Medi-Stat Rx

COMPOUNDING OF DRUGS
34-23-150. Definitions.
As used in this article, the following terms shall have the following meanings:

(1) BOARD. The Alabama State Board of Pharmacy.

(2) COMPONENT. Any ingredient used in the compounding of a drug product.

(3) COMPOUNDING. The preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a licensed practitioner's prescription drug order or initiative based on the practitioner / patient / pharmacist relationship in the course of professional practice.

a. Compounding may also be for the purpose of, or as incident to, research, teaching, or chemical analysis.

b. Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

c. Reconstitution of commercial products is not considered compounding for purposes of this article.

(4) COMPOUNDED OVER THE COUNTER (OTC) PRODUCTS. A medical product that is prepared, packaged, and labeled in a pharmacy that can be sold by the pharmacy without a prescription.

(5) 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 or substances or labeling or relabeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes any preparation of a drug or device that is given or sold for resale by a pharmacy, practitioner, or other person. The distribution of inordinate amounts of compounded products without a prescriber / patient/pharmacist relationship is considered manufacturing.

(6) PHARMACY TECHNICIAN. A person, registered with the board, who assists the pharmacist in the practice of compounding.

(7) REASONABLE AMOUNTS OF COMPOUNDED PRODUCTS IN INVENTORY. The amount that is required to meet historical dispensing needs. (Act 2003-389, p. 1094, 1. Effective September 1, 2003.)

34-23-151. Continuing education; technician assistance; duties of pharmacist.

(a) Any pharmacist who engages in drug compounding shall be proficient in compounding and shall continually expand his or her compounding knowledge by participating in seminars or studying appropriate literature, or both.
(b) Pharmacy technicians may assist pharmacists in the preparation of compounds. When a written procedure for a compound is not on file at the pharmacy, a pharmacist must direct the preparation of the compound. At all times, a pharmacist shall verify the weight or volume of all active ingredients of a compound. While compounding, there shall be no more than three technicians per pharmacist.

(1) Verify all prescriptions.

(2) Approve or reject all components of the compounded product, drug product containers, closures, and labeling.

(3) Prepare and review all compounding records to assure that no errors have occurred in the compounding process.

(4) Assure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice.

(5) Assure that only personnel authorized by the supervising pharmacist shall be in the immediate vicinity of the drug compounding operation. (Act 2003-389, p. 1094, 2. Effective September 1, 2003.)

34-23-152. Designation and maintenance of compounding area.
Any pharmacy engaged in compounding shall have a specifically designated and adequate area or space for the orderly compounding of prescriptions. The area used for the compounding of drugs shall be maintained in a good state of repair. The compounding area shall have smooth cleanable surfaces to include walls, ceilings, and floors. Adequate lighting and ventilation shall be provided in all 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. Areas used for compounding shall be maintained in a clean and sanitary condition. (Act 2003-389, p. 1094, 3. Effective September 1, 2003.)

34-23-153. Use, maintenance, and inspection of compounding equipment.
Equipment used in the compounding of drug products shall be of appropriate design and capacity, as well as suitably located to facilitate operations for its intended use, cleaning, and maintenance. Compounding equipment shall be of suitable composition so the surfaces that contact components shall not be reactive, additive, or absorptive so as to alter the purity of the product compounded. Equipment and utensils used for compounding shall be cleaned and sanitized prior to use to prevent contamination. Equipment and utensils shall be stored in a manner to protect from contamination. Automated, mechanical, electronic, limited commercial scale manufacturing, or testing equipment and other types of 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. Immediately prior to the initiation of compounding operations, the equipment and utensils shall be inspected by the pharmacist and determined to be suitable for use. When potent or hazardous drugs, such as antibiotics, cytotoxins, and steroid hormones, are involved, appropriate measures shall be utilized in order to prevent cross-contamination and proper disposal procedures shall be followed. Measures shall include either the dedication of equipment for such operations or the meticulous cleaning of equipment prior to its use for the preparation of other drugs. (Act 2003-389, p. 1094, 4. Effective September 1, 2003.)

34-23-154. Drug components to meet certain requirements.
Pharmacists compounding prescriptions shall use their professional judgment in first receiving, storing, or using drug components that meet official compendia requirements or other high quality sources. Bulk drugs and other chemicals or materials used in the compounding of drugs shall be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration. (Act 2003-389, p. 1094, 5. Effective September 1, 2003.)

34-23-155. Drug product containers and closures.
Drug product containers and closures shall be handled and stored in a manner to prevent contamination and to permit inspection and cleaning of the work area. Containers and closures shall be of suitable material in order not to alter the compounded drug as to quality, strength, or purity. (Act 2003-389, p. 1094, 6. Effective September 1, 2003.)

34-23-156. Compounding procedures.
The board shall establish written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport to have or are represented to possess. The procedures shall include, but not be limited to, a listing of the components, their amounts in weight or volume, the lot number of the components, if available, the order of component mixing, a description of the compounding process, and a designated name for the finished product. The procedures shall be followed in the execution of the compounding procedure. Components shall be accurately weighed, measured, or subdivided, as appropriate. The operations shall be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight and measure is correct as stated in the written compounding procedures. Pharmacists shall determine that all finished products have an acceptable degree of weight variation among capsules, and shall assure a reasonable uniformity and integrity of all compounded products. (Act 2003-389, p. 1094, 7. Effective September 1, 2003.)

