Office of Environmental AssistanceMichigan Department of Environmental - PDF document

1 Office of Environmental AssistanceMichig
Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 1 Revision July Why be concerned about pharmaceuticals? Pharmaceuticals are drugsthat areused to treat human and animal ailments. Some pharmaceuticals Incineration of pharmaceuticals prevents unused drugs from entering our water. Why was the ichigan ealth and Hospital ssociation (MHA)Health Care Pharmaceutical Waste Guide developedThere are manydifferent regulations that apply tothe hundreds of thousands of Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 2 Revision July Navigating environmental requirements, controlled substance regulations, medical professional licensingand the occupational safety drug handling requirements is complicated enough as it is. to that all of the newly developed pharmaceuticals, each with many different names and dosages, and you have an especially daunting taskof determining how to manage pharmaceutical wasteThis guide ismeant tosimplify the process of determining the management standards that applyto pharmaceutical and regulated medical wastein a manner that advocates a practical approach to incinerating pharmaceuticals as a best management practice(BMP. This guide providtarget compliance optionsformeetingthe waste regulationsin a manner that will facilitate proper handling formeeting the many other requirements that apply to pharmaceuticalsin a health care setting. This guide provides a toolto quickly eluate how to meetthe lawand regulations set forth by the manygoverning bodies.Most significantly, this guide simplifies the actions health care facilities can take to protect patients employees, as well as current and future generations from exposure to harmful ubstancesused in health care How do I use this waste guide?his guide does create any new regulatory requirements that a health care facility must meet. This guide is a tool that provides targetcompliance optionshealth carefacility canuseformanaging pharmaceutical and regulated medical waste. This guide advocates the use of best practices. This guide focuses strictlyon the environmentalwaste storage, transportation, and disposal requirements for handling bulkhazardous pharmaceuticalwaste, tracechemotherapywaste, universal waste pharmaceuti

2 cals, nonhazardous pharmaceutical wastea
cals, nonhazardous pharmaceutical wasteand mixed medicaldual wasteMoreover, this guide assumes that any health care facility using this guide is in compliance with the ironmentalquirements for waste characterization, personnel training, contingency planning, biennial reporting, regulated medical wastemanagement planningwell as anyother requirements that may apply.To gain a general understanding of the environmental regulations related to hazardous and nonhazardous liquid waste that apply to all Michigan businesses, please go to www.michigan.gov/deqworkshopsselect “DEQ Online LearningCurriculumand view the MDEQ online, ondemand recorded ntroduction to Hazardous Waste Regulation Webinars.To ensure a successful pharmaceutical wastemanagement programhealth care facilities should consider usingtheten step processfor managing pharmaceutical wasteTo develop a pharmaceutical waste management program, eachealth care facility must first characterize their entire pharmaceutical inventoryalong withother hazardous hazardous liquid waste, andmaintain a record of each waste determination. For pharmaceuticals, this requires a waste characterization determination foreach pharmaceutical at each dosageNewly purchased pharmaceuticals must be added to the pharmaceutical inventory acharacterized when they become a waste. After characterizing, the facility must evaluateon a continuousmonthlybasis whetherthe pharmaceuticals they generate that are defined ashazardous waste must be managed in accordance with the hazardous wasteregulations. This is determined by calculating the amount of hazardous waste generated at the facility (all contiguous property under the same ownership) each monthor determining thefacility’s hazardous waste generator statusOnly waste specifically approved for discharge tothe sanitary sewer by the local sanitary sewer authority may be disposed down the drain.Moreover, heavy loading of pharmaceuticalsto onsite septic systems, especially chemotherapy agents, can quickly cause even newly installed septic systems to fail. The pharmaceuticals take a huge toll on bacterial action in a septic tank. As such, the use of onsite septic systemat health care facilities with high levels of pharmaceutical use should be avoided. Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 3 Revision July ingthe mana

3 gement standards that best suits facilit
gement standards that best suits facility’scircumstancesfacility may segregatehazardouswaste pharmaceuticalsfrom hazardous pharmaceuticalor commingle all pharmaceuticalsIf segregatingpharmaceutical waste under this guide, the bulk hazardous pharmaceutical, trace emotherapy, nonhazardous pharmaceutical, and mixed medical/dual waste guide sheets would be used. Ifcomminglingpharmaceutical waste under this guidethe universal pharmaceutical, trace chemotherapy, and mixed medical/dual wasteguide sheets would be usedIf segregating pharmaceuticals under this guide, waste collectedin accordance with the bulk hazardous pharmaceutical guide sheet that does include spill cleanupwaste and does not include personal protective equipment may be managedin accordance with the universal waste guide sheet. This would minimize the volume of pharmaceutical waste destined for ultimate disposal ahazardous waste while providing the facility with the benefits afforded under the universal waste standards (e.g. allow for the collected waste to be accumulated/stored for up to a yearand the weight of the waste would not need to be included when determininggenerator status). resentlyonlybout percentof pharmacy’sinventoryis defined hazardouswasteoweverthe U.S. EPA is in the early stages of rulemaking to expand the list of pharmaceuticals defined as a hazardous waste to comport with the list of azardous drugs issued bythe National Institute for ccupational Safety and Health (NIOSH). Thisactionof increasing importance in light of tOffice of Inspector Generalfindingin May 2012 thatthe U.S. EPA’s inaction to expand this list may resultingin unsafe disposalIn light of these factors and the knowledge that pharmaceuticalsarepersistent in the environment, this guide advocates managing all NIOSH hazardous drugspharmaceuticals defined as a hazardous wasteand investigative chemotherapy agents in accordance with the hazardous waste regulationsas a BMP. Moreover, comminglinghazardous and nonhazardous pharmaceuticalsandmanaging theas a niversal astedestinedfor hazardous waste incinerationis the best environmental disposal option with the least long term impact on the environment. Segregated hazardous waste, as mentioned above, may also be managed as a universal waste to lessen the impact on generator status. hen considering the overhead cost associated with segregation (e.g.increased generator status, increased labeling,and increasedcontainer

