As we anticipated in our September 2, 2015, client update, the U.S. Environmental Protection Agency (EPA) has published a proposed rule for managing hazardous waste pharmaceuticals—80 Fed. Reg. 58014 (Sept. 25, 2015). The rule, if finalized in its current form, will have broad-ranging impacts on many businesses and organizations in the health care industry.
Parties who would like to submit written comments on the proposed rule have only 60-days from publication of the proposed rule (until November 24, 2015) to submit those comments. As such, the clock is nearing midnight for interested parties to provide input on this proposed new rule. The rule would add to the federal hazardous waste regulations developed under the Resource Conservation and Restoration Act, known as “RCRA.” Briefly, in this proposed rule—which has been under development since 2008—the EPA is proposing a sector-specific approach to regulating hazardous waste pharmaceuticals. Specifically, the EPA has proposed new regulations, to be codified at 40 CFR Part 266, Subpart O.
Who could be covered—and therefore who should review the proposed regulations and potentially file comments?
The scope of the proposed rule is very broad, for several reasons.
First, the definition of a regulated "healthcare facility" is expansive. The definition includes any person that provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of a human or animal body; or (2) sells or dispenses over-the-counter or prescription pharmaceuticals. The categories of covered entities include:
- Hospitals, ambulatory surgical centers, and psychiatric hospitals;
- retailers of over-the-counter medicines and dietary supplements;
- physicians offices, optical and dental offices, and chiropractors;
- outpatient care centers, ambulatory health care services;
- facilities engaged in nursing care, including assisted living facilities, nursing homes, and U.S. Veterans homes;
- veterinary clinics, and
- pharmaceutical reverse distributors.
A second reason why the reach of the proposed rule is so broad is because the EPA’s proposed definition of "pharmaceutical" is itself very broad, applying to medications in all dose forms, including tablets, capsules, medicinal gums or lozenges, medicinal liquids, ointments and lotions, intravenous (IV), or other compounded solutions, chemotherapy pharmaceuticals, vaccines, allergenics, medicinal shampoos, antiseptics, and any delivery system—including skin patches—whose primary purpose is to deliver or dispense the pharmaceutical. The EPA notes that as a rule of thumb, if an over-the-counter product is required by the FDA to include “Drug Facts” on the label, it is a pharmaceutical for the purposes of this hazardous waste rule.
The EPA also includes dietary supplements within the definition of pharmaceuticals, which results in numerous retail stores being brought into the universe of these regulations.
Importantly, the proposed definition of a pharmaceutical includes numerous wastes that contain trace pharmaceuticals, including unit dose packages, personal protective clothing contaminated with medications, spilled materials, and IV bags. These types of wastes are commonly generated at long-term care facilities such as nursing homes. Under the new rule, these wastes—which previously had been exempted from RCRA regulation as household wastes—will be regulated.
Why Should Regulated Entities Care?
Broadly speaking, the proposed regulations will create numerous new notification and tracking requirements. For pharmaceutical reverse distributors, the regulations would be even more detailed, similar to current Large Quantity Generator (LQG) RCRA standards, with additional inventory and tracking obligations. If your business will be covered by the rule, it is important to consider now the longer term issues of implementation. For example, do you have sufficient tracking information about the pharmaceuticals used or sold in your business? Do you have the necessary protocols and information technology available to comply with the proposed notice and tracking provisions? At what cost? If there are aspects of the proposed rule that your business or organization simply cannot comply with—or would create logistical or financial complications not considered by the EPA—now is the time to submit comments.
The EPA has stated that one of the goals of the new regulations is so that the regulated community will have consistent rules to follow nationwide. It is true that today different states treat hazardous pharmaceutical wastes differently. Therefore, in the end the proposed EPA rule may add certain clarity and uniformity. However, it appears that this clarity will come with a cost of broader regulations, and added administrative burdens.
When Are Comments Due?
The window for submitting written comments to the EPA is short. The agency will accept written comments from interested parties until November 24, 2015.