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Post-approval packaging, bulk testing of OTCs through FDA SUPAC-IR sought by NDMA.

This article was originally published in The Tan Sheet

Executive Summary

POST-APPROVAL CHANGES IN OTC PACKAGING AND BULK TESTS THROUGH SUPAC sought by the Nonprescription Drug Manufacturers Association. Speaking at the group's annual Manufacturing Controls Seminar in Philadelphia Oct. 10-11, Manufacturing Controls Committee Chair Donald Cadge said: "It seems reasonable" that after providing and proving equivalency through FDA's Scale-Up and Post-Approval Changes guidance for immediate-release products, "it stands to reason that a company should also be able to keep all production in place but move the packaging and/or the testing of that bulk after proving equivalency." Cadge is with McNeil Consumer Products.

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