D.C. Mun. Regs. tit. 22, r. 22-B404

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

Rule 22-B404 - APPLICATION FOR OUT-OF-STATE REGISTRATION

404.1

An out-of-state drug manufacturer, distributor, or wholesaler who conducts distribution activities within the District of Columbia shall be required to register with the Director.

404.2

No person required to be registered shall conduct distribution activities within the District of Columbia until the application for registration is issued and a Certificate of Registration is issued by the Director.

404.3

[REPEALED]

404.4

An applicant for an out-of-state registration shall submit the following:

(a) A completed application on the required form provided by the Director;

(b) The required registration fee;

(c) A certificate of good standing in the state where the principal place of business is located;

(d) A copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agent of the state in which the principal place of business is located;

(e) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices;

(f) Proof of current registration with the United States Drug Enforcement Administration for controlled substances, where applicable;

(g) The name and address of the Applicant's designated registered agent in the District of Columbia;

(h) Proof of registration, and of good standing status, in the District of Columbia as a foreign filing entity as defined by Title 29 of the District of Columbia Official Code, if applicable; and

(i) Proof of "Clean Hands" as defined by the District of Columbia Tax and Revenue.

404.5

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

404.6

The Director may require a registrant to submit documentation or written statements in support of an application. The Director may deny an application if the registrant fails to provide the requested information within fifteen (15) business days of receipt of the Director's request.

D.C. Mun. Regs. tit. 22, r. 22-B404

Final Rulemaking published at 39 DCR 7729, 7732 (October 16, 1992); amended by Final Rulemaking published at 63 DCR 8502 (6/17/2016