GLOSSARY · PHARMACY
503A compounding, custom medicine made for one patient.
503A compounding is a type of pharmacy compounding that lets a state-licensed pharmacy make a custom medication for one specific patient, based on that patient's prescription.
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What it means
The name comes from section 503A of the federal Food, Drug, and Cosmetic Act. A 503A pharmacy is regulated mainly by its state board of pharmacy. Its compounded drugs are not FDA-approved, and it does not follow the manufacturing rules drug makers follow, because each product is made for a named patient with a prescription.
The law limits what a 503A pharmacy can make. It may not regularly compound drugs that are essentially copies of a commercially available drug. The exceptions include a drug on the FDA shortage list and a change the prescriber decides makes a significant difference for that patient. When a drug comes off the shortage list, compounders lose the ability to make routine copies of it, which is what happened to compounded semaglutide and tirzepatide.
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Why it matters to a brand operator
Many telehealth programs in weight loss, hormones, hair loss, and peptides rely on compounded drugs, so the pharmacy's legal footing is a business risk. A program built on a compounded copy of a branded drug can lose its supply when the branded drug leaves the shortage list, and every patient then has to move to a different drug or dose form.
A brand should confirm that each compounding pharmacy is licensed in every state it ships to, that prescriptions are truly patient-specific, that patients are told the drug is compounded and not FDA-approved, and that marketing never implies FDA approval. The FDA has sent warning letters to telehealth companies over misleading claims about compounded drugs.
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How Tessic Health handles it
Tessic Health contracts the pharmacy network for each client's patients, passes medication through at wholesale with 0% markup, and ships temperature-sensitive medication through cold-chain fulfillment. Whether a patient receives a compounded or an FDA-approved drug stays a clinical decision for the prescriber.
See the published termsRELATED TERMS
Words that come up next.
503B outsourcing facility
A 503B outsourcing facility is an FDA-registered compounder that makes medications in larger batches under drug-manufacturing quality standards, without needing a prescription for each patient.
Formulary
A formulary is a list of medications that a health plan covers or that a clinic's providers prescribe, along with the doses, forms, and prices that apply.
Dispensing vs. prescribing
Dispensing vs. prescribing is a legal distinction that separates the clinician who decides a patient should take a drug from the pharmacy that prepares and delivers it.