Made-to-order medicine
Start with the name. Find the maker. Keep the label. Those steps make a made-to-order medicine easier to check.
Plain definition
Compounding means a medicine is made to order instead of coming ready-made from a drug company as an FDA-approved product. It may be made by a licensed pharmacist, a physician or a registered outsourcing facility, a larger operation described below.
Claim source: FDA compounding questions and answers, summarized in CA-compounding-01.
The name is not enough. Ask who made it. Ask why this form is being used.
Two federal lanes
Often called a 503A pharmacy, after the part of federal law that covers it. It prepares medicine for an identified patient with a prescription.
Often called a 503B facility. It registers with the FDA and makes larger batches of sterile (germ-free) medicines, often for clinics and hospitals.
A 503A pharmacy prepares medicine for a single patient, by name, against that patient’s prescription. A 503B outsourcing facility registers with the FDA and may make sterile batches without a prescription carrying your name.
Claim sources: federal compounding law, summarized in CA-compounding-03 and CA-compounding-04.
Both are proper routes, with different rules. For you, the practical check is the same: get the maker’s name from the label and look it up in Colorado records.
What the FDA does not check
Before a compounded medicine reaches patients, the FDA has not reviewed its safety, its effectiveness or the quality of its manufacture.
Claim source: FDA risks of compounded drugs, summarized in CA-compounding-02.
That does not make every compounded medicine improper. A finished medicine cannot truthfully be called both “compounded” and “FDA-approved.” Keep the label. It tells you which pharmacy to check.
Colorado layer
As of September 2026, an out-of-state 503B outsourcing facility has to register with Colorado itself before it ships compounded prescription medicine to anyone here.
Claim source: Colorado Revised Statutes, summarized in GEO-CO-18.
Search the recorded pharmacy or facility name in Colorado records. The name a clinic uses in its ads may not be the pharmacy name printed on the label. Write the name down before the box is gone.
Before accepting the label