Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA
State medical, nursing and pharmacy boards are taking an aggressive stance against clinical use of peptides despite FDA’s recent posture directed at easing access. Last month, an FDA advisory panel recommended that six peptides be added to the 503A Bulks List, so that they may eventually be compounded. Some believe that this represented an effort to slow down or shut down the grey/black market for peptides. Despite this, state licensing boards are leaving prescribers and pharmacists with strict enforcement, penalties, and a legal minefield.
Over the past few weeks, an increasing number of state licensing boards have issued ‘Warning Notices’ to licensees. Most, but not all, of the warnings are directed to ‘research use only’ or ‘RUO’ peptides. However, some of the warnings are broad referring to peptides as ‘unapproved substances’ and that administering them outside of strict regulatory channels constitutes unprofessional conduct and malpractice. Other states warnings broadly include both RUO and ‘non-FDA Approved peptides.’ A few warnings advise that delegation through intermediaries such as Certified Nurse Practitioners (CRNPs) or Physician Assistants (PAs) does not circumvent a physician’s duty, nor does attempts to shift responsibility to patients via waivers or disclaimers. A targeting of Scope of Practice violations without state prescriptive authority or lack of Collaborative Practice Agreements is common. Licenses have been suspended and practices have lost licenses. The warning from Mississippi is a joint statement from the Boards of nursing, pharmacy and medicine. The South Carolina warning states in part “A licensed practitioner purchasing, distributing, or dispensing drugs or its components from an unpermitted facility is aiding and abetting unlicensed practices in violating state law involving drugs and may be disciplined for unprofessional conduct.”
Other states (and FDA) are targeting wholesalers and online advertising. Some state boards warn that all prescription drugs (or components of compounded drugs) must only be purchased from an entity licensed by the Board of Pharmacy in a particular state. A partial list of states that have issued warnings and/or those considered more restrictive to peptides include Alabama, California, Connecticut, Louisiana, Mississippi, New Jersey, Ohio, and South Carolina. FDA and consumer protection agencies have, also increased enforcement of deceptive marketing and have stepped up seizures stopping peptides from importation. Telehealth companies pivot as telehealth laws vary from state-to-state and the state rules become more confusing.
Health Law Alliance can help you navigate state rules and the federal regulatory framework governing peptides to proactively mitigate exposure. Our legal team works with pharmacists, prescribers, wholesalers to analyze state-specific restrictions, including advertising, vetting pharmaceutical grade sourcing, prescribing, delegation models, patient consent and waivers, documentation, and protocols to support your goals. Confirm current requirements with counsel before marketing , sourcing, prescribing or compounding peptides to ensure solid legal standing. If your practice has already received an FDA Warning, subpoena, or state board inquiry, contact counsel before taking action.
