2016 District of Columbia Code
Title 48 - Foods and Drugs. §§ 48-101 - 48-1213
Chapter 7 - Drug Manufacture and Distribution Licensure. §§ 48-701 - 48-715
§ 48–701. Definitions.

For the purposes of this chapter, the term:

(1) “Distribute” means:

(A) To sell any drug for resale;

(B) To act as a broker, agent, distributor, jobber, or wholesaler of any drug; or

(C) To otherwise negotiate a sale for the resale of any drug.

(2) “Drug” means any substance as defined under § 47-2885.02.

(3) “Manufacture” means:

(A)(i) To prepare, produce, propagate, compound, convert, process, or package a drug, either directly or indirectly, by extraction from a substance of natural origin, or independently by means of chemical synthesis;

(ii) Any packaging or repackaging of the substance or drug; or

(iii) Labeling or relabeling of any drug package or container to further distribution from the original place of manufacture to the person who makes final delivery, distribution, or sale to the ultimate consumer or user.

(B) “Manufacture” does not include the preparation or compounding of a drug by a pharmacist, practitioner, or any other authorized person who prepares or compounds a drug incidental to administering or dispensing a drug or conducting research, teaching, or chemical analysis on a drug in the course of professional practice.

(4) “Wholesaler” means any person, including but not limited to, a manufacturer, repackager, own label distributor, jobber, broker, agent, pharmacy, private label distributor, distributor warehouse, wholesale drug warehouse, independent wholesale drug trader, chain drug warehouse, retail pharmacy, or pharmacy that sells more than 5% of its drug inventory to a hospital or other pharmacy, which distributes a drug to a person other than a consumer or patient.

(5) “Conditional license” means a license issued pursuant to specific conditions.

(June 13, 1990, D.C. Law 8-137, § 2, 37 DCR 2631; Apr. 20, 1999, D.C. Law 12-264, § 36, 46 DCR 2118.)

1981 Ed., § 33-1001.

Delegation of authority pursuant to D.C. Law 8-137, the “District of Columbia Drug Manufacture and Distribution Licensure Act of 1990”, see Mayor’s Order 98-88, May 29, 1998 ( 45 DCR 3982).