Earlier this year, FDA released two guidance documents establishing temporary policies regarding the compounding of certain drugs for hospital patients due to shortages related to the COVID-19 pandemic. The guidance documents permit compounding by outsourcing facilities registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act, as well as by pharmacy compounders who fall under section 503A, which is an unprecedented step. Accordingly, FDA does not intend to take action against an outsourcing facility for compounding a drug under certain supply disruption situations that is considered essentially a copy of an approved drug or for using bulk substances not on FDA’s approved Bulks List, for patients in hospitals and if those drug products are used to treat COVID-19. Similarly, FDA does not intend to take action against 503A compounding pharmacies if they are compounding drugs in short supply for hospital patients hospital without a patient prescription, for patients with COVID-19 provided the conditions set forth in the guidance are met. The webinar will address the qualifications, circumstances, and limitations for compounding that FDA established in these important guidance documents, and FDA’s and states’ responses to drug shortages. The panel will also consider whether FDA’s shifting position for compounding during COVID-19 will carry over after the pandemic recedes. In addition, the panel will address other FDA communications concerning compounding in 2020.
- +$100 for nonmembers
Gabrielle Cosel, Senior Advisor for Compounding (Acting), Office of Compliance, CDER, FDA
A.J. Day, Vice President of Clinical Services, Professional Compounding Centers of America (PCCA)
Ian Deveau, Division Director (Acting), Office of Compliance, CDER, FDA
Lee Rosebush, Partner, BakerHostetler
Moderated by Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC
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