---
title: "What Is a 503B Pharmacy? Outsourcing Facility Rules"
description: "A 503B outsourcing facility registers with FDA, follows CGMP and compounds sterile drugs under 21 U.S.C. 353b. The rules, and how Cuvo Health handles it."
canonical: "https://cuvo.co/glossary/503b-outsourcing-facility"
last-updated: "Oct 26, 2026"
---
**Definition:** A 503B outsourcing facility is a compounder of sterile drugs at one location that has registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b), follows current good manufacturing practice and may compound with or without patient-specific prescriptions.

# What is a 503B outsourcing facility?

Congress created outsourcing facilities in 2013, in the Drug Quality and Security Act, as compounders that register with FDA, meet manufacturing-grade quality rules and face federal inspection. A telehealth brand meets the term when it asks how a standardized preparation is made and who inspected the maker. Cuvo Health routes each order to a licensed partner pharmacy operating within the current rules for the molecule, so the brand never picks a compounder order by order.

Published Oct 26, 2026. Facts reviewed Oct 26, 2026.

A 503B outsourcing facility is a facility at one location that compounds sterile drugs and has elected to register with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b). The category was created in 2013 by the Drug Quality and Security Act. An outsourcing facility need not be a licensed pharmacy, may or may not obtain prescriptions for identified patients, follows current good manufacturing practice, and is overseen primarily by FDA on a risk-based inspection schedule. Its drugs are still not FDA-approved. On Cuvo Health, each order routes to a licensed partner pharmacy verified for the destination state and operating within the current rules for the molecule, so the brand never chooses a compounding category itself.

**At a glance**
- The law: Section 503B of the FD&C Act, 21 U.S.C. 353b, added in 2013
- Registration: With FDA on election, then every year between October 1 and December 31
- Quality standard: Current good manufacturing practice
- Oversight: FDA, on a risk-based inspection schedule
- Prescriptions: May or may not obtain them for identified patients
- On Cuvo: Orders route to licensed partner pharmacies operating within the current rules for each molecule

**What section 503B requires of an outsourcing facility**

| Requirement | What 21 U.S.C. 353b says |
| --- | --- |
| **Reporting** | A report of every drug compounded in the prior six months, filed each June and December (b)(2) |
| **Adverse events** | Adverse event reports filed with FDA (b)(5) |
| **Bulk substances** | Only substances on FDA's 503B bulks list, or for a drug on FDA's drug shortage list at the time of compounding, distribution and dispensing (a)(2) |
| **Copies** | No drug that is essentially a copy of an approved drug, unless the approved drug is on the shortage list (a)(5), (d)(2) |
| **Label** | "This is a compounded drug," the facility's name, address and phone, lot number, expiration date, storage instructions and "Not for resale" (a)(10) |
| **No wholesaling** | No sale or transfer by anyone other than the facility, though dispensing on a prescription is allowed (a)(8) |

## 01. Why does a 503B facility matter for a telehealth brand?

It is the federal route for standardized preparations made at volume, and it leaves a public record. FDA must publish the list of registered outsourcing facilities, and its list, updated as of October 22, 2026, shows each facility's last inspection date, whether a Form 483 was issued, whether a recall followed and the action taken. That record is the first diligence step for any program that depends on a facility's output.

On Cuvo, that diligence is part of the platform: Cuvo contracts its licensed partner pharmacies and verifies their licensure for every ship-to state continuously, and a brand that brings its own pharmacy can run the same checks there.

## 02. What may a 503B facility compound from bulk ingredients?

Only a bulk drug substance on FDA's 503B bulks list, or one used for a drug that is on FDA's drug shortage list at the time of compounding, distribution and dispensing. GLP-1 drugs show how this works. FDA stated on April 1, 2026 that tirzepatide and semaglutide appear on neither the 503B bulks list nor the drug shortage list, and on May 1, 2026 it proposed not to include either on the 503B bulks list (91 FR 23431), with comments extended to July 30, 2026 (91 FR 38719). No final notice had appeared in the Federal Register as of October 26, 2026.

## 03. How is a 503B facility different from a 503A pharmacy?

A 503A pharmacy compounds for a named patient on a prescription under state board oversight and is not held to current good manufacturing practice. A 503B facility registers with FDA, is held to it, and is inspected by FDA. Cuvo's 503A vs 503B guide, linked below, covers which programs use each and how to vet them. This is general information, not legal advice.

## Frequently asked questions

**Q: What is a 503B pharmacy?**

A: "503B pharmacy" usually means a 503B outsourcing facility: a sterile compounder registered with FDA under section 503B that follows current good manufacturing practice and need not be a licensed pharmacy. On Cuvo, each order routes to a licensed partner pharmacy operating within the current rules for the molecule.

**Q: 503A vs 503B: which does a telehealth brand use?**

A: Patient-specific preparations follow the 503A route, while standardized preparations made at volume can come from a 503B outsourcing facility. Cuvo Health makes that routing decision part of the platform, sending each order to a partner pharmacy licensed for the destination state and operating within the current rules for the molecule.

**Q: Are 503B outsourcing facilities FDA approved?**

A: They are registered with and inspected by FDA, but their compounded drugs are not FDA-approved. On Cuvo, a licensed provider decides whether a compounded or an FDA-approved option fits each patient.

**Q: How do I check a 503B outsourcing facility?**

A: Start with FDA's list of registered outsourcing facilities, which shows the last inspection, any Form 483, any recall and the action taken, then ask for state licenses in every ship-to state. On Cuvo, partner pharmacy licensure is verified continuously, so the brand never runs this check itself.

**Q: Can a 503B facility compound semaglutide or tirzepatide?**

A: Not from bulk substance today: FDA said on April 1, 2026 that neither appears on the 503B bulks list or the drug shortage list, and in May 2026 it proposed not to add them. On Cuvo, every GLP-1 prescription is written by a licensed provider and filled by a partner pharmacy operating within the current rules for the molecule.

**Related pages**

- [503A vs 503B compounding](/blog/compounding-503a-vs-503b): The full comparison and the vetting questions
- [503A compounding pharmacy](/glossary/503a-pharmacy): Patient-specific compounding under state boards
- [FDA drug shortage list](/glossary/fda-drug-shortage-list): How shortage status changes what may be compounded
- [FDA bulk drug substance categories](/glossary/bulk-drug-substance-categories): Category 1, 2 and 3 explained
- [Pharmacy and e-prescribing on Cuvo](/pharmacy): Licensed partner pharmacies, cold chain and lot tracking
- [How to choose a telehealth pharmacy partner](/blog/how-to-choose-a-telehealth-pharmacy-partner): Inspection evidence and the questions to ask

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