By A.J. Plunkett
After years of discussion and debate, editing and rewriting, the Environmental Protection Agency’s (EPA) latest attempt to manage hazardous pharmaceuticals maybe be close to publication as a final rule.
If published, the rule joins other new standards and regulations targeting employee and patient safety during the use and handling of hazardous pharmaceuticals. It’s also expected to have significant impact on hospitals and other healthcare organizations.
Consultants and others in the pharmaceutical industry say the EPA is expected any day now to post its final version a rule for the “Management Standards for Hazardous Waste Pharmaceuticals” that was first proposed in September 2015. However, at press time, the rule was still not posted in the Federal Register.
The rule amends regulations under the Resource Conservation and Recovery Act to create a new class for hazardous waste pharmaceuticals. The rule has been through review by the Office of Management and Budget and was released back to the EPA in mid-October, according to the OMB’s online dashboard of regulatory reviews.
Unlike rules for CMS, which is generally required by law under the Social Security Act to publish final rules within three years, the EPA is under no such requirement. A previous rule on hazardous waste pharmaceuticals that was proposed in 2009 — and roundly criticized as not strong enough in certain areas — languished until it was finally withdrawn and replaced with the “Management Standards for Hazardous Waste Pharmaceuticals” proposal.
The new proposal received wider support, although many companies and organizations were concerned that some requirements were either unnecessary or covered by other regulations, such as those in the Department of Transportation overseeing the transport of hazardous materials.
Drug supply chain concerned
And some were concerned that the newly proposed regulations were simply at odds with other laws, making it difficult to impossible for some companies to stay in business.
For instance, the rule proposed changing how hazardous pharmaceuticals returned unused to reverse distributors would be characterized. The rule indicated those drugs would be considered “waste,” which put it in a different category for how it is to be handled.
However, companies in the business of reverse distribution of such drugs pushed back, noting that they acted not as a waste company but as a link in a supply line, warehousing drugs that could still be used elsewhere or performing an important credit evaluation service.
Many of those companies are members of the Healthcare Distribution Alliance (HDA), which says its members provides a “vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide,” according to its website.
After the 2015 proposal, the HDA told the EPA that the rule could have a significant adverse impact on the entire pharmaceutical supply chain, and that parts of it were inconsistent with requirements and regulations set out under the Drug Supply Chain Security Act enacted by Congress in 2013.
That security act “outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States,” according to the FDA. That includes using unique product identifiers.
Earlier this year, after a briefing by EPA officials, the HDA took the unusual step in late summer, as did several reverse distribution companies, of reiterating their opposition to parts of the proposed rule and asking that supplemental comments be included in the official federal docket with other supporting materials.
“What prompted the latest activity was based on our meeting with EPA in February and on the latest deadline included in the Regulatory Agenda around that time. We believed that the Agency was moving forward with a final rule, and wanted to take the opportunity to again provide HDA’s perspective,” says Patrick Kelly, HDA’s Executive Vice President, Government Affairs, in a statement.
“HDA has not received any indication of what EPA did or did not include in the final rule they submitted to OMB. We also do not know if OMB recommended any changes in the proposed final rule.”