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, which was 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 August 2, 1994 (59 FR 39255), FDA partially extended the compliance date for a provision of the regulation to August 3, 1995, and requested comments on the scope of this provision. The agency is further extending the compliance date to August 2, 1996. FDA is taking this action in order to adequately assess comments received on the scope of a particular provision of that rule.