April 2008 1 07-04-024

Interim Enforcement Policy 

Pharmaceutical Waste in Healthcare 

The Washington State Department of Ecology (Ecology) is announcing an interim enforcement policy for 

pharmaceutical waste. Within its enforcement discretion, Ecology will refrain from enforcing portions of the 

Dangerous Waste Regulations [Chapter 173-303 Washington Administrative Code (WAC)] at facilities meeting 

the conditions of this policy. 

Eligible facilities may use this policy to manage all pharmaceuticals, as defined by RCW 69.04.009, that are (1) 

non-viable or (2) discarded for any reason. Facilities may not use this policy for non-pharmaceutical waste, 

radioactive pharmaceutical waste, or anesthesia gases. 

This is not a new rule. This policy provides an option to the existing rules for managing pharmaceutical waste. 

Any pharmaceutical waste not managed according to this policy is subject to full regulation under the Dangerous 

Waste Regulations. 

Why do we need this policy? 

The presence of pharmaceuticals in the environment is a worldwide concern. Recent studies identified 

pharmaceutical contaminants in the waterways of thirty US states, including Washington1

. Current wastewater 

treatment technology does not remove all pharmaceuticals. Using the sewer, regulated medical waste containers, 

or landfill to dispose of pharmaceutical waste contributes to the contamination of groundwater, surface water, and 

drinking water. The size of this waste stream will continue to grow due to the increased use of pharmaceuticals. 

Many waste pharmaceuticals designate as either federal [Resource Conservation and Recovery Act (RCRA), 

WAC 173-303-080 and -090] hazardous waste or Washington state-only dangerous waste [WAC 173-303-100]. 

In this document, dangerous waste includes both RCRA hazardous waste and state-only dangerous waste unless 

otherwise specified. 

It can be difficult to manage pharmaceutical waste in compliance with the Dangerous Waste Regulations and the 

regulations of other agencies. The goals of this policy are to (1) protect human health and the environment, (2) 

simplify compliant pharmaceutical waste management, and (3) clarify compliance standards. 

The US Environmental Protection Agency (EPA) and other states are in the process of considering options for 

how to best manage pharmaceutical waste. This policy will remain in effect until Ecology addresses this waste 

stream through rule making or modifies this policy. 

Who can use this policy? 

Eligible facilities include: 

 Patient care facilities. Hospitals, acute care facilities, outpatient surgery centers, practitioner offices, clinics, 

dental offices, nursing units, ambulatory clinics, and veterinary care facilities. 

 Retail pharmacies. Businesses that dispense pharmaceuticals to the consumer. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

2 

Ineligible facilities include: 

 Unlicensed facilities. Facilities not authorized by the Washington State Board of Pharmacy (BOP) to 

dispense and manage pharmaceuticals. 

 Drug manufacturers. Businesses that prepare, derive, manufacture, or produce pharmaceuticals from raw 

materials. This does not include compounding in a pharmacy. 

 Drug wholesalers. Businesses that sell or distribute for resale pharmaceuticals to any entity other than the 

consumer. 

 Reverse distributors. Businesses taking back viable pharmaceuticals for credit. 

 Research laboratories. 

What are the benefits of following this policy? 

Facilities that manage pharmaceutical waste according to the requirements of this policy receive the following 

benefits: 

 Use of a representative profile of the pharmaceutical waste (three month minimum) instead of continuously 

designating under WAC 173-303-070(3). 

 Accumulation of pharmaceutical waste for up to 180 days. 

 Quantity Exclusion Limits do not apply to pharmaceutical waste. 

 Pharmaceutical waste does not count toward generator status. 

 Pharmaceutical waste does not have to be reported on the Dangerous Waste Annual Report. 

What are the generator requirements? 

; Profile Your Waste. Complete a pharmaceutical waste profile by determining: 

 The waste codes that apply to pharmaceutical waste at your facility. 

 A representative percentage range by weight for each waste pharmaceutical. You can do this by using 

generator knowledge. 

For example: 

*Note: Washington State Department of Ecology considers salts of epinephrine, including epinephrine hydrochloride, epinephrine borate, 

and epinephrine bitartrate to also be P042 waste since the epinephrine is still the sole-active ingredient. The salt acts primarily as a 

carrier by facilitating solution of the epinephrine. It is not an active ingredient. Epinephrine products in combination with other drugs, 

like lidocaine, are not P042 since lidocaine is also an active ingredient. 

