D.C. Mun. Regs. tit. 22, r. 22-B10423

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

Rule 22-B10423 - SUPPLEMENTAL REPORTS

10423.1

If you are a manufacturer, when you obtain information that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to the Department within one (1) month of the day that you receive this information. On a supplemental or follow-up report, you must:

(a) Indicate on the envelope and in the report that the report being submitted is a supplemental or follow-up report;

(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (for example, your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and

(c) Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports.

D.C. Mun. Regs. tit. 22, r. 22-B10423

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.