Pharmacy Compounding Regulation - Webinar Recording/Transcript
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.
- 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.