Guide for Dangerous Pharmaceutical Waste Generators in Washington State

Transcription

1 Guide fr Dangerus Pharmaceutical in Washingtn State Optins fr Managing Pharmaceutical Waste April 2008 The was develped t address questins and needs identified by the healthcare industry. Within its enfrcement discretin, Washingtn State Department f Eclgy (Eclgy) will refrain frm enfrcing prtins f the Dangerus Waste Regulatins [Chapter Washingtn Administrative Cde (WAC)] at facilities meeting the cnditins f the plicy. This guide prvides a summary f requirements fr managing pharmaceutical waste under: The Dangerus Waste Regulatins (regulatins). The (plicy). The fr State-Only Pharmaceutical Waste (exclusin). A generatr may chse t manage pharmaceutical waste under the Dangerus Waste Regulatins r the plicy. A generatr may als use the cnditinal exclusin fr state-nly pharmaceutical waste [] with either the Dangerus Waste Regulatins r the plicy. Pharmaceutical waste management can be a cmbinatin f all three clumns in this guide. Mst waste pharmaceuticals designate as either federal [Resurce Cnservatin and Recvery Act (RCRA)] hazardus waste r Washingtn statenly dangerus waste [WAC ]. In this dcument, dangerus waste (DW) includes bth RCRA hazardus waste and state-nly dangerus waste unless therwise specified. This guide des nt include all applicable dangerus waste requirements. Always refer t the Dangerus Waste Regulatins r the plicy fr mre detail. A generatr can als call a hazardus waste specialist at their nearest Eclgy Reginal Office (phne numbers belw). Additinal requirements frm ther agencies may als apply. If yu need mre infrmatin cntact yur nearest Eclgy reginal ffice: Central Reginal Office (509) Nrthwest Reginal Office (425) Eastern Reginal Office (509) Suthwest Reginal Office (360)

2 Requirements that Apply t All This clumn highlights sme f the requirements that apply t all dangerus waste generatrs in the state, including businesses that generate pharmaceutical waste. The Dangerus Waste Regulatins can be used in cmbinatin with the cnditinal exclusin and the in Healthcare. Applicability Fr purpses f this publicatin, this clumn applies t any pharmaceutical waste frm patient r animal care facilities and retail pharmacies. Requirements differ by generatr status: LQG Large Quantity Generatr. MQG Medium Quantity Generatr. SQG 1 Small Quantity Generatr. Waste Designatin Ntificatin and Identificatin Number All pharmaceutical waste must be designated (WAC ). RCRA ID # required fr MQG and LQG facilities. Dangerus Waste Regulatins This clumn highlights hw waste pharmaceuticals that are state-nly dangerus waste can be managed under the cnditinal exclusin. The cnditinal exclusin in the Dangerus Waste Regulatins excludes state-nly pharmaceutical waste frm the regulatins prvided all the cnditins are met. The cnditinal exclusin can be used with the Dangerus Waste Regulatins r the Interim Enfrcement Plicy in Healthcare. Pharmaceutical waste that designates as a state-nly dangerus waste (WAC ) and nt a federal RCRA waste. RCRA waste must be managed as hazardus waste. Waste that des nt meet the criteria f the cnditinal exclusin is subject t the full requirements f the Dangerus Waste Regulatins. Exclusin requirements apply t all, regardless f generatr status. All pharmaceutical waste must be designated (WAC ). RCRA ID # required fr MQG and LQG facilities. This clumn highlights the cnditins necessary t receive inspectr enfrcement discretin frm the Dangerus Waste Regulatins fr pharmaceutical waste. The plicy can be used in cmbinatin with the cnditinal exclusin and the Dangerus Waste Regulatins. The applies t pharmaceutical waste frm patient care facilities and retail pharmacies except radiactive pharmaceutical waste, anesthesia gases, r cmpunding chemicals. It des nt apply t nn-pharmaceutical waste. Facilities must fllw the management requirements f the plicy t receive enfrcement discretin. Nt fllwing the plicy requirements subjects the waste t the full requirements f the Dangerus Waste Regulatins. Plicy requirements apply t all, regardless f generatr status. Establish a prfile f all applicable waste cdes and apprximate quantities fr pharmaceutical waste. RCRA ID # required fr MQG and LQG facilities. Send Eclgy ntificatin f use f the plicy and a cpy f yur prfile. 2

