Resource Directory for the Management of Pharmaceuticals in King County

Transcription

1 Resource Directory for the Management of Pharmaceuticals in King County Interagency Regulatory Analysis Committee (IRAC) and Local Hazardous Waste Management Program in King County October 2003 SQG-PHARM-1(10/03) rev. 4/04

2 This material is available in alternate formats for persons with disabilities by calling A TTY relay service is available at 711 if you have questions about the material or services in this publication.

3 Resource Directory for the Management of Pharmaceuticals in King County This directory is a practical tool for facilities that need help managing their unused and unusable pharmaceuticals and hazardous wastes. It does not constitute a reference to laws and regulations. Responsibility for the proper handling and disposal of waste belongs to the generator. If you have specific questions, call King County s Business Waste Line at or Washington Department of Ecology at The Local Hazardous Waste Management Program (LHWMP) in King County and the Interagency Regulatory Analysis Committee (IRAC) combined efforts to prepare this directory for the health care industry in King County. Special thanks go to Alice Chapman and Debra Oliver. Inclusion in this directory is not an endorsement of the companies listed. CONTENTS Pharmaceutical Management and Hazardous Waste Regulation 4 What is the purpose of this document? Why do hazardous waste regulations apply? Who is affected by hazardous waste regulations? Who regulates hazardous wastes? Best Management Practices as Suggested by Pharmaceutical Returns Companies 5 Know your liabilities Understand returns companies Ask questions Manage inventory Identify pharmaceuticals Package returns Complete DEA Paperwork Pharmaceutical Management Resource Directory (Main Directory) 7 Reverse Distributors and Returns Companies.. 13 Sharps Management Hazardous Waste Management.. 15

4 Pharmaceutical Management and Hazardous Waste Regulation Why do hazardous waste regulations apply? Medical professionals know that the dose makes the poison. Placing unusable or waste medicines into the garbage or flushing them down a drain can introduce their combined toxic effects to the environment and those living in it. Waste chemicals can contaminate soil, seep into groundwater and drinking water or streams and lakes. For this reason chemicals, including pharmaceuticals, with certain dangerous characteristics are regulated as hazardous waste. Their proper disposal will prevent releases to the environment. Who is affected by hazardous waste regulations? Most health care facilities must be aware of and comply with the hazardous waste regulations. These facilities include hospitals, medical research facilities, doctors, dentists, independent pharmacies, veterinary clinics and nursing homes. All are potential generators of hazardous wastes. For help identifying hazardous waste and finding in-depth best management practice guidance for the health care industry, refer to Focus on Pharmaceuticals published by the Washington State Department of Ecology (Ecology). See their web site at What is the purpose of this document? This document provides the health care industry in King County, Washington with a directory of vendors that can help manage unused or unusable pharmaceuticals. The directory lists returns companies and vendors who manage drugs, sharps or hazardous wastes, with suggestions about how to make the return or destruction of drugs safer, easier and compliant with regulations. Who regulates hazardous wastes? At the federal level: The United States Environmental Protection Agency (EPA) regulates certain chemicals as hazardous waste under the Resource Conservation and Recovery Act (RCRA). Federallyregulated hazardous wastes are those that are ignitable, corrosive, reactive, toxic, or listed as toxic or acutely hazardous in the Code of Federal Regulations, 40 CFR Part 261. RCRA-regulated pharmaceutical wastes must be disposed of at a permitted hazardous waste facility. At the state level: In Washington, Ecology s requirements for identifying and handling hazardous wastes are contained in the State Dangerous Waste Regulations ( WAC). The Washington State Dangerous Waste Regulations encompass more chemicals and are more stringent than RCRA. In 2003, Ecology conditionally excluded state-regulated pharmaceuticals allowing disposal in a way that minimizes diversion and risk to the environment. The text of the exclusion is in the Washington State Dangerous Waste Regulations (Chapter , Washington Administrative Code, or WAC, section -071 (3) (nn)). 4

