§ 48-704 — Licensure of a drug manufacturer, distributor, or wholesaler.

District of Columbia § 48-704

• Jurisdiction: District of Columbia
• Title 48: Foods and Drugs.
• Ch. 7: Drug Manufacture and Distribution Licensure.

Text

The Mayor shall make available a license application form that requests:

(1) The name of the applicant and the address of the place of business for which the applicant seeks a license;

(2) If the applicant is a corporation, the name and address of each officer or director of the corporation and each stockholder who owns 10% or more of any one class of stock in the corporation or who owns 10% or more of the total stock of the corporation;

(3) If the applicant is a partnership or joint venture, the name and address of each partner or joint venturer. If a partner or joint venturer is a corporation, any information required pursuant to paragraphs (2) and (9) of this section shall be provided by the partner or joint venturer;

(4) A description of the activity for which the applicant seeks a license;

(5) A list of any drugs that the applicant proposes to manufacture, distribute, or wholesale in the District;

(6) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices pursuant to § 510 of the Federal Food, Drug and Cosmetic Act (“Food, Drug and Cosmetic Act”), approved June 25, 1938 (52 Stat. 1040; 21 U.S.C. 360);

(7) If the applicant proposes to manufacture, distribute, or wholesale a controlled substance as defined in § 102 of the Drug Abuse Prevention and Control Act, approved October 27, 1970 (84 Stat. 1242; 21 U.S.C. 802), proof of current registration with the Mayor and the United States Drug Enforcement Administration;

(8) A valid certificate of occupancy; and

(9) A certificate of good standing from the Mayor if the applicant is a corporation.

Legislative History

June 13, 1990, D.C. Law 8-137, § 5, 37 DCR 2631