Waste 

Code Waste Description 

Minimum % of 

Pharmaceutical Waste 

(by weight) 

Maximum % of 

Pharmaceutical Waste 

(by weight) 

P001 Warfarin (Concentration > 0.3%) 2% 5% 

P012 Arsenic Trioxide 1% 5% 

 P042* Epinephrine, including containers 5% 15% 

P075 Nicotine, including containers 1% 5% 

U010 Mitomycin 5% 10% 

U058 Cyclophosphamide 5% 15% 

D001 Silver nitrate 1% 3% 

D009 Mercury 10% 25% 

D013 Lindane 5% 10% 

--- Conditionally excluded state-only 

pharmaceutical waste 7% 65% 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

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Send your initial profile to Ecology with your notification (see the Notify Ecology section below). Update your 

waste profile at least every three years or whenever significant changes are made to your facility’s operations. Do 

not send updated profiles to Ecology. Current pharmaceutical waste profiles must be kept on-site and are subject 

to inspection. For additional information refer to Ecology publication #07-04-026, Profiling and Notification 

Fact Sheet. 

; Notify Ecology. Send notification to Ecology at the address below, indicating that your facility is managing 

pharmaceutical waste under this policy. The notification must be signed by the pharmacy manager and the 

environmental manager. Include a copy of your completed profile(s). 

Department of Ecology 

Hazardous Waste and Toxics Reduction Program 

P2 & Regulatory Assistance Section 

PO Box 47600 

Olympia, WA 98504-7600 

; Train Your Staff. All staff involved in pharmaceutical waste management must be trained. Training must 

cover appropriate safety and emergency procedures, proper waste management, and recordkeeping. 

; Accumulate Waste. Accumulate pharmaceutical waste in a manner that reduces accidental releases and 

provides reasonable protection for safety, security, and the environment. You must: 

 Place absorbent material in the bottom of containers storing liquid waste. 

 Use containers compatible with their contents. 

 Do not mix or store incompatible wastes in the same container. 

 Keep accumulation containers closed unless adding or removing waste. 

 Keep spill cleanup materials and personal protective equipment on-site. 

 Label containers with the words “Non-Viable Hazardous Pharmaceutical Waste.” 

 Label containers with all appropriate risk labels such as “Ignitable”, “Corrosive”, or “Toxic.” 

 Label containers with an accumulation start date. The start date begins when the first item is placed in the 

container. 

 Limit accumulation to 180 days. No quantity limits apply to the accumulation of pharmaceutical waste prior 

to transportation. Check with your local fire marshal for regulations that may apply to your accumulation 

area. 

 Segregate and package pharmaceutical waste according to the U.S. Department of Transportation (DOT) 

regulations for shipment. 

; Dispose of Waste Properly. Manage all pharmaceutical waste according to this policy or the Dangerous 

Waste Regulations. Pharmaceutical waste managed under this policy must be incinerated at a RCRA permitted 

incinerator. Your facility can choose to separate RCRA waste from state-only pharmaceutical waste. State-only 

pharmaceutical waste may be incinerated according to this policy or the conditional exclusion [WAC 173-303-

071(3)(nn)]. 

 Under this policy, pharmaceutical waste must be: 

o Sent to a RCRA permitted incinerator on a Hazardous Waste Uniform Manifest regardless of generator 

status. 

 State-only pharmaceutical waste may be segregated and managed under the conditional exclusion 

[WAC 173-303-071(3)(nn)]. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

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 Under the Dangerous Waste Regulations, pharmaceutical waste must be: 

o Sent to a RCRA permitted incinerator on a Hazardous Waste Uniform Manifest, except: 

 Small Quantity Generators are not required to use a manifest and have additional disposal options as 

listed in WAC 173-303-070(8)(b)(iii). 

 State-only pharmaceutical waste may be sent segregated and managed under the conditional 

exclusion [WAC 173-303-071(3)(nn)]. 

o Counted and reported annually as described in WAC 173-303-060(5). 

o Accumulated on-site as prescribed in WAC 173-303-170(3)(a) based on generator status. 

