(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 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, abbreviated new drug application, new animal drug application, abbreviated new animal drug application, request for addition to the index, medicated feed mill license application, or a biologics license application. Owners or operators shall renew their registration information annually.
The schedule is as follows: ------------------------------------------------------------------------
First letter of company name Date FDA will mail forms------------------------------------------------------------------------A or B................................... JanuaryC, D, or E............................... FebruaryF, G, or H............................... MarchI, J, K, L. or M......................... AprilN, O, P, Q, or R......................... MayS or T................................... JuneU, 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; 66 FR 59157, Nov. 27, 2001; 72 FR 69120, Dec. 6, 2007]