3 Mnthly Waste Generatin Amunt Waste Accumulatin Amunt Accumulatin Time Limit Accumulatin Cntainer Standards Requirements that Apply t All Mnthly generatin f dangerus waste affects generatr status. (WAC (7 & 8), and -201). SQG less than 2.2 lbs f acutely hazardus waste (AHW) r extremely hazardus waste (EHW, specifically WT01 waste cde) and less than 220 lbs f dangerus waste (DW). MQG 220 lbs t 2200 lbs DW. LQG mre than 2200 lbs DW r mre than 2.2 lbs f AHW r WT01. LQG n limits. MQG/SQG n mre than 2,200 lbs at any ne time. Refer t WAC (8), and -200(1),(2). LQG 90 days. MQG 180 days. SQG n time limit. MQG/LQG gd cnditin, nnleaking, cmpatible with waste, clsed/prtected, 30 aisle space, respnse t spills, leaks and emergencies, weekly inspectins, separate incmpatible waste, cntainment system. SQG manage pharmaceutical waste in a way that des nt pse a threat t human health and the envirnment. Lcal regulatins may apply. Dangerus Waste Regulatins Mnthly generatin f dangerus waste affects generatr status. State-nly pharmaceutical waste managed under the exclusin des nt cunt tward generatr status. N limits fr applicable pharmaceutical waste. N limits fr applicable pharmaceutical waste. Accumulatin limits still apply t all ther dangerus wastes. Manage applicable pharmaceutical waste in a way that des nt pse a threat t human health and the envirnment. Mnthly generatin f dangerus waste affects generatr status. Pharmaceutical waste managed under the plicy des nt cunt tward generatr status. N limits fr pharmaceutical waste. 180 days fr all pharmaceutical waste. Accumulatin limits still apply t ther waste. Manage waste in a way that des nt pse a threat t human health r envirnment. Place absrbent material in the bttm f cntainers string liquid waste. Use cntainers cmpatible with their cntents. D nt mix incmpatible wastes. Keep accumulatin cntainers clsed unless adding r remving waste. Have spill cleanup materials and persnal prtective equipment n-site. Cllect dual waste in separate cntainers. 3

4 Cntainer Labeling Accumulatin Area Inspectins Persnnel Training Dispsal Requirements that Apply t All LQG / MQG: Dangerus Waste. Majr risk label (e.g., Ignitable, Crrsive, Txic ). Accumulatin start date. Refer t WAC (1)(c),(1)(d). SQGs: Majr risk labels Refer t WAC (8). Must be scheduled, dcumented, and deficiencies crrected. SQGs are nt required t inspect. Refer t WAC (1)(e),320(1),(2) (a), (b),(d),(3). Specific requirements vary by generatr status. LQG WAC (1)(e),-330. MQG WAC (2)(b). SQG nt required WAC (8). LQG / MQG: Ship t a RCRA permitted treatment, strage, dispsal (TSD) facility. Refer t WAC (1)(a). SQG: Must meet dispsal requirements as utlined in WAC (8)(b). Dangerus Waste Regulatins N requirements fr applicable pharmaceutical waste. Regulatin requirements still apply t all ther dangerus wastes. N requirements fr applicable waste but highly recmmended. Regulatin requirements still apply t all ther dangerus wastes. N requirements fr applicable waste. Regulatin requirements still apply t all ther dangerus wastes. Incinerate state-nly pharmaceuticals at either: A permitted municipal slid waste incineratr, r An incineratr meeting the fllwing criteria: Heat input f mre than 250 millin Btu/hr. Cmbustin zne f mre than 1500 F. Regulatin requirements still apply t all ther dangerus wastes. Nn-Viable Hazardus Pharmaceutical Waste. Dual waste is a cmbinatin f pharmaceutical and infectius waste. Majr risk label (e.g., Ignitable, Crrsive, Txic ). Accumulatin start date. Regulatin requirements still apply t all nnpharmaceutical dangerus wastes. N requirements fr pharmaceutical waste, but highly recmmended. Regulatin requirements still apply t all ther dangerus wastes. Apprpriate training fr handling f hazardus waste pharmaceuticals. Regulatin requirements still apply t all ther dangerus wastes. Ship t a RCRA permitted incineratr. State-nly pharmaceutical waste may be shipped t an incineratr that meets the exclusin criteria. Regulatin requirements still apply t all ther dangerus wastes. 4

