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USP General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations," is the United States Pharmacopeia standard that sets facility, personnel, and process requirements for compounding preparations that are not required to be sterile — most oral liquids, capsules, tablets triturated into new strengths, topical creams and ointments, and suppositories. Like <797>, the current version of <795> was published in USP-NF 2023 Issue 1 on November 1, 2022, and became official on November 1, 2023 — the first major revision of the nonsterile chapter since 2014, restructured to align more closely with <797>’s facility and documentation approach. This guide covers what the current chapter requires, and how it fits alongside USP <797> (sterile compounding) and USP <800> (hazardous drugs).
What USP <795> covers
USP <795> applies to nonsterile compounding performed in any pharmacy, outsourcing facility, physician’s office, or other healthcare setting — preparing a drug in a dosage form, strength, or combination that is not commercially available, for a specific patient or a defined patient population, using nonsterile technique. It covers the full compounding workflow: facility and equipment requirements, personnel training and garbing appropriate to nonsterile work, master formulation and compounding records, ingredient and component selection, quality control of the finished preparation, packaging and labeling, and assignment of a beyond-use date. It does not cover simple, non-compounding acts such as reconstituting a commercial product exactly per its FDA-approved labeling, or repackaging without altering the formulation, which fall outside the compounding definition entirely.
Facility and equipment requirements
Unlike <797>, nonsterile compounding under <795> does not require an ISO-classified cleanroom or a primary engineering control sited for sterility — the chapter instead requires a designated, appropriately clean and organized compounding area, with equipment (balances, mortars and pestles, ointment mills, capsule-filling equipment, and similar) that is suited to the specific preparations being compounded, calibrated and maintained on a defined schedule, and physically separated where necessary to avoid cross-contamination between incompatible preparations (for example, compounding involving certain sensitizing agents). See Pharmaceutical Balance: What It Is, USP Requirements, and How to Buy One and Balance Qualification: USP Requirements and How to Evaluate a Provider for the weighing-equipment side of this, and Chemical Grades Explained: ACS, USP, Reagent, and Technical Grade Compared for ingredient-grade selection.
Personnel training and competency
Compounding personnel must complete initial didactic and hands-on training specific to nonsterile compounding, followed by an initial competency evaluation and periodic reassessment thereafter, covering hand hygiene, garbing appropriate to the compounding being performed, and the specific compounding techniques used (weighing, measuring, mixing, comminution, and so on). The chapter does not require the sterile-specific competency tools <797> mandates, such as gloved fingertip sampling or media-fill testing, since there is no sterility claim to verify.
Documentation: master formulation and compounding records
Every nonsterile compounded preparation needs a master formulation record (the standing recipe: ingredients, quantities, equipment, compounding steps, and quality-control checks for a given preparation) and a compounding record (the specific, dated log of what was actually compounded on a given occasion, including lot numbers of components used and who performed and checked the compounding). This documentation pair is what lets a pharmacy demonstrate, after the fact, exactly what went into a specific preparation and that it was prepared consistently with its master formulation.
Beyond-use dating under USP <795>
As with <797>, a beyond-use date (BUD) for a nonsterile preparation is the date after which it must not be used. USP <795> ties the maximum allowable BUD to a combination of factors: whether the formulation is water-containing (aqueous) or not, since water-containing preparations generally support more microbial growth and require shorter default BUDs; the dosage form and its packaging; the storage condition; and, most importantly, whether there is actual supporting stability data (a published reference, a manufacturer’s stability study, or the pharmacy’s own testing) for that specific formulation. Where such data exists, it generally governs. Where it doesn’t, the chapter provides conservative default BUDs to fall back on. Because these figures are specific to formulation type and storage condition and were revised in 2023, assign a BUD from the current chapter text or the USP Compounding Compendium directly rather than from memory or an older reference table.
How USP <795> relates to USP <797> and USP <800>
- USP <795> (this chapter) governs nonsterile compounding.
- USP <797> governs the equivalent requirements when the finished preparation must be sterile — a materially more demanding facility and testing regime, since a nonsterile route of administration doesn’t create the same contamination risk as an injectable or ophthalmic product.
- USP <800> layers additional containment requirements on top of <795> whenever the drug being compounded is on the NIOSH hazardous drug list, even if the preparation itself is nonsterile — for example, non-sterile manipulation of a hazardous oral chemotherapy agent still triggers <800>’s containment requirements alongside <795>’s compounding requirements.
For the full side-by-side, see USP 797 vs. USP 795: Sterile vs. Nonsterile Compounding Compared.
Enforcement
As with <797>, USP <795> is a compendial standard rather than a self-executing federal law. It becomes enforceable chiefly through a given state’s board of pharmacy regulations (most states have incorporated some version of <795> into their pharmacy practice rules) and through accreditation surveys that reference the current USP-NF. Enforcement timing, exact adopted language, and surveyor scrutiny vary by state — confirm the specific requirements of each state board a pharmacy operates under.
Frequently asked questions
What preparations fall under USP <795> instead of <797>?
Any compounded preparation that is not required to be sterile at the point of administration — most oral solids and liquids, topical creams, gels and ointments, and suppositories, among others. If the finished preparation must be sterile (an injectable, ophthalmic, intrathecal, or similar route), it falls under <797> instead, regardless of how simple the compounding process itself is.
Does USP <795> require a cleanroom?
No. <795> requires a designated, suitably clean and organized compounding area and appropriate equipment, but not an ISO-classified cleanroom or sterile primary engineering control — that requirement is specific to <797>.
Is USP <795> new?
No, but the current version is a substantial 2023 revision of a chapter that existed in an older form since 2014. A pharmacy operating from pre-2023 <795> materials is working from a superseded version.
