USP 795 is a set of national standards governing how pharmacies and other healthcare facilities prepare non-sterile compounded medications. Published by the United States Pharmacopeia (USP), it covers everything from staff training and facility cleanliness to how long a compounded product can be used before it expires. The most recent revision became official on November 1, 2023.
Non-sterile compounding refers to preparations that don’t need to be free of all microorganisms, things like custom-made creams, ointments, capsules, oral suspensions, and suppositories. If a patient needs a medication in a dose or form that isn’t commercially available, a pharmacist compounds it. USP 795 exists to make sure that process is consistent and safe, no matter which pharmacy does the work.
Who USP 795 Applies To
The standard applies to any facility or person involved in preparing non-sterile compounded preparations. That includes community pharmacies, hospital pharmacies, and outsourcing facilities. It also covers veterinary compounding. If you work in a pharmacy that mixes, combines, or otherwise prepares a medication outside of its original manufactured form, USP 795 sets the rules you follow.
State boards of pharmacy are the primary enforcers. While USP itself doesn’t have regulatory authority, most states incorporate USP chapters into their pharmacy laws or regulations, making compliance legally required. The Food and Drug Administration also references USP standards when overseeing outsourcing facilities that compound medications on a larger scale.
What the Standard Covers
USP 795 is organized around several core areas: personnel qualifications, facility and equipment requirements, cleaning and sanitizing schedules, documentation, quality assurance, and beyond-use dating (the compounding equivalent of an expiration date). Each area includes specific, measurable requirements rather than general guidance.
The chapter introduces the term “compounded nonsterile preparation,” abbreviated CNSP, as its standard terminology. Every requirement in the chapter ties back to ensuring each CNSP is consistently made with the correct identity, strength, quality, and purity.
Personnel Training Requirements
Everyone involved in non-sterile compounding must complete initial training before they begin compounding independently. That training covers topics like hand hygiene, proper use of equipment, cleaning procedures, and the specific compounding techniques the facility uses. After the initial training, ongoing refresher training is required at least every 12 months.
Competency evaluations go beyond simply completing a course. Staff must demonstrate that they can actually perform compounding tasks correctly, not just describe them. These evaluations happen during orientation, whenever a quality issue is identified, whenever poor technique is observed, and on a recurring schedule (at minimum annually). Facilities are expected to document all training and competency results.
Facility and Cleaning Standards
The compounding area must be designed to minimize contamination. USP 795 requires a designated space for non-sterile compounding that is separate from other pharmacy activities, with adequate lighting, ventilation, and temperature control. Certain hazardous drugs require additional engineering controls, like containment ventilated enclosures or biological safety cabinets.
Cleaning schedules are spelled out in detail. Work surfaces must be cleaned and sanitized at the beginning and end of each shift on days compounding occurs, and again between preparations that use different components. Floors require daily cleaning on compounding days. Walls and ceilings must be cleaned when visibly soiled. Storage shelving needs cleaning at least every three months. Any spill or suspected contamination triggers immediate cleaning regardless of the schedule.
Equipment has its own cleaning requirements. Ventilated enclosures and biological safety cabinets follow the same shift-based cleaning schedule as work surfaces, with an additional monthly deep clean under the work surface for safety cabinets. Other compounding devices must be cleaned before first use and then according to the manufacturer’s instructions, or between different preparations if no manufacturer guidance exists.
Beyond-Use Dating
One of the most practically significant parts of USP 795 is its framework for assigning beyond-use dates (BUDs) to compounded preparations. A BUD tells the patient or facility how long the preparation can be stored and still be expected to work as intended. Unlike manufacturer expiration dates, which are based on extensive stability testing, BUDs for compounded preparations are often more conservative because pharmacies rarely have access to the same level of testing.
USP 795 sets default BUD limits based on the type of preparation and whether the pharmacy has supporting stability data. Preparations made with water tend to get shorter BUDs because water promotes microbial growth and chemical degradation. If a pharmacy wants to assign a longer BUD than the default allows, it needs stability-indicating testing data to justify it.
Documentation and Quality Assurance
Every compounded preparation requires a master formulation record, essentially a recipe that includes the name and quantity of each ingredient, the equipment needed, mixing instructions, and the assigned BUD. Each time that preparation is made, a separate compounding record documents the specific lot numbers of ingredients used, who compounded it, and the date.
USP 795 also requires an ongoing quality assurance program. This means the facility must routinely review its processes, investigate any complaints or adverse events related to compounded preparations, and take corrective action when problems are identified. The goal is to catch errors before they reach patients and to continuously improve compounding practices.
How USP 795 Differs From USP 797
The two chapters are companions, not competitors. USP 795 covers non-sterile compounding (creams, capsules, oral liquids), while USP 797 covers sterile compounding (injectable drugs, eye drops, anything that must be free of microorganisms). Sterile compounding carries higher contamination risks, so USP 797 imposes stricter requirements for cleanroom environments, air quality testing, garbing procedures, and personnel competency evaluations at more frequent intervals.
If a pharmacy compounds both sterile and non-sterile preparations, it must comply with both chapters independently. The standards don’t overlap or substitute for each other.