IACP Submits Comments on FDA's Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act

 

IACP filed yesterday the second of two formal comments to FDA - FDA's Interim Guidance for Human Drug Compounding Outsourcing Facilities 503B.

IACP also filed comments on September 2nd regarding the FDA's "do not compound" list focusing primarily on the agency's circumvention of the Pharmacy Compounding Advisory Committee and a lack of procedures for adding or modifying the list in the future - 503A.

Please click here to read IACP's FDA comments regarding 503A, and the "Do Not Compound" list.

Please click here to read IACP's extensive comments to FDA regarding 503B.