Pharmaceuticals in Washington, D.C.

by Bryan Soltysik, Senior Healthcare Account Manager

As predictable as the sun rising each day, you can pretty much guarantee to see some form of commentary regarding pharmaceuticals in the news every day. Whether it is addressing trace amounts found in lakes or drinking water, another state adopting the federal exemption for nitroglycerine, an increase in vaccine production due to the recent outbreak of the Swine Flu, or a researcher discovers a cure for a common disease, pharmaceuticals are becoming a household name and conversation piece.

For those of us who are responsible for managing environmental compliance and hazardous waste in the healthcare industry, managing pharmaceutical waste is a high priority with unique challenges. Most hospitals by now recognize this and have at least begun to address the issue of how to collect hazardous waste within a patient care setting, however, federal and state requirements are often difficult to meet and training nursing staff can propose logistical problems as well as being very time consuming.

Keeping that in mind, it is important to understand the direction of proposed regulation in Washington that could impact how waste pharmaceuticals are managed. There are three pieces of legislation that should be monitored closely:

1. H.R. 1191 Safe Drug Disposal Act of 2009 - This proposed legislation is looking to amend the Controlled Substances Act to provide state take-back programs for the disposal of controlled substances for users and care takers. Additionally it would amend the Food & Drug and Cosmetic Act to prohibit manufactures from printing on labels the recommendation of "disposal by flushing". The legislation also creates freedom for the States to include drugs or other biological products that are not controlled substances (basically all other pharmaceuticals). The proposed bill also includes a definition of "care taker" to include a physician or other health care professional, veterinarian, long-term care facility, nursing home, hospital, jail, or school.

2. H.R. 1359 Secure and Responsible Drug Disposal Act 2009 - This proposed bill seeks to amend the Controlled Substances Act so that some of the current rules and guidelines for handling and disposal of controlled substances would be relaxed. The bill would allow non-registered entities to accept material for the sole purposes of disposal.

3. EPA's proposed amendment to the Universal Waste Rule: Addition of Pharmaceuticals - This proposed amendment would classify hazardous pharmaceutical waste as universal waste, therefore reducing some of the burdens of complying with the RCRA regulations. EPA does a great job in the proposed rule making of clarifying their intent; they even describe how this rule could facilitate the management of non-RCRA pharmaceutical wastes as universal wastes eliminating the need for facilities to identify the two steams separately. This would create a streamlined waste collection system that prevents pharmaceuticals from being flushed or thrown in the trash.

My last comment is simple; the healthcare industry historically has not done a good enough job on commenting on proposed hazardous waste management legislation, despite the fact it bears the burden of implementing such legislative changes into its compliance systems. The EPA and other regulators are eager for engagement; you have the opportunity to shape how these wastes are handled in the future at your facility, so now is the time to get involved.