# Draft

Guidance Document: Best Management Practices for Unused Pharmaceuticals at
Health Care Facilities

EPA-821-R-10-006 26 August 2010 United States
Environmental Protection AgencyBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water



### Disclaimer

The discussion in this document is intended so lely as guidance. The statutory provisions and regulations of the U.S. Envir onmental Protection Agency (EPA) described in this document contain legally binding requirement s. This document is not a regula tion itself, nor does it change or substitute for those provisions and regulations . Thus, this document does not impose legally binding requirements on EPA, states or the regul ated community. This do cument does not confer legal rights or impose legal obligat ions upon any member of the public.

While EPA has made every effort to ensure the a ccuracy of the discussion in this document, the obligations of the regulated comm unity are determined by statutes , regulations or other legally binding requirements. In the even t of a conflict between the disc ussion in this document and any statute or regulation, this docum ent would not be controlling.

The general descriptions provi ded here reflect EPA's current views and may not apply to particular situations based upon the circumstances. Interested parties are free to raise questions and objections about the substance of this guidanc e and the appropriateness of the application of this guidance to a particular s ituation. EPA and other decision makers retain the discretion to adopt approaches on a case-by-case basis that differ from those desc ribed in this document where appropriate.

Mention of trade names or commercial produc ts does not constitute an endorsement or
recommendation for their use.

This document may be revised periodically without public notice. EPA welc omes public input on this document at any time.

DRAFT August 26, 2010Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### i August 26, 2010 

### CONTENTS

Page

1. I NTRODUCTION 

### .................................................................................................................... 1 1.1 About this Best Management Practices (BMP) Guidance Document .................... 1 1.2 Background............................................................................................................. 2

2. C ONDUCT AN 

### I NVENTORY OF 

### P HARMACEUTICALS AND 

### U NUSED 

### P HARMACEUTICALS 

### ......... 3 2.1 Develop a List of Pharmaceuticals Used at The Facility........................................ 3 2.2 Identify the Unused Pharmaceuti cals Generated and How They Are Currently Managed ................................................................................................. 4

3. R EDUCING OR 

### A VOIDING 

### U NUSED 

### P HARMACEUTICALS 

### ....................................................... 5 3.1 Review Purchasing Practices .................................................................................. 5
3.2 Order Smaller Container Sizes or Emphasize Unit Dose Dispensing .................... 6 3.2.1 Unit Dose Dispensing ................................................................................. 6 3.2.2 Ordering Smaller Container Sizes .............................................................. 6 3.2.3 Trial Prescriptions....................................................................................... 6 3.3 Replace Pharmaceutical Samples with Vouchers................................................... 7 3.4 On-Going Waste Reduction/Avoidance Practices: Inventory Control and
Stock Rotation......................................................................................................... 7 3.4.1 On-Going Inventory Control....................................................................... 7
3.4.2 Stock Rotation............................................................................................. 7

4. I DENTIFYING 

### & M ANAGING 

### T YPES OF 

### U NUSED 

### P HARMACEUTICALS AND 

### A PPLICABLE 

### D ISPOSAL 

### R EGULATIONS 

### ................................................................................. 9 4.1 Types of Unused Pharmaceuticals........................................................................ 10
4.2 Nonwaste Medications – Pharmaceutical Reuse .................................................. 11 4.3 Identifying Hazardous Vs. Nonhazardous Waste ................................................. 13 4.3.1 Requirements for Managing Hazardous Waste ........................................ 16 4.3.2 Recommended Management of H azardous Pharmaceutical Waste.......... 17 4.3.3 Definition of RCRA-Empty Containers.................................................... 18 4.3.4 Proposed Universal Waste Rule................................................................ 19 4.4 Recommended Management of Nonh azardous Unused Pharmaceuticals............ 20 4.4.1 Chemotherapy Pharmaceuticals................................................................ 21
4.4.2 Radioactive Pharmaceuticals .................................................................... 21 4.5 Identifying Controlled Substances........................................................................ 21 4.5.1 Requirements for Managing Controlled Substances................................. 22 4.5.2 Recommended Management of Controlled Substances ........................... 23 4.6 Additional Resources for Identifying Waste Types.............................................. 24