5 Best Management Practices Know your liabilities During our vendor surveys, reverse distributors and returns companies provided suggestions on best management practices (BMP). Their suggestions are summarized in this section. Use this information along with the in-depth information provided by Ecology in their BMP document Focus on Pharmaceuticals at Vendors that handle pharmaceutical returns and wastes are listed here. Listing does not constitute an endorsement of the vendor. Protect yourself by making sure the vendors you hire are responsible. The directory does not list all potential vendors. Every attempt was made to gather and validate all available information, yet some companies serving the King County area may have been missed and some information may have changed since its collection. You are ultimately responsible for the proper and legal management of your wastes. Understand returns companies Ask questions Manage inventory Identify pharmaceuticals Package returns Complete DEA paperwork Understand returns company operations Pharmaceutical returns companies or reverse distributors accept unusable pharmaceuticals (e.g., shelf-life expired), identify those that can be returned to manufacturers for credits, process the credits (the fee is often based on a fraction of the proceeds), designate drug wastes and dispose of drugs. Some returns companies provide destruction-only services and do not process credits. The Federal Drug Enforcement Administration (DEA) provides a regulatory definition of reverse distributor, a specific type of returns company, on its website at Ask questions while shopping for a returns company Although you may rely on other companies to haul away and dispose of your waste, you are ultimately responsible for the waste from cradle to grave. Choose your vendors carefully, considering reliability as well as cost. Is credit issued for returnable drugs? What types of drugs are accepted and what screening criteria are used for acceptance? How are drugs with no credit value managed? What services does the company provide? Destruction? Returns? Waste incineration? Mail-in or on-site pickup? Does the company provide pre-labeled shipping boxes? Does the company have permits and licenses to manage hazardous wastes, pharmaceuticals and/or controlled substances? 5

6 Does the company provide witnessed destruction of controlled substances? What protocols must the client follow to comply with regulations? Where are the drugs being designated for hazardous waste status and who is named as the generator? The generator of hazardous waste assumes specific and important regulatory responsibilities. See Ecology s website (at the URL above). Does the company have a hazardous waste identification number? Are hazardous waste drugs being managed, transported and disposed at facilities permitted to do so? Manage pharmaceutical inventory Rotate inventory often to keep product current. Return products just before shelf-life expiration to ensure credit. Inventory shelves thoroughly; missed drugs that expire may be too old to receive credit. Work with the returns company to determine shipment schedule. Complete inventory forms provided by the returns company before shipping. Include descriptive information in inventories. Use National Drug Codes (NDC) wherever possible. DEA allows some estimating of drug quantities; follow their protocols. Fax or call in the inventory prior to shipment. Identify all pharmaceuticals Complete paperwork and follow procedures as instructed by the returns company. Label all products. Use NDC wherever possible. Identify every pill. Provide product labels and NDC for spilled pills (as well as packaged products). Use shipping labels and return authorization labels as required by the returns company. Do not send wastes to the returns company. See the hazardous waste vendors directory on page 15 for companies that manage wastes. Advance notice, pre-approval and screening of proposed returns is usually required before a returns company will agree to accept a shipment. Package drugs to prevent breakage Choose sound packaging materials. Line shipping box with plastic in case of leakage. (Avoid using a red bag as a liner.) Pack pharmaceuticals carefully so containers don t break. Ensure tops are on securely, paying particular attention to liquids. Follow specific segregation policies provided by the returns company. Take special care when packing and labeling corrosives, inhalants, etc. to avoid accidents. Products inventoried and prepared for shipment by thirdparty shelf sweepers generally are packaged well and have very little refused due to leaking or damage; however, it is recommended that the client carefully oversee all paperwork accounting for credits. Complete DEA controlled substance paperwork Ship controlled substances only after completing an accurate inventory, the required paperwork, and obtaining approval for the shipment. Save ALL of your paperwork. 6

7 Resource Directory for Pharmaceuticals Management The following companies identify themselves as resources available to assist with the management of pharmaceutical returns, destruction or disposal. This directory is not all-inclusive. It represents the best effort by the Local Hazardous Waste Management Program in King County to compile practical information to help the King County, Washington health care industry manage unused and unusable pharmaceuticals. The information presented here was derived through surveys conducted in 2002 and Inclusion in this directory does not constitute endorsement of the companies listed. Company Name Capital Returns, Inc. Phone Website Reverse distributor for commercial establishments licensed to handle drugs. Accepts only unused sharps packaged with drug products; schedules II-V controlled substances, partially used legend drugs if still in original containers and samples. Company Name Certified Returns (L.L. Horizons) Phone Accepts expired, partially used, opened and dropped drugs, samples and schedules II-V controlled substances (for witnessed destruction). Accepts both used and unused sharps. Company Name Clean Harbors Environmental Services, Inc. Phone Website Hazardous waste incinerator accepts packaged hazardous and non-hazardous pharmaceutical waste and manages it all as hazardous. Accepts sharps packaged in an incinerable container. Awaiting infectious waste permits. Company Name Diversified Scientific Services, Inc. Phone Website Hazardous waste treatment, storage and disposal facility accepts only radioactive wastes. Company Name Envirotech Systems Phone Hazardous waste transporter/broker takes fixer and chemotherapy wastes and debris, but not chemotherapy drugs themselves. Company Name EXP Pharmaceutical Services Phone Website Accepts controlled substances, expired, partially used, opened and dropped drugs and samples unless declared waste by client or placed in red bags (it accepts neither); only unused prepackaged syringes. Customers include hospitals, doctor offices, fire departments, ambulance services, veterinarians. 7