 Manage dangerous waste which is also infectious, “dual waste”, under the Dangerous Waste Regulations or 

this policy. 

o Send dual waste designating as dangerous waste to a RCRA permitted facility also permitted to accept 

infectious materials. 

o Send dual waste designating as state-only dangerous waste to an incinerator meeting the requirements of 

the conditional exclusion [WAC 173-303-071(3)(nn)] and permitted to accept infectious materials. 

o Transport dual waste following DOT requirements for hazardous and infectious materials. 

 Only the following pharmaceutical wastes are eligible for sewer disposal with written approval from your 

local wastewater discharge and permit authority: 

o Saline, dextrose and sterile water solutions without vitamins or other additives. 

o Partially administered doses of controlled substances wasted by witnessed destruction in patient care 

areas only. Note: Unused controlled substances from patient-care areas should be sent back to the 

pharmacy whenever possible (see Use the Reverse Distribution System section below). 

; Empty Containers. Containers that held pharmaceuticals may be dangerous waste. Containers include but 

are not limited to: 

 Syringes 

 IV bags and tubing 

 Vials 

 Ampoules 

 Under this policy, an “empty” container may be considered solid waste. A container is “empty” when it 

meets all the following criteria: 

o All commonly used practices for emptying the type of container have been applied, and 

o The remaining waste is 3% or less of the capacity of the container, and 

o Containers from a pharmaceutical whose sole active ingredient is listed under WAC 173-303-9903 for 

“P” wastes have been triple-rinsed. 

o Some examples of when an empty container is solid waste: 

 A fully administered IV bag that contained nitroglycerin is not a listed waste since the medicinal 

formulation of nitroglycerin is not P-listed. The empty IV bag can be considered solid waste. 

 Mitomycin C is a dangerous waste but not a P-listed waste. If the drug is fully administered to the 

patient and remaining residue is less than 3% of the capacity of the IV bag, it is solid waste. 

 A syringe that contained morphine is considered “empty” when the contents have been fully 

administered to the patient by fully depressing the plunger. You can manage this “empty” syringe in 

an appropriate sharps container. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

5 

 You must manage the following containers as dangerous waste: 

o Containers not meeting all the “empty” criteria listed above. 

o Containers from chemotherapy agents. 

 Unless you identify and segregate P-listed chemotherapy containers, all chemotherapy containers 

must be managed as dangerous waste. 

o Some examples of when a container is dangerous waste: 

 A vial, syringe, or IV bag that contained epinephrine or epinephrine hydrochloride is still a P042 

listed waste, regardless of how much remains in the vial, since it is not practical or safe to triple-rinse 

the vial. 

 A vial, syringe or IV bag that held arsenic trioxide is a P012 listed waste, regardless of how much 

remains in the bag, since it is not practical to triple-rinse the bag. 

; Use the Reverse Distribution System. The following materials are eligible for reverse distribution: 

 Viable pharmaceuticals. (See definitions) 

 Waste controlled substances. Both viable and non-viable controlled substances can be sent to a Drug 

Enforcement Administration (DEA) licensed reverse distributor. You must ensure that: 

o Any controlled substances that designate as a RCRA hazardous waste are sent to a RCRA permitted 

incinerator. 

o The remaining controlled substances must be incinerated at a facility meeting the requirements of the 

conditional exclusion. 

Non-viable pharmaceuticals, that are not controlled substances, must be managed as pharmaceutical waste under 

this policy or the Dangerous Waste Regulations. To determine whether a pharmaceutical is viable: 

 Check the definition of non-viable. If a pharmaceutical cannot be used for its intended purpose, sold or 

returned for credit, and cannot be sent to the reverse distributor it is inherently “waste-like”. 

 Contact your reverse distributor. If a pharmaceutical can be credited, it may be sent to the reverse 

distributor. Follow the manufacturer’s or reverse distributor’s handling guidelines to ensure credit. 

 Check your inventory reports. Review inventory reports to verify that an item was given a credit. Items 

not credited should be considered non-viable in the future unless you have documentation to support the 

change in status. 

Note: If a pharmaceutical that previously was non-viable can be returned for credit, it is now a viable 

pharmaceutical. You should maintain communication records with your manufacturer or reverse distributor to 

support this change in status. 

