Compounding Under Sections 503A and 503B - Webinar CD/Transcript

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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.

  • Regulatory Affairs
  • Legal
  • Regulatory Attorneys
  • Quality Management

Joanne Hawana, Of Counsel at Mintz Levin
Joanne has extensive experience counseling a wide range of stakeholders in the prescription drug supply chain, including pharmacies and hospitals that engage in human drug compounding. She works with clients to understand their business realities and pressures in order to provide real-world solutions to compliance issues arising from new FDA and State laws.