From the Guidelines
The USP guidelines for compounding medications are primarily outlined in chapters <795> for non-sterile compounding, <797> for sterile compounding, and <800> for hazardous drugs, which establish comprehensive standards for safety, quality, and consistency in compounded preparations. These guidelines emphasize the importance of proper training and competency assessment for all personnel involved in compounding, including registered nurses, licensed practical nurses, medical technicians, medical assistants, physician assistants, advanced practice nurses, and physicians, as highlighted in the updated guidelines following the publication of the practice parameter second update 1. Key aspects of the USP guidelines include:
- Proper facilities with designated clean areas and specific environmental monitoring
- Standardized procedures for ingredient selection, beyond-use dating, quality assurance testing, and documentation
- Requirements for equipment calibration, cleaning, and maintenance
- Stringent requirements for sterile compounding, including classified clean rooms and regular environmental monitoring, as outlined in USP <797>
- Additional safeguards for handling hazardous drugs to protect patients and healthcare workers, as specified in USP <800>
- The physician's responsibility for providing general oversight and supervision of compounding, ensuring that compounding personnel are appropriately trained health professionals 1. By adhering to these guidelines, compounders can ensure the safety, quality, and consistency of compounded medications, ultimately protecting patient health and preventing potential harm.
From the Research
USP Guidelines for Compounding Medications
The United States Pharmacopeia (USP) provides guidelines for compounding medications to ensure their quality, safety, and efficacy. The guidelines are outlined in various chapters, including:
- USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations (CSP) [ 2, 3,4,5 ], which sets standards for the preparation, storage, and dispensing of sterile preparations.
- USP Chapter <795>, which provides guidelines for non-sterile compounding 4.
- USP Chapter <800>, which provides guidelines for hazardous drug handling 4.
Key Requirements
The USP guidelines require compounding pharmacists to follow good preparation procedures, similar to those required for pharmaceutical manufacturers 6. The guidelines also emphasize the importance of building quality into the compounding process to ensure that the resultant compounded prescription meets the patient's requirements 6.
Regulation and Oversight
State boards of pharmacy are responsible for regulating and overseeing compounding practices, and most boards incorporate USP guidelines into their regulations 4. The USP guidelines are considered the standard for sterile compounding practice and safety in the United States 2.
Patient Safety
The USP guidelines are designed to protect patients by requiring best practices and quality standards for the safe preparation and handling of compounded sterile preparations 5. Pharmacists should understand and comply with federal, state, and USP requirements when preparing compounded sterile preparations, particularly high-risk level preparations 5.