What Healthcare Providers Need to Know About Compounding Pharmacies and the New Drug Compounding Law

 

Navigating Outsourcing Facilities Regs, Understanding the Impact of the New Law, and Minimizing Risks in Outsourcing

A live 90-minute CLE webinar with interactive Q&A

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Thursday, August 21, 2014
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, July 25, 2014

Add to Your Calendar >  

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This CLE webinar will provide guidance to healthcare counsel on the new drug compounding law and its impact on hospitals and other healthcare providers. The panel will examine recent FDA action and offer strategies for healthcare providers to navigate the new drug compounding landscape.

Description

After the death of 64 people and over 700 others' sickness was traced to a drug compounder, Congress passed the Drug Quality and Security Act (DQSA), bringing about sweeping changes to ensure the safety of drug compounding. The DQSA was signed into law in Nov. 2013, giving the FDA the authority to regulate drug compounding.
Recent FDA guidance documents regarding plans for enforcement and expectations for compliance and several FDA warning letters demonstrate the agency's heightened enforcement on drug compounding facilities.
Hospitals often rely on compounded drugs to provide medication customized for patients. Hospital counsel must understand the impact of the new law on hospitals, whether the hospital does its own drug compounding or relies on outside sources for compounded drugs.
Listen as our experienced panel of healthcare counsel examines compounding pharmacies and the new drug compounding law, and the impact of the new law on healthcare providers. The panel will also discuss FDA action and current trends and strategies for hospitals and other providers.

Outline

1. Compounding pharmacies and the new drug compounding law
2. Impact of the new law on hospitals and other healthcare providers
   1. Compounding drugs
   2. Using outside sources for compounded drugs
3. FDA and current trends
4. Best practices for hospitals and other providers

Benefits

The panel will review these and other key questions:

• What do hospitals need to know before using outsourcing facilities to get compounded drugs?
• What impact will the DQSA have on hospitals?
• How is the FDA approaching enforcement of drug compounding and compounding pharmacies?

Faculty

Harry Nelson, Founder & Managing Partner
Nelson Hardiman, Los Angeles

Mr. Nelson counsels a wide range of healthcare providers on regulatory compliance, response to civil investigations and enforcement, and healthcare business issues and challenges.  He represents providers during investigations, audits, and administrative actions by the federal Drug Enforcement Administration (DEA). He also represents providers before other agencies, including the U.S. Department of Health and Human Services, the Food and Drug Administration (FDA), and numerous professional and facility licensing agencies.
Additional faculty to be announced.

Ordering

Live Webinar

You may invite an unlimited number of staff on one connection at your location. (NOTE: OH, PA and KS attorneys also registering for CLE credit processing should call for special instructions.)
Additional connections or locations for this conference can be purchased at 25% off.

Live Webinar $247.00

Includes Early Discount Savings of $50.00 (through 07/25/14)

Live Webinar & CLE Processing $312.00

Includes Live Webinar Early Discount Savings of $50.00 (through 07/25/14)