U.S. Pharmacopeia

Short answer: there’s no single “FDA stamp” for most compounded drugs. But you can verify whether an online compounded semaglutide source is operating under appropriate oversight and follow safe‑use checks. Use the checklist below and watch the red flags. What to know up front Compounded drugs are generally not FDA‑approved. That does not automatically mean they are illegal or unsafe, but oversight differs: 503A compounding pharmacies are state‑licensed and regulated by state boards and must follow USP standards (e.g., USP <797> for sterile injectables). 503B outsourcing facilities are registered with the FDA, inspected by the FDA, and held to higher quality/GMP‑like standards; they may ship interstate. For injectable semaglutide, sterility and validated compounding processes are critical. Step‑by‑step checklist to verify compliance Is it a registered 503B outsourcing facility? Search the FDA’s public list of registered outsourcing facilities. If the company appears there, it’s a 503B and inspected by FDA (higher assurance). Is the pharmacy licensed by the state board of pharmacy? Ask for the state license number and verify it on that state board’s website. Do they require a valid prescription and clinician evaluation? A legitimate pharmacy must require a prescription and provide access to a pharmacist for questions. Do they provide quality/testing documentation on request? Request Certificates of Analysis (CoA) for the API (semaglutide) and for each finished batch, plus sterility test results and lot numbers/expiry. Reputable operations will provide them. Do they state compliance with USP sterile compounding standards? For injectables, ask if they follow USP <797> (sterile compounding) and USP <800> if hazardous agents are involved. Do they have external accreditation or verification? Look for VIPPS accreditation from the National Association of Boards of Pharmacy (NABP), LegitScript certification, or listing on PharmacyChecker. These add credibility but don’t replace FDA/state oversight. Can you speak to a pharmacist and get full labeling/administration instructions? They should provide pharmacist consultation and comprehensive product labeling (storage, reconstitution, dosing). Red flags (avoid these) No prescription required or “prescription not necessary.” No physical address or phone number, or they ship from outside the U.S. without clear regulatory oversight. Refusal to provide CoAs, sterility testing, lot numbers, or compounding records. Claims that a compounded product is “FDA‑approved.” Prices that are unrealistically low for injectable drug plus sterile compounding. No pharmacist contact or no state license info. Documentation you should request Pharmacy/state license number and evidence of board inspection. If applicable, FDA outsourcing facility registration number. CoA for the API and finished product; sterility and endotoxin testing reports. Batch/lot number, manufacture/compound date, beyond‑use date, storage conditions. Evidence of USP <797> compliance and environmental/clean room testing (for steriles). Resources and places to check (by name) FDA: search “Registered outsourcing facilities” and “Warning Letters” on FDA.gov. National Association of Boards of Pharmacy (NABP): VIPPS accreditation and state board links. LegitScript: verifies telehealth & online pharmacy legitimacy. PharmacyChecker: third‑party credential checking and price comparisons. U.S. Pharmacopeia (USP): standards USP <797> and USP <800> for sterile compounding. Recommended safer alternatives (names & why) Use FDA‑approved semaglutide products (Novo Nordisk’s Ozempic or Wegovy) dispensed by major retail pharmacies (CVS, Walgreens, Walmart). These are manufactured under FDA approval and avoid compounding risks. If you need a compounded product, prefer a 503B outsourcing facility listed on the FDA site (because they are FDA‑inspected). For a telehealth route, work through established medical providers or your primary care/endocrinologist rather than unknown online prescribers. If you suspect noncompliance or receive suspect product Report to the FDA MedWatch and to the state board of pharmacy where the pharmacy is licensed. Stop using the product and contact your prescriber if you have safety concerns. If you want, tell me the pharmacy’s name and website and I’ll help you check licenses, FDA 503B registration, accreditation listings, and any public FDA warning letters.

Mentioned in position 8 of 8