense prescription orders transmitted by FAX only when signed by the authorized prescribing practitioner and transmitted from the practitioner's office by the practitioner or his designated agent.

E. A pharmacist may accept a FAX prescription from a long term care facility provided:

(1) All requirements of an oral prescription are met.

(2) The order is written and faxed by the nurse designated by the physician as his/her "agent" to be transmit the order.

(3) The pharmacist verifies the FAX is from the machine in the L.T.C. facility.

(4) The "agent" signs the order as the person authorized' to transmit the order.

F. The pharmacist shall assure that the FAX paper is of such quality to last long enough to meet legal requirements.

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

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

H. Refill authorizations for prescriptions may be transmitted using a facsimile device.

II. Patient/Prescriber Consideration:

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

B. No pharmacist shall provide a FAX machine to any prescribing practitioner or other health care facilities unless the charge equals or exceeds the pharmacists cost of the machine.

C. A pharmacist/pharmacy shall not lease FAX machines to prescribing practitioners or health care facilities.

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

53. Practice After Inactivity when Reciprocating or Reinstating a License.

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

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

If these criteria are not met, the pharmacist must:

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

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

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

55. GOOD COMPOUNDING PRACTICES APPLICABLE TO ARKANSAS LICENSED PHARMACIES

GOOD COMPOUNDING PRACTICES

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

A. General Provisions

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

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

The following definitions apply to these Good Compounding Practices.

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

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

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

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

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

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

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

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

B. Organization and Personnel

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

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

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

C. Drug Compounding Facilities

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

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

Adequate lighting and ventilation shall be provided in all drug compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product.

The area(s) used for the compounding of drugs shall be maintained in a clean and sanitary condition.

1. Sterile Products

If sterile (aseptic) products are being compounded, the following conditions shall be met: See Board Regulation #43

If radiopharmaceuticals are being compounded, the following conditions shall be met: See Board Regulation #38

2. Special Precaution Products

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

D. Equipment

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

Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond that-desired- In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug products, cleaning, sterilization, and maintenance procedures as set forth in Board Regulation #43 must be followed.

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

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

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

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

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

Drug product containers and closures intended for the compounding of sterile products must be handled, sterilized, stored, and in general maintained in keeping with Board Regulation #43. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures used in the preparation of sterile pharmaceuticals.

F. Drug Compounding Controls

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

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

(a) component name

(b) lot and expiration date if available

(c) strength and concentration

(d) weight or measure

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

(a) capsule weight variation;

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

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

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

G. Labeling Control of Excess Products

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

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

H. Records and Reports

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

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

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

(11/19/1993)

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