PCAB Collaborates on Consensus Statement on Handling of Hazardous Drugs per USP Chapter

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.

Safety issues at compounding pharmacy underscore oversight problems

In March FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by the Texas compounder IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but IV Specialty refused an agency recommendation to halt production or issue a recall until the problems were fixed. FDA, which is not aware of any adverse events attributed to the drugs, lacks authority to force the compounder to take these steps. Meanwhile, though, the medicines, which are injected or infused, remain available. In early April, the consumer advocacy group Public Citizen urged the Texas State Board of Pharmacy to suspend the compounder’s license. However, the Texas State Board of Pharmacy is declining to do so. In response to the FDA actions, the state agency sent its own inspector to review IV Specialty facilities. But “our inspector was comfortable that there wasn’t an immediate danger to the public,” said Gay Dodson, the board’s executive director. “According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down.” The incident underscores the unsettled approach to government oversight of compounders.
STAT News (04/08/16) Silverman, Ed
See More At: http://www.pharmacist.com/safety-issues-compounding-pharmacy-underscore-oversight-problems

Two Pharmacy Rules to Prevent Drug Contamination in 2016

Since the passage of the Affordable Care Act, the healthcare industry has introduced a number of regulatory changes to improve patient care. In the past year, following a string of deadly compounding errors, such as a New England meningitis outbreak that resulted in 64 patient deaths, many such changes have focused on standardized guidelines for handling, preparing, and storing drugs in a hospital environment. Two rules in particular, USP <797> and USP <800>, published by the U.S. Pharmacopeial Convention (USP), focus on preventing contamination and will require the attention of patient safety experts in 2016.

Safe handling of hazardous drugs: USP publishes new chapter <800>

A new general chapter from the U.S. Pharmacopeial Convention (USP) will do more to ensure hazardous drugs are handled properly.

Handling Hazardous Drugs: USP in Pharmacy Practice

Recently, the US Pharmacopeial Convention (USP) proposed a new General Chapter 800: “Hazardous Drugs: Handling in the Healthcare Settings.” There has been mixed reaction to this proposal across the profession. We will see what the compounding expert committee recommends, but the controversy provides an opportunity to reflect on the role of USP in pharmacy practice.

USP’s The Pharmacopoeia of the United States was first published in 1820. In 1975, USP acquired the National Formulary from the American Pharmaceutical Association, and merged it and Pharmacopoeia into a single publication containing official substances and preparation monographs. USP’s activities have changed greatly since then, but the importance of USP to pharmacy practice is still significant.

Setting preparation standards and providing reference material continue to be important, as reflected in the USP mission statement. USP has attempted a number of ventures that help demonstrate its value to pharmacy practice, including medication error prevention, providing drug information, and setting pharmacy practice standards.

Although USP has an impressive headquarters building and staff in the Washington, DC area, much of its accomplishments are due to its volunteers, who serve as delegates to the USP convention. As with medical organizations, all state pharmacy associations and schools of pharmacy are eligible to send a convention delegate, providing a unique forum for medicine and pharmacy to interact—the value of which many pharmacists may not appreciate. The expert panels primarily use volunteers to accomplish their work, too.

USP 800/Containment Segregated Compounding Area Products


USP 800 also known as USP Chapter <800> will update the current USP 797 regulations regarding the handling of hazardous drugs in compounding pharmacies, hospital pharmacies and medical centers. These new regulations and guidelines will offer more protection to pharmacists and workers to ensure safe handling of chemotherapy and other hazardous drugs. USP 800 compliance as well as USP 797 compliance is our specialty here at Aseptic Enclosures. We work with industry leaders in the pharmaceutical compounding world to make sure we are carrying the best cleanroom, isolator supplies and personal protective equipments.     Compounding Aseptic Isolator (CAI)/C-PEC an  isolator specifically designed for Aseptic preperations and USP 797 compliant Hospital Pharmacy compounding pharmaceutical ingredients or preparations.   It will  maintain an aseptic environment within the isolator throughout the compounding and material transfer processes.  Typically our isolators run at ISO CLASS 4/ASTM CLASS10 during working conditions. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter.  Please note:  This equipment provides product protection only.  Call, email or chat to get more details. Compounding Aseptic Containment Isolator (CACI)/C-PEC USP 797 compliant, hospital pharmacist protection from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer processes. They provide an superior aseptic environment for compounding sterile preparations.  Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.  Call, email or chat to get more details.