Section 22-B405. RENEWAL OF REGISTRATION FOR OUT-OF-STATE DRUG MANUFACTURERS, DISTRIBUTORS, REPACKAGERS, AND WHOLESALERS

 

405.1The Director shall mail a renewal notice to an out-of-state registrant by first class mail to the registrant’s last known address on file with the Director at least forty-five (45) calendar days prior to the expiration of the registration.

 

405.2The failure of a registrant to receive the renewal notice required by this section does not relieve the registrant of the responsibility of renewing the registration in a timely manner.

 

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

 

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

 

(b) The required renewal 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 aforeign 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.

 

405.4A registration shall lapse if the application for renewal of the registration is not received prior to the date of expiration on the registration. The registration may be reinstated within thirty (30) calendar days of its expiration, upon receipt of a completed renewal application. If the registration lapses, the fee to reinstate the registration shall accompany the application for registration.

 

 

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, 7733 (October 16, 1992); as amended by Final Rulemaking published at 63 DCR 8502 (June 17, 2016).