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50 mg per vial Purity: 99% (HPLC verified) Container: sealed glass vial (lyophilized powder) Certificate of Analysis: lot-specific COA available See the FDA Disclosure, Storage Instructions, and RUO tabs for handling, storage, and regulatory information

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doi:10.1111/ajad.13455 Egecioglu E, Steensland P, Fredriksson I, Feltmann K, Engel JA, Jerlhag E

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Sermorelin's FDA Journey: Approved, Discontinued, and Compounded Sermorelin acetate (Geref) was FDA-approved in 1997 for pediatric GHD 1 and in 1990 for diagnostic use.26 The manufacturer discontinued Geref in 2008 due to "manufacturing difficulties," not safety or efficacy concerns.12 In 2013, the FDA confirmed it wasn't withdrawn for safety/effectiveness, allowing for potential generic approvals.12 Currently, Sermorelin is primarily available as a compounded medication 3, which is permitted but not individually FDA-approved like mass-produced drugs.22 5.2