Section 22-B10300. MEDICAL DEVICES: NAME AND PLACE OF BUSINESS OF MANUFACTURER, OR DISTRIBUTOR

 

10300.1The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

 

10300.2The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation.  Abbreviations for “Company” and “Incorporated” may be used, and “The” may be omitted.  In the case of a proprietorship, partnership, or association, the name under which the business is conducted shall be used.

 

10300.3Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection the person has with the device such as “Manufactured for …,” “Distributed by …,” or any other wording that expresses the facts.

 

10300.4The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.  The requirement for inclusion of the zip code shall apply only to consumer commodity labels developed or revised after the effective date of these regulations.  In the case of non-consumer packages, the zip code shall appear on either the label or the labeling (including the invoice).

 

10300.5If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where the device was manufactured or packed or is to be distributed, unless the statement would be misleading.

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 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).