Word note ยท Compounding
When someone calls a treatment compounded, ask who makes it and why they suggest that preparation for your care.
Compounding is the work of mixing or preparing medicine to meet an individual medical need, rather than handing over a drug-company finished product. A pharmacist or doctor can do this work; a separate site registered with FDA can also prepare batches.
Source to readFDA explanation of compounding
FDA is the US Food and Drug Administration, which regulates medicines. Registration means the business has put itself on FDA's list; it does not mean FDA approved its medicines. Ask what need this preparation is meant to meet.
FDA has not assessed a compounded medicine's safety, whether it works or its quality before it is sold. Nor does it have FDA approval. This was the position recorded at the September 26, 2026 check.
Source to readFDA explanation of compounded-drug limits
A pharmacy licence and FDA approval of a medicine answer different questions.
If the ready-made approved medicine cannot meet someone's medical need, or is not available to buy, compounding may have a role. That is FDA's explanation in material checked September 26, 2026.
Source to readFDA questions and answers
The named-patient law has a separate test for raw ingredients. Where an official written quality standard exists for the ingredient, the maker must follow it. If none exists, a pharmacy must turn to an ingredient already used in an approved medicine or to one on FDA's extra-ingredient list. Regular or large-scale copying of a medicine already sold is also restricted. The copying exception depends on the prescriber finding a significant difference for that particular patient. These ingredient and copying rules were checked September 26, 2026.
A pharmacist or doctor working under the law called 503A needs a valid prescription written for one named patient. That is only one requirement; the ingredient and copying rules above still apply. This was the position at the September 26, 2026 check.
Source to readFDA on medicines made for a named patient
503A is a section number in federal law, not a medicine name.
A separate medicine-making site can register with FDA under a law called 503B and prepare batches of sterile medicines. Sterile means free of living germs. As checked September 26, 2026, that site did not need a prescription naming each patient to make the batch.
Source to readFDA on makers of medicine batches
Outsourcing means a clinic gets the medicine from a separate maker. Such a site need not be a licensed pharmacy. The batch rule does not remove the prescription requirement when a prescription medicine is supplied to you. The check on September 26, 2026 confirmed that requirement.