Does a compounded drug need a prescription?

Section 503A: pharmacies and physicians

Section 503A covers drugs compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician. The statute says the drug must be compounded for an identified individual patient based on receipt of a valid prescription order. It allows limited quantities before a prescription arrives where the pharmacist or physician has a history of receiving valid prescriptions for the drug. FDA's compounding-laws page uses the phrase valid patient-specific prescriptions.

Section 503B: outsourcing facilities

The statute says an outsourcing facility may or may not obtain prescriptions for identified individual patients. FDA's compounding-laws page says such a facility may distribute against a patient-specific prescription or a non-patient-specific order from a provider. Check that page for the current wording, because we read it through a summary.

What FDA tells patients

FDA's page on unapproved GLP-1 drugs tells patients to get a prescription from a licensed provider and fill it at a state-licensed pharmacy. It warns that unapproved versions get no FDA review for safety, effectiveness or quality.

What this does not tell you

• A prescription does not make a compounded drug FDA-approved. FDA says compounded drugs are not.
• State law adds its own requirements. We have not summarized them.
• It does not apply to products sold as “research use only,” which FDA treats as a separate matter.