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Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance

FDANEWS

Aug
9
2016

Date: August 9, 2016

Time: 1:30PM

Location: Webinar

Join Joanne Hawana, Of Counsel at Mintz Levin, on Aug. 9 for a 90-minute webinar where she’ll cover the implementation of Section 503B including outsourcing facility registration and the enforcement policies affecting traditional compounding pharmacies that rely on Section 503A.

After attending this webinar 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.

Speakers

Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.