Pharmacy Sterile Compounding Summit: Summary of a Stakeholder Meeting

The Pharmacy Sterile Compounding Summit was jointly convened by The Pew Charitable Trusts, the American Society of Health-System Pharmacists (ASHP), and the American Hospital Association (AHA) on February 6, 2013, in Washington, D.C. 

The goals of the summit were to:

• Characterize the spectrum of activities from traditional pharmacy sterile compounding to manufacturing.
• Identify the drivers of outsourced sterile compounding.
• Identify current gaps in regulatory oversight and recommend strategies to ensure the quality and safety of compounded sterile preparations.

Summit participants included representatives from health professional organizations, large and small health systems, companies providing compounded sterile preparations (CSPs), experts in compounding and manufacturing quality, group purchasing organizations and other collaboratives representing health systems, and the U.S. Centers for Disease Control and Prevention.

Representatives from the U.S. Food and Drug Administration (FDA), a state board of pharmacy, and an organization representing member state boards of pharmacy also participated in portions of the meeting.

Areas of Consensus

Outcomes of the Pharmacy Sterile Compounding Summit included the development of initial recommendations and participant agreement to continue collaborating to address safety concerns associated with sterile compounding.

Informed by these discussions, Pew, ASHP and AHA offer the following recommendations:

• Clarify the role of federal and state bodies with oversight of sterile compounding, with an emphasis on developing clear and consistent processes that will ensure the safety of CSPs regardless of origin.
• Strengthen federal oversight of activities that are not currently overseen as traditional pharmacy compounding by states and that represent a higher degree of patient safety risk based on factors such as product volume, risk category of CSPs, whether a patient-specific prescription is received, and breadth of distribution.
• Better define and standardize licensing categories for patient care sites, companies, and other entities involved in sterile compounding activities.
• Explore development of a set of standards that combine key precepts or concepts from two distinct quality specifications—the United States Pharmacopeial Convention Chapter <797>¹ Pharmaceutical Compounding: Sterile Preparations (USP <797>) and current Good Manufacturing Practices (cGMPs)²—that could be used to facilitate oversight of large-scale sterile compounding activities while also recognizing that these standards were intended for separate purposes.
• Standardize training of pharmacy inspectors, survey processes, and assessment tools.

Other areas that the stakeholders noted for further investigation and potential action are:

• Describing the universe of compounding pharmacies, including quantifying the market.
• Providing education and other resources to improve the training and competence of personnel involved in sterile compounding activities.
• Fostering the development and uptake of robust beyond-use dating, including evidence-based studies that provide extended stability and sterility information. In addition, expanding the use and quality of laboratory testing, when appropriate.
• Increasing collaboration among professional associations representing health care providers, with the goal of providing education and other information that will result in decreased demand for CSPs by reducing variation among prescriber-requested medications and increasing the standardization of medication orders, when appropriate.

¹ The United States Pharmacopeial Convention is a nongovernmental standards-setting authority for medicines manufactured or sold in the United

States. USP <797> is a quality standard for sterile compounding by pharmacies.

² Current Good Manufacturing Practices are regulations for drug manufacturers that describe the methods, equipment, facilities, and controls

required for producing safe products.