Section 22-B10807. SUBMISSION OF DATA AND REPORTS

 

10807.1All submissions such as reports, test data, product descriptions, and other information required by this chapter, or voluntarily submitted to the Department, shall be filed with the number of copies prescribed by the Department and shall be signed by the person making the submission. 

 

10807.2[Reserved]
 

10807.3Where the Department issues guides or instructions have been for the submission of material required by this chapter, such as test data, product reports, abbreviated reports, supplemental reports, and annual reports, the material submitted shall conform to the applicable reporting guides or instructions. Where it is not feasible or where it would not be appropriate to conform to any portion of a prescribed reporting guide or instruction, an alternate format for providing the information requested by that portion of the guide or instruction may be used provided the submitter of such information submits adequate explanation and justification for use of an alternate format. If the Department determines that such justification is inadequate and that it is feasible or appropriate to conform to the prescribed reporting guide or instruction, the agency may require resubmission of the information in conformance with the reporting guide or instruction.
 

10807.4Where the submission of quality control and testing information is common to more than one (1) model, or model family of the same product category, a "common aspects report" consolidating similar information  may be provided, if applicable.

 

 

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).