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Home » Store » Drug Products » Pharmacy Compounding Regulation - Webinar Recording/Transcript

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Audio Recording/Transcript - Oct. 16, 2018

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Pharmacy Compounding Regulation - Webinar Recording/Transcript

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Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities

What can you expect from the FDA’s 2018 Compounding Priorities Plan?

In this plan the FDA:

  • Addresses quality standards for outsourcing facilities
  • Regulates compounding from bulk drug substances
  • Restricts compounding of drugs that are essentially copies of FDA-approved drugs
  • Solidifies the FDA’s partnership with state regulatory authorities
  • Provides guidance on other activities that compounders undertake

FDAnews has invited Karla Palmer Esq. to bring you up to speed. Ms. Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the legislation and review in detail the current and future regulatory landscape. You’ll discover:

  • Secs. 503A and 503B: How these sections of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities
  • Draft and final guidances: Changes brought about in draft and final guidances to Secs. 503A and 503B
  • Warning letters and 483s: Understand what enforcement actions FDA has taken against compounders to date and what could lie down the road
  • Compounding inspections: What the FDA is looking for right now
  • Role of the states: The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies
  • And much more

Order today and discover the impact of federal guidance and regulations in this traditionally state-regulated activity.

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