Pharmacy Compounding Regulation – Webinar Recording/Transcript
Pharmacy Compounding Regulation: FDA’s Latest Guidance, Compliance & Enforcement Activities
Are you up to date on the latest regulation of outsourcing facilities and compounding pharmacies?
Given the FDA’s win in the FDA/Athenex litigation in DC’s District Court, the FDA has recently engaged in a review of bulk substances that may be used in compounding by outsourcing facilities. The FDA has released its preliminary determination to remove nine other substances from its Section 503B bulks list.
What can you expect from regulators going forward?
Karla Palmer Esq., Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll show 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: 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 FDA Commissioner and a new director of the Division of Compounded Drugs.
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.
Who Will Benefit:
- Compounding pharmacist
- Pharmacy owner/manager
- Chain pharmacy executive
- Outsourcing facility
- Drugmaker or other supplier to compounders
- Legal counsel