§ 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 §207.35 shall make subsequent annual registration on Form FDA-2656 as described in §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]