Sterile Compounding Resource Center

Pharmacists have a crucial role in providing extemporaneously compounded sterile preparations (CSP's) to patients and for ensuring the sterility, safety, and efficacy of these preparations. In recent years, there have been isolated published reports of patient injury and death related to improperly compounded CSP's. These reports have prompted state, federal, and professional organizations to examine the adequacy of the current framework of standards pertaining to CSP's.

Over the past decade, infusion pharmacies have used a wide range of resources to guide the preparation of CSP's, including professional practice guidelines published by the American Society of Health-System Pharmacists (ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products) and the United States Pharmacopeia (USP<1206>, "Sterile Drug Products for Home Use,"); national accreditation standards of the Joint Commission on Accreditation of Healthcare Organizations, the Accreditation Commission for Healthcare, and the Community Health Accreditation Program; and, where applicable, state laws governing pharmacy practice.

Because of an increasing focus on medication safety, especially in the case of sterile preparations, an increasing number of state boards of pharmacy have adopted specific standards and licensure requirements for pharmacies that compound sterile preparations. The National Association of Boards of Pharmacy Model Act, designed to guide the development of state board of pharmacy laws and regulation with public interest as the central precept, promotes the inclusion of Model Rules for Sterile Pharmaceuticals in state pharmacy practice Act. Visit the NABP website to download these model rules; click on "pharmacy law" and then "publications" to access the free download.

Simultaneously, efforts are occurring on a federal level to strengthen the regulatory infrastructure related to the compounding of sterile preparations, including but not limited to parenteral (IV and other non-oral) preparations.

Tools and Resources

United States Pharmacopeia (USP) Chapter <797> Compounding Sterile Preparations

Educational Resources on USP Chapter <797> Compliance

Educational Resources on Sterile Compounding

Sterile Compounding in the News

State Boards of Pharmacy

Accreditation Issues

ACHC Announces Position on USP <797>

Pharmacy Compounding Accreditation Board

Other Information