Office-use compounding lets a practice keep certain compounded medications on hand for in-office administration, without writing a prescription for a named patient before the product is made. Under federal law that product has to come from a 503B outsourcing facility: a compounder registered with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act, subject to current good manufacturing practice (CGMP), FDA inspection and adverse-event reporting.
ScriptLinkRx supports both pathways from one account. Patient-specific prescriptions go to 503A compounding pharmacies; office-use orders go to 503B facilities on the network. This guide covers how 503B office-use ordering works, what the rules allow, and what your clinic needs before the first order.
503A vs 503B: the short version
| 503A pharmacy | 503B outsourcing facility | |
|---|---|---|
| Regulated by | State board of pharmacy (FDA oversight) | FDA registration and inspection, plus state licensing |
| Manufacturing standard | USP compounding chapters | Current good manufacturing practice (CGMP) |
| Prescription required | Yes, for an identified patient | No; may compound non-patient-specific office stock |
| Typical use | Take-home prescriptions tailored to one patient | In-office administration from clinic stock |
| Bulk ingredient limits | Component of an approved drug, USP/NF monograph, or 503A bulks list | 503B bulks list, or a drug on the FDA shortage list |
Both pathways came from the Drug Quality and Security Act of 2013, and both restrict compounding drugs that are essentially copies of commercially available FDA-approved products.
What office use means in practice
An office-use order is placed by the clinic, not for a patient. The facility compounds the product in a batch, labels it for office use, and ships it to the practice. The clinic then administers it on site and documents each administration in the patient's chart. Office-use product is not dispensed to patients to take home; a take-home medication is a patient-specific prescription and belongs on the 503A side.
Because office stock is sitting in your clinic, state rules matter as much as federal ones. States differ on whether prescribers may purchase office-use compounded products, in what quantities, and for which categories. Several require specific record-keeping, and controlled substances add DEA registration and storage requirements on top. Before enrolling, confirm your state board of pharmacy's and medical board's current position.
Enrollment with each facility
503B facilities verify who they ship to. On ScriptLinkRx the enrollment is handled inside the platform:
- Open the facility's enrollment form from your account. It asks for the practice's business details, shipping address, licensing and the ordering prescriber.
- Submit for review. The facility reviews the enrollment and either approves it or asks for more information. The status of every enrollment is visible on your account.
- Order from the office-use catalog. Once approved, that facility's 503B catalog opens. Products show the facility, strength, pack size and price.
Enrollments are per facility, so a clinic that wants office stock from two facilities completes two enrollments. A PDF of each enrollment is kept with your account records.
One account, two checkouts
Patient orders and office-use orders share one login but never share a cart. A 503A order is tied to a patient record and dispensed to that patient; a 503B order is tied to your clinic's enrollment and ships to the practice. Keeping the two separate is deliberate: it keeps patient-specific prescriptions clean for the dispensing pharmacy and keeps office-stock records clean for your state board.
Office-use orders appear in the same order list as patient orders, with their own filter, and each order has a printable order record for your files.
What a 503B facility can and cannot compound
The ingredient rules are where most office-use questions end up:
- A 503B facility may compound from a bulk drug substance only if the substance appears on the FDA's 503B bulks list or is used to compound a drug that is on the FDA drug shortage list at the time of compounding, distribution and dispensing.
- Semaglutide and tirzepatide meet neither test today. The tirzepatide shortage was resolved in 2024 and the semaglutide shortage in February 2025, neither drug is on the 503B bulks list, and on April 30, 2026 the FDA proposed to formally exclude semaglutide, tirzepatide and liraglutide from that list. No final decision had been published as of October 2026. The GLP-1 sourcing guide has the full picture.
- Testosterone and other substances that are components of FDA-approved drugs can be used by 503B facilities, subject to the essentially-a-copy restriction. The TRT guide covers controlled-substance requirements for office stock.
- Products that are essentially copies of approved drugs are restricted for 503B facilities as well, with narrower exceptions than 503A.
Documentation your clinic should keep
Office stock shifts record-keeping from the pharmacy to the practice. Facilities and state boards generally expect a clinic to keep:
- Each facility's enrollment and approval.
- Order records with product, lot number, quantity and date received.
- Administration records tying each dose to a patient chart.
- Storage logs where the product requires refrigeration, and DEA records where a controlled substance is involved.
ScriptLinkRx keeps the enrollment, order and receipt side of that on your account; administration records stay in your clinical system.
Sources
- FDA: Registered Outsourcing Facilities
- FDA: Compounding and the FD&C Act (sections 503A and 503B)
- FDA: Bulk Drug Substances Used in Compounding Under Section 503B
- FDA: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (April 30, 2026)
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (April 2026)