4 maintenance, training, etc.)commingling
maintenance, training, etc.)commingling may ultimately themost cost effective optioneven when consideringthe increasedisposal cost.This is particularly true for facilities generating smaller volumes of pharmaceutical waste. Regulated medical wastewhich may include trace chemotherapycommingled with regulated medical wasteshould not be mixed with pharmaceutical waste so as to minimize disposal costssince mixed medical waste drives a premium st as resultof the additionalhandling requirements. How do I verify that this guidecomprehensively serves to meet other pharmaceutical regulations? Consistent with theten step procesfor managing pharmaceuticals, health care facilities should consider stablishinga team of pharmacyenvironmental, healthand safetyhousekeeping; and nursingstaff to determine what measures work best to handle pharmaceuticals in a manner thatsatiiesall the requirementsthat applyto their management in a health care settingThe regulations to be considered would include the U.S. EPA’s waste and water regulations, the MDEQ’s waste and water regulations, the Michigan Board of Pharmacypatientsafety regulationsthe NIOSHOccupational Health and Safety(OSHA) worker safety regulations, the American Nurses Associationworker safety regulationsany hospital accreditation agency’s regulations, and the U.S. Drug Enforcement Administration’s (U.S. DEA’s)controlled substance regulationsBe sure to oordinate with your disposal vendor(s) ensure they understand how you are collecting and managing your pharmaceutical and regulated medical wastein order to ensureyour facility meets the Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 4 Revision July various regulationsformanaging your waste, including the U.S. Department of Transportation (U.S. DOT) regulationsWhat regulations and guidelines were considered in creatingthis guide?The ederal esource onservation and ecovery ct () andTitle 40, Parts 260, of the Code of Federal Regulations40 CFR 260Part 111azardous Waste, of the Natural esource and nvironmental rotection ct (NREPA) and the Part 111 RulesPart 115Solid Waste Management, of the NREPAand the Part 115 RulesPart 121Liquid Industrial Waste, of the NREPAPart 138Medical Waste Regulatory Act, of the Public Health CodeAct 368(Act 368and the Part 138 RulesAct 138, Hazardous Materials Transpo

5 rtation Act (Act 138); Part 161, General
rtation Act (Act 138); Part 161, General Provisions, of Act 368;Part 177, Pharmacy Practice and Drug Control, of Act 368 (Board of Pharmacy) and the Part 177 Rules; NIOSH Guidelinesfor Controlling Occupational Exposure to Hazardous DrugsSHA Technical ManualOSHA Hazard Communication Standard29 CFR 1910.1200(g)and 49 CFR Parts 100Hazardous Materials and OilTransportation)Who do I contact for questions on this guide?Contact the MDEQ, Environmental Assistance Centerat 6629278 or deqassist@michigan.govfor questions this guide related to Michigan environmental regulations The MHA Health Care Pharmaceutical Waste Guide is published jointly by the MHA and the MDEQ. This guide is intended for guidance only and may be impacted by changes in legislation, rules, and regulations adopted after the date of publication. The guide makes every effort to help users evaluate how to meet applicable regulations. This guide advocates the use of BMP. The information in this guide does not constitute the rendering of legal advice. Diligent attention was given to assure that the information presented herein is accurate as of the date of publication; however, there is no guarantee, expressed or implied, that use of this guide will satisfy all regulatory requirements mandated by laws and their respective enforcement agencies. Reliance on information from this document is not usable as a defense in any enforcement action or litigation. The state of Michigan shall be held harmless for any cause of action brought on as a result of using of this publication. Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 5 Revision July Glossary of Terms Accumulation area means a hazardous waste storage area and does not include satellite accumulation area(s). For more information on hazardous waste accumulation, see the hazardous waste accumulation Webinarat www.michigan.gov/deqworkshopsunder DEQ Online Learning Curriculum,and Introduction to Hazardous Waste Regulations WebinarsAcute zardous astemeans waste that is an acute hazardous waste as defined under RCRA as defined in this guideThis includes all listed hazardous waste under the Michigan Part 111 rules and all other listed hazardous waste in the Michigan Part 111 rules witha hazard code of “HBMPmeans best management practiceBulk Hazardous Pharmaceuticalaste(Bulk Haz Pharm) isma

6 terial intended for discard that not RCR
terial intended for discard that not RCRA “empty, NIOSH hazardous drugs, investigative chemotherapy agents, spill cleanup materials from hazardous pharmaceuticals and contaminated personal protective equipment used with hazardous pharmaceuticals.For additional detail on what is a bulk hazardous pharmaceutical waste, please see the Bulk Hazardous Pharmaceutical Waste Guide Sheet providedas part of this guide.Chemotherapy meanschemical used to treat cancer.Closed ystem rug ransfer evicemeans a deviceused for hazardous drug compounding or administration that mechanically prohibits release of the hazardous drug(s) to the environment by containing the drug(s) in a systemthat preventsescape of the hazardous drug(s) or drug vapor(s)the environment outside the system. A closed system drug transfer device typically includes a needlewithin a protective device that functions to contain the hazardous drugConditionally exempt small quantity generator (CESQG) stands for a Conditionally Exempt Small Quantity Generator of hazardous waste and sitethat generates less than 100 kilograms or 220 pounds of acute hazardous waste, less than 2.2 pounds of acute hazardous wastein a calendar monthand never accumulates over 1,000 kilograms or 2,200 pounds of nonacute hazardous wasteor 1 kilogram or 2.2 pounds of acute hazardous wasteat any time Contingency lanis a plan for responding to an emergency situation (spill, fire, explosion, etc.) posed by the hazards associated with the waste handled at a site. Contingency planning requirements include a requirement to coordinate with local emergency planning officials for small large quantity generators of hazardous waste.DEAmeans Drug Enforcement Administration.DOT means United State(U.S.) Department of Transportation. Dual Waste, also commonly known as “mixed medical waste” means a mixture of regulated medicalaste that isinfectious waste and hazardous waste or nonhazardous liquid waste that is subject to Part 138 of Act 368 Part 111 (Hazardous Waste) of Act 451 or Part 138 of act 368 or Part 121(Liquid Industrial Waste) of Act 451, respectively. Mixed medical waste must be managed to meet all of the waste regulations that apply (e.g.a mixture of hazardous pharmaceuticals and infectious regulated medical waste must be managed to meet both the hazardous waste and regulated medical waste regulations).Foradditional detail on what is a dual or mixed medical waste, please see the Mixed

7 Medical/Dual Waste Guide Sheet provided
Medical/Dual Waste Guide Sheet provided as part of this guide. Hazardous Pharmaceuticalsas used in this guide includesNIOSH hazardous drugspharmaceuticals that are a RCRA hazardous waste as defined in this guide (includes Part 111 Michigan hazardous waste), and investigative chemotherapy agents Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 6 Revision July Hazardous Wasteis any waste that is alisted or characteristic hazardous waste(includes Part 111 Michigan hazardous waste as defined in this guide). Hazardous waste discharged via an authorization issued by the local sanitary sewer authority to the sanitary sewer is no longer a hazardous waste at the point of discharge to the sanitary sewer. For more information on the definition of hazardous waste, see the waste characterization and generator status Webinarat www.michigan.gov/deqworkshopsunder DEQ Online Learning Curriculum,and Introduction to Hazardous Waste Regulations Webinarsazardous waste generator statusis determined by counting the weight of all the hazardous waste generated at a site in a calendar monthThere are three generator categoriesunder the RCRA: Large Quantity Generator (LQG), Small Quantity Generator (SQG), and Conditionally Exempt Small Quantity Generator (CESQG). A site’s hazardous wastgenerator status is used to determine the handlingand disposalrequirements the generator must meet.The more hazardous waste a site generates, the more handling requirements must be metWhen calculating a site’s hazardous waste generator statustheweight of hazardous waste managed in accordance withthe Michigan universal waste regulations is not includedFor more information on hazardous waste generator status see the Webinarat www.michigan.gov/deqworkshopsunder DEQ Online Learning Curriculum,and Introduction to Hazardous Waste Regulations WebinarsInspection means a record documenting hazardous waste tank (daily) and/or container accumulation area(s) (weekly) inspections to verify there is/are no release(s) and/or to respond to release(s)required of SQG storing greater than 2,200 pounds nonacute hazardous waste LQG facilities, not CESQG or universal waste handlersmeans intravenous, within a vein, or administering by injection into a vein.When referring to an “IV” in healthcare, the reference is commonly used to describea bag of f

