EPA proposes rule on pharmaceutical waste

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Assisted living communities, continuing care retirement communities and other senior living entities would be affected by a rule proposed by the Environmental Protection Agency that would establish management standards for pharmaceutical waste classified as hazardous under the federal law.

The rule is scheduled to be published in the Federal Register Sept. 25 and is available now as a PDF. It aims to "enhance protection of human health and the environment" and reduce the burden on workers in senior living communities and other settings by creating a specific set of regulations for these facilities, according to the agency.

If the proposed rule is approved as written, senior living entities will be affected in the following ways:

  • Management standards. All facilities will follow different management standards for their noncreditable and creditable hazardous waste pharmaceuticals. Non-creditable drugs (those that are not expected to be eligible to receive a manufacturer's credit) will be managed on site similarly to how they would have been managed under the 2008 "universal waste" rule amendment for pharmaceutical waste. When shipped off site, however, the drugs must be transported as hazardous waste, with a hazardous waste manifest, and sent to a Resource Conservation and Recovery Act interim status or permitted facility. Facilities will continue to be allowed to send potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for processing manufacturers' credits.
  • Disposal. Facilities will be prohibited from disposing of hazardous waste pharmaceuticals down the toilet or drain.

Comments will be accepted for 60 days after publication. Current rules apply until the proposed one is finalized.

See the proposed rule for more information on its suggestions for recordkeeping, storage, labeling and shipping. See the EPA website for answers to frequently asked questions about the rule.

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