Made for a patient still needs an explanation.

What compounding means

Compounding is the preparation of a medicine by a pharmacist, physician or registered facility, rather than supplying an approved finished product.

As of September 26, 2026, FDA (the US Food and Drug Administration) did not approve compounded medicines or review their quality, benefit and safety before they were sold.

Compare who makes the medicine

The labels 503A and 503B refer to sections of US law; the distinctions below were checked on September 26, 2026.

With 503A, a licensed pharmacist or physician prepares a medicine for a named patient under a valid prescription, while meeting the law’s other conditions.

A maker registered with FDA under section 503B prepares sterile medicines in batches, meaning supplies made together. It can supply them without first obtaining a prescription naming each patient.

Sterile means the medicine is free of living germs.

The rule about supplying batches without a prescription naming each patient concerns the maker. A prescription medicine still requires an order from a practitioner licensed to prescribe it.

Registered 503B makers must meet federal manufacturing rules and face FDA inspection. Qualifying 503A preparations are exempt from those federal factory rules. State pharmacy-board rules and pharmacy preparation standards still apply to ordinary 503A pharmacies.

Ask for the reason, not just the category

• What need is this preparation meant to meet?
• Why is an approved finished product not meeting that need?
• Which pharmacy or facility will prepare it?
• What supports using this exact ingredient in this way?

For GHK-Cu, keep the applied-to-skin and injected entries apart when checking the answer.