Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has collaborated with industry leaders to develop a consensus statement on the handling of hazardous drugs per USP Chapter guidelines.
Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has collaborated with industry leaders to develop a consensus statement on the handling of hazardous drugs per USP Chapter 800 guidelines. PCAB joined with the International Academy of Compounding Pharmacists (IACP) to create a Hazardous Drug Consensus Group (HDCG) last year. A number of experts with extensive experience in the handling of hazardous drugs (HDs) from a wide range of backgrounds participated in the effort.
This group was charged with the development of a Hazardous Drug Consensus Statement (HDCS) to:
- Create concise summaries of key topics concerning HDs that are based on the knowledge and expertise of the HDCG members listed below.
- Provide concrete best practice recommendations (BPRs)
- Help the reader understand what is REQUIRED by 800 (“MUSTs”) versus what is only SUGGESTED (“SHOULDs”). (Such items are always presented in caps.)
- Point out those aspects of 800 most likely to require the most significant changes and/or cost.
- Ask (and answer) key questions that have generated significant interest.
- Use tables and graphics when helpful to simplify and summarize information.
Authors of the documents include L. Rad Dillon, Joe Cabaleiro, Stanley N. Chamallas, David J. Miller, Bill Mixon, Barbara Petroff, Bryan Prince, Jon Pritchett, Marc Stranz, and Bruce E. Vinson, as well as supporting contributors Felicia Schaps, Krystina Ashe, and Tom Tucker.
“PCAB is aware that pharmacies remain unclear on the interpretation of many aspects of the USP 800 chapter,” said Jon Pritchett, Pharm.D., RPh. “I believe the consensus statement will help pharmacies better understand the guidelines. PCAB is evaluating the implication of USP 800 on our accreditation standards and is working towards a solution that recognizes the accomplishment of pharmacies that choose to become USP 800 compliant in the near term without imposing those requirements on pharmacies that choose a longer timetable for implementation.”
The 100+ page HDCS document with risk assessment templates and a USP 800 Preparation Checklist may be downloaded free of charge from the USP Compliance section of the Compounding Today website: CompoundingToday.com.
With a broad and extensive array of pharmacy compliance solutions, including programs for sterile and non-sterile compounding, infusion, specialty, and long term care pharmacy services, ACHC is positioned to be the solution of choice for the industry. Beginning July 2014, PCAB became a service of ACHC, offering programs for non-sterile (ref. USP 795) and sterile (ref. USP 797) compounding services. PCAB assesses the compounding process based on a specific set of standards that concentrate on the quality and consistency of compounded medications while incorporating performance improvement and ongoing compliance requirements. AIS Inspections provide a customizable compliance solution for boards of pharmacy, including a thorough review of compounding practices as they relate to USP 795 and USP 797.
ACHC is a non-profit organization that has stood as a symbol of quality and excellence since 1986. ACHC is the provider’s choice for compliance solutions because of its personal Account Advisors, relevant and realistic standards, competitive pricing, and a friendly, consultative approach to accreditation. PCAB Accreditation reflects an organization’s dedication and commitment to meeting standards that facilitate a higher level of performance and patient care.