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