PharmE^® News Alert

EPA Guidance on Containers that Once Held P-Listed Pharmaceuticals

In a letter dated November 4, 2011, the EPA issued additional guidance for the management of containers that have held P-listed pharmaceuticals, most commonly warfarin (P001) and nicotine (P075). The EPA issued this guidance because they have received numerous inquiries regarding the regulatory status of these containers. In particular, generators have expressed concern that they are becoming large quantity generators, at least episodically, based on managing containers that have been fully dispensed and typically have very small amounts of residues in them which may not even be visually detectable.

In their letter, the EPA reviewed the applicable regulations and outlined several approaches generators may be able to use to address this issue. In particular, the EPA pointed out that only the weight of the residue counts towards the generator status and that the container itself is not a hazardous waste. While it is not yet clear how generators might take advantage of this interpretation, we are hopeful it will give organizations more flexibility in managing containers for which the contents have been fully dispensed.

The EPA also noted that their letter only discussed federal hazardous waste regulations. They pointed out that states authorized to implement the RCRA program may have regulations that are different than the federal regulations provided they are not less stringent than the federal program.

You can review the the full text of the EPA's letter at Containers That Once Held P-Listed Pharmaceuticals.

If you have any additional questions about disposal of any pharmaceutical waste or if you have any questions about managing your pharmaceutical waste, please contact us at info@pharmecology.com, call us at 877-247-7430, or visit our web site at www.pharmecology.com.

• Posted: December 05, 2011