By: Caitlin Koppenhaver, APA Chief Industry Advisor
On May 26th, the Alabama Board of Medical Examiners issued an official notice to licensees concerning the prescribing and use of non-FDA-approved, “(Research-Grade)” peptides.
The notice should be taken seriously by physicians, medical practices, medspas, wellness clinics, telehealth platforms, compounding pharmacies, and peptide businesses operating in or serving patients in the state of Alabama.
The Board states that "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". The Board further states that these substances are not subject to FDA review for safety, efficacy, manufacturing standards, or manufacturing consistency, and that neither the provider nor the patient can fully assess the risks associated with their use or verify the contents of the vial.
The Board then ties that concern to Alabama’s pharmacy sourcing and professional standards expectations. According to the notice, physicians must purchase prescription products, drugs, and ingredients from an entity permitted by the Alabama State Board of Pharmacy, and all drugs administered or dispensed to a patient must be “prescription quality.” Based on that framework, the Board states that “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.
The patient-safety concern is understandable. Where peptides are used in a clinical setting, there should be a traceable framework for evaluating sourcing, quality, identity, strength, sterility, and supply-chain accountability. Patients should also receive clear information about what they are receiving, who prepared or supplied it, and where it came from. However, the notice also raises an important implementation question: what does “prescription quality” mean in practice, and what framework should providers use to validate it?
That question is important because “non-FDA-approved” and “research-grade” are not interchangeable classifications. A research-grade product is not a prescription-quality drug product. But compounded drugs are also not FDA-approved. Federal law recognizes compounding pathways, including patient-specific compounding under Section 503A when applicable statutory requirements are met. A product may be “not FDA-approved” without being “research-grade.”
That distinction should not be lost.
The November 2025 Alabama enforcement action against an IV clinic involved allegations that the clinic advertised tirzepatide and semaglutide as “pharmaceutical-grade,” while allegedly injecting patients with research-grade versions of those drugs that were not approved for human use. That is a materially different fact pattern than a provider ordering or prescribing a medication prepared by an appropriately licensed compounding pharmacy pursuant to a valid patient-specific prescription.
The May 2026 notice appears directed at the clinical use of research-grade or non-FDA peptides. But because the notice uses the phrase “Non-FDA Approved (Research-Grade) Peptides,” additional guidance would be helpful for providers, pharmacies, and clinics trying to distinguish between prohibited research-grade patient use and potentially lawful compounded medication pathways. A categorical prohibition may stop dangerous conduct, but it is more useful when paired with an operational framework that tells providers how to comply.
Providers should have a clear way to evaluate whether a peptide product is appropriate for patient care, including whether the product is FDA-approved or lawfully compounded, whether it was sourced through appropriate pharmaceutical channels, whether the pharmacy or outsourcing facility is properly licensed or permitted, whether a patient-specific prescription is required and present, whether there is documentation supporting identity, strength, purity, sterility where applicable, and chain of custody, and whether the provider has the appropriate documented clinical rationale for use.
The Board’s notice also addresses several clinic workflow issues. The Board states that:
- a physician may not avoid his or her duty of care by permitting or delegating the purchase, administration, or dispensing of these products to Certified Nurse Midwives, Certified Registered Nurse Practitioners, or Physician Assistants.
- a medical professional cannot require or permit a patient to waive the provider’s duty of care or obligation to follow the law, and that consent forms identifying a product as “research-grade” do not mitigate or eliminate professional or legal liability.
Patient-supplied products also create risk. The Board distinguishes between a patient independently acquiring and self-administering a substance, and a medical professional becoming involved in recommending, supplying, prescribing, advising, or administering it. Once the provider becomes involved in "recommending, supplying, prescribing, or administering these substances" the Board views that conduct as the practice of medicine and prohibited.
For the broader peptide industry, this notice reinforces that FDA is not the only regulator in the room. State medical boards and pharmacy boards are independently evaluating provider conduct, sourcing, product quality, delegation, patient-care workflows, and documentation in their states.
A responsible peptide framework needs responsible and accountable sourcing, quality measures, appropriate provider-patient relationships, state-specific scope-of-practice review, patient-specific clinical documentation where required, and clear separation between research products and patient-care products. Alabama’s notice is an important patient-safety warning, but it also presents an opportunity for additional regulatory alignment and guidance for its licensees.
Providers should not be left to guess what “prescription quality” means or how to validate it. If the goal is safer patient care, the next step should be accompanying practical guidance that distinguishes impermissible research-grade use from properly documented, lawfully sourced, patient-specific compounded care.