8 luid that is to be administered to the p
luid that is to be administered to the patient intravenously.Land Disposal Restriction(LDRs) are rules that require hazardous waste to be treated prior to being sposon land to destroy or immobilize hazardous constituents that might migrate into soil and ground water. The LDRrequire that SQGs and LQGs provide notification to each destination facility prior to shipment for each hazardous waste. The notification muststate whether the waste must be treated prior to being land disposand identify the underlying hazardous constituents in the waste requiring treatment Large quantity generator(LQG) stands for arge uantity enerator of hazardous waste and means asitethat generates equal to or greater than1,000 kilogramsor 2,200 pounds of acute hazardous waste and/or equal to our greater than 1 kilogram or 2.2 pounds of acute hazardous waste in a calendar monthor accumulates1 kilogram or 2.2 poundsr more of acute hazardous waste at any given time. Beyond meeting the SQG requirements, all LQGs must also have: econdary containmentfor the hazardous waste storage area(s),More elaborate recordkeeping,More elaborate traininEstablished and maintained a contingency planfor emergenciesLQGmust meet the land disposal restrictionsLQGs must alsosubmit a biennial reportand pay higher handler and manifest fees. Lmay storhazardous waste onsite forup todayswithout obtaining a hazardous waste storage license if the LQG accumulation/storage requirements are metLiquid ndustrial astemeansall liquidwastegenerated by business that not specifically excluded from the definition of liquid industrial waste is not listed amaterials not specified as liquid industrial waste.iquidsdischarged via an authorization issued by the local sanitary Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 7 Revision July sewer authority to the sanitary sewer are no longer a liquid industrial waste at the point of discharge to the sanitary sewer. Manifestmeans UniformHazardous WasteManifest form used for tracking waste from the site of generation to the site of treatment or disposalMedical wasteis referred to hereinas regulated medical waste. See the regulated medical waste definition.Medical Waste Management Plan All medical waste producing facilities as defined under Part 138 of ct 368 musthave a medical waste management planthat listand describethe ty

9 pe(s) of regulated medical waste produce
pe(s) of regulated medical waste produced bythe facility and the method(s) of packaging, storagetreatment,and disposal implemented to minimize exposure to infectious agents. ample plan is online atwww.michigan.gov/deqmedwasteMixed Medical Waste also commonly known as “dual aste” means a mixture of regulated medical, infectious wasteand hazardous waste or nonhazardous liquid waste that is subject to Part 138 of Act 368 Part 111 (Hazardous Waste) of Act 451 or Part 138 of act 368 Part 121(Liquid Industrial Waste) of Act 451, respectively. Mixed medical waste must be managed to meet all of the waste regulations that apply (e.g. a mixture of hazardous pharmaceuticals and infectious regulated medical waste must be managed to meet both the hazardous waste and medical waste regulations).For additional detail on what is a mixed medical or dual waste, please see the Mixed Medical/Dual Waste Guide Sheet provideas part ofthis guide. Nonmptymeans a container that has residue subject to the RCRA. See empty definition for clarification on when empty is achieved under the RCRA. Nonhazardous Pharmaceutical Waste (NonHaz Pharm)means pharmaceuticals that are not a listed or characteristic RCRA waste, a NIOSH hazardous drug, or an investigative chemotherapy agent. Nonhazardous pharmaceutical waste includes liquid, solid, paste, and aerosol harmaceuticals. For additional detail on what is a nonhazardous pharmaceutical waste, please seethe Nonhazardous Pharmaceutical Waste Guide Sheet provided as part of this guide. NREPAstands for the Natural Resources and Environmental Protection Act, Public Act 451 of 1994, as amendedOSHAstands for Occupational Health and Safety Administration.Part 111means the Michigan hazardous waste law found under Part 111, Hazardous Waste Management, of the Natural Resources and Environmental Protection Act, Public Act 451 of 1994, as amended, and the Part 111 hazardous waste rules.Part 1means the Michigan Part 121, Liquid Industrial Waste, of the NREPAPharmaceuticalmeansa drug intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or animals.means personal protective equipment and includes caps, gowns, shoe covers, safety glasses, etc. used to protect people from exposure to hazardous drugs.RCRAstands for the Resource Conservation and Recovery Act of 1976and, for the purposes of this guide, includes the requirements of Part 111 and the Part 111 ru

10 lesRegulated medical wasteincludes medic
lesRegulated medical wasteincludes medical waste as definedin the Medical Waste Regulatory Act, Part 138of Public Health Code, 1978PA 368as amendedPart 138 rulesregulated medical waste as definedin 49 CFR Parts 100 Hazardous Materials TransportationAND OSHABloodborne Pathogens as defined in 29 CFR 1910.1030 Regulated edical asteas used in this guide includes clinical waste and biomedical waste as defined under the U.S. DOT regulations and is also referenced as biohazardous waste. Regulated medical waste includesany fectious or potentially infectious wasteas well as used and unused sharps pursuant toPart 138egulated medical waste is required to be placed in medical waste containers nforming with all packaging and labeling requirements described in 49 CFR 173 Regulated medical waste does Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 8 Revision July not include waste pharmaceuticals, hazardous or nonhazardous. If pharmaceuticalwaste is mixed with regulated medical waste, the waste is subject to mixed medical/dual waste regulations. Regulated medical waste specifically includes any of the following waste that is not generated from a household, home health care agency, or home for the aged meeting definition of a household found 49 CFR 171.8 and is notan agricultural product as defined in the Federal Food, Drug, and Cosmetics Act Cultures and stocks of infectious agents and associated biologicals, includinglaboratory waste, biological production waste, discarded live and attenuated vaccines, culture dishes, and related devicesLiquid human and animal waste, including bloodblood productsand body fluids, but not including urine or materials stained with blood or body fluidsPathological wasteSharpsContaminated waste from animals that have been exposed to agents infectious to humans, these being primarily research animalsRegulated medical waste must be decontaminated through autoclaving, incineration, or an alternative method approved by the DEQ at a facility permitted to accept regulated medical waste. Regulated medical waste mixed with trace chemotherapywaste (a nonhazardous solid waste)must be incinerated. Trace chemotherapy waste should neverbe treated by autoclavingdue to the emissions and autoclave operator exposure hazards associated with the treatment of aterials that may contain chemotherapy

