Office-use compounding in Illinois

What the rule requires in practice

Each item carries a confidence level. Verbatim rule text is high confidence; a reading of how two provisions interact, or a source that could not be re-verified, is not.

Administer-onlyHigh confidence

Built into the definition — "office use" means administration to a patient by the practitioner, and expressly excludes delivery against a patient-specific prescription.

Quantity conditions (non-sterile)High confidence

The quantity must not exceed what the practitioner anticipates using before the BUD expires; must be reasonable given the intended use and the nature of the practice; and — for any practitioner and for all practitioners as a whole — must not exceed what the pharmacy can compound in compliance with USP-consistent identity, strength, quality and purity standards.The aggregate-across-all-practitioners limb is unusual and easily missed: it caps the pharmacy’s whole office-use book, not just any one account.

Mandatory label legendHigh confidence

"For Office Use Only Not for Resale"Alongside pharmacy name, address and phone; drug name, strength, dosage form and active ingredients with strengths; lot number and BUD; quantity in the container; and appropriate storage, cautionary and hazardous-drug statements.

RecordsHigh confidence

Retained five years and readily retrievable: ordering practitioner’s name, address, phone and order date; name, strength, quantity and dosage form provided, including number of containers and quantity in each; date compounded; date provided to the practitioner; lot number and BUD.

VeterinaryHigh confidence

Subsection (g) — notwithstanding any other provision, a pharmacy may compound a reasonable quantity of sterile AND non-sterile drug products for office use by a veterinarian. Vets get the sterile pathway humans do not.

Resale / wholesale banHigh confidence

Subsection (e)(10) — sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or manufacturers, are not allowed other than as provided in subsection (d), except for contracted centralised prescription filling.

Sterile service approvalHigh confidence

Subsection (i) — Department inspection and approval of the compounding area is required before a licensed pharmacy may add sterile compounding; the pharmacist-in-charge must notify the Department and arrange it.

USP baselineHigh confidence

USP-NF (USP 47-NF 42, 2024 Compounding Compendium), expressly EXCEPT USP <800> as it pertains to handling hazardous drugs in healthcare settings.The <800> carve-out is specific to Illinois and differs from Ohio and Georgia.

Statutory layerHigh confidence

"Office use" does not appear anywhere in the Illinois Pharmacy Practice Act (225 ILCS 85). Illinois office use is entirely rule-based.Verified by searching the full text of the Act.

Last changeHigh confidence

Rule 1330.640 amended at 48 Ill. Reg. 10225, effective June 28, 2024 — unchanged since.

Illinois at a glance

Receiving 503B office stock in Illinois

Illinois is the clearest two-credential state in this family, and it is unusual in writing the requirement into the office-use rule itself rather than leaving it to a separate licensing chapter.

Everything above this heading answers the supply question: may a state-licensed 503A pharmacy ship non-patient-specific stock? This section answers the other half. Registration with FDA under section 503B is a federal exemption from federal law and preempts no state licensing scheme, so it is never the whole answer on its own — a state credential is the norm rather than the exception, it is not always issued by the board of pharmacy, and in some states the category you would search for does not exist. What Illinois asks for is set out below, including where we could not establish it.

What the 503B must hold to ship inHigh confidence

Two things, in the rule’s own words. 68 Ill. Adm. Code 1330.640(c) provides that sterile compounding for office use "is prohibited unless the pharmacy is in full compliance with 21 USC 353b, including becoming registered as an outsourcing facility and licensed as a wholesale drug distributor pursuant to the Wholesale Drug Distribution Licensing Act [225 ILCS 120]." Federal registration is expressly only half of what Illinois asks for.

Does your practice need a permit?Not verified

None identified. Part 1330 binds the pharmacy, and no permit for a prescriber holding office stock was found in it — but this was not researched as an affirmative negative for the receiving practice.

Administer vs dispenseHigh confidence

Built into the definition rather than bolted on. 1330.640(b): "office use" means the administration of a non-patient specific compounded drug to a patient by a practitioner, and it "does not include a pharmacy’s delivery of a compounded drug to a prescribing practitioner’s office pursuant to a valid patient-specific prescription."

Scheduled (controlled) stockNot verified

Not researched for Illinois in this review. Confirm with the Department and your counsel before holding scheduled stock.

How to check a facility’s credential before you order is set out in how to place an office-use order.

What this page does not establish

• The Pharmacy Practice Act was amended by several 104th General Assembly public acts (P.A. 104-312, 104-336, 104-417, 104-432, 104-439, 104-461). We verified that none introduced office-use language, but we did not determine what else those acts did, so this page cannot tell you how they bear on your practice in any other respect.
• 225 ILCS 85 carries a sunset and repeal date of January 1, 2028. Everything on this page that rests on that Act carries the same horizon.
• Pending JCAR rulemaking on Part 1330 is outside what this page covers; we have not checked it.