ChemoGLO™, LLC  
96 Mountain Laurel  
Chapel Hill, NC 27517  
(877) 215-2705  

regulatory compliance

USP 797 states the following:
Occupational exposure to hazardous drugs can result in (1) acute effects (such as skin rashes); (2) chronic effects (including adverse reproductive events); and (3) possibly cancer.

Hazardous drugs shall only be prepared for administration under conditions that protect the healthcare workers and other personnel in the preparation and administration area; hazardous drugs shall be handled with caution using appropriate chemotherapy gloves during distribution, receiving, stocking, inventorying, preparing for administration, and disposal.

Ongoing quality assurance shall be an integral part of hazardous drug preparation. In order to assure containment, especially in operations preparing large volumes of hazardous drugs, environmental sampling to detect uncontained hazardous drugs needs to be performed routinely( e.g., initially as a benchmark and at least every 6 months). This sampling shall include surface wipe sampling of the working area of Biological Safety Cabinet (BSC) and Compounding Aseptic Containment Isolator (CACI), counter tops where finished preparations are placed, areas adjacent to BSC and CAI, including the floor directly under the working area, and patient administration areas.

Common marker hazardous drugs that can be assayed include 5-Fluorouracil, ifosfamide, cyclophosphamide, paclitaxel, docetaxel, methotrexate, platinum analogues, busulphan, etoposide, cytarabine, doxorubicin, daunorubicin, and vincristine. If any measurable contamination (e.g., cyclophosphamide level greater than 1.00 ng/cm2 has been found to cause human uptake) is found by any of these quality assurance procedures, practitioners shall make the decision to identify, document, and contain the cause of contamination. Such action may include retraining, thorough cleaning, and improving engineering controls.

Reference: USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations. United States Pharmacopeial Convention; 2008: 13-15

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