11 agentsIf pharmaceuticals are mixed with
agentsIf pharmaceuticals are mixed with medical waste, the mixture must be managed to meet the hazardous waste (hazardous pharmaceuticals) or liquid industrial waste (nonhazardous pharmaceutical) regulations ANDe regulated medical waste regulations. Reverse distribution/reverse distributor process carried out by a thirdparty that directsunwanted and outdated pharmaceuticals from health care facilities, including controlled substances in accordance with thU.S. DEA requirements, and returns them to the manufacturer for credit or arranges for their disposal. Satellite accumulation area(most likely a soiled utility room)means an area that is at or near the point of waste generation, under the operator’s (waste generator’s) control, and used toaccumulate no more than 55 gallons of acute hazardous waste or 1 quart of acute hazardous waste at any given time. The satellite accumulation area is where hazardous waste is initially accumulated prior to moving it to the storage area.SQG and LQG hazardous waste cannot be moved from one satellite containerlocation to another satellite container locationThe benefit of using a satellite containeris that it is not subject to the 90 or day storage limitation if the site is a SQG or LQG, respectively. Satellite containers at SQGs and LQGs must be legibly labeled with thewords “Hazardous Wastethe hazardous waste number(s)(i.e., P012the chemical name i.e.,ArsenicTrioxideor BulkHazPharmaceuticalsclosed when not in use.More than one satellite accumulationcontainer can be used in one location as long as the total volume does not exceed 55 gallons for nonacutely hazardous waste or one quart for acutely hazardous waste.Once the storage capacity limit has been reached, the satellite container(s) must be labeled with an accumulation start dateand the azardous waste number, then moved to the designated storagearea with secondary containment where requiredwithin three days.For more details on satellite accumulation, see Operational Memo 111and discuss youspecific circumstance withLocal District OfficeHazardous Waste Program staff.Small quantity generator SQGstands for Small Quantity Generator of azardous asteSQG produces more than 100 kilograms or 220 pounds of hazardous wasteless than 1,000 kilograms or 2,200 pounds of nonacute hazardous waste in a calendar monthless than Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________

12 ________________________________________
________________________________________ �� 9 Revision July 1 kilogram or 2.2 pounds of acute hazardous waste in a calendar monthSQGs never accumulated 6,000 kilograms or 13,200 of nonacute hazardous waste at any time SQGs must also meet the land disposal restrictionsand pay handler and manifest feesSQGmay store hazardous waste onsite for up to180 dayswithout obtaining a hazardous waste storage license if the SQG accumulation/storage requirements are metSpillfor purposes of this guide, means any visible hazardous pharmaceuticalthat was not contained and administered to a patient as intended. Spill generally includes any releasing, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing to the environment.Storage areameans the hazardous waste storage areaand does not include satellite accumulation area(s)Trace ChemotherapyWaste(Trace Chemo) includes materials intended for discard that are not known to becontaminated with hazardous pharmaceuticalsbut were used in administering hazardous pharmaceuticals and have been exposed tohazardous pharmaceuticals. This can include empty IV bags/bottles/vials/containers and syringes. It may also include infectiousbiohazardous, regulated medical waste, in which case it must be managed as a regulated medical ste.For additional detail on what is a trace chemotherapy waste, please see the Trace Chemotherapy Waste Guide Sheet provided as part of this guide.TSDFstands for a hazardous waste treatment, storage, or disposal facility that is licensed under the RCRA to receive hazardous waste fortreatment, storage, or disposalof the hazardous waste.Universal Waste Pharmaceutical(Universal Pharm)means a waste pharmaceutical managedin accordance with streamlined universal waste standards adopted for specific, common, hazardous waste types.Pharmaceuticals have been a universal waste type in Michigansince December 16, 2004, and in Floridasince April 22, Universal Waste Pharmaceuticals includes RCRA/Part 111 pharmaceuticals intended for discard, their containers that are not RCRA “empty,” NIOSH hazardous drugs, and investigative chemotherapy agents. Nonhazardous pharmaceuticals may included; however, once mixed are all subject to RCRA/Part 111 universal waste regulationsUniversal Waste Pharmaceuticals includes only drugs. It does not include spill cleanup materialsfrom hazardous pharmaceuticalpillsor contaminate

13 d personal protective equipment used wit
d personal protective equipment used with hazardous pharmaceuticals. For additional detail on what is universal waste pharmaceutical, please see the Universal Waste Pharmaceutical Guide Sheet provided as part of this guideNote too that the satellite container requirements for SQG and LQGhazardous wastedo not apply to universal waste pharmaceuticals managed under the universal waste standards.Waste haracteristicmeans ignitable, corrosive, reactive, or toxic as defined under the RCRAseverelytoxic as defined under Part 111 of the NREPAWaste characterizationis the process of determining the waste type using the steps specified by the RCRAMichigan’snonhazardous liquid waste regulations, and other applicable waste regulations. Generally, a waste is either a hazardous,liquid industrial(nonhazardous liquid, or hazardous solid waste under the waste regulations. However, waste may also be subject to more than one waste regulation if it is also a regulated medical waste(e.g. mixed medical wastedual waste), radiological waste, or subject to the Toxic Substance Control ActMichigan also has some additional “U” listed hazardous wastetypes. When documenting a waste characterization determination, the documents must be available in writing and made available upon requestfor 3 year from the last date of offsite shipment or onsite treatment or disposalommonlylarge health care facilitieswith pharmacies willuse thefacilitpharmacformulary Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 10 Revision July (inventory)to document the waste type determination(e.g. hazardous, nonhazardous liquid, nonhazardous solid)then maintain relevant supportingdata (e.g.Material Data Safety Sheetsetc.)with other waste records (e.g. manifests, land disposal restriction notices, etc.). As new products, including pharmaceuticalsare used at the health care facility, they must be evaluated to determine how the waste must be handled. For more information on waste characterization, also see the waste characterization Webinarat www.michigan.gov/deqworkshopsunder DEQ Online Learning Curriculum,and Introduction to Hazardous Waste Regulations WebinarsWaste Data Systemis the datasystemused by the DEQ to track wasterelated activities. It can be accessed at http://www.deq.state.mi.us/wdspi/AdvancedSearch.aspx Office of Environmental Assi

