Pharmacy Compounding Regulation - Webinar Recording/Transcript

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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.

Presentation Takeaways:

  • 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: Interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies 

There’s a new director of the Division of Compounded Drugs. You won’t want to miss this up-to-the-minute update.

  • Compounding pharmacist
  • Pharmacy owner/manager
  • Chain pharmacy executive
  • Outsourcing facility
  • Drugmaker or other supplier to compounders
  • Legal counsel
  • Consultant

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.