Compounding pharmacies and GLP-1 medicines

Section 503A covers compounding by a licensed pharmacist in a state-licensed pharmacy, or by a licensed physician, for an individual patient on receipt of a prescription. Meeting its conditions exempts the product from federal requirements for FDA approval, for current good manufacturing practice, and for labelling with adequate directions for use.

Section 503B covers outsourcing facilities. These register with FDA, are subject to CGMP requirements, are inspected by FDA on a risk-based schedule, must report adverse events, and may distribute without a patient-specific prescription. By registering, a facility elects to be regulated under 503B rather than 503A.

The short version: a 503B outsourcing facility operates under manufacturing standards and federal inspection that a 503A pharmacy does not. Neither produces an FDA-approved drug, and neither product has been reviewed for safety, effectiveness or quality before marketing.

The status of compounded GLP-1 preparations is unsettled and we treat it as under review rather than stating it as settled fact. FDA's guidance to compounders sets out an "essentially a copy" test: a compounded product with the same active ingredient as a commercially available drug, in the same or an easily substitutable strength and by the same route, is generally treated as a copy unless a prescriber documents a significant difference for a specific patient. What that means for any particular preparation is a question for the pharmacy and the prescriber, not something a directory can answer for you.

FDA's guidance describes a product as essentially a copy where it has the same active ingredient as a commercially available drug in the same, similar or easily substitutable strength and can be used by the same route — unless a prescriber determines and documents that the compounded version contains a change producing a significant difference for a specific identified patient.

The agency applies the same reasoning to combinations. Its own worked example is semaglutide compounded with vitamin B12 where the strengths sit close to the commercially available products, given by the same route.

• The pharmacy's name, and whether it is registered as a 503B outsourcing facility or operating as a 503A pharmacy. FDA publishes a list of registered outsourcing facilities.
• What state it is licensed in, and whether that licence is current.
• Where the active ingredient comes from. FDA has established an import alert covering GLP-1 active ingredients with potential quality concerns.
• Whether the preparation is a combination product, and if so what else is in it.
• How it is shipped and whether it arrives refrigerated.

FDA has documented fraudulent compounded semaglutide and tirzepatide with false label information — including products naming pharmacies that do not exist, and products naming real licensed pharmacies that did not make them. Verifying the name on the label is not paranoia.

Retatrutide and cagrilintide cannot be used in compounding under federal law. FDA states they are not components of FDA-approved drugs and have not been found safe and effective for any condition, and it has issued warnings to telehealth companies marketing them, to ingredient distributors selling them to compounders, and to outsourcing facilities repackaging them.

If a programme offers you one of these, that single fact tells you what you need to know about the programme.

• FDA — Human Drug Compounding Laws — retrieved 2026-08-06
• FDA — Information for Outsourcing Facilities — retrieved 2026-08-06
• FDA — FD&C Act Provisions that Apply to Human Drug Compounding — retrieved 2026-08-06
• FDA — FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize — retrieved 2026-08-06
• FDA — FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — retrieved 2026-08-06