D.C. Mun. Regs. tit. 22, r. 22-B401

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B401 - APPLICATION FOR IN-STATE LICENSURE

401.1

No person, with the exception of an out-of-state drug manufacturer, distributor, or wholesaler, duly registered under §§ 404 and 405, may engage in the manufacture, distribution, or wholesale of any drug until the application for licensure has been approved and a license issued by the Director.

401.2

Applications for licensure shall be made on a form prescribed by the Director and shall be accompanied by the required fee.

401.3

The application shall include the following information:

(a) The name and all trade or business names of the applicant and the address and telephone number of the place of business for which the applicant seeks a license;

(b) The name, address, and telephone number of contact personnel for all facilities used by the applicant for the storage, handling, and distribution of drugs;

(c) The type of ownership or operation (i.e., partnership, corporation, joint venture, or sole proprietorship);

(d) If the applicant is a corporation, the name and address of each officer or director of the corporation and each stockholder who owns ten percent (10%) or more of any one class of stock in the corporation or who owns ten percent (10%) or more of the total stock of the corporation, and the name of the state of incorporation if other than the District of Columbia;

(e) 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 (c) and (l) of this section shall be produced by the partner or joint venturer;

(f) If the applicant is a sole proprietorship, the full name of the sole proprietor and the name of the business entity;

(g) A description of the manufacturing, wholesaling or distribution activity for which the applicant seeks a license;

(h) A list of all drugs that the applicant proposes to manufacture, distribute, or wholesale in the District of Columbia;

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

(j) Proof of current registration with the Director and the United States Drug Enforcement Administration (DEA) if the applicant proposes to manufacture, distribute, or wholesale a controlled substance as defined in § 802 of the Drug Abuse Prevention and Control Act, approved October 27, 1970 ( 21 U.S.C. §802);

(k) A valid certificate of occupancy; and

(l) A certificate of good standing from the Director if the applicant is incorporated in the District of Columbia.

401.4

The Director shall consider the following factors in determining eligibility for licensure:

(a) Any conviction of the applicant under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state or local laws;

(c) The applicant's past experience in the manufacture, distribution, or wholesale of drugs, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(e) Suspension or revocation by Federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with requirements to maintain and make available to District officials those records required under this chapter; and

(h) Any other factors or qualification the District considers relevant to and consistent with the public health and safety.

401.5

The Director shall require a separate license for each facility directly or indirectly owned or operated by the same business.

401.6

The Director shall have the right to deny a license to an applicant if it is determined that granting of such a license would not be consistent with the public health, safety and welfare.

401.7

The license must be posted in a conspicuous place in the facility to which it is issued.

D.C. Mun. Regs. tit. 22, r. 22-B401

Final Rulemaking published at 39 DCR 7729 (October 16, 1992)