FDA (the federal Food and Drug Administration) describes compounding by licensed pharmacists or doctors and by registered businesses called outsourcing facilities.(a)

These facilities prepare sterile medicines in batches, often for a hospital or clinic. Sterile means there are no living germs in the medicine.(b)(c)

Compounded drugs had no FDA approval when checked September 26, 2026; the agency did not verify their quality, safety or effectiveness before marketing.(a)

Ask which need the planned drug is meant to meet. Keep that answer attached to the exact product name. A statement about the pharmacy’s process answers a separate question from a statement about the finished medicine.

Under the federal law checked September 26, 2026, a pharmacist or doctor making medicines for named patients could not regularly make close copies of a commercially available drug or make those copies in excessive amounts.(d)

A changed medicine did not count as one of those copies if the prescriber decided the change made a significant difference for the named person. A lower price by itself did not meet that test. Other compounding rules still applied.(d)

Ask what change is being planned and why it matters in your situation. Keep a personalized reason apart from a general sales account. The needed answer is about the actual drug and the person for whom it is planned.

As of September 26, 2026, compounding under section 503A required a named patient and a valid prescription. The law also had other requirements; the ingredient tests and limits on copying are set out on this page.(d)

For the raw ingredient, ask the pharmacy: “Is there an official written standard for this ingredient’s identity and quality, and does it meet that standard?” When such a standard applies, the ingredient must meet it. Without that written standard, an approved drug must contain the ingredient. If no approved drug contains it either, the ingredient needs a place on the official compounding list.(e)

Raw ingredient means the substance used before the finished medicine is made. Ask the pharmacy to give its full name. A prescription and the ingredient rules are separate parts of the talk; neither is a reason to skip the other. Ask where the answer can be reviewed after the visit.

As of September 26, 2026, a 503B facility could supply drugs without prescriptions for individually named people.(b)

Those facilities were subject to federal manufacturing quality rules and FDA inspection; registration itself did not approve their products.(a)(f)

Sterile refers to being free of living germs. Ask which facility would make the planned drug and how its role differs from the pharmacy that would hand it over. Keep both names, if they differ, with the written product details.