[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.30]

[Page 107]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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. 207.30  Updating drug listing information.

    (a) After submitting the initial drug listing information, every 
person who is required to list drugs under Sec. 207.20 shall submit on 
Form FDA-2657 (Drug Product Listing) during each subsequent June and 
December, or at the discretion of the registrant when the change occurs, 
the following information:
    (1) A list of each drug introduced by the registrant for commerical 
distribution which has not been included in any list previously 
submitted. The registrant shall provide all of the information required 
by Sec. 207.25(b) for each such drug.
    (2) A list of each drug formerly listed in accordance with 
Sec. 207.25(b) for which commercial distribution has been discontinued, 
including for each drug so listed the National Drug Code (NDC) number, 
the identity by established name and by proprietary name, and date of 
discontinuance. It is requested but not required that the reason for 
discontinuance of distribution be included with this information.
    (3) A list of each drug for which a notice of discontinuance was 
submitted under paragraph (a)(2) of this section and for which 
commercial distribution has been resumed, including for each drug so 
listed the NDC number, the identity by established name and by 
proprietary name, the date of resumption, and any other information 
required by Sec. 207.25(b) not previously submitted.
    (4) Any material change in any information previously submitted.
    (b) When no changes have occurred since the previously submitted 
list, no report is required.