Recorded September 30, 2020 | On-Demand Webinar
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. Accordingly, FDA does not intend to take action against an outsourcing facility for compounding a drug that is considered essentially a copy of an approved drug or for using bulk substances not on FDA’s approved Bulks List. Similarly, FDA does not intend to take action against 503A compounding pharmacies if they are compounding a drug that is currently under shortage or for providing a drug to a hospital without a patient prescription, provided the conditions set forth in the guidance are met. The webinar will address the qualifications, circumstances, and limitations for compounding set forth under both guidances, FDA’s response to shortages and the role of compounding, and how the current situations may – or should – affect compounding in the future.