Changes in Pharmaceutical Waste Management Summer 2019 Joshua

CAUTION! This presentation is only a summary of changes in pharmaceutical waste management in

(Review) What must be assumed? n Every regulated pharmaceutical waste must be: qassumed to

Which waste sources are regulated? In MN : n ALL commercially-generated q q q

*Commercial – vs. - Household? Residential care facilities may be considered : n Household

Controlled Substances? n Exempt (from MPCA requirements) q or Evaluated as non-hazardous q Not

Empty Containers? n Exempt if: Stock/dispensing container ≤ 10, 000 tablets or 1 L

Nicotine? n Exempt: q FDA-approved, OTC nicotine replacement therapies (NRTs) {gum, lozenges, patches} q

Disposal Options? (for regulated pharmaceutical hazardous waste) n Ship for Reverse n Manifest with

Sewering? (regulated pharmaceutical hazardous waste) n May NOT be sewered after August 21, 2019,

Sewering? (regulated pharmaceutical hazardous waste) n May only be sewered if: q Evaluated as

Disposal Options? (for household waste) n On-site pharmacy-controlled collection receptacle n Transport to household

Expected ~2022 THE FOLLOWING PREVIEW HAS BEEN APPROVED FOR ALL AUDIENCES BY THE MINNESOTA

Compliance Resources n MPCA Small Business Environmental Assistance Program (SBEAP) Free q Confidential q

Questions/More Information Joshua Burman (507) 344 -5243 Joshua. Burman@state. mn. us Any MPCA staff

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Changes in Pharmaceutical Waste Management Summer 2019 Joshua Burman MPCA #w-hw 3 -33; Changes in pharmaceutical waste management 1

CAUTION! This presentation is only a summary of changes in pharmaceutical waste management in Minnesota and does not detail all final applicable requirements. MPCA #w-hw 1 -00; Basic Hazardous Waste for Business 2

(Review) What must be assumed? n Every regulated pharmaceutical waste must be: qassumed to be hazardous OR qevaluated as non-hazardous (documented as non-hazardous) n documented knowledge and/or n testing MPCA #w-hw 4 -45 a; Evaluating Pharmaceutical Wastes 3

Which waste sources are regulated? In MN : n ALL commercially-generated q q q n Pharmacies Hospitals/clinics Veterinary hospitals/clinics Dentists Nursing homes, hospices Household-generated (LTCFs )* once collected Home-based care facilities* q Schools q Shelters q MPCA #w-hw 3 -35; Regulatory Consensus on Healthcare 4

*Commercial – vs. - Household? Residential care facilities may be considered : n Household if: q in-home care OR q 6 resident capacity OR q n pharmacy-controlled collection receptacle installed Otherwise considered commercial MPCA #w-hw 3 -35; Regulatory Consensus on Healthcare 5

Controlled Substances? n Exempt (from MPCA requirements) q or Evaluated as non-hazardous q Not sewered if: AND q Managed under DEA/Board requirements AND q Destroyed by DEA-approved method (approval in writing from DEA) * MPCA #w-hw 3 -33; Changes in pharmaceutical waste management 6

Empty Containers? n Exempt if: Stock/dispensing container ≤ 10, 000 tablets or 1 L q and q All product removed by normal means x No rinsing or measurement necessary warfarin) (includes or q Meet normal hazardous waste empty container standard MPCA #w-hw 4 -16; Containers that held hazardous waste or product 7

Nicotine? n Exempt: q FDA-approved, OTC nicotine replacement therapies (NRTs) {gum, lozenges, patches} q Not exempt: Prescription NRTs {sprays, inhalers} q E-cigarettes q Vaping liquids q MPCA #w-hw 3 -33; Changes in pharmaceutical waste management 8

Disposal Options? (for regulated pharmaceutical hazardous waste) n Ship for Reverse n Manifest with Hazardous Waste Transporter q n Distribution must use waste code ‘PHARMS’ Treat on-site then Manifest MPCA #w-hw 3 -35; Regulatory Consensus on Healthcare 9

Sewering? (regulated pharmaceutical hazardous waste) n May NOT be sewered after August 21, 2019, if: q Unevaluated or q Evaluated as ‘federally-regulated’ MPCA #w-hw 4 -45 a; Evaluating Pharmaceutical Wastes 10

Sewering? (regulated pharmaceutical hazardous waste) n May only be sewered if: q Evaluated as non-hazardous or q q Evaluated as only Lethal pharmaceutical Then, only to Publicly Owned Treatment Works (POTW), NOT septic system; and q POTW has been notified prior to discharge and q POTW conditions are complied with MPCA #w-hw 4 -45 a; Evaluating Pharmaceutical Wastes 11

Disposal Options? (for household waste) n On-site pharmacy-controlled collection receptacle n Transport to household collection receptacle q at pharmacies & law enforcement n Sewer (strongly discouraged) n Treat on-site (optional) then solid waste MPCA; Managing unwanted medications https: //www. pca. state. mn. us/living-green/managing-unwanted- 12

Expected ~2022 THE FOLLOWING PREVIEW HAS BEEN APPROVED FOR ALL AUDIENCES BY THE MINNESOTA POLLUTION CONTROL AGENCY Lethal pharmaceutical wastes sewering ban n Pharmaceutical wastes containers secured n MPCA #w-hw 3 -33; Changes in pharmaceutical waste management 13

Compliance Resources n MPCA Small Business Environmental Assistance Program (SBEAP) Free q Confidential q 651 -282 -6143 q 800 -657 -3938 q MPCA Small Business Environmental Assistance Program 14

Questions/More Information Joshua Burman (507) 344 -5243 Joshua. Burman@state. mn. us Any MPCA staff (651) 296 -6300 Info. pca@state. mn. us Metro Counties https : // www. pca. state. mn. us/waste/hazardous-waste-documentsand-forms ( scroll to the bottom of the page ) MPCA; Assistance https: //www. pca. state. mn. us/about-mpca/assistance 15