5. S TARTING 

### A W ASTE 

### M ANAGEMENT 

### P ROGRAM 

### ................................................................. 28 5.1 Waste Segregation ................................................................................................ 28 5.2 Training Staff in Proper Disposal Methods .......................................................... 28

6. O THER 

### R ESOURCES 

### ............................................................................................................ 29Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water 

### CONTENTS (Continued)

Page

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### ii August 26, 2010 

### Appendix A: S TATE 

### L AWS AND 

### L OCAL 

### O RDINANCES 

### Appendix B: S AMPLE 

### U NUSED 

### P HARMACEUTICAL 

### T RACKING 

### S HEET 

### Appendix C: C ONSIDERATIONS 

### W HEN 

### C ONTRACTING WITH A 

### S PECIALTY 

### W ASTE 

### H AULERBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 1 August 26, 2010 

### 1. I NTRODUCTION



### 1.1 About this Best Management Pr actices (BMP) Guidance Document

The U.S. Environmental Protection Agency (EPA ) conducted outreach and identified that there
is near-universal interest from stakeholders to better manage unused pharmaceuticals at health care facilities, as well as general interest in EPA’s guidance on managing unused pharmaceuticals. This guidance document describes Best Management Practices (BMPs) that EPA recommends to health care facilities, such as hospitals, long-term care facilities, medical clinics, and doctors’ offices, when managing and disposing of unused pharmaceuticals. Environmental managers at health care facilities can use these BMPs to minimize sewer disposal of pharmaceuticals and properly manage unused pharmaceuticals. EPA’s goal is to keep pharmaceuticals out of U.S. waters. EPA identified thes e BMPs after site visits at 12 health care
facilities 1 

### ; consulting with over 700 stakeholders including health care professionals, government entities, health care industry associations, and unused pharmaceutical management companies; review of disposal data from 20 hosp itals and long-term care f acilities; and review o literature data, reports, and st ate recommendations. These practices are a combination of recommended and implemented practices w ith the goal of proper unused pharmaceutical

manageme f

nt and disposal.

uler. This document presents the steps that environmen tal managers of health care facilities can take to identify and properly manage unused pharmaceuticals. The steps include:

 

### Conduct an inventory of pharmaceuticals and unused pharmaceuticals to quantify
the amount of medication the facility is disposing of.

 

### Reduce unused pharmaceuticals by reviewing purchasing practices, using limited dose or unit dose dispensing, replacing pharmaceutical samples with vouchers, and performing ongoing inventory control and stock rotation.

 

### Properly manage unused pharmaceuticals by identifying types of pharmaceuticals and any federal and state requirements; when possible: reusing or donating unused pharmaceuticals, returning them to the pharmacy; sending them to a reverse distributor for credit and proper disposal; and using EPA recommended practices to dispose of pharmaceu tical waste at the facility.

 

### Segregate waste for disposal to ensure regulations are met and to reduce costs (e.g., nonhazardous pharmaceutical waste disposal in a solid waste landfill may be less expensive than disposal via hazardous waste hauler).

 

### Train staff in proper disposal methods.

This document also provides a list of other resources, such as EPA and industry association websites, list of current state repository programs 2 

### , sample unused pharmaceutical tracking sheet, and considerations when contr acting with a specia lty waste ha

1 EPA also visited a long-term care pharmacy, waste management vendor, and reverse distributor.

2 Current as of 2009.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 1.2 Background

To date, scientists have identified nume rous pharmaceutical compounds at discernable
concentrations in our nation’s ri vers, lakes, streams and drinking waters. As a result, the U.S. Environmental Protection Agency (EPA) initiated a study on unused pharmaceutical disposal practices at health care faciliti es. While EPA understands that th ere are many factors influencing the handling and disposal of pharmaceuticals by th e health care industry, the focus of this study was on disposal to sewers. EPA decided to study medical facilities because the Agency believes that these facilities dispos e large quantities of unused pharmaceuticals to sewers.

