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Comments on FDA’s Draft Compounding Guidances Reflect Complex Factors and Varied Stakeholders Involved

Apr 13th, 2014

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Draft guidances and Federal Register (FR) notices issued by FDA in December to help implement the compounding provisions in the Drug Quality and Safety Act (DQSA) drew a wide array of comments that reflect the complexity of the factors that need to be considered in advancing the regulatory processes for compounding.

The three draft guidances and three FR notices that were issued in early December (IPQ December 28, 2013) received significant numbers of comments from across the broad spectrum of stakeholders impacted.

The draft guidances cover: ● overarching rules for what constitutes pharmacy compounding and how enforcement for violations may be applied ● a definition of a new category of compounder created by the DQSA – an “outsourcing facility” – and the registration requirements, and ● interim requirements for ongoing reporting of information to FDA by the outsourcers on their products and services.

One of the FR notices requests nominations for “difficult-to-compound” drugs. The other two provide instructions and a template for completing the nominations.  The comment periods ended in early February for the draft guidances and early March for the FR notices.

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