Tag Archives: Healthcare

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

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