14 stanceMichigan Department of Environment
stanceMichigan Department of Environmental Quality______________________________________________________________________ �� 11 Revision July BulkHazardous PharmaceuticalsWasteMHA Health Care Pharmaceutical Waste Management GuideSheetWhat is Bulk Hazardous PharmaceuticalWaste (Bulk Haz PhaBulk azardous pharmaceuticalwaste or BulkHaz Pharmincludes pharmaceuticalsintended for discard that are a RCRA hazardous wasteas defined inthis guide, NIOSH hazardous drugsand investigative chemotherapy agents. Bulk Haz Pharmincludes spill cleanup materials from hazardous pharmaceuticals;contaminated personal protective equipmentused with hazardous pharmaceuticals;mptycontainers used with hazardous pharmaceuticals vialsampulesIVsbottles, tubing, and syringes with no sharpsBulk Haz Pharmincludes closed system drug transfer devices and sharpsused for armacy compounding of hazardous pharmaceuticalsnoninfectiousif approved by the disposal vendor. Bulk Haz Pharmdoes not include closed system drug transfer devices sharpsused administhazardous pharmaceuticalsto patientBulk Haz Pharmis not to include fluids and/or devices removed from intracavity installationsunless approved by the vendor as noninfectiousBulk Haz Pharm does not include unused and intact pharmaceuticals in their original packagingdirected for sale and reuse for its original intended purposeCheck with your disposal vendor to determine whether Mixed Medical/Dual Waste includes losedsystem drug transfer devices used in hazardous pharmaceutical compounding, sharps used in hazardous pharmaceutical compounding, and fluids and/or devices removed from intracavity hazardous pharmaceutical installationsWhat is Included Bulk Haz Pharm RCRA/Part 111 hazardous waste pharmaceuticals NIOSH h azardous drugs Investigative chemotherapy agents P - listed hazardous wast e pharmaceuticals N on - E mpty containers , including vials, ampules, IVs, bottles, tubing, and syringes with no sharps Materials used in hazardous pharmaceutical spill cleanup including PPE (gowns, gloves, shoe covers, absorbent pads, absorbent materials) C ontaminated items used in hazardous pharmaceutical compounding C ontaminated PPE used in hazardous pharmaceutical compounding and administration Pharmacy containers that held hazardous pharmaceuticals Closed system drug transfer devices and sharps use d in pharmacy compounding of hazardous pharmaceutic

15 als with approval as noninfectious
als with approval as noninfectious by disposal vendor Fluids and/or devices removed from intracavity hazardous pharmaceutical installations with approval as noninfectious by disposal vendor Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 12 Revision July Notepty and nonmpty containers (ampules, vialsIVs, and closed system drug transfer devices used in compounding) used with hazardous pharmaceuticals may be segregated from spill materials and managed as niversal aste in Michigan. See the Universal Pharmaceutical Waste Guide SheetWhat is xcluded from Bulk Haz Pharm Closed system drug transfer devices and sharps used in pharmacy compounding of hazardous pharmaceuticals without approval as noninfectious by disposal vendor Fluids and/or devices removed from intracavity hazardous pharmaceutical installations without approval as noninfectious by disposal vendor Closed system drug transfer devices and sharps used in administration of a hazardous pharmaceutical to a patient Empty , undamaged unit dose pac kaging / containers used to administer P - listed hazardous pharmaceuticalcompressedor coatedtablet(s), capsul(s), andgum to a patient if there are no visible residues in the container (non - hazardous solid waste) Note: excluded Bulk Haz Pharmitemswithout vendor approval as infectious, see the Mixed Medical/Dual Waste Guide Sheet Containeronstructed of material that is compatible with the wasteSpill, leakand punctureproofKept closed except during active addition or removal of waste to/from the containerMeettheDOT packaging regulationsSeparate incompatibles (ignitables and oxidizers)Satellite Area LabelingLabel with words “Hazardous Waste”Label waste as “Bulk Haz Pharmaceuticalsor chemical nameove satellitecontainero storage area when full or within three days of collectingquart ofacute hazardouswasteor 55 gallonsof nonute hazardous waste, whichever occurs firstacute hazardous wasteabel with accumulation date and waste codes when moved storagearea AccumulationLabel Storage and TransportationMaintain label as Hazardous Waste” Maintainlabel with content waste code(s) Maintain label with accumulation dateProtectfrom we

16 ather, firephysical damage, and vandalsS
ather, firephysical damage, and vandalsSeparate incompatiblesInspect weekly Provide secondary containment for liquids Do not store over 90 days LQGor over 180 days SQG ShippingLabel Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 13 Revision July Transport usingpermitted/registered hazardous waste transporter Use Uniform Hazardous Waste Manifest as shipping documentComply with DOT requirements Attach proper shipping labelfor transportDispBulk Haz Pharmmust be transported to a licensed hazardous waste TSDFin Michigan, an state equivalent facility, or a facility otherwise authorized to accept hazardous waste pharmaceuticalsIncinerationis the BMP for all pharmaceuticalsIncineration at a licensed hazardous waste TSDFis required for Plisted and Ulisted RCRA pharmaceuticals and any pharmaceuticals mixed with Plisted or Ulisted RCRA pharmaceuticals perthe RCRA Land Disposal RestrictionrequirementsRecordeepingMaintain records at least threeyearsWaste characterization determination(most likely from facility pharmaceutical formulary analysisand support records(MSDS)Monthly waste inventoryisposal estriction notificationsMaintain Uniform Hazardous Waste nifest copies and send copy to the MDEQ by 10thday of month following shipment Accumulation area inspection logsTraining records Note:Materials managed as Bulk Haz Pharm must be included inthe monthly hazardous waste generator statusdetermination Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 14 Revision July Trace ChemotherapyWasteMHA Health Care Pharmaceutical Waste Management GuideSheetWhat is Trace ChemotherapyWaste(Trace Chemo Trace Chemotherapyaste or Trace Chemoincludes solid materials intended for discard that are notknown to be contaminatedwith chemotherapy agents but were exposed to chemotherapy agents and are nota hazardous wasteThis material includes uncontaminated personal protective equipmentempty packaging, vialsampules,IVsbottles,tubing. These materials do not include hazardous pharmaceuticalor chemotherapy agentspill cleanup materials. Trace Chemomay includeregulated medical wastelike syringes used in administration of chemotherapy agentsWhere desirable, likelarge inf