Unused pharmaceuticals are dispensed prescriptions that patients do not use and medications that have expired. The term "unused pharmaceuticals" does not include excreted pharmaceuticals. Another source of unused pharmaceuticals is residue in used and partially-used dispensers, containers, and devices. Health care facilities may dispose of unused pharmaceuticals, especially residues, down the drain (e.g., in travenous (IV) bags emptied into the sink). For many years, a standard disposal practice at many health ca re facilities was to flush unused pharmaceuticals
down the toilet or drain. EPA believes that facili ties should not dispose of their pharmaceuticals
down the drain. Pharmaceutical chemicals are also biologically excreted fo llowing patient use of drugs. Excretion is not addressed in this guidance.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 2. C ONDUCT AN 

### I NVENTORY OF 

### P HARMACEUTICALS AND 

### U NUSED 

### P HARMACEUTICALS



### How many waste streams are genera ted? Before a facility can identify the best means for reducing waste and disposing of th e waste, it must understand what the facility is throwing out. This section will help facili ties to determine the unused pharmaceuticals being generated and disposed of. EPA recommends that faciliti es take two steps to understand their unused pharmaceutical generation:

1. Develop a list of pharmaceuticals used at the facility.

2. Identify the unused pharmaceuticals generated and how they are currently managed.

2.1 Develop a List of Pharmaceuticals Used at The Facility

The first step in managing unused pharmaceuticals at health care faci lities is to identify the types of pharmaceuticals that the facility uses. EPA reco mmends starting either at the on-site pharmacy or by contacting the pharmaceutical supplier. Most hospital pharmacies maintain a formulary—a list of pharmaceuticals approved fo r prescriptions to patients by attending physicians. The hospital pharmacy may also purchase pharmaceuticals not listed in the formulary to meet special circumstances. For this reason, purchasing records will provide a more complete list of what the pharmacy has in stock than the approved formul ary alone. EPA suggest s reviewing a 12-month summary of purchasing records. Th is initial review w ill assist the facility to most accurately categorize the unused pharmaceuticals.

To develop a list of pharmaceuticals used at the f acility, find the following information for all of the pharmaceuticals administ ered at the facility:

 

### National drug code (NDC);

 

### Brand name;

 

### Generic name;

 

### Manufacturer;

 

### Dosage(s);

 

### Form (i.e., liquid, tablet, cream, etc) – different forms of the same medication may expire more quickly or remain in stock longer; and

 

### Package size.

Using the list of pharmaceuticals prescribed at the facility, next de termine how often those pharmaceuticals become waste. Once wasted pharmaceuticals are identified, the facility can use
the BMPs recommended in Section 3 to reduce waste. 3 

### In addition, by knowing what is being disposed of, the facility can re duce its disposal costs by finding ways to reduce waste. Also, the facility could reduce purchasing costs by reducin g the pharmacy’s inventory of drugs that are identified as often being disposed.

3 Some health care facilities conduct their own inventory; others hire commercial services that have expertise in cataloging inventories and find that this is cost effective and less burdensome on existing staff.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 4 August 26, 2010 

### 2.2 Identify the Unused Pharmaceuticals Generated and How They Are Currently Managed

After the facility has a comprehensive list of the pharmaceuticals used, the next step in developing a waste management program is to identify the unused pharmaceuticals generated. Unused pharmaceuticals may be generated at num erous locations throughout the facility, for example at the pharmacy or on the nursing floor. At all possible waste locations, the facility should keep track of the following:

 

### Pharmaceutical identificati on (see list in Section 2.1), including any manufacturer samples that need to be disposed. A good initial step is to document the amount and frequency of outdated (expired) sample s or stock per out-patient clinic or medical practice area.

 

### Reason for waste generation. At the pharmac y, reasons include expiration prior to use or spills. On the nursing floor, reas ons include patient refusing medication, medication left behind when a patient l eaves, or stopping of IV mid-stream.

 

### Where the waste goes. For example, the facility might currently throw pharmaceuticals away in the trash, collect them for other disposal, drain them in the sink, or flush them down the toilet.

