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Management of Residues in Pharmaceutical Containers

The Hazardous Waste Pharmaceuticals (HWP) Rule made some changes to the regulatory status of residues in certain types of containers that once held hazardous waste pharmaceuticals and under what conditions such containers are "RCRA empty". These new empty containers provisions are not just limited to healthcare facilities and reverse distributors operating under Subpart P, but apply to any generator of HWP.

Background

Previously, the definition of RCRA Empty applied to all types of containers that held all types of hazardous waste from all types of businesses including HWP. Under the previous regulations, all types of containers were empty if they had all the contents removed by conventional methods, provided that any remaining residue fell below certain depth and percentage limits. Fifty five (55) gallon containers that held industrial waste were regulated the same as one-ounce medicine vials. Any hazardous waste determined to be remaining in these containers was regulated as hazardous waste. In the case of acutely hazardous P-listed wastes, the container was not deemed RCRA empty unless an inner liner was removed and managed as hazardous waste, or until the container had been triple rinsed and the rinsate managed as hazardous waste. This was impractical in the case of small medicine containers, and the unrinsed containers had to be managed as acute hazardous waste. Because it only takes 1 kg of acute hazardous waste to make a generator a large quantity generator, many healthcare facilities found themselves to be large quantity generators of hazardous wastes. Under the new final rule, the definition of empty container types of containers that held HWPs has been re-defined.

Requirements Under the Hazardous Waste Pharmaceuticals Rule

The empty container provisions of 40 CFR § 261.7 of the VHWMR have been revised to indicate that containers of HWP are subject to the new requirements found in 40 CFR § 266.507. Under Subpart P, empty is re-defined for HWP remaining in certain types of containers as outlined in the table below. Note that triple rinsing of these types of containers with acute P-listed HWP is no longer required or allowed based on the type of container.

Empty Container Standards for Hazardous Waste Pharmaceuticals

Table: HW Pharmaceuticals Empty Container Standards

Type of Container RCRA Empty: Non-Acute HWP RCRA Empty: Acute HWP
Stock/Dispensing Bottles (1 liter or 10,000 pills) and Unit Dose Containers Remove Contents Remove Contents
Syringes Fully Depress Plunger Fully Depress Plunger
IV Bags Fully Administer Contents or Meets 40 CFR § 261.7(b)(1) Fully Administer Contents
Other Containers (includes but is not limited to inhalers, aerosols, neutralizers, and tubes or ointments, gels or creams) Meets 40 CFR § 261.7(b)(1) or (2) Can Not Be RCRA Empty

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Virginia Department of
Environmental Quality
P.O. Box 1105
Richmond, VA 23218
(804) 698-4000


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