In short. A 503B outsourcing facility is a compounder that registers with FDA, compounds under current good manufacturing practice (CGMP), and is inspected by FDA on a risk-based schedule. Unlike a 503A pharmacy, it may supply a health care provider without a prescription for an identified patient, for example as office stock.
What a 503B outsourcing facility is
“503B” refers to section 503B of the Federal Food, Drug, and Cosmetic Act. The Drug Quality and Security Act of 2013 added it, and FDA describes it as having “established a new, voluntary category of compounders known as outsourcing facilities.” FDA describes an outsourcing facility as “a facility at one geographic location or address that is engaged in the compounding of sterile drugs” and that “has elected to register as an outsourcing facility.”
Compounding there is done “by or under the direct supervision of a licensed pharmacist,” but the facility itself is not required to be a licensed pharmacy. That is the first difference from a 503A compounding pharmacy, which is licensed by its state board of pharmacy.
The rules it follows
FDA says that “unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements,” the manufacturing quality standard. FDA also says outsourcing facilities “are inspected by FDA according to a risk-based schedule,” and must meet other conditions, “such as reporting adverse events and providing FDA with certain information about the products they compound.” Twice a year, in June and December, an outsourcing facility gives FDA a list of the drugs it compounded during the previous six months.
The label and container of what it compounds must carry certain information, including a statement that the drug is compounded. Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness or quality.
Office stock: the difference that matters to a clinic
FDA says outsourcing facilities “may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock).” In FDA’s words, “an outsourcing facility may or may not obtain prescriptions for identified individual patients.”
A 503A pharmacy is different: its compounding is based on a valid prescription for an identified individual patient. So when a clinic wants product on hand to use in the office rather than one patient’s prescription, that order belongs with a 503B outsourcing facility. Your state’s rules also apply, so check what your state board of pharmacy and medical board allow.
Which bulk substances it may use
An outsourcing facility “may not compound a drug product that includes a bulk drug substance unless” the substance appears on FDA’s list of bulk drug substances for which there is a clinical need, or the drug compounded from it appears on FDA’s drug shortage list “at the time of compounding, distribution and dispensing.” That is a different list from the one that governs 503A pharmacies.
Crossing state lines
FDA lists “no explicit condition in section 503B” on interstate distribution, where section 503A caps how much a 503A pharmacy may ship across state lines. FDA also says the drug may not be sold or transferred by an entity other than the outsourcing facility that compounded it.
503B outsourcing facility vs 503A pharmacy
| 503B outsourcing facility | 503A compounding pharmacy | |
|---|---|---|
| Who oversees it | Registers with FDA; inspected by FDA on a risk-based schedule | Licensed by its state board of pharmacy |
| Quality standard | Current good manufacturing practice (CGMP) | Not subject to CGMP under 503A |
| Prescription | May fill patient-specific prescriptions or supply a provider without one | A valid prescription for an identified individual patient |
| Office stock | May supply a health care provider for office stock | Not covered by the federal exemption for 503A compounding |
| Interstate distribution | No explicit federal condition | Capped under section 503A |
How to check an outsourcing facility
FDA publishes the list of registered outsourcing facilities, with each facility’s last inspection. Before you buy, confirm the facility is on that list and ask how each product it offers meets the law today.
Where TrueRoute fits
TrueRoute is ordering software, not a pharmacy or an outsourcing facility, and never prescribes. Orders are filled by licensed pharmacies in our network. A patient prescription and an office-use purchase are separate orders in TrueRoute, and office-use purchasing is available once your account’s program is set up. Every order keeps its status, payment and fulfillment on one append-only record.
What is a 503A compounding pharmacy? · 503A vs 503B: what a clinic can order, and how · The pharmacy network