Unapproved Human Growth Hormone (HGH)

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 4/07/2026 updates the guidance section including agency contacts, charge code language, and PAC. Changes to the import alert are bracketed by asterisks (***). HGH is the active ingredient in a number of human prescription drug products approved for marketing in the U.S. under biologics license applications (BLAs). FDA-approved HGH can be legally prescribed for a limited number of conditions including, among others: � Treatment of children with growth failure or short stature due to chronic kidney disease, growth hormone deficiency (GHD), idiopathic short stature, Noonan Syndrome, Prader-Willi Syndrome, short stature homeobox-containing gene (SHOX) deficiency, Small for Gestational Age, or Turner Syndrome; or � Treatment of adults with adult-onset or childhood-onset GHD or short bowel syndrome in patients receiving specialized nutritional

Quoted from the “Reason for Alert” section of the FDA page for 66-71, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.