8 Resource Directory for Pharmaceuticals Management Company Name Guaranteed Returns (Devos Ltd) Phone Website Reverse distributor provides credit for returnable drugs and witnessed destruction of controlled substances. Accepts recalled, damaged, expired, dropped and partial drugs and samples. Sharps accepted when packaged and labeled according to company protocols. Accepts OTC drugs. Company Name Inventory Management Company Phone Website Accepts schedules II-V controlled substances, expired, partially used, opened, damaged, sample, OTC and patient-returned drugs. License application in process to accept schedule I controlled substances. Company Name Keep It Clean Recycling & Equipment Phone Hazardous waste transporter/broker designates, picks up and disposes of legend drugs in King County. Company Name Kleen Environmental Technologies Phone Hazardous waste transporter/broker manages and takes to an incinerator chemotherapy, "U" and "P" listed wastes, state toxic wastes rejected by returns programs. Can provide outlet for destruction of controlled substances. Company Name LWD, Inc. Phone Website Waste treatment service provides recycling, fuels blending, incinerations, etc. Company Name Maximum RX Credit, Inc. Phone Website Reverse distributor provides credit on returnable drugs and destruction of non-returnable drugs. Accepts schedules II-V controlled substances. Accepts expired, partially used, opened and dropped drugs and samples. Company Name MedShop Phone Website Reverse distributor serves hospitals, nursing homes, veterinarians, clinics and pharmacies. Accepts expired, partially used, opened and dropped drugs and samples. 8

9 Resource Directory for Pharmaceuticals Management Company Name Onyx Environmental Services Phone Website Company Name Med-Turn, Inc. Phone Website Hazardous waste transporter/broker with hazardous waste incinerators can take legend drugs and oversee witnessed destruction of controlled substances. Accepts schedules II-V controlled substances. Accepts expired, partially used, opened drugs and samples; no loose pills or spilled liquids. Accepts only unused sharps in original packaging. Company Name National Pharmaceutical Returns, Inc. Phone Website Accepts expired and in-dated, partially used, opened, dropped drugs and samples, no waste. Accepts only unused sharps. Will determine what drug products accepted are actually waste. Company Name OneSource Returns (Excess Management Systems, Inc.) Phone Website Accepts full or partial expired drugs, schedules II-V controlled substances, only unused sharps. No waste drugs or samples accepted. Company Name P.S. Industries, Inc. Phone Health care consultant provides proper drug disposal service with all paperwork. Provides free guidance on processing credits for returned drugs. Accepts controlled substances, outdated, partially used, opened drugs and samples and only unused sharps. Does not accept chemotherapy drugs or patient returns. Company Name Pacific Industrial Resources (PIR) Phone Website Hazardous waste transporter/broker currently does not manage pharmaceutical wastes, but will if demand for services increases. Company Name PCI Phone Website RCRA treatment, storage and disposal facility accepts hazardous wastes and lab packs. Does not accept DEAregulated wastes or infectious wastes. 9

10 Resource Directory for Pharmaceuticals Management Company Name Philip Services Phone Website Hazardous waste treatment, storage and disposal facility and transporter manages x-ray and chemotherapy wastes. Small quantity generator drop-off service is available. Company Name Prime Environmental Services Phone Website Company Name Pharmaceutical Credit Corp. Phone Website Accepts schedules II-V controlled substances, expired, partially used, opened, dropped and OTC drugs and samples. Company Name Pharmaceutical Returns Service, Inc. Phone Reverse distributor and infectious waste management. Accepts schedules II-V controlled substances, expired, partially used, opened, dropped and OTC drugs and samples. Accepts both used and unused sharps. Company Name Pharmacy Software Solutions, Inc. (Direct Return) Phone Website Reverse distributor picks up drugs nationwide, provides mail-in service, pre-labeled bins for segregation, processes credits and provides destruction. Accepts schedules II-V controlled substances, expired, partially used, opened, dropped drugs and samples. Accepts sharps from households and patient returns. Hazardous waste transporter/broker accepts hazardous wastes lab-packed or in a DOT-approved container. Company Name Professional Returns Phone Reverse distributor accepts controlled substances, expired, opened, partially used and OTC drugs, samples and broken vials. Company Name Reliable RX Return, Inc. Phone Website Accepts schedules II-V controlled substances, unused injectables, expired, partially used, dropped and some OTC drugs and samples. Company Name Return Logistics International Corp. Phone Website Accepts schedules I-V controlled substances, expired, partially used, opened and dropped drugs and samples. Accepts some patient returns through pharmacies. Accepts product only and makes waste designation after receipt. 10

