6076097 Health, Department of - Notice of Final Rulemaking - Requiring out ofstate drug manufacturers, distributors, repackagers, and wholesalers that conduct activities within the District to maintain a registered agent in DC

DEPARTMENT OF HEALTH

 

NOTICE OF FINAL RULEMAKING

 

The Director of the Department of Health (“Department”), pursuant to the authority set forth in the 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; hereby gives notice of the adoption of the following amendment to Chapter 4 (Drug Manufacture and Distribution) of Title 22 (Health), Subtitle B (Public Health and Medicine), of the District of Columbia Municipal Regulations (DCMR).

 

The purpose of these amendments is to ensure that out-of-state drug manufacturers, distributors, repackagers, and wholesalers, that conduct distribution activities within the District of Columbia, are required to maintain a registered agent in the District.

 

This rulemaking was published in the D.C. Register on October 9, 2015 at 62 DCR 013320.  The Department did not receive any comments in response to this notice.  Therefore, no changes have been made to the rulemaking. 

 

These rules were adopted as final on May 12, 2016 and will be effective upon publication of this notice in the D.C. Register.

 

Chapter 4, DRUG MANUFACTURE AND DISTRIBUTION, of Title 22-B DCMR, PUBLIC HEALTH AND MEDICINE, is amended as follows:

 

Section 404, APPLICATION FOR OUT-OF-STATE REGISTRATION, is amended as follows:

 

Subsection 404.3 is repealed.

 

Subsection 404.4 is amended to read as follows:

 

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.

 

Section 405, RENEWAL OF REGISTRATION FOR OUT-OF-STATE DRUG MANUFACTURERS, DISTRIBUTORS, REPACKAGERS, AND WHOLESALERS, is amended as follows:

 

Subsection 405.3 is amended to read as follows:

 

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 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.