Compliance with New USP-NF Chapter on Compounding Sterile Preparations

JCAHO Requirement

Manual: AMCAH
Effective Date: immediately

Joint Commission to Survey Compliance with New USP-NF Chapter on Compounding Sterile Preparations

Effective immediately, the Joint Commission is surveying compliance with a new chapter in the 2004 United States Pharmacopeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This new chapter deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations. The requirement extends to any health care practitioner involved in the preparation and compounding of sterile products and goes beyond the pharmacy to address compounding and preparation by nurses and physicians in patient care areas of the organization. This will impact hospitals, including critical access hospitals, and can impact ambulatory care, behavioral health care, home care, and long term care organizations in which medications are prepared.

“The new requirements match extremely well with our 2004 standards, but are more detailed,” explains Darryl Rich, Pharm.D., associate director for surveyor management and development at the Joint Commission. “Compliance with the USP-NF Chapter 797 will certainly help organizations comply with our standards in the area of sterile medication preparation and infection control.”
The Federal Food, Drug and Cosmetic Act recognizes the USP-NF as an “official compendia” of drug standards. Under the act, if a drug product that appears in the USP-NF fails to meet the standards for strength, quality, purity, preparing, packaging, or labeling contained in the USP-NF, the drug may be deemed “misbranded” or “adulterated” by the Food and Drug Administration under the act. USP-NF standards in the chapter on compounding sterile preparations contain requirements related to product standards and additional good pharmacy practices. As such, the Joint Commission requires compliance with them.

The new USP-NF chapter addresses the following issues:
* Responsibilities of all compounding personnel
* Classification of IV products into three risk levels, with quality assurance practices specific to each
* Verification of compounding accuracy and sterilization
* Personnel training and competence assessment in aseptic manipulation skills
* Environmental quality and control
* Equipment used in the preparation of compounded sterile products
* Verification of automated compounding devices for parenteral nutrition
* Finished product release checks and tests
* Storage and beyond-use (expiration) dating
* Maintaining product quality and control once the product leaves the compounding facility
* Packing, handling, storage, and transport of compounded sterile products
* Patient or caregiver training
* Patient monitoring and adverse events reporting
* A quality assurance program for compounded sterile products
Starting July 1, 2004, Joint Commission surveyors will address these requirements during surveys of organizations that compound sterile products (for example, intravenous solutions, eye drops) in the following ways:
* Surveyors will help organizations become aware of these new requirements (if unaware)
* While USP-NF Chapter 797 is not the focus of surveyors during an on-site survey, noncompliance with the major requirements in this USP-NF chapter that relate to Joint Commission standards will be scored at the appropriate element of performance effective immediately using the appropriate track record for compliance with the new requirements. Since the requirements were first released by the USP in November 2003, implementation of plans of action to comply with them will be considered an acceptable approach in 2004 towards meeting the requirements.

To comply with these requirements, organizations should immediately evaluate their current practices in the light of the new USP-NF chapter and make appropriate changes. Based on a national survey in 2003, only 5.2% of hospitals were in compliance with similar guidelines.

Copyright 2004 by the Joint Commission on Accreditation of Healthcare Organizations

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