February 15, 2017

Managing Pharmaceutical Wastes Today Under RCRA

Do you work at a pharmacy, hospital, nursing home, DOD base, or large manufacturing plant with a medical clinic? Do they dispense or sell pharmaceuticals within the boundaries of your facility? If you answered “yes,” then how do you manage expired nitroglycerin pills, empty warfarin pill bottles, or blister-packs from nicotine patches or gum?

You may not have been aware that expired or discarded drugs, see examples listed below, could be regulated as RCRA hazardous waste—just like the spent paint solvent generated by your maintenance department.

Coumadin (P001),
Warfarin (U248),
Epinephrine (P012),
Phentermine (P046),
Nicotine (P075),
Chloral Hydrate (U034),
Inhalers (D001), and
Others.

This raises the question, do the RCRA rules really apply to hospitals and pharmacies? Do we need satellite accumulation areas (SAA) at every nursing station, or ways to manage empty P-listed containers at pharmacies? Here is what EPA states on their website:

“Until a new rule is finalized and adopted by authorized states, healthcare facilities and other business entities that generate pharmaceutical hazardous waste must manage these wastes in accordance with the hazardous waste generator requirements.”

Thus, until the agency promulgates new rules, you must have SAAs and ways to manage P-listed containers. In addition, depending on how much hazardous waste you generate, training, contingency plans, and a central accumulation area requiring weekly inspections and special labeling may also be necessary.

So what’s up with this “new rule” EPA mentioned above? The agency’s first attempt was a universal waste pharmaceutical proposal, published December 2, 2008 [73 FR 73520], that was met with adversity from both the regulators and the regulated community during the comment period. So, a new “sector-specific” approach was developed and published in draft rule form on September 25, 2015. [80 FR 58014] EPA’s latest Regulatory Agenda indicates that the final pharmaceutical rule has been pushed out to the end of 2017, again due to a significant number of comments.

What do you do in the meantime? EPA does have a website devoted to the regulation of hazardous waste pharmaceuticals. The website has some useful guidance documents to help you until a new rule is finalized. Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States; revised August 2008, is full of information on how to assess and comply with the current RCRA regulations for your pharmaceutical wastes.

The agency’s website also contains specific guidance on subjects including:

Containers that once held P-listed pharmaceuticals;
P- & U-waste left in syringes (including used epinephrine syringes);
The scope of the P046 phentermine and P042 epinephrine listings;
Whether choral hydrate is U034; and
Whether unused discarded nicotine patches, gum, and lozenges are P075.

We look forward to seeing what direction EPA is headed for pharmaceutical wastes in 2017.

McCoy and Associates has provided in-depth information to assist environmental professionals with complex compliance issues since 1982. Our seminars and publications are widely trusted by environmental professionals for their consistent quality, clarity, and comprehensiveness.

Disclaimer

Considerable care has been exercised in preparing this document; however, McCoy and Associates, Inc. makes no representation, warranty, or guarantee in connection with the publication of this information. McCoy and Associates, Inc. expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any federal, state, or municipal law or regulation with which this information may conflict. McCoy and Associates, Inc. does not undertake any duty to ensure the continued accuracy of this information.

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.