The EPA’s recently finalized Pharmaceutical Rule is effective on August 21, 2019 – six months after being published in the Federal Register. This final rule, referred to as Subpart P, and titled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” is a sector-based rule for the healthcare industry.
The rule takes effect immediately in Alaska and Iowa, as these are the two states that do not have final authorization of their base RCRA programs. Several other states will incorporate the rule by reference, which means the rule will also take effect in Florida, Kentucky, New Jersey, New Mexico, and Pennsylvania on August 21, 2019. Additionally, North Carolina has chosen to adopt the Amendment to the P075 Listing for Nicotine effective August 21, 2019, but, the remainder of the new pharmaceutical rule will go through the state’s normal adoption process, which takes approximately a year.
Since the new rule is MORE stringent than the current federal standards, these more stringent provisions MUST be adopted by the other states. The authorized states will be required to modify their hazardous waste (HW) programs to adopt these revisions.
- Authorized states have until July 1, 2021 to adopt Subpart P
- Authorized states that require a statutory amendment have until July 1, 2022 to adopt Subpart P
- Sharps Compliance will track the progress of the adoptions in the states that did not approve the rule on the first effective day
The intent of the rule is to help alleviate the cumbersome RCRA regulations, initially promulgated for manufacturing industries. The rule will lessen the regulatory burdens on healthcare employees and improve the management and disposal of Hazardous Waste Pharmaceuticals (HWP) across the healthcare facilities.
When adopted, the new Pharmaceutical Rule will:
- Prohibit the sewering of HWP immediately in all states
- Exempt the P075 listing of nicotine replacement therapy (NRT) products
- Relax the regulation on what constitutes empty stock and dispensing containers (P-listed reference)
- Reduce overlapping regulations from other governmental agencies ,including the DEA and FDA, on safe pharmaceutical management
- Provide regulatory clarity and national consistency on how RCRA applies to Reverse Distribution and Reverse Logistics
Sharps Compliance will be available to guide you along the path to 100% compliance as the new Pharma Rule involves the management of pharmaceutical waste at your facility. Stay tuned for further updates on how this rule will affect your drug management program.
Read part 1 of the series: “EPA’s New Pharmaceutical Rule – Origin and Reason for the Rule” .
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