FDAnews Announces — Pharmacy Compounding Regulation: FDA’s Latest Guidance, Compliance & Enforcement Activities Webinar, Feb. 18, 2020

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Discuss the latest guidance, compliance and enforcement activities affecting compounders. It’s time for a review.

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Pharmacy Compounding Regulation
FDA’s Latest Guidance, Compliance & Enforcement Activities
An FDAnews Webinar
Tuesday, Feb. 18, 2020 · 1:30 p.m. - 3:00 p.m. EST
https://www.fdanews.com/pharmacyreg

FDA scrutiny on compounding pharmacies remains high.

Given the FDA’s win in the FDA/Athenex litigation in DC District Court, the FDA has recently engaged in a review of bulk substances that may be used in compounding by outsourcing facilities. The FDA has released its preliminary determination to remove nine other substances from its Section 503B bulks list. What does this mean for the future?

Tune in Tuesday, February 18, when Karla Palmer Esq, one of Washington FDA bar’s foremost experts on compounding, explains the 2018 Compounding Priorities Plan, shows what’s behind the accelerating enforcement and discusses:

•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: 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: Interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies

There’s a new FDA Commissioner and a new director of the Division of Compounded Drugs. This webinar is a must-attend.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Pharmacy Compounding Regulation
FDA’s Latest Guidance, Compliance & Enforcement Activities
An FDAnews Webinar
Tuesday, Feb. 18, 2020 · 1:30 p.m. - 3:00 p.m. EST
https://www.fdanews.com/pharmacyreg

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pharmacyreg
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

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Michelle Butler
FDAnews
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