5 Empty Cntainers Requirements that Apply t All Cntainers are empty and slid waste when: Emptied using all nrmal means, and Cntain less than 3% f cntainer capacity, and either Did nt cntain a pharmaceutical designating as P-listed (AHW) r WT01 (EHW), r Cntained a P-listed r WT01 EHW pharmaceutical and have been triple-rinsed (WAC ). Since rinsing pharmaceutical cntainers is nt practical, cntainers frm P-listed r WT01 pharmaceuticals are usually managed as dangerus waste. All chem cntainers shuld be managed as dangerus waste unless designatin infrmatin shws they are nt dangerus waste. Refer t WAC Sme examples f P-listed cntainers include used epinephrine syringes, physstigmine ampules, and IV bags frm arsenic trixide. Nte: Nrmal means f emptying pharmaceutical cntainers include fully depressing a syringe, fully administering an IV bag, and withdrawing all the cntents f a vial with a syringe. Dangerus Waste Regulatins Cntainers are empty and slid waste when: Emptied using all nrmal means, and Cntain less than 3% f cntainer capacity, and either Did nt cntain a pharmaceutical designating as P-listed (AHW) r WT01 (EHW), r Cntained a P-listed r WT01 pharmaceutical and have been triplerinsed (WAC ). Manage cntainers frm pharmaceuticals designating as WT01 EHW under WAC as dangerus waste r under the cnditinal exclusin (see Dispsal). Eclgy recmmends handling all empty chem cntainers as pharmaceutical waste. As a best management practice (BMP), empty chem cntainers nt frm a P-listed cmpund shuld be sent t an incineratr under the cnditinal exclusin. Nte: Nrmal means f emptying pharmaceutical cntainers include fully depressing a syringe, fully administering an IV bag, and withdrawing all the cntents f a vial with a syringe. Cntainers are empty and slid waste when: Emptied using all nrmal means, and Cntain less than 3% f cntainer capacity, and either Did nt cntain a pharmaceutical designating as P-listed (AHW) r WT01 (EHW), r Cntained a P-listed r WT01 pharmaceutical and have been triplerinsed (WAC ). Manage all empty chem cntainers as dangerus waste under the plicy unless they are designated and segregated. Manage P-listed cntainers as dangerus waste. Empty chem cntainers that did nt carry a P-listed chem may be sent t an incineratr under the cnditinal exclusin. Manage cntainers nt meeting the empty criteria as dangerus waste and sent t a RCRA permitted incineratr. Nte: Nrmal means f emptying pharmaceutical cntainers include fully depressing a syringe, fully administering an IV bag, and withdrawing all the cntents f a vial with a syringe. 5

6 Waste Cntrlled Substances Requirements that Apply t All Manifest waste cntrlled substances that are als hazardus waste t a RCRA permitted incineratr with Drug Enfrcement Administratin (DEA) registratin. Transprter must have a RCRA transprter ID # and DEA registratin. Dispsal f dangerus waste by any ther means, including sewer, sharps cntainers and linens, is nt allwed. Send nly viable cntrlled substances t reverse distributrs. Dual Waste Send t an incineratr permitted t accept bth RCRA hazardus waste and infectius r ptentially-infectius materials. Transprter must have a RCRA transprter ID # and meet infectius waste requirements. Dangerus Waste Regulatins Cntrlled substances that designate as state-nly pharmaceutical waste may be incinerated at a facility that meets the requirements f the exclusin (see Dispsal) and has DEA registratin. Transprter must be a DEA registrant. State-nly dual waste may be dispsed at an incineratr meeting the criteria f the exclusin and permitted t accept infectius r ptentially-infectius materials (see Dispsal). Transprter must meet infectius waste requirements. Waste cntrlled substances may be sent t either a: DEA-registered and RCRA permitted incineratr, r Reverse distributr if final dispsal is at an apprpriately permitted incineratr: Hazardus waste sent t a RCRA permitted incineratr. State-nly pharmaceutical waste sent t an incineratr that meets the cnditinal exclusin criteria. Partially administered cntrlled substances frm patient-care areas that cannt be returned t the pharmacy are nly eligible fr dispsal t sewer with authrizatin frm the sewer authrity. Send t an incineratr permitted t accept bth RCRA hazardus waste and infectius r ptentially-infectius materials. Transprter must have a RCRA transprter ID # and meet infectius waste requirements. State-nly dual waste can be segregated and managed under the cnditinal exclusin. 6

