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.
Last modified: May 3, 2021