What is USP 797? It's the United States Pharmacopeia's standard for preparing sterile compounded medicines, including injections. Sterile means free of living germs. Compounding means combining or altering ingredients to prepare a medicine.
The number names a chapter in USP's collection of medicine-quality standards. It describes how a preparation is made, tested, labeled and stored. It doesn't tell someone whether that medicine fits their health history.
What is USP 797 in the official standard?
The official title is Pharmaceutical Compounding—Sterile Preparations. USP's chapter page lists November 1, 2023 as the date the revised chapter became official. USP writes the standard; regulators enforce the requirements that apply in their jurisdiction.
Section 503A is the federal framework for traditional compounding for an identified patient. A monograph is an official ingredient-quality standard. The National Formulary is USP's companion collection of quality standards. For one route using starting active ingredients, 21 U.S.C. 353a(b)(1)(A)(i)(I) requires that substances:
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 statute doesn't name chapter <797> by number. State pharmacy rules help connect the chapter to inspection and daily practice.
As of October 1, 2026, the day this article was written, two recent board actions show how that works. Missouri's notice, marked “Effective 7/30/2026,” requires its sterile-compounding permit holders to follow the 2023 chapter. Massachusetts Policy 2026-03, marked “Adopted: 9/3/26,” requires pharmacies to report excessive contamination within one business day of receiving the testing report. State adoption dates and inspection requirements matter alongside USP's official date.
A 503B outsourcing facility follows a different federal framework. It must meet current good manufacturing practice, or CGMP: federal requirements for making and controlling medicines. The U.S. Food and Drug Administration (FDA) confirms that obligation in its comparison of compounding frameworks; 21 CFR parts 210–211 contain the manufacturing rules.
The term can come up during a visit about tirzepatide. It helps separate the provider's prescribing decision from the pharmacy's responsibility for preparing the medicine.
Why sterile compounding needs a standard
Chapter <797> predates the 2012 outbreak: it was first published in 2004, as APIC's injection-safety position paper records. APIC is the Association for Professionals in Infection Control and Epidemiology.
The New England Compounding Center outbreak involved contaminated steroid injections, medicines used to treat inflammation, as documented by Smith and colleagues in the New England Journal of Medicine, 2013.
The standard makes prevention a repeatable job: trained staff, controlled air, cleaning, preparation records and checks before dispensing. Later revisions clarified requirements and connected longer storage periods to additional safeguards.
What the cleanroom standards cover
Air and rooms. ISO classes describe airborne particle limits. In a typical cleanroom suite, ISO Class 5 protects the mixing work area. An ISO Class 7 room surrounds that area, with an ISO Class 7 or 8 entry room. Filtered air and controlled pressure help limit contamination.
Clothing and handling. Garbing means protective clothing, including gloves and covers. Aseptic technique means handling supplies without introducing germs. Staff demonstrate those skills through observed assessments and practice preparations using liquid that supports germ growth.
In Trissel and colleagues' 2005 study in the American Journal of Health-System Pharmacy, about 1 in 20 practice preparations grew microbes: 28 of 539 evaluations, or 5.2%. These were complex staff simulations at one institution, not a patient infection rate. They illustrate why experience alone doesn't replace skill checks.
Category 1, 2 and 3: what changes?
The categories describe preparation conditions and permitted usable time. They don't rank how well a medicine works.
Missouri's board guide summarizes the chapter's categories and air requirements:
| Category | What it means |
|---|---|
| 1 | A protected work area may sit in a designated space outside a full cleanroom suite. Maximum beyond-use time is 12 hours at controlled room temperature or 24 hours refrigerated. |
| 2 | A cleanroom suite supports longer dates. Limits depend on ingredients, preparation method, testing and storage conditions. |
| 3 | Longer dates require additional safeguards, including evidence that the medicine keeps its quality, checks that the container stays properly sealed, sterility testing and more frequent monitoring. |
Those are ceilings, not dates someone can assign at home. Stability means how well a medicine keeps its strength and quality over time. A preparation that breaks down sooner needs a shorter date.
BPC-157 is a peptide, a short chain of protein building blocks. If a pharmacy prepares a sterile formulation, its category describes preparation controls. The category doesn't establish a treatment benefit.
Sterility and endotoxin are separate checks
Sterility testing looks for living germs. Endotoxin testing looks for bacterial material that can trigger reactions even without living bacteria. The required tests depend on the preparation, ingredients and category; every preparation doesn't have the same testing schedule.
As of October 1, 2026, the day this article was written, FDA's alert, marked “Content current as of: 08/27/2026,” reinforces the ingredient distinction. It says dietary-supplement-grade glutathione isn't appropriate for injectable drugs. FDA described reactions consistent with excessive endotoxin exposure. The reported reactions involved glutathione prepared by compounding pharmacies, so ingredient grade and supplier records matter even for a prescribed medicine; a named pharmacy and prescriber make a reaction traceable.
Beyond-use date meaning on a prescription label
A beyond-use date, or BUD, is the date or time after which a compounded preparation must not be used. It belongs to that preparation, under its stated storage conditions.
A manufacturer's expiration date comes from testing its finished product. A compounded preparation has its own ingredients, container and preparation process. It cannot borrow another product's clock. Our semaglutide expiration and BUD guide separates those dates; how to store peptides covers handling.
The USP FAQs, updated December 11, 2023, explain that refrigeration cannot extend an originally assigned BUD. Returning a preparation to the fridge doesn't restart it. Clear appearance doesn't establish sterility either.
Three mistakes people make with “USP-compliant”
Treating it as a drug endorsement. USP compliance describes preparation standards. As of October 1, 2026, the day this article was written, FDA's explanation, marked “Content current as of: 06/22/2026,” says compounded medicines do not undergo its review before marketing. Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. A licensed provider may still prescribe — that decision is between you and your doctor.
Treating a purity report as sterility evidence. A certificate of analysis reports batch testing. Chemical identity or purity results cannot substitute for contamination tests. FDA's sterile-manufacturing guidance, section XI, also explains why a small tested sample cannot establish sterility across an entire batch by itself.
Treating the BUD as a suggestion. Remaining medicine, refrigeration or a normal appearance doesn't extend the assigned date. For a semaglutide prescription, the specific preparation's label and dispensing pharmacy settle dating questions.
Related terms in the prescription conversation
USP <795> covers nonsterile compounding. USP <800> covers handling hazardous drugs to limit exposure; it can apply alongside <797>.
A bulk drug substance is a starting active ingredient. The 503A bulks list describes one ingredient pathway. Bacteriostatic water contains a preservative that limits bacterial growth; it doesn't set a mixed medicine's BUD.
At Promise, a licensed provider reviews every request, and not everyone qualifies. The provider evaluates the person; a licensed U.S. compounding pharmacy is responsible for the preparation it dispenses.
