[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: 21CFR207.21]

[Page 105]
 
                        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. 207.21  Times for registration and drug listing.

    (a) The owner or operator of an establishment entering into the 
manufacture or processing of a drug or drugs shall register the 
establishment within 5 days after the beginning of the operation and 
shall submit a list of every drug in commercial distribution at that 
time. If the owner or operator of the establishment has not previously 
entered into such an operation, the owner or operator shall register 
within 5 days after submitting a new drug application, abbreviated new 
drug application, new animal drug application, abbreviated new animal 
drug application, medicated feed mill license application, or a 
biologics license application. Owners or operators shall renew their 
registration information annually.
    The schedule is as follows:

------------------------------------------------------------------------
       First letter of company name           Date FDA will mail forms
------------------------------------------------------------------------
A or B...................................  January
C, D, or E...............................  February
F, G, or H...............................  March
I, J, K, L. or M.........................  April
N, O, P, Q, or R.........................  May
S or T...................................  June
U, V, W, X, Y, or Z......................  July
------------------------------------------------------------------------

    (b) Owners and operators of all registered establishments shall 
update their drug listing information every June and December.

[45 FR 38043, June 6, 1980, as amended at 55 FR 11576, Mar. 29, 1990; 64 
FR 400, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 64 FR 63203, Nov. 19, 
1999; 66 FR 59157, Nov. 27, 2001]