La. Admin. Code tit. 46 § LIII-2717

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-2717 - Physical Security Controls for Practitioners and Pharmacies

A. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

B. Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

C. This Section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration.

D. Carfentanil etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

E. The licensee shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this Subsection, the term "for cause" includes surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances.

F. The licensee shall notify the board and the Field Division Office of the DEA in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The licensee shall also complete, and submit to the board and the Field Division Office of the DEA in his area, DEA Form 106, or its electronic equivalent, regarding the loss or theft. When determining whether a loss is significant, a licensee should consider, among others, the following factors:

1. the actual quantity of controlled substances lost in relation to the type of business;

2. the specific controlled substances lost;

3. whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;

4. a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;

5. whether the specific controlled substances are likely candidates for diversion;

6. local trends and other indicators of the diversion potential of the missing controlled substance.

G. Whenever the licensee distributes a controlled substance (without being registered as a distributor, as permitted by law) he shall comply with the requirements imposed on non-practitioners.

H. Central fill pharmacies shall comply with federal and state law when selecting private, common or contract carriers to transport filled prescriptions to a retail pharmacy for delivery to the ultimate user. When central fill pharmacies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106 or its electronic equivalent. Retail pharmacies shall comply with federal and state law when selecting private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy. When retail pharmacies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106 or its electronic equivalent.

La. Admin. Code tit. 46, § LIII-2717

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2137 (October 2008).

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