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Press Release

ASHP Takes Steps to Ensure Sterile Preparation of Compounded Medicines

A new reference published by the American Society of Health-System Pharmacists (ASHP), in collaboration with Baxter Healthcare Corporation, will help health-system pharmacists meet new requirements for sterile preparation of compounded medications in accordance with provisions in the United States Pharmacopeia (USP) Chapter <797>, Pharmaceutical Compounding: Sterile Preparations. 

The USP Chapter <797> describes the procedures and requirements for compounding sterile preparations, which are enforceable by state boards of pharmacy and may be cited by Food and Drug Administration reviewers and accreditation surveyors from the Joint Commission on the Accreditation of Health Care Organizations.  The chapter’s requirements apply to all practice settings in which sterile preparations are compounded, including hospitals, ambulatory care clinics, home infusion pharmacies, and physicians’ offices. 

The ASHP Discussion Guide for Compounding Sterile Preparations includes a detailed summary of Chapter <797> provisions, highlights potential areas of concern for pharmacies, and emphasizes the dangers compounding errors pose to patients.  The publication also recommends ways pharmacists can begin implementing the requirements, including conducting a thorough evaluation of current practices and operational facilities and the use of product configurations such as unit-of-use closed transfer packaging. 

The discussion guide is part of ASHP’s ongoing commitment to medication safety.  The Society has published numerous guidelines and other reference materials to aid health-system pharmacists in improving the quality of compounded materials.  Three ASHP-published references, Principles of Compounding Sterile Preparations, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, and Sterile Product Preparation: A Multimedia Tool are being revised to include information on compliance with Chapter <797>. 

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, ambulatory care clinics, long-term care facilities, home care, and other components of health care systems.  ASHP, which has a long history of medication-error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medications.  Assisting pharmacists in fulfilling this mission is ASHP’s primary objective. The Society has extensive publishing and educational programs designed to help members improve their professional practice, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs.  For more information, visit or