Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls; Partial Extension of Compliance Date

The Food and Drug Administration (FDA) is announcing a continuation of the partial extension of the compliance date for a provision of the final rule published in the Federal Register of August 3, 1993 (58 FR 41348). The document revised the current good manufacturing practice (CGMP) regulations for certain labeling control provisions. In the Federal Register of April 28, 1995 (60 FR 20897), FDA partially extended the compliance date to August 2, 1996, for that part of the final rule pertaining to items of cut labeling other than immediate container labels. This document extends the compliance date to August 1, 1997. FDA is taking this action to afford the industry sufficient time to purchase necessary equipment or to take other steps necessary to comply with certain provisions of the final rule, and to provide additional time for the agency to consider any revisions to the final rule.