By Angie Cameron Smith
Introduction
Peptides have emerged as one of the most rapidly evolving areas in modern medicine. According to those that promote the benefits of peptides, these short chains of amino acids can play critical roles in numerous biological processes and have become increasingly prominent in therapeutic applications. As the use of peptide-based therapies expands across medical specialties ranging from endocrinology to dermatology and anti-aging medicine, practitioners must understand the legal risks that may accompany their clinical use. This article provides an overview of some of the litigation-related issues that physicians, nurse practitioners, and other prescribers should consider when incorporating peptide therapies into their practices.
Regulatory Status of Peptides
In the United States, the Food and Drug Administration (FDA) categorizes peptides along a spectrum. There are some FDA-approved peptide drugs, such as semaglutide, tirzepatide, and certain formulations of growth hormone, which have obtained approval by undergoing clinical trials that demonstrate safety and efficacy for specific uses. Compounded peptides occupy a more complex regulatory space; these are peptides prepared by compounding pharmacies under either Section 503A or Section 503B of the Federal Food, Drug, and Cosmetic Act. The FDA has taken an increasingly active role in regulating compounded peptides, and in recent years has placed several formerly available peptides on its “difficult to compound” list or has otherwise restricted their availability through compounding. Research-use-only peptides represent yet another category and are not intended for human use, though they have at times been diverted into clinical or consumer channels through gray-market suppliers.
Changes to the Regulatory Landscape
The regulatory environment surrounding peptides has shifted considerably in recent years and continues to evolve. The FDA’s increased scrutiny of compounding pharmacies, particularly those producing peptide therapies such as BPC-157 (body protection compound-157) and thymosin alpha-1, has created a landscape in which the legal permissibility of prescribing certain peptides can change rapidly. In 2023 and 2024, the FDA added several popular peptides to its list of Category 2 substances, effectively restricting their availability from compounding pharmacies. However, as recently as February 2026, United States Secretary of Health and Human Services Robert F. Kennedy promised more access to compounded peptides.
Additionally, practitioners must keep in mind whether state medical boards and state pharmacy boards may impose additional restrictions or requirements beyond those established at the federal level.
Litigation Risks Associated with Prescribing Peptides
The prescription of peptide therapies exposes practitioners to several distinct categories of litigation risk, and an understanding of those risks is an essential component of responsible clinical practice.
Medical Malpractice Claims
The most straightforward litigation risk associated with peptide prescribing is medical malpractice. Malpractice claims in this area may arise from several factual scenarios. A practitioner who prescribes a peptide for an off-label indication without adequately informing the patient of the off-label nature of the use, the limited evidence supporting it, or the potential risks involved may face claims grounded in failure to obtain informed consent. Similarly, adverse reactions to peptide therapies, including injection-site reactions or more serious systemic effects, may give rise to negligence claims if the prescribing practitioner failed to conduct appropriate baseline assessments, failed to monitor the patient during treatment, or failed to recognize and respond to warning signs of adverse effects.
The standard of care for prescribing peptide therapies remains somewhat unsettled because many peptide uses are relatively novel and lack the depth of clinical trial data that supports more established therapies. This ambiguity can cut both ways in litigation: plaintiffs may argue that the absence of robust evidence should have deterred the practitioner from prescribing the peptide at all, while defendants may argue that the emerging nature of the field makes it inappropriate to judge their clinical decisions by standards that have not yet been firmly established.
Regulatory and Licensing Violations
Prescribing peptides that are not FDA-approved, or that are obtained from non-compliant sources, may expose practitioners to regulatory enforcement actions by state medical boards. These regulatory actions may, in turn, give rise to civil litigation. For example, a finding by a state medical board that a practitioner engaged in unprofessional conduct by prescribing an unapproved peptide could be used as evidence in a subsequent malpractice action.
Fraud and Misrepresentation Claims
The marketing and promotion of peptide therapies is another area of concern. Practitioners who make unsupported claims about the efficacy of peptide therapies, whether in direct patient communications, on practice websites, or through social media, may face claims of fraud or misrepresentation. These claims may be brought by individual patients or, in some cases, by state attorneys general or the Federal Trade Commission.
Risk Mitigation Strategies for Practitioners
Given the litigation risks associated with peptide prescribing, practitioners should adopt comprehensive risk mitigation strategies. Thorough informed consent processes are paramount and should include clear documentation that the patient understands the regulatory status of the prescribed peptide, the level of evidence supporting its use, the known and potential risks, and any alternative treatments that may be available. Practitioners should source peptides exclusively from appropriately licensed and accredited pharmacies and should maintain documentation verifying the credentials of any compounding pharmacy from which they obtain peptide products.
Ongoing patient monitoring is essential, including baseline laboratory assessments and periodic follow-up testing appropriate to the specific peptide being prescribed. Practitioners should maintain detailed clinical records documenting the medical indication for the peptide therapy, the clinical rationale supporting its use, and the patient’s response to treatment over time. Continuing education in both the clinical science of peptide therapies and the evolving regulatory landscape is advisable, as is consultation with legal counsel experienced in healthcare regulatory matters when questions arise regarding the permissibility of a particular peptide therapy.
Conclusion
The rapid expansion of peptide prescribing has outpaced the development of clear regulatory frameworks and established standards of care, creating a legal environment characterized by uncertainty and evolving risk. Practitioners who choose to incorporate peptide therapies into their clinical practice must do so with a clear-eyed understanding of the classification of these compounds, the regulatory requirements governing their use, and the litigation risks that may follow from their prescription.
The information provided in this article is for educational purposes only and does not constitute legal advice. Practitioners with specific questions regarding the legality of prescribing particular peptide therapies should consult qualified legal counsel in their jurisdiction.
Angie Cameron Smith is a partner in the Health Care Practice Group at Burr & Forman.
