Compounded and Unapproved Peptides: Regulatory Exposure and Defense for Prescribers and Clinics

David (“DJ”) Holt, Attorney and Owner | Holt Law

David (“DJ”) Holt is the attorney and owner of Holt Law, a boutique multi-state health law firm built exclusively for healthcare businesses. A biomedical engineer before he became a lawyer, he counsels healthcare professionals, licensed facilities, medical spas, management services organizations, and healthcare investors, and writes regularly on the regulatory and liability risks of compounded and unapproved peptides, including the 503A and 503B compounding rules.

• Education & Credentials

Holt earned his J.D. from Mitchell Hamline School of Law and holds a B.S. in Biomedical Engineering. He practices as a multi-jurisdictional health lawyer through Holt Law, LLC in Minnesota and Holt Law, PC in California.

• Recognition & Leadership

Holt holds Avvo’s highest rating, a 10.0 “Superb”, and Holt Law carries an A+ rating from the Better Business Bureau. He hosts The David Holt Show podcast.

• Professional Involvement

Holt founded DocuHealth, an online marketplace providing legal documents to healthcare providers, and co-founded miVoyce and CutMedicalBills, ventures focused on helping individuals manage medical bills and healthcare decisions. He has volunteered with LegalCORPS, providing pro bono transactional legal assistance to Minnesota entrepreneurs.

• Experience

Holt’s practice concentrates on the legal problems of operating a healthcare business, including entity structure and the corporate practice of medicine, management services agreements, compliance, and regulatory defense. His published analysis of peptide compliance covers the FDA’s Category 2 designation of BPC-157 and the limits of the 503A and 503B compounding pathways for unapproved peptides.

Patricia Vilma Graham, Associate Attorney | Holt Law

Patricia Vilma Graham is an associate attorney at Holt Law, where she works with healthcare businesses and professionals on the regulatory and business-law matters the firm concentrates on. She is based in the San Diego area.

• Education & Credentials

Graham earned her J.D. from Michigan State University College of Law and is a member of the State Bar of California (License #356432). She participated in the International Student Ambassador Program at the University of San Francisco.

• Recognition & Leadership

Graham served as President of Phi Alpha Delta and took first place in a competition addressing how AI technology can be used to increase access to justice.

• Professional Involvement

Graham publishes legal scholarship on technology and the courts. Her note, Emojis: An Approach to Interpretation, appeared at 46 UC Law SF Communications & Entertainment Law Journal 123 (2024), and her companion piece, Decoding Emojis: Lessons from Abroad, ran in the Michigan State Law Review Forum (2024).

• Experience

Graham’s practice at Holt Law centers on healthcare business matters.

SESSION 1 – FDA Compounding Rules and Medical Board Defense for Peptide-Prescribing Clinics | 1:00pm – 2:00pm

This session examines the FDA’s regulatory framework governing peptide compounding under 503A and 503B of the FD&C Act, the enforcement cascade triggered by Category 2 designations and shortage-list determinations, and the state-level medical board and pharmacy board actions now targeting peptideprescribing clinics. Attorneys will gain working knowledge of the compliance obligations, documentation standards, and defense strategies applicable to prescribers and clinics facing regulatory scrutiny. Attendees will leave able to identify the specific legal theories being deployed by state and federal regulators and to counsel clients on reducing exposure before and during an investigation.

BREAK | 2:00pm – 2:10pm

SESSION 2 – Defending Malpractice Claims and Coverage Disputes in Peptide Prescribing | 2:10pm – 3:10pm

This session examines the malpractice and insurance coverage risks facing clinics and prescribers who administer or prescribe compounded and unapproved peptide therapies. Attorneys will learn how to identify and counter the malpractice per se theory, build a documentation-based defense, and navigate coverage gaps that standard medical malpractice policies routinely create for unapproved substances. Participants will leave with a concrete framework for pre-claim risk reduction, post-claim defense strategy, and coverage dispute litigation in an area where appellate precedent is still forming.