La. Admin. Code tit. 46 § LIII-2751

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

Section LIII-2751 - Distributions and Transfers of Controlled Substances

A. Distribution by Dispenser to Another Practitioner or Reverse Distributor

1. A dispenser may distribute (without being registered to distribute) a quantity of such controlled substance to:

a. another practitioner for the purpose of general dispensing by the practitioner to patients, provided that:

i. the receiving practitioner is authorized to dispense that controlled substance;

ii. the distribution is recorded by the dispenser and the receiving practitioner, in accordance with §2735. B of this Chapter;

iii. a DEA 222 order form is used as required for controlled substances listed in Schedule II; and

iv. the total number of dosage units of all controlled substances distributed by the dispenser pursuant to this Section during each calendar year shall not exceed 5 percent of the total number of dosage units distributed and dispensed by the dispenser during the same calendar year;

b. a reverse distributor who is authorized to receive such controlled substances.

2. If, during any calendar year the dispenser has reason to believe the total number of dosage units of all controlled substances which will be distributed by him pursuant to this Section will exceed 5 percent of his total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the dispenser shall obtain a license to distribute controlled substances.

3. The distributions made by a retail pharmacy to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations shall not count toward the 5 percent limit described in this Section.

B. Distribution to Supplier, Third-Party Logistics Provider, or Manufacturer

1. Any person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he obtained it or to the manufacturer of the controlled substance, or if designated, to the manufacturer's registered agent or accepting returns, provided that a written record is maintained which indicates the date of the transaction, the name, form and quantity of the controlled substance, the name, address, and DEA Registration Number, if any, of the person making the distribution, and the name, address, and DEA registration number of the supplier or manufacturer. In the case of returning a controlled substance listed in Schedule I or II, a DEA 222 order form shall be used and maintained as the written record of the transaction. Any person not required to register shall be exempt from maintaining the records required by this Section.

2. Distributions referred to in this Subsection may be made through a freight forwarding facility operated by the person to whom the controlled substance is being returned, provided that prior arrangement has been made for the return and the person making the distribution delivers the controlled substance directly to an agent or employee of the person to whom the controlled substance is being returned.

La. Admin. Code tit. 46, § LIII-2751

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2157 (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.