In short. A 503A pharmacy compounds for individual patients on prescriptions. A 503B outsourcing facility is registered with FDA, compounds under manufacturing standards, and may supply a practice without a patient-specific prescription. Patient prescriptions can go to either; office stock belongs with a 503B.
Two kinds of compounder
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act set out two ways a compounded drug can be lawfully made without going through FDA approval. They differ in who oversees the compounder, what standard it works to, and whom it may supply.
| 503A compounding pharmacy | 503B outsourcing facility | |
|---|---|---|
| What it is | A state-licensed pharmacy (or physician) compounding for individual patients | A facility that chooses to register with FDA as an outsourcing facility |
| Main oversight | State boards of pharmacy | FDA, plus state licensing where it operates and ships |
| Quality standard | State law and USP compounding chapters | Current good manufacturing practice |
| Prescription | A valid prescription for an identified patient | May supply a facility without one, or fill patient-specific prescriptions |
| Office stock | Not covered federally; some states allow limited office use | Yes: this is what it is for |
| Where to check it | The board of pharmacy in its state and yours | FDA’s list of registered outsourcing facilities |
Patient-specific prescriptions
Most compounded medications a medspa or wellness clinic prescribes are for a named patient. Under 503A, FDA expects the drug to be compounded on a valid prescription for an identified individual patient, and a compounded product may not be essentially a copy of a commercially available drug unless the prescriber documents a change that makes a significant difference for that patient. A 503B may also fill patient-specific prescriptions.
The prescription is the prescriber’s: the patient, the product, the quantity and the directions, signed under the prescriber’s own licence in the patient’s state.
Office use and practice stock
Office use means medication bought for the practice and given in the clinic, not dispensed to a named patient. FDA’s 2016 guidance says 503A does not cover distributing compounded drugs without a prescription for an identified patient. States go further in different directions: some permit limited office use by pharmacies under state law, and a 2018 Pew review found most states prohibit sterile office-stock compounding by pharmacies. Check your own state’s rules and the pharmacy’s state rules before relying on it.
Registered 503B outsourcing facilities exist for this case. They may supply hospitals, clinics and practices without patient-specific prescriptions, under FDA registration, manufacturing standards and inspection. A practice that wants stock on the shelf should be buying it as a purchase order from a 503B, not by writing prescriptions to fill a cabinet.
How to check each one
- A 503A pharmacy: look up its licence on its home state’s board of pharmacy, and check that it holds a non-resident licence in the states where your patients are. NABP lists every state board.
- A 503B facility: find it on FDA’s list of registered outsourcing facilities, which shows its last FDA inspection and whether a Form FDA 483 was issued. Facilities re-register each year between October and December, so check the current list.
How each order is placed in TrueRoute
TrueRoute keeps the two apart because they are different orders. A patient prescription is written on the prescription screen: patient, prescriber, product and quantity, reviewed with its total and signed by the prescriber. An office-use purchase is a separate purchase-order flow with no patient, no directions and no prescription signature, and an office-use order may go only to a 503B. Office-use purchasing is available once your account’s program and an approved delivery location are set up, including the ordering provider’s NPI and credentials. Both kinds of order end on the same order record, with status, payment and fulfillment together, and a group sees every location’s orders in one organization.
The office-use path, step by step · For clinics