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"USP <800> HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS" was published over a year ago. While its effective date of July 1, 2018 is still over a year in the future, many pharmacies and other "entities" are raising unprecedented numbers of questions concerning the Chapter, how to interpret it, and where to obtain additional guidance.
In an effort to meet this need, a Hazardous Drug Consensus Group (HDCG) was formed last year. A joint effort of the Accreditation Commission for Health Care/Pharmacy Compounding Accreditation Board (ACHC/PCAB) and the International Academy of Compounding Pharmacists (IACP), it consists of a number of experts with extensive experience in the handling of hazardous drugs (HDs) from a wide range of backgrounds.
This group was charged with the development of a Hazardous Drug Consensus Statement (HDCS) that will:
- Not simply rehash <800>, but create concise summaries of key topics concerning HDs based on all a set of relevant sources listed below, and the knowledge and experiences of HDCG members.
- Provide concrete best practice recommendations (BPRs) when these sources described below do not provide adequate or concise guidance.
- 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) some key questions that are likely on the minds of many.
- 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, and supporting contributors, Felicia Schaps, Krystina Ashe, and Tom Tucker.
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.
There are actually two documents that make up the HDCS and include:
1. HDCS Consensus Statement
2. Risk Assessment Templates
To obtain a FREE copy of the USP <800> Hazardous Drug Consensus Statement (HDCS):
Go to CompoundingToday.com website; then
- On the left column about half way down, select USP Compliance.
- Fill in the:
- Email address
- First Name
- Last Name
- Company/Organization
- Click "Submit" and a link for the free HDCS will be sent to you for the free download.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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