CFR

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 Records Repository Team (HFD-143), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 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 Division of Manufacturing and Product Quality, Foreign Inspection Team (HFD-325), Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Upon request and receipt of a stamped, self-addressed envelope, the Records Repository Team, the Foreign Inspection Team, or the appropriate FDA district office will verify registration numbers or provide the location of a registered establishment. The mailing address for the Foreign Inspection Team is: Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research (HFD-325), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

(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):

(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.

Code of Federal Regulations

[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; 69 FR 48775, Aug. 11, 2004]

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