Pharmacy Compounding Regulation – Webinar Recording/Transcript
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Compounding pharmacies are facing increased scrutiny. The FDA has recently published new guidances, including the Final Memorandum of Understanding between States and the FDA, sponsored research and a report on compounded bioidentical hormone products and the narrowing of “Bulk Substances List 1” for Section 503B facilities.
The Pharmacy Compounding Regulation presentation, will help give you a better understanding of how the FDA and the Department of Justice are engaging in significant enforcement activity concerning compounders and outsourcing facilities, including issuing recalls, shutting down sterile operations and serving consent decrees.
The presentation will also consider the effect of the COVID pandemic on compounders and outsourcing facilities, FDA’s guidance on permitting certain drug products to be compounded and what effect, if any, this has had on this struggling industry and patient access.
DEA and FDA enforcement and litigation expert Karla Palmer will share tips on navigating the regulation of outsourcing facilities and compounding activities. She’ll talk about what to expect from regulators, recent enforcement activities and the FDA’s most recent guidance and regulatory positions.
- The significant differences between Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA)
- The FDA’s final memorandum of understanding (MOU) and updates to the bulk substances lists
- The FDA’s position with respect to compounding pharmacies and outsourcing facilities considering drug shortages caused by the COVID-19 pandemic
- The implications of recent enforcement actions the FDA has taken against compounders, including those against ABC Compounding in Georgia for inaccurate listing information for its antiseptic hand wash
- The current focus of FDA inspections, including insanitary conditions
- The important interplay between the FDA and states concerning the regulation of outsourcing facilities and compounding pharmacies
- The recent case for Oxitriptan’s inclusion on the 503A list from the Summit Health Pharmacy in Georgia
The FDA is frequently releasing new guidance documents — shifting expectations and requirements constantly. Let our expert guide you through these changes.
Meet Your Presenter
Karla Palmer, an attorney with extensive enforcement and litigation experience, advises clients throughout the supply chain — from manufacturers and distributors to outsourcing facilities and pharmacies — on a range of issues involving DEA and FDA regulations, guidance, investigations and enforcement. She guides clients through government inspections — including responding to FDA Form 483s and warning letters, investigations, consent decrees and administrative and federal proceedings. She has appeared before various state pharmacy boards to defend compounders and outsourcing facilities and routinely represents entities concerning licensing and related issues.
Palmer has also written numerous blog posts, articles and book chapters on enforcement concerns while addressing industry audiences across the country on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act. She covers compounding and supply chain issues, guidance documents and implementation regulations.
Who Will Benefit
- Pharmacies and outsourcing facilities
- Drug manufacturers
- Law firms that represent compounding pharmacies and outsourcing facilities
- Compounding pharmacists
- Owners and employees of pharmacies and outsourcing facilities
- Quality professionals
- Regulatory affairs professionals
- GMP professionals
- Inspections and audit professionals
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Oct. 14, 2020