How FDA Shortage Status Changed GLP-1 Compliance Requirements
Regulatory Landscape
The regulatory framework for compounded GLP-1s has changed significantly. Back when semaglutide and tirzepatide were on the FDA shortage list, both 503A and 503B pharmacies could compound these drugs, and bulk or office-stock ordering was widely tolerated. Now that both drugs are off the shortage list, 503B outsourcing facilities may no longer compound GLP-1s for office use. The only lawful pathway is through 503A pharmacies, which may compound only pursuant to patient-specific prescriptions. Bulk office stock and ordering under a medspa’s name are no longer permissible.
This shift comes amid increased FDA enforcement, including warning letters related to unauthorized salt forms and non-compliant marketing and distribution. State boards of pharmacy and medicine are reinforcing that only licensed pharmacies may dispense to patients and that spas must hold appropriate licensure to store or administer compounded drugs. Practices tolerated during shortage conditions are no longer defensible.
Practices That Are Now High-Risk
Several models are now considered high-risk and likely non-compliant, including middleman pricing structures, office-specific bulk ordering, marking up pharmacy-dispensed prescriptions, and repackaging or relabeling compounded drugs. These arrangements expose clinics and medspas to allegations of unlicensed pharmacy activity, fee-splitting, and misrepresentation.
Compliant Pathways Going Forward
There are still lawful ways to offer compounded GLP-1s, all of which require patient-specific prescriptions and depend on state law and licensure:
- Direct Pharmacy Dispense: Pharmacy dispenses directly to the patient; clinic bills only for professional services.
- In-Office Administration (with licensure): Medication tied to patient-specific prescriptions may be stored and administered on site if properly licensed.
- Membership Model: Medication cost is billed separately from a recurring membership or program fee covering non-drug services, with clear invoice separation.
- Dispensing (state-specific): Permitted in limited states with strict registration, labeling, reporting, and supply limits.
- Pharmacy or Distributor Licensure: An option for larger organizations, requiring significant compliance investment.
Membership Model Example
Many successful membership models are structured at a flat monthly price “plus the cost of medications”, which clearly separate the cost of the non-drug services from the medications. These non-drug services may include a consultation, regular check-ups, discounts on or access to other non-medication related services or supplements, etc.
Next Steps
Practices should immediately evaluate their GLP-1 programs. If you are billing patients for drugs dispensed and shipped by a pharmacy, discontinue this practice unless it is part of a Membership Model (as explained above). Transition away from office stock, markups, and middleman structures, and select a compliant pathway aligned with your licensure and state law.
The removal of GLP-1s from the FDA shortage list has closed the door on bulk office stock and hybrid pricing models. What remains are clear, patient-specific pathways. Reviewing your processes now will reduce enforcement risk and allow you to continue offering these therapies confidently.
Need help evaluating whether your GLP-1 program is compliant? Our team works with clinics, medspas, and telehealth organizations to assess regulatory risk, clarify lawful pathways, and design compliant care and pricing models. Schedule a consultation today.
Written by Christina Malik, JD, MBA
Arora Health Compliance Officer
