FDAnews Announces — Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities Webinar, Oct. 16, 2018
FALLS CHURCH, Va. (PRWEB) September 28, 2018 -- Pharmacy Compounding Regulation:
Deconstructing Latest Guidance, Compliance & Enforcement Activities
**An FDAnews Webinar**
Oct. 16, 2018 — 1:30 p.m. – 3:00 p.m. ET
Pharmacy Compounding
What can drugmakers 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 drugmakers 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. Attendees will 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
Register today and discover the impact of federal guidance and regulations in this traditionally state-regulated activity.
Meet the Presenter:
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.
Who Will Benefit:
- Compounding pharmacist
- Pharmacy owner/manager
- Chain pharmacy executive
- Outsourcing facility
- Drugmaker or other supplier to compounders
- Legal counsel
- Consultant
Webinar Details:
Pharmacy Compounding Regulation:
Deconstructing Latest Guidance, Compliance & Enforcement Activities
**An FDAnews Webinar**
Oct. 16, 2018 — 1:30 p.m. – 3:00 p.m. ET
Pharmacy Compounding
Tuition:
$287 per site
Easy Ways to Register:
Online: Pharmacy Compounding
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]
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