What Is USP 795?
USP 795 is a standard that the United States Pharmacopoeia has created that establishes the rules for compounding nonsterile pharmaceutical preparations.
USP 795 addresses the process of altering or combining drugs to create nonsterile medications for human or animal use. It helps personnel learn how to assign beyond use dates as well as the criteria for stability. The types of dosage forms that apply to USP 795 include liquid oral, solid oral, vaginal and rectal preparations, otic and topical preparations, and local nasal sinus preparations.
Additionally, it addresses personal hygiene and garbing, including the need for the removal of any unnecessary outer garments, jewelry, watches, earbuds, and piercings before beginning. It shows how to practice good hand hygiene, including washing with soap for at least 30 seconds. It states that hand sanitizer is not a substitute.
USP 795 also goes into the need to wear gloves for every compounding activity and change them after each preparation. The standard speaks on wearing gowns, shoe covers, and glasses, too, stating that their requirement could be facility-specific.
Furthermore, it discusses cleaning frequency for work surfaces, ceilings, floors, and walls. Work surfaces must be cleaned at the start and end of each shift, after spills, between compounding preparations, and when contamination is suspected/known, while floors should be washed once a day or when there’s a spill or suspected contamination.
Storage shelves need cleaning every three months. If there has been contamination or any form of splashing from ingredients, you must clean the floors and walls.
What Is USP 797?
USP 797 is a standard set forth by the United States Pharmacopoeia that establishes the regulations for compounding sterile pharmaceuticals. There is a more significant focus on hygiene in this standard than in the nonsterile USP 795.
For USP 797, compounds are divided into low-risk, medium-risk, and high-risk, requiring more significant gowning processes and cleaning protocols than in USP 795.
USP 797 outlines the gowning process, beginning with shoe covers and continuing all the way to handwashing, putting your gown on, and gloving.
Putting on your gloves requires that you thoroughly cleanse your hands. You must use a pick and warm water to clean under your nails, followed by washing up to your elbows with soap for at least 30 seconds.
You must then rinse and dry your arms with a lint-free wipe. The next step is to use waterless alcohol on your hands, let them air dry, and place the gloves on, being sure not to touch the sterile outer parts.
There are also cleanroom changes from USP 795. USP 797 requires a separation of spaces for compounding non-hazardous drugs from hazardous drugs. You can find water column specifications to create the necessary pressure differentials.
Key Differences Between USP 795 & 797
When considering USP 795 vs. 797, one of the first things to remember is that 795 focuses on non-sterile compounding, while 797 addresses sterile compounding.
With 795, you can expect to learn how to prevent issues like variability in dosage and microbial growth, both of which assist in protecting patients using topical creams or oral liquids.
For USP 795 vs. 797, also remember that 797 offers much more stringent regulations for gowning, gloving, and maintaining a sterile work environment.
Under USP 795, the facility requirements for hazardous drugs or non-hazardous drugs are the same. USP 797, however, requires a vented laminar flow hood for hazardous drugs and other environmental controls.
The biggest difference in USP 795 vs. 797 is the full focus of the latter on maintaining a sterile environment. While 795 addresses the proper handling and storage of ingredients and assigning beyond-use dates, 797 zeroes in on environmental control, including the creation of a cleanroom.
How RxCe Supports Pharmacy Professionals in Adhering to Compounding Standards
Whether you’re a pharmacist or a pharmacy technician, you will also need to maintain your credentials and make yourself as competitive as possible. That is where RxCe comes in. Our team offers continuing education courses you can benefit from, including a non-sterile compounding certificate.
Pharmacists and pharmacy technicians receive the compounding education they need in intensive courses that combine video training on demand with live faculty interface over Zoom with our qualified pharmacist instructors.
These courses have been approved by the Accreditation Council for Pharmacy Education and offer the knowledge you need to enhance your skills and fulfill professional development requirements.
