The Alabama Board of Medical Examiners (ALBME) recently issued a notice to physicians in Alabama, warning against prescribing research-grade peptides that have not been approved by the Food and Drug Administration (FDA).
There has been a global explosion of peptides in recent years. These exogenous proteins have been popularized by internet commentators and influencers, who boast of the benefits various peptides offer for health, fat loss, energy, skin health and more.
Since the vast majority of these peptides have not received FDA approval, many people buy peptides marketed for “research purposes” and explicitly not for human consumption. In some places, physicians also use compounding pharmacies to dispense peptides, even though the medications aren’t FDA-approved.
In its warning letter to Alabama doctors, the ALBME did not list an instance of peptide use causing harm or death. However, it did claim there were "potential risks.”
“These substances are not subject to regulation or oversight by the FDA regarding safety, efficacy, or manufacturing standards and consistency,” the ALBME said. “As a result, neither the provider nor the patient can fully assess, quantify, or understand the potential risks associated with their use. Nor can they verify the contents of any vials.”
The ALBME also warned that it is against the law for a physician even to advise or recommend peptides, even if delegated through an intermediary.
“Physicians must purchase all prescription products, drugs, and ingredients from an entity permitted by the Alabama State Board of Pharmacy,” ALBME continued. “All drugs administered or dispensed to a patient must be prescription quality; therefore, under no circumstances is it permissible for a physician to compound, administer, or dispense a non-FDA-approved or research-grade peptide to a patient.”
“A physician may not circumvent his or her duty of care to patients by permitting or delegating the purchase, administration, or dispensing of these drugs to Certified Nurse Midwives (CNMs), Certified Registered Nurse Practitioners (CRNPs) or Physician Assistants (PAs). This prohibition includes advising, recommending, supplying, prescribing, or administering.”
It continued, “By law, CNMs, CRNPs, and PAs may only administer, dispense, and prescribe legend drugs that are included on a formulary approved by the Board of Medical Examiners and the Alabama Board of Nursing. No research-grade or non-FDA-approved peptide is included on any approved formulary. Therefore, no CNM, CRNP, or PA is legally authorized to prescribe, administer, advise, or dispense a non-FDA-approved or research-grade peptide.”
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