Georgia / Care briefings
A guide to finding and understanding care
Made-to-order medicine
The situation
An offer says the medicine will be made just for you. Ask which patient need calls for this change.
Compounding involves preparing or mixing medicine for an individual order. The finished product needs its own questions.
FDA is the federal drug agency: the Food and Drug Administration.
Compounding can meet a need a ready-made drug cannot, such as avoiding an ingredient a patient is allergic to.
Ask what is changed, why it matters for you and who will make the medicine.
From the record
As of September 2026, FDA has not approved compounded drugs; the agency does not check their quality, safety or how well they work before they are marketed.
Record checked in September 2026.
FDA: the limits of compounding reviewAs of September 2026, a regular compounding pharmacy uses a valid prescription to make medicine for a named patient. That route is called 503A, after its section of federal law.
A larger maker can prepare sterile medicines in batches for places such as hospitals and clinics, under a part of federal law called 503B. It does not need a prescription naming each patient.
Sterile describes something with no living germs.
As of September 2026, a 503B batch maker must follow the federal quality rules used by drug factories, and FDA inspects it. A regular 503A pharmacy must meet state pharmacy rules and medicine quality standards, but does not have to follow those federal factory rules.
Neither route gives the finished medicine FDA approval.
Ask which kind of maker prepares your medicine and which board or agency checks its work.
From the record
Federal rules checked in September 2026 bar regular pharmacies from making copies of available drugs as a routine practice or in unusually large amounts. The copy restriction has an exception if the prescriber finds a change makes a major difference in a named patient's care. A price cut by itself cannot satisfy that test.
Record checked in September 2026.
FDA: compounding questions and answersAs of September 2026, FDA says adding a vitamin to semaglutide can still make it a copy of an available drug. The copy restriction still applies unless the prescriber records a change that makes a major difference for the named patient.
Ask for the reason for the change in writing. Keep the exact ingredient name with the pharmacy details.