CFR

207.31—Additional drug listing information.

(a) In addition to the information routinely required by §§ 207.25 and 207.30, FDA may require submission of the following information by letter or by Federal Register notice:

(1) For a particular prescription drug so listed that the registrant regards as not subject to section 505 of the act, upon request by FDA for good cause, a copy of all advertisements.

(2) For a particular drug product so listed that the registrant regards as not subject to section 505 or 512 of the act, upon a finding by FDA that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients.

(3) For a particular drug product, upon request by FDA, a brief statement of the basis for the registrant's belief that the drug product is not subject to section 505 or 512 of the act.

(4) For each registrant, upon a finding by FDA that it is necessary to carry out the purposes of the act, a list of each listed drug product containing a particular ingredient.

(b) It is requested but not required that a qualitative listing of the inactive ingredients be submitted for all listed drugs in the format prescribed in Form FDA-2657 (Drug Product Listing).

(c) It is requested but not required that a quantitative listing of the active ingredients be submitted for all drugs listed that are subject to section 505 or 512 of the act or section 351 of the Public Health Service Act.

Code of Federal Regulations

[45 FR 38043, June 6, 1980, as amended at 63 FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999]

Tips