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FDA says pharmacies may not use it to make drugs.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"}],"previous_value":null,"reviewed_at":"2026-10-26T13:39:12.978Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","stale":false},{"id":"013fc1b7-3d7c-45d4-9d3d-e200a6883ba0","object":"status_change","slug":"mk-677","name":"MK-677","url":"/compound/mk-677","key":"regulatory_status","value":"category-2","previous_value":null,"reviewed_at":"2026-10-26T13:39:12.164Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false},{"id":"b69c1987-d792-4065-a5b8-0b6a9a6d4ae5","object":"status_change","slug":"mk-677","name":"MK-677","url":"/compound/mk-677","key":"pcac","value":{"vote":{"no":13,"yes":1,"abstain":0},"outcome":"The committee recommended against adding ibutamoren mesylate to the 503A bulks list, as FDA had proposed. FDA decides by rulemaking.","meeting_date":"2024-10-29","indication_reviewed":"Growth hormone shortage, weak bones, hip fracture, muscle loss with age, obesity and Alzheimer's disease"},"previous_value":null,"reviewed_at":"2026-10-26T13:39:12.159Z","source_url":"https://www.fda.gov/media/185412/download","source_type":"primary","stale":false},{"id":"ffb440d8-d35e-442f-babd-a0ea499c4b0f","object":"status_change","slug":"mk-677","name":"MK-677","url":"/compound/mk-677","key":"access","value":[{"type":"clinical-trial","detail":"A phase 3 trial of LUM-201 is recruiting children with growth hormone deficiency at US sites. Open trials are listed in the trials block below, with the date the official registry was last checked.","source_url":"https://clinicaltrials.gov/study/NCT06948214"}],"previous_value":null,"reviewed_at":"2026-10-26T13:39:12.138Z","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","stale":false},{"id":"1854bacd-005e-4b2b-b7d8-231550b414a1","object":"status_change","slug":"glutathione","name":"Glutathione","url":"/compound/glutathione","key":"status_by_route","value":[{"route":"Compounded by a pharmacy, such as shots, drips and nasal sprays","status":"category-1","source_url":"https://www.fda.gov/media/94155/download"},{"route":"Sold as an ingredient in dietary supplements","status":"dietary-supplement","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"}],"previous_value":null,"reviewed_at":"2026-10-26T13:36:28.644Z","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","stale":false},{"id":"e84a3453-4efc-4462-937b-30530aad2d11","object":"status_change","slug":"glutathione","name":"Glutathione","url":"/compound/glutathione","key":"regulatory_status","value":"category-1","previous_value":null,"reviewed_at":"2026-10-26T13:36:28.632Z","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","stale":false},{"id":"7511081b-7e02-43bf-83cd-99bb75e9c67e","object":"status_change","slug":"glutathione","name":"Glutathione","url":"/compound/glutathione","key":"pcac","value":{"vote":{"no":5,"yes":8,"abstain":1},"outcome":"The committee recommended adding glutathione to the 503A bulks list, against FDA's proposal to leave it off. FDA decides by rulemaking.","meeting_date":"2022-06-08","indication_reviewed":"Skin lightening and more than 20 other uses, including lung disease, Parkinson's disease, autism and heavy metal poisoning"},"previous_value":null,"reviewed_at":"2026-10-26T13:36:28.628Z","source_url":"https://www.fda.gov/media/161293/download","source_type":"primary","stale":false},{"id":"8f145229-2c8f-4802-a581-c43b768c1aec","object":"status_change","slug":"glutathione","name":"Glutathione","url":"/compound/glutathione","key":"access","value":[{"type":"dietary-supplement","detail":"Sold as a dietary supplement. FDA calls glutathione a dietary ingredient, and one maker told FDA it sells it in the US only for supplements.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"type":"lawful-compounding","detail":"A pharmacy may compound glutathione because it is in Category 1. FDA does not intend to act against it when the policy conditions are met. That is not FDA approval.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"type":"clinical-trial","detail":"Trials of glutathione are recruiting in the US, for example a nasal spray in Parkinson's disease. The trials block lists open trials.","source_url":"https://clinicaltrials.gov/study/NCT05266417"}],"previous_value":null,"reviewed_at":"2026-10-26T13:36:28.607Z","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","stale":false},{"id":"bc7c8413-6f52-460d-b398-c388bc3b8a3b","object":"status_change","slug":"oxytocin","name":"Oxytocin","url":"/compound/oxytocin","key":"regulatory_status","value":"fda-approved","previous_value":null,"reviewed_at":"2026-10-26T13:36:27.774Z","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261","source_type":"primary","stale":false},{"id":"1cb0b26f-205b-49ec-a5ba-87853ae2e0a8","object":"status_change","slug":"oxytocin","name":"Oxytocin","url":"/compound/oxytocin","key":"access","value":[{"type":"approved-product","detail":"Approved by FDA and given with a prescription in a hospital, by drip into a vein or as a shot into a muscle.","indication":"Starting or strengthening labor when there is a medical reason, helping empty the womb after an incomplete abortion, and controlling bleeding after birth.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad","brand_names":["Pitocin"],"manufacturer":"Par Health USA"},{"type":"lawful-compounding","detail":"Pharmacies may compound with raw oxytocin because it is part of FDA-approved drugs. A compounded product is not FDA-approved.