Final Rule on Combo Product cGMPs Contains Few Changes From Proposal

With few changes, the FDA has finalized a rule clarifying GMP requirements for single-entity and co-packaged drug-device products. The final rule takes effect on or about July 21.The agency made no dramatic alterations to the rule after receiving 25 comments from manufacturers and trade groups on the 2009 proposed rule. Further guidance on implementing the rule is forthcoming, the agency noted, partly as consolation for some industry commenters whose proposals were downplayed or roundly rejected. Several commenters called on the FDA to delay the effective date of the final rule by as much as one year to allow manufacturers more time to prepare for its implementation. 
Drug GMP Report