The Compounding/Manufacturing Debate: When Is a Duck Not a Duck? ACPE #205-000-13-001-L03-P

Saturday, May 18, 2013

2 - 4 PM

Pre-Meeting CPE

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck?

ACPE #205-000-13-001-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning ObjectivesAt the conclusion of this session participants will be able to:

1. Explain how a compounding pharmacy might be registered as a manufacturer by Food and Drug Administration (FDA).
2. Describe how states can enforce their regulations when it comes to the activities of compounding pharmacies acting as manufacturers.
3. Describe how compounding pharmacies that are acting as manufacturers may be regulated in the future.

DescriptionThe New England Compounding Center tragedy resulted in regulators conducting in-depth investigations of compounding pharmacies. This has brought to light the realization that these types of entities may be operating in a gray area of law. During this special pre-meeting continuing pharmacy education (CPE) panel session, federal and state regulators and compounding experts will discuss the perplexities surrounding the issue of compounding pharmacies acting as manufacturers and the resultant and ongoing regulatory challenges facing the boards of pharmacy.

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