FDAnews Announces — Pharmacy Compounding Regulation Webinar Oct. 14, 2020

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Manage the newest drug compounding regulations, discuss the COVID-19 effects on operations and learn the latest on FDA inspections.

WCG FDAnews

WCG FDAnews

Pharmacy Compounding Regulation:
FDA’s Latest Guidance, Compliance and Enforcement Activities
An FDAnews Webinar
Wednesday, Oct. 14, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/pharmacycompounding

The Pharmacy Compounding Regulation webinar on Oct. 14, will help one form a better understanding of how the FDA and the Department of Justice are engaging in significant enforcement activity concerning compounders and outsourcing facilities, including issuing recalls, shutting down sterile operations and serving consent decrees.

The webinar will also consider the effect of the COVID pandemic on compounders and outsourcing facilities, FDA’s guidance on permitting certain drug products to be compounded and what effect, if any, this has had on this struggling industry and patient access.

DEA and FDA enforcement and litigation expert Karla Palmer will share critical current information around the FDA’s recent guidance and regulatory positions.

During this webinar, we’ll cover:

  • The significant differences between Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA)
  • The FDA’s final memorandum of understanding (MOU) and updates to the bulk substances lists
  • The FDA’s position with respect to compounding pharmacies and outsourcing facilities considering drug shortages caused by the COVID-19 pandemic
  • The implications of recent enforcement actions the FDA has taken against compounders, including those against ABC Compounding in Georgia for inaccurate listing information for its antiseptic hand wash
  • The current focus of FDA inspections, including insanitary conditions
  • The important interplay between the FDA and states concerning the regulation of outsourcing facilities and compounding pharmacies
  • The recent case for Oxitriptan’s inclusion on the 503A list from the Summit Health Pharmacy in Georgia

The FDA is frequently releasing new guidance documents — shifting expectations and requirements constantly. Let our expert guide you through these changes.

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 and Enforcement Activities
An FDAnews Webinar
Wednesday, Oct. 14, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/pharmacycompounding

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pharmacycompounding
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
703.538.7600
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