17 usion clinics, race Chemowaste can be co
usion clinics, race Chemowaste can be combined withbiohazardousregulated medical waste to eliminate the need for additional containers. However, if biohazardous, regulatedmedical waste is combined with uncontaminated PPE and empty chemotherapycontainers(nonhazardous solid waste), Trace Chemo Trace Chemowithout must be incinerated at a facility authorized to accepthazardous medical wastesolid waste and regulated medical waste,and the containers mustproperlylabeled and managedas aiohazardous, regulated medical waste. What is ncluded in Trace Chemo Pharmacy items , except containers, tubing and sharps, not known to be contaminated used in preparation of chemotherapy agentslike: PPE (gowns, gloves, bouffant caps, shoe covers)Absorbent pads Disposable wipes E mpty hazardous pharmaceutical containers , including vials, ampules, IVs, bottles, and tubing Nursing tems not known to be contaminatedand used in administration of chemotherapy agentslike:PPE (gowns, gloves, bouffant caps, shoe covers)Absorbent pads Disposable wipes Closed system drug transfer devices and sharps used in administration of a chemotherapy agents to a patient (medical waste) 1 Where desirable, likelarge infusion clinics, race Chemowaste can be combined with regulated medical waste to eliminate the need for additional containers. However, the combined waste must be incineratedat a facility authorized to accept nonhazardous solid waste and regulated medical wasteand the containers must be properly labeled and managed as an infectious, Biohazard Symbol iohazardousregulated medical waste. Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 15 Revision July What is xcluded from Trace Chemo RCRA/Pa rt 111 hazardous waste pharmaceuticals Non - hazardous liquid and solid pharmaceuticals unless the incinerator is authorized to incinerate non - hazardous pharmaceuticals NIOSH h azardous drugs Investigative chemotherapy agents Pharmacy items like: ontaminateditems used in hazardous pharmaceuticalcompoundingNonmpty containers used in hazardous pharmaceutical compoundingAcutehazardous waste containers used for compoundingMaterials used in hazardous pharmaceuticalspill cleanup including PPE (gowns,g

18 loves, bouffant caps, shoe covers, absor
loves, bouffant caps, shoe covers, absorbent pads, disposable wipes)Closed system drug transfer devices and sharps used in compounding hazardous pharmaceuticals Nursing items used in hazardous pharmaceuticaladministration like: Partially filled/infused hazardous pharmaceuticalsincluding bags, bottles, tubingMaterials used in hazardous pharmaceutical spill cleanup including PPE (gowns, gloves, shoe covers, absorbent pads, absorbent materials, and bouffant caps) Fluids and/or devices removed fromintracavity hazardous pharmaceutical installations Non - empty hazardous pharmaceutical containers Note:Items excluded from Trace Chemomust follow appropriate hazardous waste disposal requirements and be managed as Bulk Haz PharmUniversal Waste rmaceuticalNonhazardous Pharmaceutical, or Mixed Medical/Dual WasteGuide SheetsContainerCompatible with the waste Spill, leakif containing regulated medical waste, punctureproof Kept closed except duringactive addition of waste to containerMeettheDOT packaging regulations Satellite Area and Labeling Label container “Trace Chemo Incineration Only” or “Trace Chemo Medical WasteIncinerationnly” Move sealed containers to torage rea within threedays of container being threefourthsfull (routinely)if containing regulated medical wasteDate container when waste is first added to the containerchedule pickup when full or 90 days from date when use of container initiated Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 16 Revision July Close when not actively adding wasteSatellite area must be securedfrom unauthorized access to wasteStorage AreaSecure from weather, firephysical damage, and vandalsInspect weekly Do not store over 90 daysfrom date of first use of container (satellite and storage combineMaintain labelTransportationComply withtheDOT requirementsAttach proper shipping labelUse a properly prepared shipping document, generally bill of ladingRecordeepingShipping papers or manifest are required to be signedMaintain trainingrecords Inspection of storage areas (BMP) Maintain Medical Waste Management PlanDisposalTrace Chemomust be transported to a facility properly licensed or otherwise authorized to accept regulated medical waste, if mixed with regulated medicalwasteIncineration is the Bfor Trace Chemo Incineration is required for

19 Trace Chemo mixed with regulated medical
Trace Chemo mixed with regulated medical wasteTrace Chemo cannotbe treated by autoclaveTrace ChemoRegulated Medical aste must be disposed of 90 days from the first day waste placed in the container. Start date begins when waste is first added to the container Note:Trace Chemois notincludedin the monthlyhazardous waste generator statusdetermination Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 17 Revision July UniversalWastePharmaceuticMHA Health Care Pharmaceutical Waste Management Guide SheetWhat Universal WastePharmaceuticalUniversal Pharm)Universal Waste Pharmaceuticalor Universal Pharmincludeharmaceuticals that cannot be usedor administered because of expiration, contamination, or any other reasonUniversal Pharm may be liquid, solidpaste, or aerosol,and includedrugs identified as Ulistedlisted hazardous waste, andcharacteristic hazardous wasteUniversal Pharm includeNIOSH hazardous drugs anddrugs that are not currently regulated but considered hazardousUniversal Pharmincludefull or partially used pharmaceutical containers. Universal Pharmnot include infectious, biohazardousregulated medical wastepharmaceutical spill cleanup waste, or personal protective equipment contaminated with pharmaceuticals. Universal Pharm donot includeunused and intact harmaceuticals in their original packagingdirected for resale and reuse for its original intended purposeCheck with your disposal vendor to determine whether Mixed Medical/Dual Waste includes losedsystem drug transfer devices used in hazardous pharmaceutical compounding, sharps used in hazardous pharmaceutical compounding, and fluids and/or devices removed from intracavity hazardous pharmaceutical installationsNoteUniversal Pharm can include nonhazardous solid and liquid pharmaceuticals. When hazardous pharmaceuticals are mixed with Universal Pharm waste, the entire mixture must be managed as a Universal Pharm. at is ncluded in Universal Pharm RCRA/Part 111 hazardous waste pharmaceuticals NIOSH h azardous drugs Investigative chemotherapy agents N on - E mpty hazardous pharmaceutical containers , including vials, ampules, IVs, bottles, and tubing without sharps Closed system drug transfer devices and sharps used in pharmacy compounding of hazardous pharmaceuticals with approval as noni

20 nfectious by disposal vendor Fluids
nfectious by disposal vendor Fluids and/or devices removed from intracavity hazardous pharmaceutical installations with approval as noninfectious by disposal vendor What is xcluded from Universal Pharm Closed system drug transfer devices and sharps used in pharmacy compounding of hazardous pharmaceuticals without approval as noninfectious by disposal vendor Fluids and/or dev ices removed from intracavity hazardous pharmaceutical installations without approval as noninfectious by disposal vendor Materials used in hazardous pharmaceuticalspill cleanup including PPE (gowns, gloves, shoe covers, absorbent pads, absorbent materi als) C ontaminated items used in hazardous pharmaceutical compounding Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 18 Revision July Contaminated PPE used in hazardous pharmaceutical compounding and administration Closed system drug transfer devices and sharps used in administration of a hazardous or non - hazardous pharmaceutical to a patient Note: excluded UniversalPharmitems without vendor approval as noninfectious, see the Mixed Medical/Dual Waste Guide Sheet Container and LabelingCompatible with the waste Separate incompatible materialsLabeled niversal aste harmaceuticalKept closed except to add or remove wasteMeet the DOT packaging regulations Date container when waste is first added to containerSatellite and Storage AreaBe secured from weather, fire, physical damage, and vandalsSeparate incompatible materialsInspected weekly (BProvide secondary containment(BMP)TransportationOccur within one year of accumulationBe in compliance with the DOT requirementsAccompanied by a Uniform ManifestDisposalDisposal must ultimatelyinclude treatment and/or destruction at a hazardous waste TSDF Universal Pharmmay also be transported to another universal waste handlerwithin the State of Michiganprior to ultimate disposalUniversal Pharmmust ultimately be transported to a licensedhazardous waste TSDFin Michigan, an outstate equivalent facility, or a facility otherwise authorized to accept the hazardous waste pharmaceuticalsIncineration is the Bfor all pharmaceuticalsIncineration at a licensed hazardous waste TSDFis required for Plisted and Ulisted RCRA pharmaceuticals and any pharmaceuticals mixed with Plisted or Ulisted RCRA pharmace

