[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.22]

[Page 122]
 
                        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.  207.22  How and where to register and list drugs.

    (a) An establishment shall register the first time on Form FDA-2656 
(Registration of Drug Establishment), obtainable on request from the 
Records Repository Team (HFD-143), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, or from FDA district offices. An establishment whose drug 
registration for that year was validated under Sec.  207.35 shall make 
subsequent annual registration on Form FDA-2656 as described in Sec.  
207.21(a) by mailing the completed form to the above address within 30 
days after receipt from FDA.
    (b) The first list of drugs and later June and December updatings 
shall be on Form FDA-2657 (Drug Product Listing), obtainable upon 
request as described in paragraph (a) of this section. An establishment 
may submit, in lieu of Form FDA-2657, tapes for computer inputs 
containing the information specified in Form FDA-2657 if formats 
proposed for this use were reviewed and approved by the Records 
Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA.

[45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985; 55 
FR 11576, Mar. 29, 1990; 69 FR 48775, Aug. 11, 2004]