FDA Regulation in Pharmacy Compounding - Risks and Critical Issues to Consider

Instructor: J Mason Weeda
Product ID: 703164
Training Level: Intermediate
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

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

Instructor Profile:

J Mason Weeda, Associate Attorney, Olsson Frank Weeda, Healthcare Compliance. He devotes his practice to a blend of regulatory and litigation matters, principally representing medical device, biologics, pharmaceutical and food manufacturers, distributors and importers.

Mr. Weeda has worked in sales and marketing for a biologics manufacturer and a laboratory that provided neurogenetic diagnostic testing. Since receiving his juris doctorate, Mr. Weeda has advised clients on a wide array of topics ranging from the U.S. Food and Drug Administration (FDA) regulatory status of clinical trials to compliance with the complexities of the Health Insurance Portability and Accountability Act (HIPAA). In addition to maintaining a food, drug and device-based practice, Mr. Weeda represents clients in civil litigation matters.

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