Peptide Law Update: FDA Changes and Protecting Your Practice

The legal landscape for peptide therapy is changing. In this episode, Dr. Greg Jones talks with healthcare attorney Jeff Cohen about recent regulatory updates and their implications for providers. Jeff explains the risks of using "Research Use Only" products in a clinical setting and how to properly verify your suppliers' quality and safety. 

You will learn why it is important to focus on education rather than promotion on your website and how to improve your informed consent process to protect your license. Jeff also discusses the goals of the new American Peptide Association in setting industry standards. This conversation provides clear steps for clinic owners and practitioners to stay compliant while using compounded medications.

📌 Jeff L. Cohen, Esq.

Jeff L. Cohen, Esq., is a Board Certified Specialist in Health Law and the founder of the Florida Healthcare Law Firm. Prior to founding the firm, Mr. Cohen was in-house counsel for the Florida Medical Association and served for 13 years as a partner at a respected law firm in South Florida. He is equally knowledgeable about contract law, corporate and employment law, and all of the specific laws and compliance regulations that relate to healthcare entities, including Stark, Anti-Kickback, fraud and abuse, and HIPAA. An AV-rated attorney, he has developed a reputation for providing exceptional legal services and ethical counsel.

With over 35 years of experience, Mr. Cohen is a member of the American Health Lawyers Association, the Doctor’s Advisory Network of the American Medical Association, and the American Society for Medical Association Counsel. He is also a member of the Florida Hospital Association and a certified arbitrator with the American Health Lawyers Association (AHLA). Throughout his career, he has been recognized as a leader in his field, being named "Best Health Care Attorney" and consistently selected by his peers for the Florida Legal Elite.

🔗 Learn more about Jeff L. Cohen, Esq.

LinkedIn: www.linkedin.com/in/jeff-cohen-42847413

Website: https://floridahealthcarelawfirm.com

Instagram: www.instagram.com/flhealthcarelawfirm

Connect with Dr. Greg Jones

Instagram: @doctorjones_doctorjones 

Enovative Wellness Center: https://enovativewellness.com/ 

🔬 Timestamps

Introduction to Jeff's Journey in Healthcare Law (00:00 - 02:29)

The Shift from Traditional Medicine to Wellness (02:29 - 08:06)

The Impact of Regulatory Changes on Peptides (08:06 - 12:12)

Understanding Category One and Two Products (12:12 - 16:02)

The Black Market of Peptides and Its Implications (16:02 - 17:02)

Research-Only Peptides: Risks and Realities (17:02 - 24:25)

The Role of Professional Use-Only Products (24:25 - 27:09)

Auditioning Suppliers: Ensuring Quality and Safety (27:09 - 29:13)

The Future of Compounded Peptides and Regulatory Landscape (29:13 - 31:44)

Navigating Compound Pharmacy Regulations (31:44 - 36:01)

The Impact of the SAFE Act in Indiana (36:01 - 38:24)

The Irony of GLP Shortages and Regulations (38:24 - 41:28)

Customizing Informed Consent in Peptide Therapy (41:28 - 45:22)

Website Risks for Clinics (45:22 - 52:12)

Handling Cease and Desist Letters (52:12 - 55:24)

The Role of the American Peptide Association (55:24 - 01:01:04)