7 Chemtherapy Waste Requirements that Apply t All Send chemtherapy waste that is als dangerus waste t a RCRA permitted facility. Manage any materials cntaminated with RCRA listed chemtherapy agents (P- r U-) as RCRA hazardus waste. Manage any materials cntaminated with ther chemtherapy agents as dangerus waste unless designatin dcumentatin shws they are nt dangerus waste. Materials cntaminated with state-nly dangerus waste are eligible fr the cnditinal exclusin. Cntainers that held chemtherapy agents might be dangerus waste (see Empty Cntainers). Eclgy recmmends fllwing the NIOSH i Alert: Preventing Occupatinal Expsures t Antineplastic and Other Hazardus Drugs in Health Care Settings (2004), Label chemtherapy waste cntainers accrding t the OSHA ii Hazard Cmmunicatin Standard 29 CFR in additin t Eclgy requirements. Dangerus Waste Regulatins Waste cntaining chemtherapy agents designating as state-nly dangerus waste can be dispsed at an incineratr meeting the dispsal criteria abve (see Dispsal). As a BMP cnsider managing all bulk chemtherapy at a hazardus waste incineratr. Cntainers which held chemtherapy agents that designated as WT01 must either be managed as dangerus waste r under the cnditinal exclusin (see Empty Cntainers). Eclgy recmmends fllwing the NIOSH Alert: Preventing Occupatinal Expsures t Antineplastic and Other Hazardus Drugs in Health Care Settings (2004), Label chemtherapy waste cntainers accrding t the OSHA Hazard Cmmunicatin Standard 29 CFR in additin t Eclgy requirements. Dispse f all chemtherapy waste (bulk, trace and cntaminated materials) at a RCRA permitted incineratr, unless the RCRA hazardus waste is designated and segregated: Send RCRA hazardus chemtherapy waste t a RCRA permitted incineratr under the plicy. State-nly chemtherapy waste may be sent t either a RCRA permitted incineratr under the plicy r t an incineratr meeting the cnditins f the exclusin []. As a BMP, cnsider managing all bulk chemtherapy waste at a RCRA permitted incineratr. Cntainers that held chemtherapy agents might be dangerus waste (see Empty Cntainers). Eclgy recmmends fllwing the NIOSH Alert: Preventing Occupatinal Expsures t Antineplastic and Other Hazardus Drugs in Health Care Settings (2004), Label chemtherapy waste cntainers accrding t the OSHA Hazard Cmmunicatin Standard 29 CFR in additin t Eclgy requirements. i Natinal Institute f Occupatinal Safety and Health ii Occupatinal Safety and Health Administratin 7

