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Pharmaceutical Compounding


Resources for Pharmacy Compounding, Sterile Drug Preparation, and Hazardous Drug Preparation

Over a decade ago, the United States Pharmacopeia issued Chapter 797 "Pharmaceutical Compounding – Sterile Preparations" (USP <797>), which provides the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. With the addition of USP <800> "Hazardous Drugs – Handling in Healthcare Settings," this resource center has been prepared to help you stay current on the latest issues about aseptic preparation of parenteral hazardous and non-hazardous drug products.

Pharmaceutical Compounding

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Isolator Performance Test

Baker Compounding Isolators and USP Requirements

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General Information

CETA Applications Guides

Covering topics from pharmaceutical compounding to general biosafety cabinet information, these guides are available to CETA members as a free download and to others for a nominal fee. 

Hazardous Drug Preparation

Free Webinar: USP <800> Impact to Engineering Controls

Learn how USP <800> will impact primary and secondary engineering controls (e.g., biological safety cabinets, clean rooms, etc.). The webinar is intended to inform facilities that need to implement the new standards.

Frequently Asked Questions about USP <800>

Answers to questions from attendees of the above webinar for the benefit of all who are preparing to implement the proposed USP <800> guidelines.

ASHP Guidelines on Handling Hazardous Drugs

Includes information from the recommendations issued in the 2004 NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazarous Drugs in Health Care Setting.

2004 NIOSH Alert

View the NIOSH publication Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Setting and other information from the CDC.

Safe Handling of Hazardous Drugs: Reviewing Standards for Work Protection

Article published in March 2011 in Pharmacy Practice News by Luci A Power, MS, RPh and Martha Polovich, PhD, RN, AOCN.

OSHA.gov

Overview of OSHA standards and standard interpretations for handling hazardous drugs. Also includes state standards related to hazardous drugs.

Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States.

This study provides evidence from a sample of facilities indicating that antineoplastic agents were detected on surfaces in pharmacy drug preparation and administration areas in cancer treatment centers, and includes a brief overview of the potential risks of exposure. 

Compounded Sterile Preparation

USP797.org

A full website developed to aid your understanding of the USP <797> regulation and its JCAHO-mandated schedule for implementation. Includes articles, consulting information, and a Q & A section.

USP <797> Blog

A blog focused exclusively on USP <797> topics.

Wenzel R. Edmond M; The Impact of Hospital-Acquired Bloodstream Infections: Emerging Infectious Diseases, Vol. 7 No. 2, March-April 2001

This report assesses the scope and cost of bloodstream infections in the hospital, underscoring the importance of maintaining sterile conditions during preparation.

Guidelines and Standards for Laboratory Safety & Hazardous Drug Preparation

The 2012 USP <797> Compliance Survey: Measuring Progress

Report of a study done by Kate Douglass, Eric S. Kastango, MBA, RPh, and Peter Cantor that show current compliance with USP <797>. Published in Pharmacy Purchasing & Products in October 2012.

Barrier Isolator and Glovebox Technology

Cazin JL, Gosselin P; Implementing a Multiple-isolator Unit for Centralized Preparation of Cytotoxic Drugs in a Cancer Center Pharmacy; Pharm World Sci 1999 Aug;21(4):177-83

Another case study, this article details the selection process of equipment for an area within the pharmacy for the preparation of cytotoxic drugs. In addition to explaining the reasons for use of barrier isolators, this article also underscores the importance of a safety and quality standards.

Explore Baker’s Pharmacy Isolator Products

Tillet, L; Barrier Isolators as an Alternative to a Cleanroom; Am J Health Syst Pharm 1999 Jul 15;56(14):1433-6

This case study uses barrier isolators to insure sterility and containment in the preparation of cytotoxic and other hazardous agents. Relative to a cleanroom, the analysis found a reduction in costs attributable to reduced gown and glove use.

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