11 Resource Directory for Pharmaceuticals Management Company Name Return Solutions, Inc. Phone Website Reverse distributor provides credit for returnable drugs; provides destruction of drugs. Returns to customer drug waste that may designate as hazardous. Accepts schedules II-V controlled substances, expired, partially used, opened and dropped drugs and samples. Company Name Romic Environmental Technologies Corp. Phone Website Hazardous waste transporter and treatment, storage and disposal facility can accept schedule III wastes from semiconductor industry, but no other DEA-regulated wastes. Company Name RX Automation, Inc. Phone Website Can provide on-site service for very large sites. Accepts schedules II-V controlled substances, expired, partial or full drugs only. Does not accept samples or waste drugs or veterinary drugs for return. Accepts only unused sharps prepackaged with drug. Can facilitate disposal of damaged drugs and hazardous waste drugs through an incinerator. Company Name Safety-Kleen Phone Website Hazardous waste transporter and treatment, storage and disposal facility will make case-by-case determination of disposal methods based on materials to be disposed and regulatory factors. Allows third-party witnessed destruction at incinerator. Company Name SAI Transport Phone Website Reverse distributor offers destruction service only. Provides no credits. Accepts schedules II-V controlled substances, expired, partially used, opened, dropped drugs; samples, sweepings, dust and HVAC cleaning debris. Bottles must contain at least two ounces. Will not manage hazardous waste. Company Name Stericycle, Inc. of Arizona Phone Medical waste management company accepts sharps, but does not accept pharmaceuticals. Company Name Strong Environmental, Inc. Phone Website Reverse distributor offers destruction service only. Provides no credits. Accepts schedules I-V controlled substances, expired, partially used, opened drugs and samples. Will not accept hazardous waste or RCRAregulated drugs sent through mail. 11

12 Resource Directory for Pharmaceuticals Management Company Name Teris/ENSCO Phone Website Hazardous waste transfer facility and RCRA-permitted incinerator with treatment, storage and disposal facility. Recycling, witnessed destruction and other services available. Company Name Universal RX Solutions of Georgia Phone Website Reverse distributor accepts schedules II-V controlled substances, expired, opened, damaged, recalled, dropped and partially used drugs and samples for certain manufacturers. Accepts OTC drugs and consumer product returns from large grocery or pharmacy chains only. Company Name Universal RX Solutions of New Jersey Phone Website Reverse distributor accepts drugs for certain manufacturers, according to manufacturers' policies, including schedules II-V controlled substances. Accepts only a few OTC drugs that are returnable. Company Name Universal Solutions Phone Reverse distributor with seven companies in five states accepts legend drugs and schedules II-V controlled substances for destruction and credit with specific policies based on service location. Company Name USF Processors Phone Website usfc.com/usfprocessors/ Reverse distributor accepts schedules II-V controlled substances and legend drugs for credit processing and witnessed destruction. Accepts expired, partially used, dropped and opened drugs and samples. Company Name Von Roll WTI Phone Website Hazardous waste incineration company allows third-party witnessed destruction. 12

13 Reverse Distributors and Returns Companies These companies are licensed to accept controlled substances. Refer to the main directory on page 7 for contact information. Capital Returns, Inc. Certified Returns (L.L. Horizons) EXP Pharmaceutical Services Pick up in King County Pharmaceutical Returns Service, Inc. Pharmacy Software Solutions, Inc. (Direct Return) Pick up in King County Professional Returns Pick up in King County Guaranteed Returns (Devos Ltd) Inventory Management Company Maximum RX Credit, Inc. MedShop Med-Turn, Inc. National Pharmaceutical Returns, Inc. Pick up in King County Pick up in King County OneSource Returns (Excess Management Systems, Inc.) P.S. Industries, Inc. Pick up in King County Reliable RX Return, Inc. Return Logistics International Corp. Return Solutions, Inc. RX Automation, Inc. SAI Transport Strong Environmental, Inc. Universal RX Solutions of Georgia Universal RX Solutions of New Jersey Universal Solutions Pick up in King County Pharmaceutical Credit Corp. USF Processors 13

