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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:
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:
Order today and discover the impact of federal guidance and regulations in this traditionally state-regulated activity.
Karla Palmer Esq., Director, Hyman Phelps & McNamara P.C. With 25 years’ experience as a litigator, Ms. Palmer focuses her practice on DEA and FDA enforcement and litigation at all ends of the supply chain. She has appeared before numerous state boards of pharmacy defending compounders and outsourcing facilities, and routinely represents entities concerning licensing and related issues. She is an authority on the 2013 Drug Quality and Security Act (Compounding Quality Act) including compounding and supply-chain issues, guidance documents and implementing regulations, and is well-versed in compounding laws, regulations and guidance at other levels of government.
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