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RangeYourself, GLP-1 for Women Over 40: What to Know Before Starting

By RangeYourselfUpdated May 17, 20261 min read

About compounded GLP-1 medicationsCompounded semaglutide and tirzepatide are not FDA-approved finished products. They are prepared by state-licensed 503A pharmacies or 503B outsourcing facilities and are not individually reviewed by the FDA for safety, effectiveness, or quality. Compounders describe these preparations as using the same active ingredient as the approved medicines; the FDA has warned that some compounded products use salt forms, semaglutide sodium or semaglutide acetate, that it considers different active ingredients from the approved drug, and has issued warning letters over marketing that presents a compounded preparation as interchangeable with an approved one. The FDA declared the semaglutide shortage resolved on February 21, 2025 and the tirzepatide shortage resolved in December 2024, so the shortage-era pathway for broad compounding of these drugs has ended. Compounding now proceeds under the ordinary rules: a 503A pharmacy compounding for an individual patient on a prescription, or a 503B outsourcing facility, which compounds in bulk under CGMP and FDA registration rather than per patient. Those rules generally do not cover a product that is “essentially a copy” of an approved drug unless a prescriber documents a change that makes a significant difference for an individual patient. Talk to a clinician about contraindications including personal or family history of medullary thyroid carcinoma or MEN 2. RangeYourself does not provide medical advice, does not guarantee a prescription, and does not guarantee weight-loss results.

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