Tag Archives: Pharmaceutical Waste

Now Effective: EPA’s Sewer Ban and (in some states) Management Standards for Hazardous Waste Pharmaceuticals

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Today, August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally.  The sewer ban component of the new rule applies in all states.  Healthcare facilities are now prohibited from flushing hazardous waste pharmaceuticals, including DEA controlled substances and “pharmaceutical wastage” that are hazardous waste.  This sewering ban may drive many facilities to stop flushing pharmaceuticals entirely (even those that are not hazardous waste), given how complicated it is in practice for healthcare provides to determine which drugs are hazardous [...]Read more

Final Management Standards for Hazardous Waste Pharmaceuticals Released

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On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine replacement therapies (NRTs) in this rulemaking, but challenges remain in the new management standards. Here are a few noteworthy takeaways as we continue to analyze the rule and its implications: The exclusion of NRTs is a big win … so long as states follow suit FDA-approved, over-the-counter NRTs (nicotine patches, gums, and lozenges) have been removed from the P075 hazardous [...]Read more

California’s Drug and Sharps Takeback Bill Triggers Statewide Obligations

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All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. It currently sits on the Governor’s desk awaiting signature. SB 212 requires manufacturers of sharps and pharmaceuticals to create and fund a statewide take-back program covering prescription and OTC drugs. If a manufacturer is not located in the state, responsibility shifts down the chain to the wholesale distributor, then repackager, followed by the owner or licensee of the trademark, and lastly [...]Read more

EPA Commits to Hazardous Waste Retail Strategy, Policy Expected to Address Point of Generation Issues

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On September 12, 2016, the U.S. Environmental Protection Agency (EPA) issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework.  As part of this strategy, EPA will finalize the Resource Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule this fall, and is working to finalize the Management Standards for Hazardous Waste Pharmaceuticals Rule, but appears to need additional time to do so.  While EPA states that it is focusing efforts on these rulemakings, it will also issue a Policy on Reverse Distribution and RCRA. EPA recognizes that [...]Read more

County-Level Pharmaceutical Take-Back Programs May Be Spreading in California and Illinois

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Los Angeles County, the nation’s largest County, has proposed a pharmaceutical take-back ordinance that would require businesses to finance a local government program for disposal of unwanted medications and potentially hazardous medical products like needles and syringes. Under the draft ordinance, termed the “Los Angeles County Pharmaceuticals and Sharps Collection and Disposal Stewardship Ordinance,” certain manufacturers, producers, or distributors of covered medications and supplies would be responsible for designing, implementing and financing the collection program. At its March 22, [...]Read more

EPA Extends Comment Period for Proposed RCRA Rules

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EPA announced this morning that it extended the comment period for both the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule and the Hazardous Waste Generators Improvements Proposed Rule until December 24, 2015, according to the pre-publication notices here and here.  All healthcare facilities, pharmaceutical reverse distributors and other hazardous waste generators should read the proposed rules, and each should analyze the impacts it will have on its operations and waste management practices.  The proposed rules have broad-reaching implications, and generators should provide [...]Read more

EPA Released its Proposed Management Standards for Hazardous Waste Pharmaceuticals Rule

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Today, EPA released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule.  A pre-publication copy is available here. The proposed rule, if finalized, will add a subpart P under 40 CFR part 266, which applies to the management of hazardous waste (HW) pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors.  All pharmaceutical reverse distributors will be required to manage HW pharmaceuticals under this subpart, not 40 CFR part 262.  Subpart P creates a new category of hazardous waste entities, pharmaceutical reverse distributors – such entities [...]Read more

The Floodgates Are Open for EPR Laws

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Last week, the United States Supreme Court denied industry’s petition for certiorari in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v. County of Alameda. The petitioners contended that Alameda’s Safe Drug Disposal Ordinance violated the dormant commerce clause by requiring pharmaceutical companies to finance a drug take-back program. The impact of the Court’s denial—which lets stand a Ninth Circuit ruling upholding the ordinance—will be widespread, both for the pharmaceutical industry, and more broadly, for extended producer responsibility (EPR) laws and ordinances [...]Read more

RCRA Regulation of Hazardous Waste Pharmaceuticals –Proposed Rule Forthcoming this Summer

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On March 19, 2015, EPA sent its proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” to the White House Office of Management and Budget (OMB) for pre-publication review.  This review may take up to 90 days (barring a one-time 30-day extension).  Unless OMB returns the rule to EPA for reconsideration, we expect the proposed rule to be released this summer.  This rule will have major implications for the pharmaceutical reverse distribution industry and the management of non-dispensable pharmaceuticals at health care facilities. The fall 2014 Unified Agenda states that [...]Read more

EPA’s Forthcoming RCRA Regulations May Threaten Reverse Distribution of Pharmaceutical Waste

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In February, the Environmental Protection Agency (EPA) issued a Notice of Data Availability (NODA) seeking information on ways to more effectively regulate hazardous waste—including pharmaceuticals—in the retail sector under the Resource Conservation and Recovery Act (RCRA). The healthcare industry has already submitted comments expressing concern that EPA may modify the “reverse distribution” system currently in place for disposal of outdated or unsold pharmaceuticals. Under the reverse distribution system, retailers send expired and unsold pharmaceuticals to a central [...]Read more