21 uticals per the RCRA Land Disposal Restr
uticals per the RCRA Land Disposal Restriction requirementsUniversal Pharm, when managed inMichiganmust be managed in compliance with the liquid industrial waste requirements Note: The weight of Universal Pharm notincluded in the monthlyhazardous waste generator statusdeterminationresently only Michigan and Florida have adopted pharmaceuticals as a universal waste typeTherefore, upon crossing the Michigan state line, Universal Pharm become Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 19 Revision July subject to e otherstate’s lawsWhen manifesting Universal Pharm, note in box 14 of the Uniform Manifestthatthe waste was managed as Universal Waste Pharmaceuticalin Michiga Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 20 Revision July NonHazardous PharmaceuticalWasteMHA Health Care Pharmaceutical Waste Management Guide SheetWhat Nonhazardous Pharmaceutical Waste(Nonhaz Pharm) Nonazardous Pharmaceutical Waste or Nonaz Pharmincludesall pharmaceuticals that are nota listed or characteristic RCRA waste, not a NIOSH hazardous drugand not an investigative chemotherapy agent. hazardous Pharm waste includeliquidsolid, paste, and aerosol pharmaceuticals.Nonhazardous Pharm Waste does not include unused and intact hazardous pharmaceuticals in their original packaging directed for resale and reuse for its original intended purpose Note:Conditionally Exempt Small Quantity Generator (CESQG) hazardous pharmaceutical waste may be excluded from regulation as a hazardous waste if records demonstrating the exempt generator status are maintained and the waste is managed as a Nonhaz Pharm. However, due their unique handling requirements, CESQG should consult with their disposal vendor to determine how to manage CESQG hazardous waste. Moreover, Nonhazardous Pharm waste may be commingled with Universal Pharm waste and managed as a Universal Pharmdestined for hazardous waste incineration. What is ncluded in Nonhaz Pharm Non - hazar dous pharmaceuticals in all forms - liquid, solid, paste , or aerosol Non - hazardous pharmaceutical spill cleanup materials Household pharmaceuticals E mpty hazardous pharmaceutical containers not containing acute hazardous wast

22 e, including vials, ampule s, IVs, bot
e, including vials, ampule s, IVs, bottles, and tubing What is xcluded from Nonhaz Pharm RCRA/Part 111 hazardous pharmaceutical NIOSH h azardous drugs Investigative chemotherapy agents N on - empty hazardous pharmaceutical containers , including vials, ampules, IVs, bottles, a nd tubing Closed system drug transfer devices used in pharmacy compounding or administration of hazardous pharmaceuticals Materials used in hazardous pharmaceutical spill cleanup including PPE (gowns, gloves, shoe covers, absorbent pads, absorbent mate rials) C ontaminated PPE used in hazardous pharmaceutical compounding and administration Sharps Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 21 Revision July Infectious materials/biohazardous materials (medical waste) including: Closedsystem drug transfer devices and sharps used in administrationof a hazardous pharmaceutical to a patient Fluids and/or devices removed from intracavity hazardous pharmaceutical installations Pharmacy items like: ontaminateditems used in hazardous pharmaceuticalcompoundingNonempty containers used in hazardous pharmaceutical ompoundingAcutehazardous waste containers used for compounding Materials used in hazardous pharmaceuticalspill cleanup including PPE (gowns, gloves, bouffant caps, shoe covers, absorbent pads, disposable wipes) Nursing items used in hazardous pharmaceu tical administration like: Partially filled/infused hazardous pharmaceuticalsincluding bags, bottles, tubing Materials used in hazardous pharmaceutical spill cleanup including PPE (gowns, gloves, shoe covers, absorbent pads, absorbent materials, and b ouffant caps) Containeronstructed of material that is compatible with the wasteSpill, leakand puncture proofept closed except during active addition of waste tothe containerSeparate incompatiblesMeet the DOT packaging regulations StorageLabelingLabel waste as “NonHazardous PharmaceuticalsSeparate incompatiblesSecure from weather, firephysical damage, and vandalsManage to prevent escape to the environment TransportationTransport usingpermitted/registeretransporterliquid industrial waste transporterUse Uniform Hazardous Waste Manifest as shipping documentor other shipping document if only solid pharmaceuticalsComply with DOT requirements Dispo

23 salNonhazardous Pharm, when transported
salNonhazardous Pharm, when transported to a Michigan facility, must be transported to a facility notified as a designated facility receiving liquid industrial wasteDisposal must occur at a disposalfacility authorized to accept hazardous pharmaceutical wasteor licensed hazardous waste TSDFncineration is the BMP for all pharmaceuticals Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 22 Revision July RecordeepingMaintain records at least threeyearsWaste characterization determination(most likely from facility pharmaceutical formulary analysisand support records (MSDS)Monthly waste inventory(generator status records) if managing as exempt hazardous waste Maintain Uniform Hazardous Waste Manifest copies and send copy to the MDEQ by 10thday of month following shipment or other shipping document if only solid pharmaceuticals NoteNonHazardousPharmaceuticalsthat are not a characteristic or listed hazardous waste and are not CESQG hazardous waste are included in the monthly hazardous waste generator status determination Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 23 Revision July Mixed Medical/Dual WasteMHA Health Care Pharmaceutical Waste Management Guide SheetWhat Mixed MedicalDual WasteMixed edicalDual Wasterefers to regulated medical waste mixed with hazardous waste hazardous liquid waste. When regulated medical waste is mixed with waste subject to these regulation, the waste becomes subject to the management standards under both regulations due to the unique hazards associated with biohazardousregulated medical waste. Regulated medical wastemixed with pharmaceuticalwaste cannot be autoclaved. Mixed Medicalal Waste included vaccinations with live or attenuated viruses that are a RCRA/Part 111 hazardous waste (e.g. vaccinations preserved with thimerosal) and pharmaceutical waste inadvertently mixed with infectious, biohazardous, regulated medical waste. Check with your disposal vendor to determine whether Mixed Medical/Dual Waste includelosedsystem drug transfer devices used in hazardous pharmaceutical compounding, sharps used in hazardous pharmaceutical compoundingand fluids and/or devices removed fromintracavity hazardous pharmaceutical installations. What is ncluded in Mixed Me

