What is a 503B outsourcing facility?
A 503B outsourcing facility is a compounder that registers with the FDA, makes drugs in batches without a prescription for each patient and must meet current good manufacturing practice, with FDA inspections.
How it differs from a 503A pharmacy
A 503A pharmacy compounds for one named patient under state board oversight. A 503B facility answers to the FDA directly, reports what it makes, and can sell to clinics and hospitals for office use. The FDA publishes the list of registered facilities, so you can check a name.
Two cash programs to check.
No insurance needed.
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- Check price →SnagRx's homepage shows its 12-month prepaid prices first
Is a 503B product FDA-approved?
No. A 503B facility is FDA-registered and inspected, but the drugs it makes are still compounded drugs, not FDA-approved ones. The same essentially-a-copy limits apply once a drug is off the shortage list.
What it means for the price
Sellers that say their GLP-1 comes from a 503B facility often charge a little more than 503A-sourced programs. The chart prints each program's monthly price as published, whichever pharmacy type it uses.
Questions
Is 503B better than 503A?
A 503B facility works under federal manufacturing standards and FDA inspection, which is a stricter quality system. Neither makes an FDA-approved drug.
How do I check a 503B facility?
The FDA keeps a public list of registered outsourcing facilities. Search it for the name your program gives.
Sources
- 21 U.S.C. 353b (section 503B)
- FDA, Information for outsourcing facilities
- FDA, Registered outsourcing facilities
Prices on GLP Chart are read from each program's own pricing page. How: how we check prices. Every program's price this month: the GLP-1 price index.