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IACP Files Comments on 503A and 503B
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IACP Submits Comments on FDA's Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and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

On September 2nd, IACP filed comments 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.

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

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.

IACP Provides Timely AdvanCE Webinar on CGMPs

Register today to attend IACP’s September live webinar Current Good Manufacturing Practices – A Compounding Pharmacy Perspective, presented by Matt Bestercy and Nancy Daniels. This one-hour webinar will discuss the importance of the Food & Drug Administration (FDA) Code of Federal Regulations, Current Good X Practices (CGXPs), and how they impact the compounding pharmaceuticals industry. 

With more and more compounding pharmacies being inspected and held to CGMP standards by the FDA, this webinar is a "must" to understand what the differences are between them and, USP <795> and <797>.  For any IACP member considering opening or working for a 503B outsourcing facility, this educational program will provide a solid basis in the "new world" of working under CGMPs in those entities. Click here for more information and to register.

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