Compounding Under Sections 503A and 503B - Webinar CD/Transcript
Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance
What does the FDA take into consideration when reviewing nominated compounded substances? Safety concerns… efficiency of the evaluation process… nomination by multiple parties?
Listen to Joanne Hawana, Of Counsel at Mintz Levin, in this 90-minute presentation where she covers the implementation of Section 503B including outsourcing facility registration and the enforcement policies affecting traditional compounding pharmacies that rely on Section 503A.
After listening to this presentation you’ll know:
- What states have created new license requirements for FDA-registered outsourcing facilities
- How the FDA has interpreted the restrictions in Section 503A, including the restrictions on so-called anticipatory compounding?
- How the FDA has interpreted Section 503B, such as its restrictive reading of a “facility at one geographic location or address,” as used to define an outsourcing facility
- The facts of some of the more extensive enforcement actions in the past year against compounding entities or pharmacists
Order today and keep abreast of the rapidly changing rules and enforcement policies affecting compounding.