La. Admin. Code tit. 46 § LIII-2739

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2739 - Manufacture

A. A licensee located in Louisiana engaged in the manufacture of controlled dangerous substances within Schedules I, II, III, IV, or V shall prepare a complete and accurate record of the date of manufacture, the theoretical and actual yields, the quantity used for quality control, the identity of batch numbers or other appropriate identification, and the quantity of any product reworked for any reason for each manufactured batch of controlled dangerous substances or each manufactured batch of drugs in which a controlled dangerous substance was used as a raw material.

B. The licensee shall maintain manufacturing records in such a manner that the identity of a batch of controlled dangerous substances finished product can be matched to the identity of the controlled dangerous substance raw material used to make that product.

C. The licensee shall maintain any other such records as are necessary to account for all controlled dangerous substances used in the manufacturing process.

D. A building where manufacturing takes place shall be maintained in a clean and orderly manner and shall be of a suitable size, construction, and location to facilitate cleaning, maintenance, processing, and packing, labeling, or storing of legend drugs pursuant to federal and state requirements.

E. All manufacturers shall employ security precautions by ensuring controlled access to premises to avoid drug diversion, including adequate legend drug storage, alarm system security, and adequate lighting and protection of the premises.

F. Finished products, warehouse control, and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. Records within the system shall contain the name and address of the consignee, date and quantity shipped, and the lot or control number of the drug. Records shall be retained a minimum of two years after the distribution of the drug has been completed, or for one year after the expiration date of the drug, whichever is longer.

G. To assure the quality of the finished product, warehouse control shall include a system whereby the oldest approved stock is distributed first.

La. Admin. Code tit. 46, § LIII-2739

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2147 (October 2008).

AUTHORITY NOTE: Promulgated in accordance with R.S.40:972.