EPA recommends that the facility keep track of the unused pharmaceutical s for two weeks to one month. This time period may differ depending on th e variety and frequency of services that the facility provides. Seasonality may also play a ro le in the types and quant ities of pharmaceuticals being used. For example, the length of time de pends upon how often doctors’ offices dispose of expired pharmaceutical stock and samples, how often hospitals check their crash carts for expired medications, or how often long-term car e facilities check thei r emergency kits for expired medications. Once the facility has the lis t of discarded pharmaceuticals, it can identify commonly wasted pharmaceuticals and identify reasons for the waste generation. Then, the facility can use the BMPs provi ded in Section 3 to reduce the amount wasted. See Appendix B of this document for a Sample Unused Pharmaceutical Tracking Sheet.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 3. R EDUCING OR 

### A VOIDING 

### U NUSED 

### P HARMACEUTICALS



### How can a health care facility reduce unused pha rmaceuticals? The simplest and least expensive way to minimize pharmaceutical disposal is to reduce and avoid generating unused pharmaceuticals. During outreach activities, EPA h eard many facilities give examples of the cost savings from smart pharmaceutical management. Buying medicine in smaller quantities means fewer expire. By using vouchers from pharmaceutic al sales representatives instead of using free “sample” pharmaceuticals, facilities can eliminate an entire waste stream. This section walks through how many health care facilities have reduced their waste and cut costs at the same time.

After completing a waste review as described in Section 2, the facility can determine the pharmaceuticals commonly wasted and the reas ons. Depending on the reason for the waste generation, it can use the BMPs in this s ection to reduce waste. Typical reasons why pharmaceuticals become waste include the following:

 

### Purchased medications expire before they are used;

 

### Patient refuses the medication;

 

### Pharmaceutical sales representatives leave samples that expire before they are used;

 

### Patient dies or is transferred;

 

### Patient has an adverse reaction, or is su ccessfully treated, and stops medication;
and

 

### Dispensing or other medication error occurs.

3.1 Review Purchasing Practices

Once the unused pharmaceutical profile is comp leted, the facility should review purchasing practices to determine ways to re duce waste. The review includes:

 

### Identify any pharmaceuticals that comm only expire before use – buy less to
reduce wasted amount.

 

### Identify pharmaceuticals used by multiple departments – purchasing a standard package size, dose, or form can reduce waste. This allows multiple departments to use the same supply.

Example: Using the same dosage form for medi cations used in different departments of a hospital can facilitate stoc k rotation. For example, Hennepin County Medical Center (HCMC) in Minnesota was using 15-gram glucos e (dextrose) gel tubes in its crash boxes. It was also dispensing 45-gram tubes to di abetic patients. The facility’s Diabetics Committee recommends 30-gram doses; theref ore a portion of the 45-gram tubes went unused. The facility switched all departments to 15-gram glucose gel tubes and was able
to rotate short-dated tubes from crash boxes to departments with high er usage, potentially eliminating waste. 4

4 Reference: Minnesota Technical Assistance Program (MnTAP). Reducing pharmaceutical waste from patient-care settings. www.mntap.umn.edu/health/94-PharmWaste.htm

.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 6 August 26, 2010 

### 3.2 Order Smaller Container Sizes or Emphasi ze Unit Dose Dispensing

Dispensed pharmaceuticals may go unused for a variety of reasons: patient refuses the medication, medicine is no longer needed or not effective, treatment or dosage changes, or patient is discharged. To reduce the quantity of unused pharmaceuticals, facilities may want to limit the number of doses dispensed to a patien t at one time (unit dose packaging), use trial prescriptions or samples to dete rmine medication effectiveness before writing a full prescription, and use smaller containers of pharmaceuti cals at the pharmacy a nd on nursing floors.

3.2.1 Unit Dose Dispensing

The facility can purchas e prepackaged unit doses, fo r example, in blister p acks or bingo cards. It can also prepare unit doses at the on-site pharmacy for dispensi ng to patients (e.g., individually wrapped or dispensed via an automated disp ensing system). By limiting the amount of medication dispensed to a patient at one tim e, unopened pharmaceuticals can more readily be restocked and reused. As long as the packaging is not opened and has been stored properly, the facility may be able to return medications to it s pharmacy for reuse (i.e ., prescribed to another patient). Reuse of unit doses to another patient is often possible at hospitals, but not always possible for facilities with off-site pharmacies, such as long-term car e facilities. However, even if it is not possible for a medication to be dispensed to another patient, an off-site pharmacy will usually accept the return of the unused medi cations (excluding controlled substances) and dispose of them fo r the facility.

