Category Archives: Supply Chain

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

SB 657 – California Attorney General Gearing up for Enforcement Actions

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Perhaps you have just received a letter from the California Attorney General seeking your voluntary participation in an on-line survey regarding your company’s compliance with the supply chain and anti-slavery and anti-human trafficking disclosures required by the California Transparency in Supply Chains Act? Be careful.   Compliance with SB 657 was required by January 1, 2012 for certain companies that sell goods in California with annual worldwide gross receipts over $100 million.  In 2012, compliance consisted of make 5-6 disclosures on a company’s website – its business homepage [...]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

DEA Releases Regulations Implementing the Secure and Responsible Drug Disposal Act

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The Department of Justice (DOJ), Drug Enforcement Administration (DEA) released a final rule that implements the Secure and Responsible Drug Disposal Act of 2010, also referred to as the “Disposal Act.” The new regulations take effect on October 9, 2014. They provide additional options for ultimate users to dispose of controlled substances, and create a voluntary role for industry registrants, i.e. “collectors,” which are entities that ultimate users can transfer controlled substances to for disposal. An “ultimate user” includes a person a controlled substance is prescribed to; [...]Read more

Minnesota Formaldehyde Ban Applies to Which Children’s Products?

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The state regulatory environment for manufacture and sale of consumer products is growing in number and complexity every year. The problem with this growing patchwork is not only the multiple, duplicative paperwork and deadline tracking duties this imposes on businesses, but the fact that each state legislature chooses to define basic key words just ever so slightly differently to make planning and compliance difficult. For instance, each state defines “children’s product” slightly differently. The term is usually defined as a product marketed to a child under a certain age, with some specifications [...]Read more

California DTSC to Hold Workshops on Priority Product Work Plan

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The California Department of Toxic Substances Control (DTSC) will hold two workshops later this month on its draft Priority Products Work Plan, which will be released later this month prior to the workshops. The workshops, which will be held on August 19 and August 25, will provide an overview of the work plan and provide detailed information on how future Priority Products will be listed. The draft work plan will be open to public comment once it is released. We will provide more details on the work plan as well as an update on the workshops later this month. In March, DTSC announced their [...]Read more

Oral Arguments Held in PhRMA v. Alameda Co., California

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On August 28, 2013 the U.S. District Court for the Northern District of California upheld the Alameda County Safe Drug Disposal Ordinance (“the Ordinance”), the first pharmaceutical extended producer responsibility law in the United States. Three pharmaceutical industry associations brought a dormant Commerce Clause challenge to the Ordinance, but the court held that the Ordinance treats all drug companies alike and does not discriminate against those located outside of the county. PhRMA filed an appeal on September 12, 2013 and last Friday, July 11, 2013, the U.S. Court of Appeals for the [...]Read more

King County Adopts Fee Schedule for Drug Take Back Program

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The King County Board of Health adopted a fee schedule as part of the requirements of its Secure Medicine Return Regulations. The scheduled fees include an annual operating fee, as well as plan review fees for: • Review of a proposed stewardship plan; • Resubmittal of a proposed stewardship plan; • Review of changes to an approved stewardship plan; • Submittal of an updated stewardship plan at least every four years; and • Review of any petition for approval to use alternative final disposal technologies. As we previously mentioned here, the total cost for each of [...]Read more

DTSC Announces Draft Initial Priority Products

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The California Department of Toxic Substances Control (DTSC) has announced their first set of draft Priority Products as part of the Safer Consumer Products regulations. Being named a Priority Product, means the products are consumer goods that are solid in California and each contain at least one Candidate Chemical that have a hazard trait that can harm people or the environment. The three Priority Products and Candidate Chemicals are as follows: Spray Polyurethane Foam (SPF) Systems containing unreacted diisocyanates, Children’s Foam Padded Sleeping Products containing TRIS phosphate or TDCPP, [...]Read more