Glossary
USP <795>: the non-sterile compounding standard, and who enforces it
USP <795> is the standard for compounding non-sterile preparations — capsules, creams, oral liquids, troches — and USP’s own page records it as having become official on 1 November 2023. USP writes the chapter. It does not enforce it, inspect anyone, certify anyone or approve anything: the chapter binds a pharmacy only when some other body adopts it, which in practice means a state board of pharmacy adopting a named, dated version by rule, or an accreditor making it contractual. Neither of those routes is FDA approval, and compounded drugs are not FDA-approved.
What <795> covers
<795> is the standard for preparations that do not have to be sterile: capsules, creams, oral liquids, troches. It is the floor for was this made properly when sterility is not the risk in play. USP’s public page describes the chapter as providing "standards for compounding quality nonsterile preparations", and names the risks it is written against — "contamination, infection or incorrect dosing".
The date on it is more recent than most people assume, and that matters:
November 1, 2023 – USP General Chapter <795> Becomes Official
The same page lists an earlier milestone, "November 1, 2022 – Revisions to USP General Chapters <795> and <797>". Published in 2022, official in 2023: a one-year runway between the text existing and the text counting. That gap is why a pharmacy can be doing everything right and still be working to a different edition than the pharmacy across the state line.
What it tells you about a pharmacy, and what it does not
A pharmacy working to <795> has documented procedures, ingredient controls, personnel training and assigned beyond-use dates for its non-sterile work. That is a real statement about how the preparation was made.
It says nothing whatever about sterile capability. <795> and <797> answer different questions, and a pharmacy can be current on one and behind on the other. Neither answers the hazardous-drug handling question, which is <800>.
The phrasing to be wary of is the bare one — a pharmacy described as compliant with USP, with no chapter named and no state named. There is no such condition to be in. The checkable version names both: compliant with <795> as adopted by Illinois, in the edition Illinois adopted. Anything shorter cannot be verified by you or by anyone else, because adoption is version-dated and staggered.
How a chapter becomes binding
USP describes itself in terms that are easy to read past:
While not a government entity, USP works closely with government agencies, ministries, and regulatory authorities around the world
Across its <795>, <797>, <800> and legal-recognition pages, USP names no enforcement body at all. So a sentence beginning "USP requires you to…" is really "your state board, having adopted this chapter, requires you to…". Three routes do that work instead.
A state board adopts a named, dated version
This is the binding route, and it is version-dated and staggered. Adoption is not "the state follows USP"; it is "the state follows this edition of USP".
| State | How the chapter enters the rules | What that means in practice |
|---|---|---|
| Ohio | OAC 4729:7-1-01 defines each chapter by version date: <795> as the version dated 1 November 2023, <797> as a version dated 1 February 2026, <800> as the version dated 1 December 2022 | The rule carries an effective date of 1 June 2026, with prior effective dates of 31 March 2021 and 28 February 2026 — and the Board has separately delayed enforcement |
| Illinois | 68 Ill. Adm. Code 1330.640 adopts USP-NF (USP 47-NF 42, the 2024 Compounding Compendium), expressly excepting <800> as it pertains to handling hazardous drugs in healthcare settings | An edition-level adoption rather than a chapter-by-chapter one, with one chapter carved out of it |
| Georgia | Rule 480-11-.02(8) names <795> for non-sterile work and <797> for sterile | Chapter by chapter, with no version date in the rule text read |
| New York | Neither <795> nor <797> appears by regulation — zero occurrences across 8 NYCRR Part 63 and § 29.7 on the text fetched | A pharmacy there is not working to a state-adopted USP chapter at all, on that text |
A pharmacy in one state and a pharmacy in another can both be entirely in order and be working to different editions of the same chapter. That is the single most useful thing a buyer can know about USP.
An incorporation date is also not a USP publication date. Ohio defining <800> as the version dated 1 December 2022 says something about Ohio’s rule, and nothing about when USP revised anything.
Adoption and enforcement are separate dates too, and the gap can be generous:
To allow for licensees to transition to the most current version of USP 797 and USP 795, the Ohio Board of Pharmacy hereby delays the implementation of paragraphs (B) and (C) of OAC 4729:7-1-01 until February 28, 2027.
An accreditor makes it contractual
PCAB is operated by ACHC, and its accreditations are written directly onto the chapters: "PCAB Non-Sterile Pharmacy Compounding Accreditation references USP <795>", with the sterile accreditation referencing <797> and the hazardous-drug programme incorporating <800>. ACHC records that "Revised PCAB CFNS Standards that include USP updates to Chapter <795> took effect June 1, 2024."
Accreditation is per scope, not global: non-sterile, sterile and hazardous-drug handling are separate accreditations. "PCAB accredited", with no scope named, is an incomplete statement — ask which.
Federal statute reaches ingredients, and stops there
This is the most overstated fact in the vertical. Section 353a references USP twice, and both references are about what goes into the preparation:
comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding
The defensible sentence is this one: federal law conditions the 503A exemption on ingredients conforming to the applicable USP monograph and to the USP chapter on pharmacy compounding, while the facility and process standards come from state adoption and from accreditation. Note as well that the statute says "chapter", singular, and names no number at all.
What you can ask a pharmacy to demonstrate
Framed as what a pharmacy is generally able to produce, which is not the same thing as something you are entitled to.
- Which chapter version they work to, and — in a state running a transition — whether they can demonstrate full compliance with the newer version whose beyond-use dates they are using. Ohio makes that a live question in its own words, quoted on the <797> page.
- Accreditation status and scope. PCAB non-sterile is the one that maps to <795>. Ask which accreditation, not whether they hold one.
- State licensure in your own state, including non-resident licensure. ACHC is explicit that a receiving state’s board may require a licence that depends on a non-resident inspection, and that "This is not the same as accreditation." Both get checked, not one.
- Per-batch documentation — lot number, assigned beyond-use date, the compounding record. Record-keeping duties of this kind exist by rule in several of the states reviewed on this site, but they run to the pharmacy; sharing them with a prescriber is a commercial courtesy rather than a statutory right.
- A certificate of analysis for a given lot. Many pharmacies will provide one. No rule compelling disclosure to a prescriber was found here, so read a refusal as a commercial signal rather than as a violation.
What USP does not do
USP does not certify, approve or accredit a compounding pharmacy. There is no such credential to hold. "USP Verified" is a real programme, but it covers dietary supplements, dietary ingredients, APIs and excipients — manufacturers — and USP’s verification pages make no mention of compounded preparations at all. On a compounding page it is a factual error rather than a matter of tone.
Nor is any of this FDA approval. FDA’s own words are that compounded drugs are not FDA-approved, which it explains as meaning that it does not review them for safety, effectiveness or quality before they reach patients. A state-adopted process standard and a premarket review are different things, and treating one as the other is the most consequential error available in this subject.
Where this sits
<797> is the sterile counterpart, and the chapter that carries beyond-use dating. <800> is not a preparation-quality chapter at all. The glossary index sets the three side by side.
Which pathway a pharmacy operates under — and what that changes about the dating on the label — is 503A vs 503B. The questions above are the diligence half of placing an office-use order.