D.C. Mun. Regs. tit. 22, r. 22-B10825

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10825 - NOTIFICATION BY THE MANUFACTURER TO THE DEPARTMENT OF HEALTH

10825.1

The notification to the Department required by § 10823.1(a) shall be confirmed in writing and, in addition to other relevant information which the Department may require, shall include the following:

(a) Identification of the product or products involved;

(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;

(c) The expected usage for the product if known to the manufacturer;

(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable standard;

(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the standard;

(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the standard;

(g) The date and circumstances under which the defect was discovered; and

(h) The identification of any trade secret information which the manufacturer desires be kept confidential.

D.C. Mun. Regs. tit. 22, r. 22-B10825

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

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.