GLOSSARY · PHARMACY
503B outsourcing facility, a lab that makes custom medicine in batches.
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.
01
What it means
The name comes from section 503B of the federal Food, Drug, and Cosmetic Act. Unlike a 503A pharmacy, a 503B facility registers with the FDA, is inspected by the FDA, follows current good manufacturing practice (CGMP), and reports the products it makes. In exchange, it can compound in bulk and supply clinics and other health-care facilities.
Its bulk ingredients are limited to substances on an FDA list or drugs in shortage, and like any compounder it may not make copies of approved drugs outside those limits. Its products are still compounded drugs, not FDA-approved ones.
02
Why it matters to a brand operator
A 503B facility matters to a brand for quality and consistency. Batch production under CGMP with FDA inspection means more testing and more predictable product than one-off compounding, which counts most for injectables and high-volume programs.
The trade-off is flexibility. A 503B facility makes standardized products in set strengths, and those products face the same shortage-list limits as other compounded drugs. Many programs use both: 503B for standardized, high-volume products and 503A for patient-specific adjustments.
[ 03 ]
How Tessic Health handles it
Tessic Health contracts pharmacy fulfillment for each client's patients at wholesale with 0% markup, including cold-chain delivery for injectable and temperature-sensitive medication, so the brand never negotiates a pharmacy contract itself.
See the published termsRELATED TERMS
Words that come up next.
503A compounding
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.
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.
Titration protocol
A titration protocol is a dosing plan that starts a patient on a low dose and adjusts it in set steps, based on how the patient responds and tolerates side effects.