[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: 21CFR207.21]

[Page 103-104]
 
                        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. 207.21  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

[[Page 104]]

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, new 
animal drug application, medicated feed mill license application, or a 
biologics license application. Owners or operators of all establishments 
engaged in the drug activities described in Sec. 207.3(a)(8) shall 
register annually within 30 days after receiving registration forms from 
FDA. FDA will mail Forms FDA-2656 (Registration of Drug Establishment) 
to registered establishments according to a schedule based on the first 
letter of the name of the establishment's parent company as stated on 
the firm's registration form. If no parent company name is given on that 
form, the schedule is based on the first letter of the establishment's 
name. In scheduling the mailing of forms based on the first letter of 
the company name, FDA will not consider the word ``the'' when it appears 
as the first word in the name of the parent company or establishment.
    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]