Example: At the Walter Reed Army Medica l Center in Washington, DC, approximately 99 percent of the pharmaceuticals are dispen sed as unit doses to reduce waste. The majority of unit doses are blister packs purch ased from the manufacturer as unit doses. Other unit doses are packaged at the on-site pharmacy. For example, liquid medications are dispensed in 5, 15, and 30 milliliter (mL) doses.

3.2.2 Ordering Smaller Container Sizes

If a health care facility f inds that portions of bottled liquid pharmaceuticals are going unused and require disposal, it may be able to purchase smaller bottles of liquid pharmaceuticals and reduce the amount wasted. Using smaller container size s and reducing waste has the additional benefit of reducing the purchasing costs related to the pharmaceutical.

Example: The Marshfield Clinic in Wisconsin uses lidocaine in small amounts. Rather than purchasing lidocaine in 50 milliliter (mL) bottles that need to be discarded 30 days after opening, the clinic bega n purchasing 15 mL vials or smaller to minimize wasted medication. This change also reduced the purchasing costs for lidocaine.

3.2.3 Trial Prescriptions

Certain m edications have high inci dences of side effects, and pa tients frequently stop taking the medication before the dispensed quantity is used . For these medications, EPA recommends that pharmacies use “trial prescriptions” in which onl y a small quantity (e.g., 7 to 14 day supply) is dispensed. If the patient stops taking the medication, the unused amount is reduced.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 7 August 26, 2010 

### Title III of the Affordable Care Act (2010) includes Section 3310, “Reducing wasteful dispensing of outpatient prescrip tion drugs in long-term care fa cilities under prescription drug plans and MA-PD (Medicare Advantage Prescrip tion Drug) plans.” This section limits the number of days (no more than 7) that a long -term care facility can provide prescription supplies to residents. This amendment takes effect January 1, 2012.

Example: MaineCare, the Medicaid health insurance program managed by the Maine Department of Health and Human Services, instituted a new 15-day limit on initial prescriptions for certain medications they iden tified as having high rate of waste. These are medications that have high side effect pr ofiles, high discontinuati on rates, or require frequent dose adjustments. In addition to reducing wasted medication, MaineCare’s policy aims to control health care costs.

3.3 Replace Pharmaceutical Samples with Vouchers

Pharmaceutical sales representatives often provide sample medications to health care facilities. These samples can then be provided to patients at no cost as trial prescriptions. The use of sample medications is more common at doctors’ offices and clinics than at hospitals and longterm care facilities. If the samples expire prior to use, the health care facility must properly dispose of the unused pharmaceuticals.

To reduce waste, EPA recommends that health ca re facilities replace the use of samples with manufacturer vouchers which the patient take s to the pharmacy for a free sample. This minimizes generation of waste from expired sample medications. Another approach is to accept only samples of the pharmaceuticals most fr equently prescribed in each clinic.

Example: The Marshfield Clinic in Wisconsin discourages their i ndividual offices and clinics from accepting samples from pharmaceutical manufacturing company representatives. Instead, clin ics and doctors’ offices provide their patients with vouchers, which the patients take to a retail pharm acy for a free sample. If the pharmaceutical manufacturing company does not have a vouche r system in place, Marshfield Clinic requires that the company representative remove the samples from the clinic before their expiration date.

3.4 On-Going Waste Reduction/Avoidance Pr actices: Inventory Control and Stock
Rotation

3.4.1 On-Going Inventory Control

Once the in itial inventory review is complete, a periodic review of the inventory should be established. This periodic inventory review w ill allow the list of pharm aceuticals to be updated and will aid the facility in identifying pharmaceu ticals nearing expiration. Finally, this review will allow the facility to de termine whether its waste redu ction practices are working.

3.4.2 Stock Rotation

Stock rotation is a practice to reduce expired ph armaceuticals. During the periodic inventory review, any short-dated pharmaceuticals are redistribu ted to other areas of the facility where they are needed and used immediately.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 8 August 26, 2010 

### Example: Fairfax-Northern Virginia Hematol ogy-Oncology is a network of six clinics in the Northern Virginia area. The Fairfax loca tion houses the IV admi xture service, which is the central pharmaceutical distribution point fo r all of the other facilities. Each satellite facility receives a daily delivery of patient-s pecific doses prepared in most cases the day before treatment. Any pharmaceuticals that ar e not used are returned to the admixture site. If possible based on stab ility and dose, the returned pharmaceuticals are used at a
later date.

