Regular compounding pharmacy
A regular compounding pharmacy, called a 503A pharmacy in federal law, makes a medicine for one named patient who has a prescription.
This is the common made-to-order route.
Where compounding forks
What does “compounded” really tell you?
It tells you how a medicine was made. It does not mean approved, fake or automatically wrong. The patient need and compounding route still matter.
The basic split
Who can make a compounded medicine?
Outsourcing facility
An outsourcing facility, called a 503B facility in federal law, makes batches of sterile medicines and must follow federal manufacturing quality rules.
It can supply clinics and hospitals without a prescription naming each patient.
What both share
No compounded medicine is FDA-approved.
The licence, ingredients, reason for compounding and where the ingredients came from still need checking.
Copies and shortages
Can a pharmacy simply copy a medicine?
Federal law limits regular compounding of a product that is essentially a copy of a medicine already available, unless the prescriber identifies a change that makes a significant difference for one patient.
An official FDA shortage can open a temporary route for copies, but a local out-of-stock notice is not the same as the national shortage list.
As of September 2026, the weight and diabetes medicines semaglutide and tirzepatide were not on the FDA drug shortage list.
Named peptides
Does an FDA list make a peptide cleared for compounding?
BPC-157 and TB-500 are names of two peptide ingredients that people asked the FDA to allow for compounding. As of September 2026, those requests had been withdrawn, and the ingredients were not on the FDA’s approved list for compounding.
Withdrawal of a request is not FDA clearance or approval.
Brief source note
The FDA calls raw ingredients “bulk drug substances.” Its pages below show the ingredient list for regular compounding and current compounding alerts.
The question that matters
“What medical need makes this compounded product a better fit than an approved, commercially available product?”