24 dicalDual Pharmaceutical Waste Vaccinati
dicalDual Pharmaceutical Waste Vaccinations with live or attenuated viruses and a RCRA/Part 111 hazardous waste pharmaceuticals (e.g. vaccinations preserved with thimero sal ) Closed system drug transfer devices and sharps used in pharmacy compounding of hazardous pharmaceuticals with out approval as noninfectious by disposal vendor Fluids and/or devices removed from intracavity hazardous pharmaceutical installations with o ut approval as noninfectious by disposal vendor Pharmaceutical waste inadvertently mi x ed with infectious/biohazardous materials (medical waste) What is xcluded from Mixed Medical Dual Pharmaceutical Waste Waste included in the Bulk Haz Pharm, Trace Chemo , Universal Pharm, and Non - hazardous Pharm Guide Sheets ContainerCompatible with the wasteSpill, leakpunctureproof Thickleakproof liner Separate incompatible materialsKept closed except duringactive addition of waste to containerMeettheDOT packaging regulations Date container when waste is first added to container Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 24 Revision July SatelliteArea and LabelingLabel with words “Hazardous Waste”Label container “Pharmaceutical & Medical WasteIncinerationnly”Locate secure satellite area as near as possible to where waste is generatedMove satellite container to storage area when full or within three days of collectingquart ofacute hazardouswasteor 55 gallons of nonacute hazardous waste, whichever comes firstabel with waste codes when movedstorageareaDo not store over 90 daysfrom date of first use of container (satellite and storage combined)Storage AreaMaintain label as Hazardous Waste” Maintainlabel with content waste code(s)Maintain label “Pharmaceutical & Medical WasteIncinerationnly”Protectfrom weather, fire, physical damage, and vandalsSeparate incompatible materialsInspect weekly Provide secondary containmentMaintain Label “Hazardous Waste Pharmaceutical & Medical WasteIncinerationnly”Add hazardous waste codes to labelDo not store over 90 daysfrom date of first use of container (satellite and storage combined)TransportationTransport usingpermitted/registered hazardous waste transporterUse Uniform Hazardous Waste Manifest as shipping documentComply with DOT requirements Attach proper shi

25 pping labelDisposalMixed Medical/Dual Ph
pping labelDisposalMixed Medical/Dual Pharmmust be transported to a licensed hazardous waste TSDFcineratorMichiganan outstate equivalent facility at is also authorized to dispose of infectious, biohazardous, medical wasteIncinerationis required for mixed medical/dual wasteIncineration at a licensed hazardous waste TSDFis required for Plisted and Ulisted RCRA pharmaceuticals and any pharmaceuticals mixed with Plisted or Ulisted RCRA pharmaceuticals per the RCRA Land Disposal Restriction requirementsHazardous pharmaceuticals after administration and use by a patient are not a hazardous waste subject to RCRA, but are included in the Mixed/Medical Dual Guide Sheet as a BMP Office of Environmental AssistanceMichigan Department of Environmental Quality______________________________________________________________________ �� 25 Revision July RecordeepingMaintain records at least threeyearsWaste characterization determination(most likely from facility pharmaceutical formulary analysisand support records (MSDS)Monthly waste inventoryisposal estriction notificationsSQG or LQGMaintain Uniform Hazardous Waste Manifest copies and send copy to the MDEQ by 10thday of month following shipment Medical Waste Management PlanAccumulation area inspection logsif LQGTraining records if LQG Note: Materials managed as Mixed Medical/Dual Pharm must be included inthe monthly hazardous waste generator statusdetermination Office of Environmental Assistance Michigan Department of Environmental Quality ______________________________________________________________________ �� 1 Revision July Why be concerned about pharmaceuticals? Pharmaceuticals are drugsthat areused to treat human and animal ailments. Some pharmaceuticals are toxic (chemotherapy agents) while others function to cause more limited physiological changes. Unused pharmaceuticals are problematic because they do not readily break down once released to the environment. As such, they generally remain intact and can be absorbed by other plants, animals, and/or humans.What is the environmentally preferred disposal option for unused pharmaceuticals? The preferred disposal method for unused pharmaceuticals is incineration. Incineration is preferred because of its high burn temperatures and effective emissioncontrol systems, which prevent unused drugsfrom cycling back intoour water Incineration of pharmaceuticals prevents unused drugs from entering

26 our water. Why was the ichigan ealth a
our water. Why was the ichigan ealth and Hospital ssociation (MHA)Health Care Pharmaceutical Waste Guide developed? There are manydifferent regulations that apply tothe hundreds of thousands of pharmaceuticalsmanufactured today. Under the U.S. Environmental rotection gency (U.S. EPA)and the Michigan Department of nvironmental uality (MDEQ)environmental regulations, unused medications that can no longer be used for their original intended purpose are waste. aste harmaceuticals from Michigan businesses canbe classified as a hazardouswasteliquidindustrial waste,nonhazardous solid waste, or a mixed medical waste(also referred to as “dual” waste The waste classification depends on the character, nature, and composition of the waste. It also depends on what types of waste are mixed together. Because pharmaceutical waste is a common waste, the MDEQ has established pharmaceutical waste as a universal wastetype that can be managed under streamlined hazardous waste standards. Complicating the waste classification determination further is the fact that the less hazardous waste a site generates, the less regulation they mustmeetand the more disposal options available to the site. To determine the level of management that must be metand how pharmaceuticals must be disposed, each site mustcharacterize each of thewastestreams, evaluate how the waste is mixed with other waste types, determine how much hazardous waste igenerated on a monthlybasisBased on this information, they can determine the waste classification. Ultimately, pharmaceutical waste should not be mixed with regulated medical waste unless specific decision to do so is made asit results in the highestdisposal costdue to the additional management requirements that must be met. When evaluating a site’s hazardous waste generator status, hazardous waste from medicaland diagnostic tests and services e.g., xylene, methanol, etc.from histology, cytology, pathology, and chemistryfrombuildingmaintenance (fluorescent bulbs, batteries, computers, and degreasing solvents); and from pharmaceutical preparation infusion/dispensingand vaccinations) all need to be evaluated for inclusion in the monthly hazardous waste generator status determination, which must be documented to prove the management standards a site must meetwhen managing hazardous waste ̀Ȁ�ሀȀ\t؀\rጀ଀܀؀က\tЀ଀؀က฀؀܀\t᐀ጀ\f܀؀\rԀ؀ᄀጀ\tሀ̀؀ༀ؀\n\t฀\tༀáŒ