This fall, the Environmental Protection Agency (EPA) has proposed a new rule for the regulation of pharmaceuticals as hazardous waste under the Resource Conservation and Recovery Act (RCRA) [42 U.S.C. § 6901 et. seq. (1976)]. On September 25, 2015, EPA published the proposed Management Standards for Hazardous Waste Pharmaceuticals Rule, in the Federal Register for comment. The comment period has been extended to December 24, 2015.

Hospitals, pharmacies, residential care facilities, veterinary clinics, dental offices, schools and households all dispose of medications that may be regulated under RCRA. RCRA identifies certain hazardous wastes by identifying them in the RCRA Listed Waste group, and others by evaluating 4 characteristics: ignitability, corrosivity, reactivity and toxicity. Included within the Listed Waste are chemotherapy drugs such as arsenic trioxide, allergy drugs such as epinephrine, and cholesterol testing drugs such as acetyl chloride. Thus, EpiPens are listed under the RCRA as being hazardous or acutely hazardous.

Regulating pharmaceuticals in the health care industry has presented a challenged to EPA. Opponents have criticized the RCRA rules in this industry as it required health care workers to learn how to recognize hazardous pharmaceuticals, and then to correctly dispose of them. Critics say such requirements divert attention from the care of patients to RCRA compliance issues.

In 2008, the Environmental Protection Agency (EPA) proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes. However, there were many concerns with the proposed rule. First, the rule lacked adequate notification requirements for facilities that routinely dispose of pharmaceutical waste. Next, there was a lack of tracking requirements for shipment of these wastes. Also, critics worried that the rule would have effectively given generators the discretion to treat hazardous pharmaceuticals as non-hazardous waste. The 2008 rule was never adopted. Instead, the EPA decided to develop a new proposal for addressing the issue of pharmaceutical waste management.

The 2015 proposed pharmaceutical rule is focused on the management of hazardous waste pharmaceuticals by health care facilities, including pharmacies and reverse distributors, and is tailored for the health care sector. The rule regulates those pharmaceutical wastes that meet the RCRA definition of a hazardous waste and are generated by health-care related facilities. EPA is promoting the proposed rule as addressing the notification and tracking deficiencies raised by comments to the 2008 rule. The proposal will not define pharmaceutical waste as Universal Wastes. Until the rule is finalized, pharmaceutical waste will continued to be governed by Subtitle C of RCRA. Currently, health care industries can manage their waste through take-program programs, reverse distribution, or other programs that send unused, damaged or mishandled medications back to the manufacturer.

Philadelphia Environmental Compliance Lawyers at Michelman & Bricker, P.C. Provide Counsel Regarding Changing Pharmaceutical Waste Regulations

Medical practices need to be aware that their activities often trigger state and federal environmental laws. Health care facilities, including pharmacies and reverse distributors, are affected by state and federal environmental rules and regulations, including the proposed rule governing hazardous pharmaceutical waste. For example, health care facilities using x-ray machines are subject to the regulations under the Pennsylvania Department of Environmental Protection’s Bureau of Radiation Protection. The experienced Philadelphia environmental lawyers at Michelman & Bricker, P.C. stay abreast of proposed changes in the law and can ensure that you are in full compliance with the most recent EPA requirements.

We have represented clients with a variety of different RCRA issues. For example, we have previously represented chemical exporter in a criminal investigation into whether chemicals shipped overseas (that leaked in port, causing one million Euros of damage) were legally shipped as salable product or were actually waste that was improperly exported without a permit for disposal.

With offices located in Philadelphia, Pennsylvania; Cherry Hill, New Jersey; and Longmeadow, Massachusetts, we represent health care facilities in Harrisburg, Cherry Hill, Philadelphia and Camden County. Call us at 215-557-9440 or contact us online today.