Board Issues Official Notice Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides
Research-grade peptides are not approved by the FDA and have not been tested, reviewed, or determined to be safe or effective for human use.
These substances are not subject to regulation or oversight by the FDA regarding safety, efficacy, or manufacturing standards and consistency. 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.
Physicians must purchase all prescription products, drugs, and ingredients from an entity permitted by the Alabama State Board of Pharmacy. 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.
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.
A medical professional cannot require or permit a patient to “waive” the provider’s duty of care to the patient and the professional’s personal obligation to follow the law. Patient consent forms purporting to identify a product as “research-grade” are ineffective and do not mitigate or eliminate the health care provider’s professional or legal liability.
In circumstances where a patient independently acquires and self-administers such substances, the associated risk rests solely with the patient. However, any involvement by a medical professional in recommending, supplying, prescribing, or administering these substances constitutes the practice of medicine and is prohibited.
The Alabama Board of Medical Examiners remains committed to protecting the health and safety of all Alabama patients and expects all practitioners to uphold the highest standards of care.