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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:
Order today and keep abreast of the rapidly changing rules and enforcement policies affecting compounding.
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.
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