Pill BottleEPA's acting administrator signed the final rule, titled, "Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine" on December 11, 2018 with a Federal Register publish date of February 22, 2019. This rule is expected to make our drinking and surface waters safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering the nations waters by 1,644 to 2,300 tons annually. This reduction is expected to occur by prohibiting the disposal of unused, expired, or unwanted medications in the sewer system.

The sewer prohibition became effective August 21, 2019 in all states, territories, and Indian country. This is because a portion of the Rule was promulgated pursuant to the 1984 Hazardous and Solid Waste Amendments (HSWA). The sewer prohibition is the only provision of the Hazardous Waste Pharmaceuticals Final Rule that was promulgated under HSWA authority. As a HSWA provision, the sewer prohibition goes into effect on the effective date of the rule (August 21, 2019) regardless of whether a government has received authorization to implement Resource Conservation and Recovery Act (RCRA) or has implemented Subpart P.

Once North Carolina receives authorization to implement the rule in its entirety, all facilities subjected to this rule may require further action. Please stay informed on this regulation as it progresses.

If you would like to learn more about this rule please visit the EPA Hazardous Pharmaceuticals Website.

Please see the FAQ's below for more information pertaining to the Sewer Ban.

Section 266.505 of title 40 of the CFR prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW). The sewer prohibition applies to RCRA hazardous waste pharmaceuticals that are also controlled substances under the Drug Enforcement Administration (DEA) regulations and collected household pharmaceuticals (see 40 CFR section 266.506). We note that although the sewer prohibition applies to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical.

Yes. All healthcare facilities, including VSQGs, must comply with the sewer prohibition for hazardous waste pharmaceuticals. See 40 CFR section 266.505.

The sewer prohibition is effective August 21, 2019, in all states, territories and Indian Country.  This is because this portion of the Rule was promulgated pursuant to the 1984 Hazardous and Solid Waste Amendments (HSWA). The sewer prohibition is the only provision of the Hazardous Waste Pharmaceuticals Final Rule that was promulgated under HSWA authority. As a HSWA provision, the sewer prohibition goes into effect on the effective date of the rule (August 21, 2019) regardless of whether a government has received authorization to implement RCRA or has adopted Subpart P.

Healthcare facilities and reverse distributors that are in an authorized state or territory that has not yet adopted Subpart P do not have to submit a notification to EPA until after the state or territory adopts Subpart P. Because the sewer prohibition is a HSWA provision, it becomes effective on August 21, 2019 in all states, territories and Indian Country regardless of whether the government is authorized to implement RCRA or has adopted Subpart P. However, the rest of Subpart P, including requirements for healthcare facilities and reverse distributors to submit a notification, is not effective in an authorized state or territory until the state or territory adopts this final rule.

Healthcare facilities and reverse distributors that are in Indian Country, territories other than Guam, or unauthorized states (Alaska and Iowa), are required to notify EPA by 20 October 2019 (using form 8700-12) or 01 March 2020 (for those who choose to notify via their Biennial Report).

The sewer prohibition of Subpart P will be enforced through RCRA inspections of healthcare facilities and reverse distributors by state or federal officials. The Clean Water Act’s NPDES pretreatment program may also apply and result in enforcement of requirements of the sewer prohibition if such requirements are adopted as part of a publicly owned treatment works’ approved pretreatment program.  Further, elements of the sewer prohibition may be reflected currently in the specific prohibitions on discharge by indirect users of POTWs in EPA’s Pretreatment Regulations at 40 CFR Part 403.

No. Hazardous waste pharmaceuticals that also contain a radioactive component subject to the Atomic Energy Act of 1954 (i.e., “mixed waste”) are regulated by multiple agencies. The hazardous waste component is regulated under EPA or the authorized state RCRA programs, while either the Nuclear Regulatory Commission or the Department of Energy regulates the radioactive component of the waste under the Atomic Energy Act. Therefore, a “mixed waste” pharmaceutical that is both radioactive and RCRA hazardous waste is prohibited from being discharged to the sewer.

No, 40 CFR section 261.4(a)(1)(ii) allows the discharge of what would otherwise be a hazardous waste to publicly owned treatment works (POTWs), without being considered solid or hazardous waste. The prohibition on discharges of hazardous waste pharmaceuticals that was promulgated as part of the Hazardous Waste Pharmaceuticals final rule reduces the scope of the exclusion in the existing regulations. Discharges of hazardous waste to other types of sewage systems, such as septic tanks, privately owned treatment works and federally owned treatment works are not allowed by the exclusion in 40 CFR section 261.4(a)(1)(ii). Therefore, the discharge of hazardous wastes to septic tanks, privately owned treatment works and federally owned treatment works is already prohibited, even though it is not explicitly stated in the sewer prohibition of Subpart P.

No, 40 CFR section 266.505 prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW), regardless of whether the POTW or state has issued a pretreatment permit to the healthcare facility or reverse distributor.

The sewer prohibition does not apply to pharmaceutical manufacturers unless those same facilities are also reverse distributors.  A reverse distributor is defined in 40 CFR section 266.500, “as any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.”

While the sewer prohibition legally applies only to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting. EPA promulgated Effluent Guidelines and Standards for Pharmaceutical Manufacturing at 40 CFR Part 439, which address CWA discharges of pollutants associated with this industry.