Section 22-B404. APPLICATION FOR OUT-OF-STATE REGISTRATION

 

404.1An 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.

 

404.2No 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404.3[REPEALED].

 

404.4An 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.

 

404.5The Director shall require a separate registration for each facility directly or indirectly owned or operated by the same business.

 

404.6The 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.

 

 

authority

District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code § 48-903.01 (2014 Repl.)); 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 (2012 Repl.)); 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) (2014 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

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