FDAnews Announces — Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance Webinar, Aug. 9, 2016

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Compounders, new federal policies may make some existing practices unlawful. Join Joanne Hawana, Counsel at Mintz Levin, on Aug. 9 for a 90-minute webinar where she’ll cover the implementation of Section 503B including outsourcing facility registration and the enforcement policies affecting traditional compounding pharmacies that rely on Section 503A.

Compounding Under Sections 503A and 503B:
Distinctions, Limitation, Liabilities, and Compliance
**An FDAnews Webinar**
Aug. 9, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/compoundingundersections503AB

Compounders, new federal policies may make some existing practices unlawful.

The FDA’s final guidance puts drugmakers on equal footing with other drugmakers. The agency doesn’t need to identify a particular safety problem before pursuing enforcement action.

How does this affect business?

Join Joanne Hawana, Counsel at Mintz Levin, on Aug. 9 for a 90-minute webinar where she’ll cover the implementation of Section 503B including outsourcing facility registration and the enforcement policies affecting traditional compounding pharmacies that rely on Section 503A.

After attending this webinar drugmakers will know:

  •     What states have created new license requirements for FDA-registered outsourcing facilities, and how to meet these new obligations
  •     What “anticipatory compounding” really means, how the FDA is interpreting this dicey provision, and how it intends to enforce adherence
  •     How the FDA is interpreting Section 503B, including its restrictive reading of a “facility at one geographic location or address,” as used to define an outsourcing facility and what it means for the bottom line
  •     How the FDA is dramatically increasing enforcement
  •     Why this is one space in drug regulation that noncompliance can lead directly to the closing of a business, especially after an unfavorable state or federal inspection
  •     What kind of inspections to expect under FFDCA by the FDA that will clearly impact the risk management program

Register today and keep abreast of the rapidly changing rules and enforcement policies affecting compounding.

Meet the Presenter:
Joanne Hawana, Of Counsel at Mintz Levin

Joanne has extensive experience counseling a wide range of stakeholders in the prescription drug supply chain, including pharmacies and hospitals that engage in human drug compounding. She works with clients to understand their business realities and pressures in order to provide real-world solutions to compliance issues arising from new FDA and State laws.

Who Will Benefit:

  •     Regulatory Affairs
  •     Legal
  •     Regulatory Attorneys
  •     Quality Management

Webinar Details:
Compounding Under Sections 503A and 503B:
Distinctions, Limitation, Liabilities, and Compliance
**An FDAnews Webinar**
Aug. 9, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/compoundingundersections503AB    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/compoundingundersections503AB            
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
+1 (703) 538-7665
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