8 Cntaminated Materials Reverse Distributin Manifest Exceptin Reprting Requirements that Apply t All Manage any materials cntaminated with P-listed r U-listed pharmaceuticals as a listed RCRA hazardus waste. Any materials cntaminated with ther dangerus waste pharmaceuticals must be managed as dangerus waste unless the cntaminated material designatin infrmatin shws it des nt designate. Send nly viable 2 pharmaceuticals t a reverse distributr. LQG / MQG: Must use a Unifrm Hazardus Waste Manifest [EPA Frm ]. Refer t WAC SQG: Bill f lading may be substituted. Refer t WAC (8). 45 days if signed manifest is nt received back frm TSD. Refer t WAC (2). Recrdkeeping Keep the fllwing recrds n-site fr 5 years: Manifests. Annual reprts. Exceptin reprts. Designatin dcumentatin. SQG nt required, but encuraged. Refer t WAC (2),(3)(a). Dangerus Waste Regulatins Materials cntaminated with pharmaceuticals that d nt designate as RCRA hazardus waste (WAC ), are eligible t be managed under the cnditinal exclusin. A generatr may manage cntaminated materials as slid waste nly when designatin infrmatin shws they are nt a state-nly dangerus waste. Send nly viable pharmaceuticals t a reverse distributr. N manifest requirements fr state-nly pharmaceutical waste managed under the cnditinal exclusin. Dcumentatin f shipment and dispsal is highly recmmended. State-nly pharmaceutical waste managed under the cnditinal exclusin des nt have any waste cdes. N requirements fr state-nly pharmaceutical waste managed under the exclusin. Nt required fr state-nly pharmaceutical waste, but highly recmmended. Recrds f shipment and dispsal may be required t shw prf f prper management under the cnditinal exclusin. Any materials cntaminated with pharmaceutical waste may be managed as pharmaceutical waste under the Interim Enfrcement Plicy. Send nly viable pharmaceuticals t a reverse distributr. Nn-viable waste cntrlled substances may be sent t a DEA-licensed reverse distributr if final dispsal is at an apprpriately permitted incineratr (see Waste Cntrlled Substances). Must use a Unifrm Hazardus Waste Manifest [EPA Frm ] fr all pharmaceutical waste managed under the plicy. 45 days if signed manifest is nt received back frm the permitted incineratr. Refer t WAC (2). Keep the fllwing recrds n-site fr 5 years: Manifests. Annual reprts. Exceptin reprts. Pharmaceutical waste prfile. Reverse distributr receipts/invices/credits. 8

9 Annual Reprting Transprtatin Requirements Exprt Requirements Requirements that Apply t All Dangerus waste pharmaceutical included and cunted tward generatr status. Required fr all generatrs with a RCRA ID #. Refer t WAC (8)(b)(iv), -220(1). Hazardus waste transprter required. Transprters must have all ther apprpriate licenses such as: Utilities and Transprtatin (UTC) Department f Transprtatin (DOT) Drug Enfrcement Administratin (DEA) WA State Bard f Pharmacy (BOP) SQGs may ship ff-site t a permitted TSD, a mderate risk waste facility, r t a permitted slid waste facility [WAC (8)]. Cmply with EPA exprt requirements as required by WAC (1). Recmmend fllwing Wrld Health Organizatin s Guidelines fr Drug Dnatins. Dangerus Waste Regulatins State-nly pharmaceutical waste excluded frm reprting and nt cunted tward generatr status. Nne by Eclgy. Transprters must have all ther apprpriate licenses such as: UTC, DOT, DEA, and BOP If incinerated ut f the US, EPA exprt requirements as required by WAC (1) must be met in additin t the cnditinal exclusin. 9 Exclude pharmaceutical waste managed under the plicy frm reprting and d nt cunt it tward generatr status. Hazardus waste transprter required. Transprters must have all ther apprpriate licenses such as: UTC, DOT, DEA, and BOP Cmply with EPA exprt requirements as required by WAC (1). Recmmend fllwing Wrld Health Organizatin s Guidelines fr Drug Dnatins. End Ntes: 1 SQG standards fr management under WAC can be fund at SQGs must designate their waste, manage it in a matter that prevents harm t human health and the envirnment, and dispse f pharmaceutical waste prperly. SQGs chsing t manage pharmaceutical waste under the must fllw the management utlined in the plicy t receive the enfrcement discretin. Nt fllwing the management utlined in the plicy subjects a facility t enfrcement f the Dangerus Waste Regulatins. 2 A nn-viable pharmaceutical is a pharmaceutical that cannt be used, sld, r returned t the manufacturer, whlesaler r reverse distributr fr credit. A viable pharmaceutical is a pharmaceutical that can be returned t a manufacturer, whlesaler, r reverse distributr fr credit. Any pharmaceutical dispsed withut credit is nn-viable. If yu need this infrmatin in an alternate frmat, please call the Hazardus Waste and Txics Reductin Prgram at If yu are a persn with a speech r hearing impairment, call 711, r fr TTY.