[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.31]

[Page 106]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION--Table of Contents
 
         Subpart C--Procedures for Domestic Drug Establishments
 
Sec. 207.31  Additional drug listing information.

    (a) In addition to the information routinely required by 
Secs. 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.

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