Consistently sending non-viable pharmaceuticals to a reverse distributor is a violation of the Dangerous Waste 

Regulations and this policy unless: 

 Transportation and final disposal comply with requirements of the Dangerous Waste Regulations or this 

policy, and 

 The reverse distributor has a RCRA Treatment, Storage or Disposal Facility (TSDF) Permit or complies with 

the transfer facility requirements of WAC 173-303-240(6). 

; Keep Records. The following records must be available for inspection on-site for five years: 

 Pharmaceutical waste profile. 

 Uniform Hazardous Waste Manifests. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

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 Reverse distributor inventory reports. 

 All appropriate transfer paperwork for the destruction of controlled substances including a Form 222 for 

Schedule II pharmaceuticals and an inventory for all other schedules. 

; Other Applicable Regulations. At a minimum, all facilities are subject to the following sections of the 

Dangerous Waste Regulations: 

 WAC 173-303-050: Department of Ecology cleanup authority. 

 WAC 173-303-145: Spills and discharges into the environment. 

 WAC 173-303-960: Special powers and authorities of the department. 

What are the transporter requirements? 

Transporters of dangerous waste pharmaceuticals must: 

 Maintain a current RCRA ID number as a Hazardous Waste Transporter. 

 Meet all the dangerous waste transporter requirements under WAC 173-303-240. 

 Meet all DOT transportation requirements for shipping hazardous materials and waste, including 49 CFR and 

WAC 173-303-190. 

Transporters of viable and non-viable pharmaceuticals must also maintain all necessary licenses with the BOP 

and/or DEA for the handling of pharmaceuticals. 

What are the export and donation requirements? 

All pharmaceutical waste exports must comply with EPA export requirements under 40 Code of Federal 

Regulations (CFR) Part 262 Subparts E & H. Records of the pharmaceutical export must be kept on-site and are 

subject to inspection. 

Ecology encourages facilities to follow the World Health Organization’s (WHO) Guidelines for Drug Donation

[http://www.who.int/inf-pr-1999/en/pr99-45.html]. The WHO’s core principles ask donors to ensure that 

pharmaceutical donations: 

 Are of maximum benefit to the recipient. 

 Respect the wishes and authority of the recipient. 

 Strictly avoid any double standards in quality. 

 Are based on effective communication between donor and recipient. 

________________________ 

1 Kolpin, D.W., Furlong, E.T., Meyer, M.T., Thurman, E.M., Zaugg, S.D., Barber, L.B., and Buxton, H.T., 2002, Pharmaceuticals, 

hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000--A national reconnaissance: Environmental Science 

and Technology, v. 36, no. 6, p. 1202-1211. 

Johnson, A., Carey, B., and Golding, S., November 2004, Results of a Screening Analysis for Pharmaceuticals in Wastewater Treatment 

Plant Effluents, Wells, and Creeks in the Sequim-Dungeness Area: Environmental Assessment Program, Washington State Department of 

Ecology, Publication Number 04-03-051. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

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Definitions 

The following terms are for the purpose of the Interim Enforcement Policy for Pharmaceutical Waste in Healthcare

only. Some of the terms are defined in the Dangerous Waste Regulations and others were written to provide clarity for 

pharmaceutical waste managed under this policy. 

Conditional exclusion [WAC 173-303-071(nn)]. Pharmaceutical that designates as state-only dangerous waste 

and not a RCRA waste is eligible for management under the conditional exclusion to the Dangerous Waste 

Regulations. 

If managed as prescribed in the exclusion, the state-only pharmaceutical waste does not need to be counted towards 

generator status and does not need to be reported annually. The conditional exclusion requires the incineration of stateonly pharmaceutical waste at either: 

(i) A facility permitted to incinerate municipal solid waste; or 

(ii) A controlled combustion unit with: 

(A) heat input greater than 250 million British Thermal Units per hour (BTUs/hr), and 

(B) combustion zone temperatures greater than 1500 °F. 

The conditional exclusion does not apply to any RCRA hazardous pharmaceutical waste. 

Dangerous waste. Any waste that designates under WAC 173-303-070(3). Dangerous waste includes both RCRA 

hazardous waste and state-only dangerous waste. 

Dual waste. Dangerous waste pharmaceuticals that are also infectious or potentially infectious. Examples of dual 

waste include non-empty syringes containing dangerous waste pharmaceuticals with needles attached. 

