I would like information about handling materials that may fall into the "hazardous" category.
Although a pharmacist's professional judgment generally is a reliable guide for handling these materials, the following references may be useful in the decision-making process.
First, US Pharmacopoeia 30 <795> and <797> are essential guides for nonsterile and aseptic extemporaneous compounding, respectively. Maintaining a file of current Material Safety Data Sheets for each pharmaceutical ingredient and excipient carried in stock can be accomplished in a variety of ways, including on-line. A certificate of analysis must be obtained for each specific container or lot of material received.
The Hazard Analysis Critical Control Point system was developed by the National Aeronautics and Space Administration and Pillsbury Foods to ensure food safety for the first human space missions. It has been applied to the food and pharmaceutical industries since 1971. It focuses on problem prevention in critical areas and can increase cost-effectiveness when used appropriately. Documentation is, of course, central to the process.
The Occupational Safety and Health Administration (OSHA) Web site has much to say about the presence of hazardous materials in the workplace. Title 29CFR1910, Subpart Z, especially 29CFR1910.1200, is helpful. Remember, for example, that when a container of powder is opened, the "puff" of material escaping can float throughout the pharmacy. Everyone, including staff and customers, can be exposed to it. Usually, the material is not hazardous (as to 1910.1200). Containment, gowning, gloving, eye protection, and masking or respirator application generally will reduce exposure levels to OSHA standards. The Web site is particularly useful for its definitions of "hazardous" materialnot all materials one might ordinarily consider hazardous fall into this area, and the opposite also is true.
A separate compounding area with filtered ventilation and perhaps isolated exhaust can be desirable. Of course, a suitable clean room is required when compounding aseptically.
The American Society of Health-System Pharmacists' and OSHA's technical bulletins and policies complement each other. See, for example, the OSHA bulletin on preventing exposure to hazardous drugs in the workplace at http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
E-mail your compounding questions to firstname.lastname@example.org
Mr. Erickson is director of professional affairs at Gallipot Inc.