La. Admin. Code tit. 46 § LIII-2741

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

Section LIII-2741 - Distribution

A. A distributor or third-party logistics provider handling controlled substances in Schedules I or II shall maintain complete and accurate records of the original copies of all order forms received and filled for orders of controlled substances within these schedules. This file shall be kept separate from the licensee's other business and professional records and shall be kept in this file a minimum of two years from the date the order was filled.

B. A distributor or third-party logistics provider handling controlled substances in Schedules III, IV, and V shall maintain complete and accurate records of all distributions for a minimum of two years from the date of each distribution. These records shall contain the full name, address, and registration number, if any, of the recipient, the common or established name of the controlled substance, its dosage, form, and strength, amount, and date of distribution.

C. A distributor or third-party logistics provider shall not sell or distribute drugs or drug devices except to a person or facility authorized by law or regulation to procure or possess drugs or drug devices.

D. A distributor or third-party logistics provider shall maintain and follow a written procedure to assure the proper handling and disposal of returned goods.

E. A distributor or third-party logistics provider shall maintain a written policy for handling recalls and withdrawals of products due to:

1. any voluntary action on the part of the manufacturer;

2. the direction of the Food and Drug Administration, or any other federal, state, or local government agency; or

3. replacement of existing merchandise with an approved product with a new package design.

La. Admin. Code tit. 46, § LIII-2741

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2147 (October 2008), Amended by the Department of Health, Board of Pharmacy, LR 46571 (4/1/2020).

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