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.

  • Compounding pharmacist
  • Pharmacy owner/manager
  • Chain pharmacy executive
  • Outsourcing facility
  • Drugmaker or other supplier to compounders
  • Legal counsel
  • Consultant

Karla Palmer Esq., Director, Hyman Phelps & McNamara P.C. With 25 years’ experience as a litigator, Ms. Palmer focuses her practice on DEA and FDA enforcement and litigation at all ends of the supply chain. She has appeared before numerous state boards of pharmacy defending compounders and outsourcing facilities, and routinely represents entities concerning licensing and related issues. She is an authority on the 2013 Drug Quality and Security Act (Compounding Quality Act) including compounding and supply-chain issues, guidance documents and implementing regulations, and is well-versed in compounding laws, regulations and guidance at other levels of government.