Example: The Walter Reed Army Medical Center in Washington, DC uses an automated dispensing system to distribute 95% of all pharmaceuticals. These machines are primarily used to ensure patient safety and for track ing pharmaceutical distribut ion, but the facility has found that a secondary use is for invent ory control and reduc tion of overstocking certain pharmaceuticals.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 9 August 26, 2010 

### 4. I DENTIFYING 

### & M ANAGING 

### T YPES OF 

### U NUSED 

### P HARMACEUTICALS AND 

### A PPLICABLE


### D ISPOSAL 

### R EGULATIONS



### Can the facility send the unused pharmaceutical b ack to the pharmacy for reuse? How many of the facility pharmaceuticals are h azardous waste? How should the f acility dispose of controlled substances? This section will help answer these questions.

After waste reduction measures ar e taken, EPA recommends the following general practices for managing unused pharmaceuticals:

 

### Reuse unopened pharmaceuticals where possible: either through the pharmacy or through state donation programs.

 

### Send creditable pharmaceuticals to reverse distributors. Reverse distributors are private companies that provide a servi ce to the health care industry by keeping track of manufacturer unused pharmaceuti cal reimbursement policies, and thus get facilities credit for the pharmaceuticals prior to sending them off-site for disposal. Reverse distributors are regist ered with the Drug Enforcement Agency (DEA) and are authorized under the Cont rolled Substances Act to handle
controlled substances that are unused, outdated, or unwan ted. Under current law, reverse distributors, however, are only permitted to accept controlled substances from other DEA registrants. EPA recommends that facilities consult with their state regulatory agency to ensure co mpliance with all state environmental regulations when unused pharmaceuticals ar e sent to reverse distributors.

 

### Hospital/clinic’s and doctor’s controlled substance stock can be transferred to a reverse distributor for disposal.

 

### Practice proper on-site waste management and waste disposal. Consider using a contracted waste management provider for pharmaceutical waste (specialty waste hauler).

A facility must meet federal and state require ments for managing unused pharmaceuticals. There are federal statutes and programs that regul ate the management and disposal of unused pharmaceuticals, including:

 

### The Controlled Substances Act (CSA). Administered by the DEA, CSA provides a closed system for distributing controlled substances. As part of this system, DEA prohibits the return of c ontrolled substances from end-users to nearly all DEA registrants, including pharmacies, hospital staff, and clinic employees. In certain cases, a full duty law-enforcement agent 5 

### is allowed to accept a controlled substance. Disposal of controlled substances by DEA registrants is carefully regulated to en sure that the substance is destroyed. Voluntary survey submittals, outreach mee tings, and site visits indicate that disposing of controlled substances down th e drain is a common practice to ensure

5 An agent is “any officer or employee of any state, or any political subdivision of agency thereof, who is engaged in the enforcement of any state or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his/her official duties.” 21 CFR 1301.24(a)(2)Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 10 August 26, 2010 

### destruction of controlled substances due to its affordability and ease. However, EPA is recommending BMPs in this guidan ce to reduce and avoid drain disposal.

 

### The Resource Conservation and Recovery Act (RCRA). RCRA gives EPA the authority to control hazardous waste fr om “cradle-to-grave.” This includes the generation, transportation, treatment, stor age, and disposal of hazardous waste. Some pharmaceuticals may be consider ed RCRA hazardous wastes upon discard. As a result, health care facilities ma y have to comply with RCRA laws and regulations for the generation, transpor tation, storage, treatment, and ultimate disposal of some pharmaceuticals. Ma ny states are authorized by EPA to implement their own hazardous waste pr ograms in lieu of the federal RCRA program. States’ hazardous wa ste regulations may be broader or more stringent than the federal RCRA program. Therefore, health care facili ties should contact their state environmental regulatory agency to ensure full compliance.

