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Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities
What can you expect from the FDA’s 2018 Compounding Priorities Plan?
In this plan the FDA:
- Addresses quality standards for outsourcing facilities
- Regulates compounding from bulk drug substances
- Restricts compounding of drugs that are essentially copies of FDA-approved drugs
- Solidifies the FDA’s partnership with state regulatory authorities
- Provides guidance on other activities that compounders undertake
FDAnews has invited Karla Palmer Esq. to bring you up to speed. Ms. Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the legislation and review in detail the current and future regulatory landscape. You’ll discover:
- Secs. 503A and 503B: How these sections of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities
- Draft and final guidances: Changes brought about in draft and final guidances to Secs. 503A and 503B
- Warning letters and 483s: Understand what enforcement actions FDA has taken against compounders to date and what could lie down the road
- Compounding inspections: What the FDA is looking for right now
- Role of the states: The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies
- And much more
Order today and discover the impact of federal guidance and regulations in this traditionally state-regulated activity.