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"type":"clinical-trial","detail":"Trials of nasal oxytocin are recruiting in the US, for example in veterans with PTSD and their partners. The trials block lists open trials.","source_url":"https://clinicaltrials.gov/study/NCT06194851"}],"previous_value":null,"reviewed_at":"2026-10-26T13:36:27.759Z","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261","source_type":"primary","stale":false},{"id":"95cf4f77-1f04-43ce-b1d8-49338ef052af","object":"status_change","slug":"thymalin","name":"Thymalin","url":"/compound/thymalin","key":"regulatory_status","value":"no-approved-use","previous_value":null,"reviewed_at":"2026-10-26T13:36:26.943Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024","source_type":"primary","stale":false},{"id":"492f4df2-96dc-46c2-a316-93e0dc38715e","object":"status_change","slug":"thymalin","name":"Thymalin","url":"/compound/thymalin","key":"access","value":[{"type":"none","detail":"There is no legal route to Thymalin in the US today. It is in no approved drug, and FDA calls Thymalin products sold online unapproved new drugs.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024"}],"previous_value":null,"reviewed_at":"2026-10-26T13:36:26.923Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024","source_type":"primary","stale":false},{"id":"7fc9acab-b4a6-416a-ad64-843d0f99757c","object":"status_change","slug":"cerebrolysin","name":"Cerebrolysin","url":"/compound/cerebrolysin","key":"regulatory_status","value":"no-approved-use","previous_value":null,"reviewed_at":"2026-10-26T13:32:24.062Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","stale":false},{"id":"5383e3ca-d3c5-4cb1-99fd-385d0401100f","object":"status_change","slug":"cerebrolysin","name":"Cerebrolysin","url":"/compound/cerebrolysin","key":"access","value":[{"type":"none","detail":"There is no legal route to Cerebrolysin in the US today. It is in no approved drug and is not on the list pharmacies may use.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"}],"previous_value":null,"reviewed_at":"2026-10-26T13:32:24.046Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","stale":false},{"id":"2a777cbf-e917-48b5-b301-ecff2d27cc02","object":"status_change","slug":"ghrp-6","name":"GHRP-6","url":"/compound/ghrp-6","key":"regulatory_status","value":"category-2","previous_value":null,"reviewed_at":"2026-10-26T13:32:23.197Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false},{"id":"6918ab96-7805-4ac1-87cc-fb7d3f89cc9b","object":"status_change","slug":"ghrp-6","name":"GHRP-6","url":"/compound/ghrp-6","key":"access","value":[{"type":"none","detail":"There is no legal route to GHRP-6 in the US today. It is in no approved drug, pharmacies may not use it, and every form is in Category 2 on FDA's outsourcing list.","source_url":"https://www.fda.gov/media/94164/download"}],"previous_value":null,"reviewed_at":"2026-10-26T13:32:23.174Z","source_url":"https://www.fda.gov/media/94164/download","source_type":"primary","stale":false},{"id":"b8b0b89f-8091-4282-a4e8-db64e37d1dd5","object":"status_change","slug":"ghrp-2","name":"GHRP-2","url":"/compound/ghrp-2","key":"status_by_route","value":[{"route":"Shots and nasal sprays","status":"category-2","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"route":"Other forms, such as by mouth","status":"no-approved-use","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/triad-rx-inc-569659-02052019"}],"previous_value":null,"reviewed_at":"2026-10-26T13:32:22.347Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false},{"id":"a8e08741-c2e1-4e87-afc4-ab682d7b90e6","object":"status_change","slug":"ghrp-2","name":"GHRP-2","url":"/compound/ghrp-2","key":"regulatory_status","value":"no-approved-use","previous_value":null,"reviewed_at":"2026-10-26T13:32:22.332Z","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/triad-rx-inc-569659-02052019","source_type":"primary","stale":false},{"id":"b9933639-732e-4b44-8cda-9404cb4aa2a8","object":"status_change","slug":"ghrp-2","name":"GHRP-2","url":"/compound/ghrp-2","key":"access","value":[{"type":"lawful-compounding","detail":"For forms other than shots and nasal sprays, GHRP-2 is in Category 1 of FDA's outsourcing list. An outsourcing facility may make it while FDA decides, if it meets the policy's conditions. No pharmacy may make it, and no shot or nasal spray has a legal route.","source_url":"https://www.fda.gov/media/94164/download"}],"previous_value":null,"reviewed_at":"2026-10-26T13:32:22.313Z","source_url":"https://www.fda.gov/media/94164/download","source_type":"primary","stale":false},{"id":"db141586-fc29-4662-a826-1733083e5901","object":"status_change","slug":"melanotan-ii","name":"Melanotan II","url":"/compound/melanotan-ii","key":"regulatory_status","value":"limbo","previous_value":null,"reviewed_at":"2026-10-25T23:59:28.203Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false},{"id":"d00c35fd-8f2c-4af4-9356-515cbc634f7f","object":"status_change","slug":"melanotan-ii","name":"Melanotan II","url":"/compound/melanotan-ii","key":"access","value":[{"type":"none","detail":"There is no legal route to Melanotan II in the US today. FDA lists it as withdrawn from Category 2, and it is not on the list of substances pharmacies may use.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"}],"previous_value":null,"reviewed_at":"2026-10-25T23:59:28.193Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false},{"id":"9ac6bfc7-490f-4c86-bf96-e20f4ec1ad8f","object":"status_change","slug":"peg-mgf","name":"PEG-MGF","url":"/compound/peg-mgf","key":"regulatory_status","value":"limbo","previous_value":null,"reviewed_at":"2026-10-25T23:58:30.000Z","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","stale":false}],"has_more":true,"total_count":91,"limit":50,"offset":0}