What is a 503A pharmacy?
A 503A pharmacy is a state-licensed compounding pharmacy that makes a medicine for one named patient from that patient's prescription. Most compounded semaglutide and tirzepatide sold by telehealth programs is made at one.
Who oversees it
Section 503A of the Federal Food, Drug and Cosmetic Act sets the federal rules, and the state board of pharmacy licenses and inspects the pharmacy. A 503A pharmacy does not register with the FDA as a manufacturer and its products are not FDA-approved.
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What it can and cannot make
It needs a prescription for each patient. It may not regularly make what the FDA calls essentially a copy of an approved drug on the market. Since semaglutide and tirzepatide left the FDA shortage list, that is why most compounded GLP-1s are sold as personalized formulations, for example with vitamin B12 added.
What it means for the price
Compounded GLP-1s made at 503A pharmacies are the cheapest cash route on the chart, often a fraction of the branded price. The trade-off is FDA review: the FDA does not check these products for safety, effectiveness or quality before they are sold.
Questions
Is a 503A pharmacy FDA-approved?
No. A 503A pharmacy is licensed by its state board of pharmacy. Its compounded products are not FDA-approved drugs.
What is the difference between 503A and 503B?
A 503A pharmacy compounds for one patient at a time under state oversight. A 503B outsourcing facility registers with the FDA, can make batches without a prescription for each patient and follows manufacturing standards with FDA inspections.
Sources
- 21 U.S.C. 353a (section 503A)
- FDA, Human drug compounding
- FDA, Compounding and the FDA: questions and answers
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.