D.C. Mun. Regs. tit. 22, r. 22-B1321

Current through Register Vol. 71, No. 52, December 27, 2024

Rule 22-B1321 - DISTRIBUTION TO SUPPLIER

1321.1

A 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 or she obtained it or to the manufacturer of the substance, or, if designated, to the manufacturer's registered agent for accepting returns, provided that a written record is maintained containing the following:

(a) The date of the transaction;

(b) The name, form, and quantity of the substance;

(c) The name, address, and controlled substance registration number(s), if any, of the person making the distribution; and

(d) The name, address, and controlled substance registration number(s), if known, of the supplier or manufacturer.

1321.2

An order form shall be used in the manner prescribed in 21 C.F.R. § 1305, and shall be maintained as the written record for a controlled substance listed in Schedule I or II which is returned. Any person not required to register pursuant to Sections 302(c) or 1007(b)(1) of the Federal Act 21 U.S.C. § 822(c) or 957(b)(1) shall be exempt from maintaining the records required by this section.

1321.3

Distributions referred to in this section 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.

D.C. Mun. Regs. tit. 22, r. 22-B1321

Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980, (D.C. Law 3-98; D.C. Official Code § 47-2885.18.01(a)(3)); the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code § 48-901.01); Mayor's Order 98-48, dated April 15, 1998, Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731); Section 15 of the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a)); and Mayor's Order 98-88, dated May 29, 1998.