Supplier Verification: How Med Spas Should Vet Pharmacies and Drug Suppliers

By Patrick O’Brien, JD, American Med Spa Association (AmSpa)

Key Takeaways

• Med spas must verify that any pharmacy, outsourcing facility or distributor is licensed and authorized to ship into their state before purchasing.
• In Ohio, regulators may presume a purchase is unlawful if no documented supplier check was done beforehand.
• “Research use only” peptides and other products not intended for human use are a major red flag.
• Verification records (screenshots, licenses, approval forms) are your best evidence of compliance.
• Every practice should have a written supplier-verification policy and re-verify suppliers periodically.

Why Are Regulators Focusing on Med Spa Drug Sourcing?

Recent enforcement actions in Ohio provide an important reminder for medical spas: verifying your pharmacy and drug suppliers is not optional. In a recent action by the Ohio Board of Pharmacy, inspectors found that a medical spa purchased injectable products from an unlicensed supplier and failed to document required supplier verification checks. Regulators specifically noted that if no documented supplier query is conducted before a purchase is made, the purchase may be presumed unlawful. This follows an earlier story where the Ohio Board of Pharmacy issued fines and revoked drug distribution licenses from a number of medical spas.

This is not just an Ohio issue. Across the country, regulators are increasing scrutiny of drug sourcing, compounded medications, peptides, and other injectable products. Compliance failures involving drug sourcing and the purchase of unapproved products have become recurring concerns in medical spa enforcement actions. The good news is that many of these issues are preventable with a simple supplier verification procedure.

How Do You Verify a Pharmacy or Drug Supplier?

Medical spas should never assume a supplier is legitimate simply because it has a professional-looking website or markets directly to healthcare providers. Before purchasing any prescription product, practices should verify that the supplier is properly licensed and authorized to distribute products into their state.

For a traditional pharmacy or 503A compounding pharmacy, practices should verify:

• Active pharmacy licensure;
• Any required nonresident pharmacy licenses;
• Good standing with applicable pharmacy boards; and
• Authorization to ship into the practice’s state.

For a 503B outsourcing facility, practices should also verify:

• FDA registration as a 503B outsourcing facility;
• State licensure where required; and
• FDA inspection history and publicly available compliance information.

Document these checks and retain copies of the results.

What’s the difference between 503A and 503B pharmacies? 503A pharmacies compound for individual patient prescriptions and are primarily state-regulated, while 503B outsourcing facilities register with FDA, follow cGMP and can produce in bulk without patient-specific prescriptions.

Can Med Spas Use “Research Use Only” Peptides?

One of the more common red flags is a supplier marketing products as “research use only” or “not for human consumption.” This often signals that the supplier is not complying with FDA rules for compounding drugs intended for human use. We recently covered a joint warning from the Mississippi medical, nursing, and pharmacy boards, noting that healthcare providers should not prescribe, administer, dispense, or otherwise facilitate the use of non-FDA-approved “research-grade” peptides in patients. The warning also emphasized that providers should purchase prescription products only from appropriately authorized entities and verify supplier licensure. If a product is advertised primarily as a research chemical, that should prompt immediate additional review before any purchase is considered.

What Else Should You Check Beyond Licensure?

Licensure is only part of the process. Practices should also review publicly available enforcement history, including:

• FDA warning letters;
• FDA inspection reports;
• State board disciplinary actions; and
• Consent orders or enforcement settlements.

These can help identify suppliers with recurring compliance, sterility, recordkeeping, or quality-control issues.

For practices utilizing compounded medications, particularly compounded GLP-1 products, supplier due diligence is increasingly important. As we covered recently, the FDA issued a warning letter to a pharmacy finding deficiencies in their GLP-1 compounding practices and documentation supporting the medical necessity exception for compounded prescriptions.

What Supplier Verification Records Should Med Spas Keep?

The most important compliance step may be maintaining proof that supplier verification occurred.

Medical spas should retain:

• Screenshots of license verification searches;
• Copies of licenses and registrations;
• Supplier approval forms;
• Compliance questionnaires; and
• Periodic re-verification records.

Increasingly, regulators are taking closer looks at sourcing of medications; having appropriate documentation can determine whether an inspection ends with no action or with fines and license discipline. Earlier this year the FDA investigated a medical spa that was unable to appropriately document where they were obtaining their neuromodulators.

Takeaway: Build a Written Supplier-Verification Policy

Medical spas are increasingly being held accountable not only for the products they use, but also for where those products originate. As regulators continue to focus on drug sourcing, compounding, peptides, and practice oversight, supplier verification should be treated as a main point of compliance.

Similar themes are appearing in new medical spa regulatory efforts around the country, including Indiana’s recent medical spa legislation, which is now in effect and requires that practices maintain certain documentation related to compounding and procuring of compounded medication.

Every practice should have a written supplier-verification policy. Before purchasing any prescription drug, compounded medication, peptide, or injectable product, verify the supplier’s credentials, document the review, and maintain the records. In today’s enforcement environment, being able to prove you checked may be just as important as the results of the check itself.

Don’t Leave Compliance to Chance

Regulations on drug sourcing, compounding and med spa oversight are changing state by state. AmSpa members get access to state-specific legal resources, compliance guidance and expert support to help protect their practice and their patients. Become an AmSpa Member today.