14 Sharps Management These companies manage sharps (syringes and needles) that may have contained pharmaceuticals. Used sharps are those that may have come into contact with bodily fluids. Refer to the main directory on page 7 for contact information. Capital Returns, Inc. Accepts only unused sharps packaged with drug products. Certified Returns (L.L. Horizons) Accepts both used and unused sharps. Clean Harbors Environmental Services, Inc. Accepts sharps when packaged in an incinerable container. Awaiting infectious waste transportation permits. Envirotech Systems EXP Pharmaceutical Services Accepts only unused prepackaged syringes. Guaranteed Returns (Devos Ltd) Accepts sharps packaged and labeled according to company protocols. Inventory Management Company Subcontractor handles sharps. Maximum RX Credit, Inc. Accepts only unused sharps packaged with returnable drugs. Med-Turn, Inc. Accepts only unused sharps in original packaging. National Pharmaceutical Returns, Inc. OneSource Returns (Excess Management Systems, Inc.) P.S. Industries, Inc. Pharmaceutical Returns Service, Inc. Accepts both used and unused sharps. Pharmacy Software Solutions, Inc. (Direct Return) Accepts used and unused sharps, even in small amounts, e.g., doctor s offices. Philip Services Can take unused sharps if packaged separately (e.g., in a one-gallon plastic jug). Professional Returns Accepts sharps. Progressive Return, Inc. Accepts sharps. Reliable RX Return, Inc. Accepts only unused injectables in original containers. Return Logistics International Corp. Return Solutions, Inc. Accepts only unused sharps packaged with unused drugs. RX Automation, Inc. Accepts only unused sharps prepackaged with drugs. Safety-Kleen Has a mail-in program for sharps. SAI Transport Stericycle, Inc. of Arizona Accepts used sharps and unused sharps without drugs. Teris/ENSCO Accepts sharps packaged in 5- or 30-gallon kiln-ready poly drums. Universal RX Solutions of Georgia Universal RX Solutions of New Jersey Accepts only unused sharps in original packaging. Requires special labeling and packaging to protect workers. Universal Solutions USF Processors Accepts only unused sharps in original packaging. Von Roll WTI 14

15 Hazardous Waste Management These companies specialize in the brokering, transport, treatment, storage and/or disposal of RCRA-regulated materials and waste and identified themselves as resources for pharmaceutical management. Refer to the main directory on page 7 for contact information. Clean Harbors Environmental Services, Inc. Hazardous waste incinerator accepts packaged hazardous, nonhazardous and infectious pharmaceutical waste and manages it as hazardous. Awaiting infectious waste transportation permits. Diversified Scientific Services, Inc. Hazardous waste treatment, storage and disposal facility accepts only radioactive wastes. Envirotech Systems Hazardous waste transporter/broker takes fixer and chemotherapy wastes, but not the chemotherapy drugs themselves. Keep It Clean Recycling & Equipment Hazardous waste transporter/broker designates, picks up and disposes of legend drugs in King County. Kleen Environmental Technologies Hazardous waste transporter/broker manages chemotherapy, "U" and "P" listed wastes and state toxic wastes rejected by returns programs by taking to incinerator. Can provide outlet to destroy controlled substances. LWD, Inc. Waste treatment service provides recycling, fuels blending, incineration, etc. Onyx Environmental Services Hazardous waste transporter/broker with hazardous waste incinerators can take legend drugs and oversee witnessed destruction of controlled substances. Pacific Industrial Resources (PIR) Hazardous waste transporter/broker currently does not manage pharmaceutical wastes, but will if demand for service increases. PCI RCRA treatment, storage and disposal facility accepts hazardous wastes and lab packs. Does not accept DEA-regulated wastes or infectious wastes. Phillip Services Hazardous waste treatment, storage and disposal facility and transporter manages x-ray and chemotherapy wastes. Small quantity generator drop-off service is available. Call for more information. Prime Environmental Services Hazardous waste transporter/broker accepts hazardous wastes labpacked or in a DOT-approved container. Romic Environmental Technologies Corp. Hazardous waste transporter and treatment, storage and disposal facility can accept schedule III wastes from semi-conductor industry, but no other DEA-regulated wastes. Safety-Kleen Hazardous waste transporter and treatment, storage and disposal facility will make case-by-case determination of disposal methods based on materials to be disposed and regulatory factors. Allows third-party witnessed destruction at incinerator. Teris/ENSCO Hazardous waste transfer facility and RCRA-permitted incinerator with treatment, storage and disposal facility. Recycling, witnessed destruction and other services available. Von Roll WTI Hazardous waste incineration company allows third-party witnessed destruction. 15