This webinar will provide an overview of current FDA regulation of pharmacy compounding in the wake of the 2012 meningitis outbreak. It will discuss the legislative efforts taken by Congress to clarify the FDA's authority over compounding pharmacies. The webinar will cover the FDA's traditional approach to regulating compounding, its current policy statement, recent enforcement trends, and two pieces of pending legislation - HR 3089 and HR 3204. Pharmacists, pharmacy technicians, and those in regulatory affairs and quality control in the pharmaceutical industry would benefit from attending.

1. FDA Regulation in Pharmacy Compounding - Risks and Critical
Issues to Consider
This webinar on FDA Pharmacy Compounding will detail the current thinking, the efforts made
and steps taken by FDA and legislatures since the “meningitis outbreak” in 2012.
Why Should You Attend:
Since the meningitis outbreak caused by contaminated compounded drugs, congressional
hearings ensued and Congress has sought to pass legislation. Did you know that there are
currently two versions of legislation in the works by the House of Representatives that attempt
to clarify FDA’s authority?
This webinar will review how the government may potentially regulate pharmacy
compounding. There are many questions surrounding the scope of what should be regulated should ever compounding pharmacy worry whether they will be compliant? This webinar
details FDA’s traditional approach to compounding and how it has regulated compounding to
date, FDA’s current thought process on why it does not believe it has authority to regulate and
its policy statement which states that violations related to activities viewed as “drug
manufacturing” may lead to FDA enforcement.
Areas Covered in the Webinar:
Overview of FDA regulation over FDA compounding
Issues regarding FDA Enforcement on New England Compounding Center
Current FDA compounding policy
Recent FDA Enforcement Trends
HR 3089
HR 3204
Who Will Benefit:
Compounding Pharmacists
Subcontractors of Compounding Pharmacies
Technicians
Chemists and Druggists
Pharma Regulatory affairs
Pharma QA/ QC
For more details visit us at:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~produc
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