[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.37]

[Page 109-110]
 
                        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. 207.37  Inspection of registrations and drug listings.

    (a) A copy of the Form FDA-2656 (Registration of Drug Establishment) 
filed by the registrant will be available for inspection in accordance 
with section 510(f) of the act, at the Division of Labeling and Non-
Prescription Drug Compliance (HFD-310), Office of Compliance, Center for 
Drug Evaluation and Research, Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855. In addition, copies of these forms 
for establishments located within a particular geographic area are 
available for inspection at FDA district offices responsible for that 
geographical area. Copies of forms submitted by foreign drug 
establishments are available for inspection at the Foreign Inspection 
Team (HFD-322), Office of Compliance, Center for Drug Evaluation and 
Research, 7520 Standish Pl., Rockville, MD 20855. Upon request and 
receipt of a stamped, self-addressed envelope, the Division of Labeling 
and Non-Prescription Drug Compliance, the Foreign Inspection Team, or 
the appropriate FDA district office will verify registration numbers or 
provide the location of a registered establishment.
    (1) The following types of information submitted under the drug 
listing requirements will be available for public disclosure when 
compiled:
    (i) A list of all drug products.
    (ii) A list of all drug products arranged by labeled indications or 
pharmacological category.
    (iii) A list of all drug products arranged by manufacturer.
    (iv) A list of a drug product's active ingredients.
    (v) A list of drug products newly marketed or for which marketing is 
resumed.
    (vi) A list of drug products discontinued.
    (vii) Labeling.
    (viii) Advertising.
    (ix) Information that has become a matter of public knowledge.
    (x) A list of drug products containing a particular active 
ingredient.
    (xi) A list of all code imprints.
    (2) The following types of information submitted in accordance with 
the drug listing requirements will not be available for public 
disclosure (except that any of the information will be available for 
public disclosure if it has become a matter of public knowledge or if 
FDA finds that confidentiality would be inconsistent with protection of 
the public health):

[[Page 110]]

    (i) Any information submitted as the basis upon which it has been 
determined that a particular drug product is not subject to section 505 
or 512 of the act.
    (ii) A list of a drug product's inactive ingredients.
    (iii) A list of drugs containing a particular inactive ingredient.
    (b) Requests for information about registrations and drug listings 
of an establishment should be directed to the Information Management 
Team (HFD-095), Office of Information Technology, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857 or, with respect to the information described 
in paragraph (a) of this section, to the FDA district office responsible 
for the geographic area in which the establishment is located.

[45 FR 38043, June 6, 1980, as amended at 50 FR 8996, Mar. 6, 1985; 55 
FR 11577, Mar. 29, 1990; 58 FR 47959, Sept. 13, 1993; 63 FR 26698, May 
13, 1998; 64 FR 400, Jan. 5, 1999; 66 FR 59157, Nov. 27, 2001]