USP <797> and <795>: The Standards That Govern Your Compounded Prescription

When a compounding pharmacy prepares your semaglutide injection, two documents set the rules for how they do it: USP General Chapter <797> for sterile preparations and USP General Chapter <795> for non-sterile preparations. These are not guidelines or suggestions. They are enforceable standards that most state boards of pharmacy have adopted as the legal baseline for compounding quality.

Understanding what these standards require — and where they draw the lines — helps you evaluate whether the pharmacy behind your prescription is meeting the minimum standard or exceeding it.

What Is the USP?

The United States Pharmacopeia (USP) is a nonprofit scientific organization that sets quality standards for medicines, dietary supplements, and food ingredients. Founded in 1820, the USP publishes a compendium of standards that carry the force of law when adopted by the FDA or state regulatory agencies. USP standards are not academic exercises — they are the operational rulebook for pharmacies, manufacturers, and laboratories across the United States.

When your state board of pharmacy inspects a compounding pharmacy, the inspector is checking compliance with USP standards. When the FDA issues a warning letter to a compounder, the citation often references specific USP chapter requirements. These standards are the lingua franca of pharmaceutical quality.

USP <797>: Sterile Compounding Standards

If your compounded GLP-1 is an injectable — and most are — it was prepared under USP <797> requirements. This chapter covers everything involved in producing a sterile preparation: the facility design, personnel qualifications, environmental monitoring, compounding procedures, quality testing, and beyond-use dating.

Key Requirements Under <797>

Facility design and air quality: Sterile compounding must occur within an ISO Class 5 primary engineering control (laminar airflow workbench or compounding aseptic isolator) located inside an ISO Class 7 buffer room, accessible through an ISO Class 8 anteroom. These classifications define the maximum allowable airborne particle counts and are verified through routine environmental monitoring.

Personnel training and competency: Everyone who compounds sterile preparations must complete initial training in aseptic technique, garbing procedures, and cleanroom behavior. This is not a one-time certification — <797> requires ongoing competency assessments, including media fill tests (where personnel prepare mock sterile products using growth media instead of drug solution to test whether their technique introduces contamination) at defined intervals.

Environmental monitoring: Pharmacies must conduct viable and non-viable air sampling, surface sampling, and gloved fingertip testing on a defined schedule. Results must be trended and reviewed — not just filed. Excursions above action levels require documented investigations and corrective actions.

Beyond-use dating: <797> sets default maximum BUDs based on the compounding category and testing performed. Pharmacies can extend BUDs beyond defaults only with supporting stability data from validated testing protocols. This requirement prevents pharmacies from assigning arbitrarily long dating without scientific evidence.

Quality testing: Finished sterile preparations must undergo appropriate testing before release. For injectable compounded preparations, this typically includes sterility testing (USP <71>), bacterial endotoxin testing (USP <85>), and visual inspection for particulate matter.

USP <795>: Non-Sterile Compounding Standards

If your GLP-1 comes as an oral tablet, troche, sublingual drop, or other non-injectable format, it falls under USP <795>. This chapter covers non-sterile compounding — preparations that do not need to be sterile because they are not injected.

Key Requirements Under <795>

Component quality: All ingredients (APIs, excipients, vehicles) must meet USP-NF compendial standards or, if no compendial standard exists, be accompanied by a certificate of analysis from the supplier with identity verification by the pharmacy.

Master formulation and compounding records: Each compounded preparation must have a master formulation record (the "recipe") that documents ingredients, quantities, procedures, equipment, and quality control measures. Each batch must also have a compounding record documenting the actual process, lot numbers used, and the person who compounded and verified it.

Beyond-use dating: <795> provides default BUD guidelines for non-sterile preparations. Non-aqueous formulations can have BUDs up to 180 days; aqueous formulations are limited to 14 days unless stability data supports longer dating. Oral solid dosage forms (tablets, capsules) follow different defaults based on their characteristics.

Quality checks: Finished non-sterile preparations must undergo appropriate quality checks, which may include weight variation testing, pH measurement, visual inspection, and — for preparations where potency is critical — assay testing.

The November 2023 Revision: What Changed

The current version of USP <797> took effect on November 1, 2023, after years of revision and public comment. The updated chapter introduced several significant changes:

• Simplified categorization: The old risk-level system (low, medium, high) was replaced with two categories (Category 1 and Category 2), based on the conditions of compounding and the BUD assigned.
• Stricter personnel requirements: More frequent competency assessments and media fill testing.
• Enhanced environmental monitoring: More prescriptive requirements for sampling locations, frequencies, and action level responses.
• Clearer BUD framework: Default BUDs are now tied directly to the category designation and the availability of stability data.

Enforcement: Who Checks Compliance?

USP standards are enforced primarily by state boards of pharmacy, which conduct routine and for-cause inspections of compounding pharmacies. The FDA also has enforcement authority over compounding, particularly for 503B outsourcing facilities, and can issue warning letters, injunctions, or consent decrees for violations.

Third-party accreditation bodies — PCAB (Pharmacy Compounding Accreditation Board), ACHC (Accreditation Commission for Health Care), and others — provide voluntary accreditation programs that audit pharmacies against USP standards (and sometimes beyond them). PCAB accreditation, in particular, is widely regarded as the gold standard for compounding pharmacy quality because it requires on-site inspections, proficiency testing, and ongoing compliance monitoring.

What Patients Should Look For

• Ask about <797> compliance: "Does your pharmacy comply with the current (November 2023) version of USP <797>?" This is a basic competency question — any pharmacy compounding sterile products should answer yes without hesitation.
• Ask about accreditation: PCAB or ACHC accreditation indicates a pharmacy has been independently audited against USP standards. It's not required by law, but it demonstrates a commitment to quality beyond the regulatory minimum.
• Ask about testing: "Do you perform sterility and endotoxin testing on finished injectable preparations?" Pharmacies that release sterile products without testing are relying entirely on process controls — which is permitted under certain USP categories but carries more risk than pharmacies that test finished products.

Providers Partnered With USP-Compliant Pharmacies