USP <795/797/800/825>

The USP Compounding Guidelines

USP General Chapters for Compounding

United States Pharmacopeia (USP) is a scientific, non-profit organization that sets public standards for the identity, strength, quality and purity of medicines. The organization develops standards for compounding medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

Relevant USP General Chapters include:

<795> Pharmaceutical Compounding — Nonsterile Preparations
<797> Pharmaceutical Compounding — Sterile Preparations
<800> Hazardous Drugs — Handling in Healthcare Settings
<825> Radiopharmaceuticals — Preparation, Compounding, Dispensing and Repackaging

The Importance of USP Standards

In the health industry, ensuring that every relevant facility is in compliance with the compounding standards is of utmost importance. If the standards are compromised in any way, the consequences could be detrimental to patients and/or healthcare professionals. That is why clearly understanding the standards as they are enacted is so important to ensure that your business meets all government standards.

USP <797> sets standards for the compounding of sterile preparations and protects the sterility of the drug. USP <800> provides standards for the safe handling of hazardous drugs and is focused on the safety of those who come in contact with them.

Together, USP <797/800> establish an environment for compounding drugs that reduces the risk of contamination in the drugs themselves while striving to increase safety for healthcare personnel, patients and the environment.

About USP Chapter <797>

The goal of USP Chapter <797> is to prevent potential patient harm or death that could result from:

Microbial contamination
Excessive bacteria endotoxins
Significant content errors in the strength of correct ingredients
Incorrect ingredients

USP <797> cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. The positive pressure ensures that the space maintains sterility if a barrier is breached.

About USP Chapter <800>

The intent of USP <800> is to minimize the risk of exposure and protect personnel and the environment during the handling of hazardous drugs. This includes, but is not limited to, the receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing and otherwise altering, counting, crushing or pouring hazardous drugs, and includes both sterile and non-sterile products and preparations.

USP <800> applies to all personnel who compound hazardous drugs and all the places in which they are handled, including pharmacies, hospitals, physicians’ offices, patient clinics, veterinarians’ offices and all other locations where hazardous drugs are stored, transported and administered.

USP <797/800> Upgrades

Updating a facility so that it is appropriate for the handling of sterile compounded preparations (CSP’s) means that the facility must be designed and built to the rigorous requirements of USP <797> for non-hazardous drugs, and USP <797/800> for hazardous drugs. To accomplish this, you need the assistance of an experienced, knowledgeable consulting firm specializing in critical environments. CEPro is that firm — and we have extensive experience in supporting the design and construction of USP <797/800> compliance upgrade projects.

CEPro Value-Added Services

Our USP <795/797/800/825> environmental quality and control services include:

Gap analysis of current operations to new compliance standards
Specialty general contracting — plan, design, budget, build, commission, certification
USP compliance certification
Compounding area — cleanroom and equipment testing, certification standardized services
Compounding area certification and equipment failure remediation
Media fill testing and initial/ongoing gloved fingertip testing and consulting
The Joint Commission accreditation and survey preparedness