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A CHECKLIST FOR COMPOUND SEMAGLUTIDE AND TIRZEPATIDE

August 14, 20242 min read

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide:

  1. Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.

  2. Ask for the pharmacy's state board inspection report. There should be at least one of these reports, issued at the pharmacy's founding, and there may be more depending on individual state regulations on frequencies of inspections.

  3. Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.

  4. Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.

  5. Ask your compounding pharmacy where they source the medication's active pharmaceutical ingredient (API).

  6. Find out if this supplier is registered with the FDA by searching here or here.

  7. Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.

  8. Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.

  9. Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

I fully endorse compounding pharmacies and I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere.

compound pharmacy
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Stefanie Raya

Stefanie Raya is an advocate for healthy living and growing sustainable businesses.

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