How can I tell if an online compounded semaglutide pharmacy is FDA compliant?

To determine if an online compounded semaglutide pharmacy is compliant, you must verify that it is either a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility, and that it holds PCAB or ACHC accreditation while providing a third-party Certificate of Analysis (COA) [1][2][5]. Since the FDA does not "approve" compounded drugs, "FDA compliance" in this context means the pharmacy correctly follows federal compounding laws (FD&C Act), sources pharmaceutical-grade ingredients from FDA-registered facilities, and adheres to USP sterility standards [3][10][15].

Step-by-Step Verification Checklist

1. Confirm Pharmacy Identity and License Type

• Ask explicitly: "What is the name of the pharmacy filling my prescription, and what state is it licensed in?" A refusal to answer is a disqualifying red flag [1][5].
• Verify the license: Search the pharmacy’s name on the relevant State Board of Pharmacy website to confirm an active, unrestricted license [1][4].
• Determine the regulatory category:
  • 503A: State-licensed for individual prescriptions; verify via state board [4][8].
  • 503B: FDA-registered outsourcing facility; verify via the FDA 503B Outsourcing Facility Registry at fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities to check inspection status [4][9].

2. Check Accreditation (The Gold Standard)

• Look for PCAB (Pharmacy Compounding Accreditation Board) or ACHC (Accreditation Commission for Health Care) accreditation. These indicate compliance with national standards for sterile compounding [1][2][5].
• Verify accreditation directly at pcab.org or achc.org/directory [1][9].
• Note: While some sources mention VIPPS (NABP), PCAB is the specific standard for compounding quality [2][3].

3. Demand a Certificate of Analysis (COA)

• Request a third-party COA for the specific batch. Legitimate pharmacies will provide this without hesitation [1][2].
• The COA must confirm:
  • HPLC purity > 95%
  • Potency within 10% of the label
  • Sterility pass
  • Endotoxin levels within USP limits [1][2].
• If the pharmacy refuses or cannot provide a COA, treat it as a sign of counterfeit or unsafe product [1][14].

4. Verify Ingredient Sourcing and Form

• API Source: Ensure the active pharmaceutical ingredient (API) is pharmaceutical grade (not "research use only") and sourced from an FDA-registered facility [10][13].
• Chemical Form: Confirm the product is semaglutide base, not semaglutide sodium or acetate, which are not approved for compounding [2][13].
• Drug Shortage Justification: The pharmacy must be compounding because semaglutide is on the FDA drug shortage list (not "resolved"). You can verify this at accessdata.fda.gov/scripts/drugshortages [9][10].

5. Additional Safety Indicators

• Physical Presence: The pharmacy must have a physical U.S. address and phone number where you can speak with a licensed pharmacist [3][6].
• Telehealth Compliance: The provider must require a real medical evaluation (not just an online questionnaire) and have a LegitScript certification seal for telehealth compliance [5].
• Price Range: Legitimate compounded semaglutide typically costs $99–$400/month. Prices under $50 likely indicate counterfeit product, while over $400 may be overcharging [2].

Critical Warning

If a provider refuses to name their pharmacy, lacks PCAB/ACHC accreditation, cannot provide a COA with the specified purity/sterility metrics, or sells semaglutide without a prescription evaluation, the pharmacy is not compliant and should be avoided [1][5]. The FDA explicitly urges patients to purchase only from state-licensed pharmacies [12].