E-DRUG: Guidelines on pharmaceutical waste disposal (5)
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Dear Manusika Rai,
There are significant problems finding national or international guidelines that provide effective "road maps" for real actions to take in handling waste management. There are reasons for this:
1. Responsible management of waste includes oversight at the stages of drug manufacturing (API and finished dosage form) as well as consumption (hospital and home settings). So this raises a response question -- what are your areas of interest in managing pharmaceutical waste?
2. Regulatory agencies for medicines most often default to national programs responsible for environmental health and safety to establish guidelines for waste disposal and worker exposure. So the US FDA (for instance) defaults this responsibility to the Environmental Protection Agency for worker exposure and disposal of waste from chemical manufacturing. Environmental Health and Safety (EHS) is a responsibility of the EPA.
3. Chemical waste from manufacturing usually falls into categories of solid or liquid/aqueous waste streams. Solid waste can be incinerated or put into landfills, depending upon the degree of concern. Liquid chemical wastes (distinguished from aqueous waste streams) are most often either recycled (if possible) or incinerated in a manner demonstrated to destroy hazardous contents. Aqueous waste must usually be treated, and treatment methods are developed so as to demonstrate adequate destruction of drug-related hazards contained.
4. The most common way of dealing with manufacturing is to have the company provide an assessment of their waste generation and disposal plans for review. But this is done most thoroughly when the manufacturer is the "originator" for drugs. However, generic manufacturers in India nowadays must have treatment plans for their waste streams in place, along with assessments of their effectiveness.
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Joseph M. Fortunak
Associate Professor
Chemistry and Pharmaceutical Sciences
Howard University
Washington, DC 20059 USA
+1 202 806 6880 (office)
+1 301 928 7568 (mobile)
jfortunak@comcast.net