Weight Loss & GLP-1 Peptides
Are Compounded GLP-1 Products the Same as FDA-Approved Drugs?
02
Sep
Sep
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No. FDA-approved medicines undergo agency review for safety, effectiveness, manufacturing quality and labeling. Compounded drugs are not FDA approved and are not reviewed through the same premarket process.
FDA has stated that the national shortages of semaglutide and tirzepatide injection products are resolved. Compounding exemptions are limited and generally do not permit routine production of copies of commercially available approved products.
FDA has also reported concerns involving dosing errors, fraudulent labels, unapproved semaglutide salt forms and adverse-event reports associated with compounded products. These issues do not mean every compounded prescription is inappropriate, but they make the source, prescription and licensed pharmacy important.
A compounded product should not be described as an FDA-approved generic or assumed to be clinically identical to an approved medicine. The formulation, concentration, excipients, container and quality controls may differ.
It may be appropriate when a patient has a medical need that cannot be met by an available approved product and legal compounding requirements are satisfied.
FDA says these salt forms are different active ingredients from the one used in approved products and has identified no lawful basis for their use in compounding.
FDA states that retatrutide cannot be used in compounding under federal law and is not an FDA-approved drug.
Authoritative sources: FDA concerns page: Authoritative source ; FDA compounding update: Authoritative source