34-23-157. Components transferred to nonoriginal container; advance product preparation; labeling.

(a) If a component is transferred from the original container to another container, including, but not limited to, a powder being taken from the original container and stored in another container, the new container shall be identified with the following information:

(1) Component name and supplier.

(2) Lot number and expiration date, if available.

(3) Strength and concentration.

(b) Products prepared in anticipation of a prescription prior to receiving a valid prescription shall be prepared in reasonable amounts. Products shall be labeled or documentation referenced with all of the following information:

(1) A complete list of ingredients or designated name of the preparation.

(2) Preparation date.

(3) Beyond use date.

(4) Storage under conditions dictated by composition and stability, including storage in a clean, dry place or in the refrigerator.

(5) Batch or lot number.

(b) Upon the completion of the drug preparation operation, the pharmacist shall examine the product for correct labeling. The prescription label shall contain all of the information required of other prescriptions. (Act 2003-389, p. 1094, 8. Effective September 1, 2003.)

34-23-158. Retention of records.
Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records. All records required to be retained under good compounding practices, or copies of such records, shall be readily available for authorized inspection. Computer information and the hard copy of the prescription shall indicate that the prescription is to be compounded. Adequate records are required to be kept of any controlled dangerous substances or scheduled drugs which are used in compounding. (Act 2003-389, p. 1094, 9. Effective September 1, 2003.)

34-23-159. Preparation of compounded drug products for over the counter sale.
A pharmacy may prepare a compounded drug product to be sold over the counter without a
prescription order. The product shall not contain an ingredient which exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a prescription is required. It shall be properly labeled with the products name, directions for use, list of active ingredients, and any necessary warnings. A compounded product shall be sold directly to the consumer after professional interaction or consultation between the pharmacist and the consumer. The product may be prepared in advance in reasonable amounts in anticipation of estimated needs. The product shall be stored within the prescription department. The product may not be sold in bulk to other pharmacies or vendors for resale. (Act 2003-389, p. 1094, 10. Effective September 1, 2003.)

34-23-160. Preparation of compounded drug products for prescribers office use; labeling.

(a) A pharmacy may prepare a compounded drug product for a prescribers office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescribers office and shall not be dispensed to the consumer. A record of the compounded drug product may be kept as a prescription record in the computer of the pharmacy. A label may be generated and a number assigned by the computer of the pharmacy for the compounded product. A record of the products written procedure shall be on file in the pharmacy as provided in Section 34-23-156. A record of the products sale to the prescriber shall remain on file at the pharmacy for not less than one year. The record shall contain the following information:

(1) The name and address of the prescriber.

(2) The date of sale.

(3) A description and amount of the product sold.

(b) The label on the compounded product shall include the following information:

(1) The designated name and the strength of the finished product.

(2) The quantity dispensed.

(3) The date on which the product was compounded.

(4) The beyond use date.

(5) A lot or batch number.

(6) Any other information the pharmacist deems necessary.

(7) The name and address of the pharmacy.

34-23-161. Prescriptions for animals.
Drugs for animals may be compounded based upon an order or prescription. Prescriptions for animals shall be handled and filled in the same manner as prescriptions for humans. (Act 2003-389, p. 1094, 12. Effective September 1, 2003.)

34-23-162. Rules and regulations.
The board shall promulgate such rules and regulations as are necessary for the implementation, administration, and enforcement of this article. (Act 2003-389, p. 1094, 13. Effective September 1, 2003.)

The following information can be found on the FDA website

Compounding pharmacies are regulated on two levels, state and federal. On the federal level we follow guidelines as set forth by the United States Pharmacopeia (USP), more specifically 795 and 797 for non-sterile and sterile compounded products. Both the DEA and FDA have some jurisdiction, however, historically the FDA regulates pharmaceutical manufacturers and not pharmacy. The FDA also has jurisdiction when a pharmacy sends medication across state lines. The state boards of pharmacy govern pharmacies within each state and while the regulations vary slightly state to state they are the main regulatory local body. Most pharmacies are subject to random site visits by the state.

FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner. This traditional activity is not the subject of the following guidance.

Generally, FDA will continue to defer to state authorities regarding less significant violations of the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states.

However, when the scope and nature of a pharmacys activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the pharmacy engages in any of the following acts:

Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.

Compounding drugs that were withdrawn or removed from the market for safety reasons. Appendix A provides a list of such drugs that will be updated in the future, as appropriate.

Compounding finished drugs from bulk active ingredients that are not components of
FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. 355(i) and 21 CFR 312.

Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA registered facility.

Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.

Using commercial scale manufacturing or testing equipment for compounding drug products.

Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.

Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.

Failing to operate in conformance with applicable state law regulating the practice of pharmacy.

The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate for consideration in a particular case.

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