IACP Submits Comments on FDA 503B Draft Guidance
Wednesday, September 03, 2014
Posted by: Dagmar Anderson
IACP Submits Comments on FDA's Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and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 IACP 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.
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.
This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.
Click here for more information and to register.