P-listed hazardous waste. Any commercial chemical products in which the listed chemical is the sole active 

ingredient. Pharmaceuticals are commercial chemical products. A commercial chemical product is a substance 

manufactured or formulated for commercial or manufacturing use which consists of the commercially pure grade of the 

chemical, any technical grades of the chemical, and all formulations in which the chemical is the sole active ingredient. 

Non-viable pharmaceutical. A pharmaceutical that cannot be used for its intended purpose, sold, or returned to the 

manufacturer, wholesaler, or reverse distributor for credit. This may include, but is not limited to: 

 Expired pharmaceuticals. 

 Outdated items repackaged at the pharmacy. 

 Dropped pills. 

 Partial IVs, ampoules, ointments, creams, lotions 

and inhalers. 

 Patient medications left at the hospital. 

 Samples. 

RCRA hazardous waste. For the purposes of pharmaceutical waste, RCRA hazardous waste refers to any 

pharmaceuticals that designate as dangerous waste under WAC 173-303-080 through -090. RCRA hazardous wastes 

include lists of certain discarded chemical products, manufacturing/industrial processes, or wastes with hazardous 

characteristics of ignitability, corrosivity, reactivity, or toxicity. 

Reverse distribution. The practice of shipping unwanted, viable pharmaceutical products to a third party with the 

intent of receiving manufacturer credit. 

State-only dangerous waste. Washington considers toxicity and persistence as criteria used to designate waste as 

dangerous in addition to the RCRA listing and characteristics. For the purpose of this policy, state-only dangerous 

waste refers to any pharmaceutical waste designating as dangerous waste under WAC 173-303-100 that is not a RCRA 

hazardous waste. 

Viable pharmaceutical. A pharmaceutical that can be used for its intended purpose or returned to a manufacturer, 

wholesaler, or reverse distributor for credit is viable. Viable pharmaceuticals are not subject to the Dangerous Waste 

Regulations since they are considered product-like. Any pharmaceutical disposed without credit is non-viable unless 

there is a documented change in credit status by the reverse distributor. 
Interim Enforcement Policy: Pharmaceutical Waste in Healthcare 

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Additional Resources 

 Washington State Department of Ecology Hazardous Waste and Toxics Reduction Program: 

o Additional guidance to the Interim Enforcement Policy for Pharmaceutical Waste in Healthcare

 Ecology Publication #07-04-025, Quick Guide to Pharmaceutical Waste Management 

 Ecology Publication #07-04-026, Profile and Notification 

o Managing Pharmaceutical Waste Web site: 

http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/index.html

o Regulatory Information & Assistance: 

http://www.ecy.wa.gov/programs/hwtr/reg_comp_guide/index.html 

o Hazardous Waste Service Provider: http://www.ecy.wa.gov/apps/hwtr/hwsd/default.htm 

 Washington State Board of Pharmacy Web site: 

https://fortress.wa.gov/doh/hpqa1/HPS4/Pharmacy/default.htm

 Washington State Utilities and Transportation Commission: http://www.wutc.wa.gov/ 

 US Drug Enforcement Administration: http://www.deadiversion.usdoj.gov/ 

 US Department of Transportation: http://www.dot.gov/

 Practice Greenhealth (formerly Hospitals for a Healthy Environment - H2E) 

o http://www.practicegreenhealth.org 

o Managing Pharmaceutical Waste – a 10-step Blueprint: http://cms.h2eonline.org/ee/hazmat/hazmatconcern/pharma/ 

 Maryadele J. O’Neil, Patricia E. Heckeman, Cherie B. Koch, Kristin J. Roman, Catherine M. Kenny (2006). 

“The Merck Index (14th ed.). Whitehouse Station, NJ: Merck Research Laboratories, a Division of Merck & 

Co., Inc. PDF of the title page: http://www.merckbooks.com/mindex/pdf/title_page_14.pdf

If you need more information contact your nearest Ecology regional office:

If you need this information in an 

alternate format, please call the 

Hazardous Waste and Toxics 

Reduction Program at 360-407-6700. 

Persons with hearing loss can call 711 

for Washington Relay Service. Persons 

with a speech disability can call 877-

833-6341.