Section 22-B10201. APPLICABLE LAWS AND REGULATIONS

 

10201.1The Department of Health (Department or DOH) adopts by reference the following laws and regulations:

 

(a)  Federal Food, Drug, and Cosmetic Act, approve June 25, 1938, 21 U.S.C. § 301, et seq. (“act”) as amended;
 

(b)  21 Code of Federal Regulations (C.F.R.), part 801, Labeling, as amended;

 

(c)  21 C.F.R., part 803, Medical Device Reporting, as amended;

 

(d)  21 C.F.R., part 807, Establishment Registration and Device Listing for  Manufacturers and Initial Importers of Devices, as amended;

 

(e)  21 C.F.R., part 814, Premarket Approval of Medical Devices, as amended;

 

(f)  21 C.F.R., part 820, Quality System Regulation, as amended; and

 

(g)  21 C.F.R., Subchapter J--Radiological Health, as amended.

 

10201.2 Copies of these laws and regulations are indexed and filed at the Department, 899 North Capitol Street, N.E., Washington, D.C. 20002 and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.hpla.doh.dc.gov.

 

10201.3 Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable District of Columbia and federal laws and regulations.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effectiveSeptember 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; 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 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).