USP <797>: the sterile compounding standard, and beyond-use dating

What <797> covers

<797> governs anything that has to be sterile. USP’s public page names the routes that puts in scope:

Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).

USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

For an injectable preparation this is the chapter that matters most, because it is where the cleanroom engineering controls, the environmental monitoring, the garbing and competency testing, and the beyond-use dating all live. Its status line reads the same way <795>’s does: "November 1, 2023 – USP General Chapter <797> Becomes Official".

Official is not the same as enforced

USP writes the chapter and stops there. It does not inspect anyone and names no enforcement body on any of its public chapter pages. What makes <797> bind a pharmacy is a state board adopting a version of it by rule — and boards adopt on their own timetables, with their own transition periods.

Ohio is the worked example, and it is a generous transition. Its Board wrote, in guidance updated 11 May 2026:

While the rule is effective currently, the Board has extended the enforcement date of the rule until February 28, 2027, via resolution

Ohio’s own enforcement table holds the sterile row at the 2008 text of USP 797 until 27 February 2027. An Ohio pharmacy can therefore be entirely lawful today while working to a chapter edition that is old enough to vote, and the phrase "meets <797>" tells you nothing until you know which <797> and under whose rule. Extensions past that date exist under 4729:7-1-01(E) on three showings — prior compliance, significant hardship, sufficient progress — described as given on a very limited basis, with requests not reviewed until 1 August 2026.

The version conflict, stated rather than smoothed over

Ohio’s rule names a version of <797> dated 1 February 2026. USP’s public page shows only the 1 November 2023 official date. Either a later revision exists that USP’s summary page does not surface, or Ohio is naming a USP-NF edition or snapshot date rather than a revision date. We could not resolve which, so nothing on this page asserts a February 2026 revision of anything.

That is not a footnote. It is the same trap in miniature: a state’s incorporation-by-reference date is a fact about the state’s rule, and converting it into a claimed USP publication event manufactures a fact.

Beyond-use dating, and why it is not an expiration date

A beyond-use date is defined in government text, which is fortunate, because the dating tables themselves are paywalled:

'Beyond-use date' means either the date or time and date after which a compounded drug preparation must not be used or administration must not begin.

The same rule supplies the vocabulary that makes the distinction land. A "product" is "a drug in a commercially manufactured pharmaceutical dosage form that has been evaluated for safety and efficacy by the United States food and drug administration"; a "preparation" is "a drug compounded in a licensed pharmacy or other healthcare-related facility". Different words, deliberately, for different things.

An expiration date is a current-good-manufacturing-practice artefact, and the regulation says what has to sit behind it:

To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166.

The chain that connects dating to the pathway

FDA supplies both ends of it. On one side:

Section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use.

Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements, and they 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).

So: CGMP makes an expiration date conditional on stability testing. A 503A pharmacy is exempt from CGMP, and a 503B outsourcing facility is not. It follows that a 503A preparation carries a beyond-use date assigned under the USP chapter its state adopted — a conservative default keyed to dosage form, compounding environment and category — while a 503B product operates in a regime where the date on the label is determined by stability testing on that product.

The publishable claim is about the kind of evidence behind the date, not about its length. Nothing here establishes that one pathway’s dating runs further than the other’s, and this page does not say so. What it says is that the two dates are answers to different questions, backed by different work. The pathways themselves are compared in 503A vs 503B.

Dating is version-dependent, and it has to be earned

This is the most citable beyond-use dating fact available outside the paywall, and it is Ohio’s:

Only licensees that have fully adopted the newest versions may utilize the new beyond-use dates in USP 797 & USP 795.

IMPORTANT: Licensees are prohibited from utilizing beyond-use dates from the newest versions of USP 797/795 unless they can demonstrate full compliance with those new versions.

Two things follow, and both are useful to a buyer. Dating limits changed between chapter editions, so the edition a pharmacy works to is a live operational fact rather than paperwork. And the newer dating has to be earned by demonstrating full compliance with the newer version — which makes which version are you dating to, and can you demonstrate full compliance with it? a question a pharmacy in a transitioning state should be able to answer without hesitating.

Where beyond-use dating shows up in state rules

Not decorative, and not only the pharmacy’s problem. Among the states with a completed briefing on this site:

• Illinois caps the quantity of a non-sterile preparation supplied to a practitioner at not more than the practitioner anticipates using before the beyond-use date, and requires that date on every such container’s label.
• Georgia requires the veterinarian to chart the lot number and the beyond-use date.
• Louisiana includes the beyond-use date in its mandatory label set, and requires an estimated one on preparations made in anticipation.
• Ohio requires a report to the Board within 72 hours of any significant chemical, physical or other change or deterioration of a dispensed compounded drug preparation within that preparation’s assigned beyond-use date. The date is the tripwire for a mandatory quality report.

What you can check yourself, and what you can ask

Two of these cost nothing and need no cooperation from anyone.

1. For a 503B outsourcing facility, FDA publishes the register. Its table of registered outsourcing facilities carries per-facility columns — initial and most recent registration, last inspection, a Form 483 column, a recall column and an action-taken column — which a prescriber can consult directly. It listed 97 facilities as of 28 August 2026, and it updates weekly, so the number is only true with its date attached. This page does not mirror that table with names against compliance values, and neither should any vendor: read it at the source.
2. FDA also publishes its compounding inspections, recalls and other actions.
3. There is no federal equivalent for a 503A pharmacy. They are licensed by states, and FDA maintains no comparable public inspection table for them. That asymmetry is real and worth understanding: diligence on a 503A runs through the state board and the accreditor instead, which is why the next two items exist.
4. State licensure in your own state, including non-resident licensure. ACHC says plainly that a receiving state’s board may require a licence dependent on a non-resident inspection, and that "This is not the same as accreditation." Accreditation is not a substitute for it; a prescriber checks both.
5. Accreditation scope. PCAB sterile accreditation is the one that references <797>; non-sterile and hazardous-drug handling are separate accreditations. ACHC records that "Revised ACHC IRX Standards that include USP updates to Chapter <797> took effect June 1, 2024."

Two sentences that should not be written

"Federal law requires 503A pharmacies to follow USP 797." It does not. Section 353a’s USP references are ingredient-level — bulk substances and other ingredients conforming to the applicable monograph and to "the United States Pharmacopoeia chapter on pharmacy compounding", singular and unnumbered. Cleanroom and facility standards reach a pharmacy through state adoption and accreditation, not through the federal exemption.

Never "USP certified", of a pharmacy. No such credential exists, because USP does not certify, approve or accredit compounders. And no chapter conformity is FDA approval: compounded drugs are not FDA-approved, which FDA explains as meaning it does not review them for safety, effectiveness or quality before they reach patients.

Where this sits

<795> is the non-sterile counterpart. <800> protects the people handling hazardous drugs and says nothing about how a preparation was made. All three sit together in the glossary index.

The dating question above is one of the things worth raising before a first order — see placing an office-use order.