June 1, 2018
pills on a tray with someone writing something on a piece of paper next to it

How Did We Get Here?

In the early 2000s, regulators began forcing large national retailers to comply with State and Federal  hazardous waste rules designed for industrial and manufacturing entities. These retailers found themselves the subject of regulatory inspections and often the recipient of fines for non-compliance.  Furthermore, differences in the regulations and their interpretations left retailers having to manage different compliance schemes based on the local jurisdiction. One of the areas where there was significant regulatory discrepancy was the management of end of life pharmaceuticals.

For years, it had been the practice of most retailers to ship end of life pharmaceuticals through reverse distribution companies that would evaluate the specific drugs for viability, process credits and manage them for either resale or disposal. This DEA-acceptable practice was challenged by various states that found it inconsistent with environmental regulations which required generators to make waste determinations at the point of generation, which has no provisions for a reverse distribution type scenario. 

Making the situation even more difficult were other RCRA requirements, specifically for the management of acutely hazardous wastes. These requirements pushed retail pharmacies into Large Quantity Generator (LQG) status if they generated more than 2.2 pounds per month of certain pharmacy wastes, including smoking cessation products (nicotine) and blood thinning medications (warfarin). Within a few years, retailers operating pharmacies had to spend millions of dollars per year simply to manage small quantities of these wastes, and their operations fell under the same regulatory scrutiny as large manufacturers.

Retailers sought for consistency and regulatory harmonization as they engaged with EPA to evaluate the situation. In 2008, EPA began to fix the regulatory discrepancies by issuing a proposed rule tailored to retailers and the healthcare industry. 

How Does The New Rule Affect Me?

After ten years of feedback and revisions, EPA released the Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine to the Federal Register on February 22, 2019.

EPA states in the preamble, “this final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.” Specifically, healthcare facilities and retailers with pharmacies are able to determine if the pharmaceutical waste is potentially eligible for manufacturer credit. If so, then it becomes a potentially creditable hazardous waste pharmaceutical. The final rule allows facilities to send the potentially creditable hazardous waste pharmaceuticals to reverse distributors, provided they meet minimal requirements including recordkeeping, spill response, and DOT shipping provisions. A hazardous waste manifest is not required. 

The new rule is less stringent on P075 nicotine cessation products. Under the rule patches, gums and lozenges that are FDA-approved, over-the-counter nicotine replacement therapies are exempt, and instead can be recycled, reused or discarded in other manners. This significant declassification reduces generators’ statuses back to Small Quantity (SQG) and will help retailers save hundreds of thousands of dollars annually with no impact on the environment. This exception from the P075 listing does not include e-cigarettes, nicotine-containing e-liquids or prescription nicotine replacement therapies (NRTs).

The new rule also makes it easier for healthcare facilities to dispose of certain size-restricted containers with hazardous waste residue that were not previously considered RCRA-empty. If the pharmaceuticals have been removed using standard practices for that type of container, or if syringe plungers have been fully depressed, then they are now considered empty.

The new rule enforces more regulations to protect waterways from the age-old practice of sewering pharmaceuticals. Under the new rule, EPA has prohibited all facilities from sewering any hazardous waste pharmaceuticals including Very Small Quantity Generators (VSQGs). This ban extends to pharmaceuticals that are DEA-controlled substances or mixed waste pharmaceuticals. This will result in EPA’s cited “1,644 to 2,300 less tons” of hazardous pharmaceutical waste from entering our drinking water on an annual basis, protecting both human lives and reducing impacts to aquatic ecosystems.

The entire final rule will become effective in the non-RCRA-authorized states (i.e., Alaska and Iowa) on July 22, 2019. For the remaining 48 RCRA-authorized states, the prohibition on sewering hazardous waste pharmaceuticals will also become effective on July 22, 2019 as this is the one rule provision that is promulgated under HSWA authority.

The P075 nicotine listing revision is a new provision that is less stringent than existing regulations. Authorized states are not required to adopt this change, although EPA and US Ecology encourages all states to do so to promote uniform procedures.

How Can US Ecology Help?

There are many complicated facets of the new 2019 rule, such as regulations that allow non-prescription pharmaceuticals to be reused or reclaimed, intricate categorization of drugs and other flexibilities with the reverse distributors’ business practices adhering to RCRA regulations. US Ecology is here to ensure you fully understand the complexities of the new rule and help you achieve compliance across all of your stores and avoid fines as states adopt varying degrees of the rule.

US Ecology’s team of professionals has over 65 years of experience helping retailers of all sizes manage hazardous waste. In addition to receiving a dedicated US Ecology customer service team educated on the nuances of your business, you have access to Environmental, Health, Safety and Regulatory professionals to review all elements of your complicated pharmaceutical waste management. Our team optimizes the most sustainable and innovative solutions to treat your pharmaceuticals safely, compliantly and with the intent to reduce your generator status as much as permitted by regulators in order to save you money. The combination of our state-of-the-art RCRA landfills, DEA permits, wholly-owned DOT-certified trucks and technicians, and certified Lab Pack field chemists provides you with unequaled service and solutions you can trust. 

Are you interested in learning more about how the new rule can affect your existing hazardous waste program? Partnering with US Ecology as a single source for all hazardous and non-hazardous waste management solutions can help maximize company efficiencies, and result in hundreds of thousands of dollars in savings annually. Contact Vince Scheerer, Vice President of Business Development – National Programs for US Ecology, at vince.scheerer@usecology.com or (800) 592-5489 to learn how easy it is to establish or optimize your environmental compliance program today.