The peptide industry is approaching one of its most consequential regulatory moments in recent years.
On July 23 and 24, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will consider whether seven peptides, including BPC-157 and TB-500, should be added to the 503A Bulks List. The meeting comes at a pivotal time, with FDA scientific reviewers recommending against compounding all seven peptides while HHS leadership has publicly signaled support for expanding access. The outcome could have significant implications for compounding pharmacies, healthcare providers, and businesses throughout the peptide industry.
Join attorneys Edgar J. Asebey and Jesse C. Dresser on July 22, the day before the FDA meeting, for a timely legal and regulatory briefing on what to expect, what the potential outcomes could mean, and how organizations can prepare for the evolving regulatory landscape.
What You’ll Learn
During this webinar, our presenters will discuss:
- Why the July PCAC meeting is one of the most significant FDA peptide developments in years.
- The seven peptides under review and what the FDA is being asked to consider.
- The potential legal and regulatory implications for compounding pharmacies, healthcare providers, and peptide companies.
- The compliance risks and business considerations that may follow the committee’s recommendations.
- Practical steps organizations should consider before and after the FDA meeting.
Who Should Attend
- 503A compounding pharmacies and 503B outsourcing facilities
- Physicians, clinics, and other healthcare providers utilizing peptide therapies
- Peptide manufacturers, distributors, and product companies
- Healthcare executives and legal, regulatory, and compliance professionals
Presenters
Edgar J. Asebey
Edgar J. Asebey advises FDA-regulated companies on complex regulatory, compliance, and enforcement matters involving pharmaceuticals, biologics, medical devices, dietary supplements, and other FDA-regulated products. His scientific background and extensive FDA regulatory experience provide clients with practical guidance on navigating evolving agency policies and enforcement priorities.
Jesse C. Dresser
Jesse C. Dresser counsels pharmacies, pharmacy owners, healthcare providers, and other healthcare businesses on pharmacy law, regulatory compliance, reimbursement, licensing, and government investigations. He regularly advises clients on legal and regulatory developments affecting the compounding industry.
Don’t miss this opportunity to gain practical legal insights before one of the year’s most closely watched FDA peptide meetings.
Why Frier Levitt
Frier Levitt is a nationally recognized healthcare and life sciences law firm representing compounding pharmacies, outsourcing facilities, healthcare providers, manufacturers, distributors, and other businesses operating within highly regulated healthcare markets. Our attorneys regularly advise clients on FDA compliance, pharmacy regulation, healthcare enforcement, reimbursement, and emerging legal issues affecting the peptide and GLP-1 industries.
As the legal and regulatory landscape continues to evolve, our team remains at the forefront of the issues shaping the future of peptide therapies and pharmaceutical compounding.
