Regulatory Focus™ > News Articles > FDA Releases New CGMP Labeling Provisions for Drug Products

FDA Releases New CGMP Labeling Provisions for Drug Products

Posted 19 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is making changes to the packaging and labeling control portions of the current good manufacturing practice (CGMP) regulations for drug products, the agency announced in the Federal Register.

In its 19 March posting, FDA said it would limit "the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons."

The agency said it is "also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used."

The new provisions are intended to mitigate any known and potential issues with mislabeling drug products. The provisions also finalize a rule first proposed in 1997, adopting it "without change."

Read more:

Federal Register - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs: Revision of Certain Labeling Controls

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