Section 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 […]
Section 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 […]
Section 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 cleanable surfaces to include […]
Section 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 […]
Section 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 […]
Section 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. […]
Section 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 […]
Section 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 […]
Section 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. […]
Section 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 […]
Section 34-23-160 Preparation of compounded drug products for prescriber’s office use; labeling. (a) A pharmacy may prepare a compounded drug product for a prescriber’s 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 prescriber’s office and shall not […]
Section 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 are prescriptions for humans. (Act 2003-389, p. 1094, §12.)
Section 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.)
