September 17, 2019

New Pharma Rule Guidance in FAQs

On August 21, 2019, EPA’s hazardous waste pharmaceutical rule took effect at the federal level and in the states of Iowa and Alaska. The newly established Part 266, Subpart P not only includes regulations on the proper management of hazardous waste pharmaceuticals and a ban on sewering them, but it also contains provisions for emptying containers once holding these pharmaceuticals and rules on managing hazardous waste pharmaceuticals that are also DEA-controlled substances. The “pharma rule” also provides an exemption from the P075 nicotine listing, exempting FDA-approved over-the-counter nicotine replacement therapies. The ban on sewering pharmaceuticals, promulgated under the HSWA statute, is currently in effect in all states. All other portions of the rule will take effect in RCRA-authorized states once those states have adopted the new rule.

The agency has brought online a map showing state adoption of the new rule and the less-stringent P075 nicotine exemption. The page also has a table with links to state regulations where available.

In terms of understanding the pharmaceutical rule, a comprehensive overview of this new rule can be found in our white paper, but as with any new rule, user and industry questions abound. EPA provided some clarification with a series of frequently asked questions, broken up into three sections: general questions, definitions, and the sewer ban.

One question we have received lately is, “Does a clinic/nurse’s station inside of a manufacturing facility need to comply with the new regulations?” Under the “What is a ‘healthcare facility’ under this final rule?” question, EPA says yes. This answer is critical as not only would stand-alone hospitals, pharmacies, chiropractors, etc. be subject to Subpart P, but so would an onsite clinic/nurse’s station at a manufacturer, military base, school, or other facility. The agency noted that if the entire facility is a very small quantity generator, it would not be subject to Subpart P, except for the sewer ban and §266.507 empty container standards.

Another interesting wrinkle is that the sewer ban applies to healthcare facilities and reverse distributors only. Pharmaceutical manufacturers that are not reverse distributors are not subject to the ban. That said, the Clean Water Act (CWA) sewer ban would still apply.

 


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This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.