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Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, Enforcement
Compounding pharmacies are facing increased scrutiny. Recently the FDA found 11 adulteration violations including visibly dirty surfaces and non-sterile cleaning methods in ISO 5 areas at Triad Rx.
Last October Karla Palmer Esq. delivered a standout presentation on what to expect from the FDA’s 2018 Compounding Priorities Plan. Since then the agency’s compounding crackdown has accelerated. It’s time for a fresh look.
Ms. Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the 2018 Compounding Priorities Plan and shows what’s behind the accelerating enforcement.
There’s a new director of the Division of Compounded Drugs. You won’t want to miss this up-to-the-minute update.
Meet Your Presenter
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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