Medicines mixed to order
A lower price does not explain a compounded drug
If a pharmacy offers to mix or change a medicine for you, ask what you need changed and why. A lower quote cannot answer that question.
A preparation for a particular need
Compounding means a pharmacist or doctor mixes or changes ingredients to make a medicine for a patient, instead of supplying the drug company’s ready-made product. One reason could be a patient’s allergy to a dye in that product.
In its September 2026 record, the FDA describes a role for this when an approved drug cannot meet a person’s need. That role can also apply when the approved drug is unavailable.
- A patient-specific pharmacy
Section 503A is the federal route for a pharmacy or doctor to prepare drugs for a named person with a valid prescription.
- A maker supplying batches to clinics and hospitals
This kind of maker is called a 503B outsourcing facility. It registers with the FDA and makes sterile medicines, meaning medicines free from living germs. It need not be a licensed pharmacy and can prepare batches before there are prescriptions naming individual patients.
That batch-making rule does not remove the requirement for a valid prescription before a prescription drug is dispensed to you.
The copy restriction still matters
A copy means a medicine that is essentially the same as an approved product already available to buy. Under the September 2026 rules, a pharmacy or doctor cannot make such copies regularly or in excessive amounts. A pharmacy’s preparation for a named patient is outside this restriction when the prescriber judges a change made for that individual makes a significant difference to that person.
A national shortage can allow copies while an approved medicine is hard to obtain. Neither semaglutide injection nor tirzepatide appeared on the shortage list in September 2026, so a pharmacy could no longer rely on a shortage to make copies of them.
The FDA’s April 2026 update says a vitamin added to the same drug can still leave it classed as a copy.