 

### The Centers for Medicare & Medicaid Services (CMS) . CMS is a federal agency within the Department of He alth and Human Services (HHS) that
administers the Medicare and Medicaid programs. Medicare provides health insurance to elderly and disabled Amer icans, while Medicaid provides health insurance for low income Americans, in cluding long-term care coverage. While Medicare is a federal program, Medicaid is a state-run progra m that is partly funded by federal dollars. Ther efore, many Medicaid requ irements are set at the state level, including regulations for ma nagement of unused pharmaceuticals. The primary role of CMS is to pay for me dical products and services through the Medicaid and Medicare programs. CMS does not directly regulate pharmaceutical disposal. These policies are determined by each state’s board of pharmacy and state health departments as we ll as any federal regulations.

 

### The Health Insurance Portability and Accountability Act (HIPAA). The Department of HHS administers HIP AA, which provides protection for the privacy of certain individually identifiabl e health data, such as the names of medications taken by patients. Before a patient's unused pharmaceuticals are disposed of from the health care fac ility, personal information on the container
should be removed or obscured.

This section describes how to identify and properly manage waste under these federal laws. Appendix A provides additional information on state and local requirements and programs. Note that state and local requirements may be broader or more stringent than federal requirements, so it is important to check requirements for the corresponding state and locality. Each subsection provides guidance for managing and disposing of each type of unused pharmaceutical. Table 3 at the end of this section presents EPA’s reco mmended practices for unused pharmaceuticals by type and form.

4.1 Types of Unused Pharmaceuticals

Unused pharmaceuticals include expired medications, unwanted medications (e.g., patient/resident discontinues use), and waste medicat ion (e.g., patient/resident refuses to take or spits out). Unused pharmaceuticals are generated at health care facilities before, during, and afterBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water



### treatm ent, as well as during stoc king activities needed to ensure sufficient materials are available for regular care. In order to properly manage unused pharmaceuticals, th e facility needs to identify the types of mate rials on site, including:

 

### Nonwaste (i.e., reusable or returnable medications);

 

### Hazardous waste, including dual wa stes (hazardous and biohazardous);

 

### Nonhazardous waste;

 

### Controlled substances; and

 

### Chemotherapeutic pharmaceuticals.

Figure 1 presents a summary flowchart to assist facilities in identifying proper management methods. The flowchart provides a summary of the unused pharm aceutical types and how to manage them; a more complete explanation of how to manage unused pharmaceuticals follows
the chart.

4.2 Nonwaste Medications – Pharmaceutical Reuse

Many health care facilities return their unused ph armaceuticals, or at leas t a portion of them, to the dispensing pharmacy. Upon receipt, th e pharmacy determines how the unused pharmaceuticals should be managed, including:

 

### Credit and reuse of medication;

 

### Donation of medication to state programs;

 

### Credit and disposal of the unused pharmaceuticals; and

 

### Disposal of the unused pharmaceuticals.

To determine whether stock unused medication can be reused or donated following return to the facility’s pharmacy, ask the following questions:

DRAFT 

### 11 August 26, 2010  

### Is the medication in the original packaging or still in prepackaged unit doses from the pharmacy? Reuse of Medications

When patients pay for part of the

m edication (and the remaining cost is covered by Medicare Part D and/or private insurance), long-term care facility pharmacies typically cannot give credit to the patient for returned medicines. They are unable to give partial credit to the patient under ex isting Medicare and private insurance financial tracking systems. Thus, the long-term care facility pharmacies can accept the returned medicines (excluding controlled
substances  

### Is the expiration date a future date at
least six months out?

 

### Is the label intact? Is all the
information for the medication such as type, dose, and expiration date clearly marked?

 

### Has the medication been properly stored, such as within the proper ranges for temperature, humidity, and light? ) , but can not resell them.Best Management Practices for Unused Pharmaceuticals at Health Care EPA Office of Water



### 12Figure 1. Summary Unused Pharmaceutical Management FlowChartDRAFTAugust 26, 2010Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

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### 13 August 26, 2010 

### If the facility answers “yes” to all the above questi ons, it might be able to return the unused medication to the pharmacy for reuse, or the ph armacy may be able to donate the unused
medication to charitable instituti ons, such as programs that assi st lower-income patients (state repository programs). State boards of pharmacy se t policies for the return and reuse of unused pharmaceuticals. Although the policies vary by state, most allow reuse of uncontaminated medications that have been in a controlled environment, excluding controlled substances

. Medications that can be reused ar e typically solid doses such as pi lls, tablets, and capsules that do not require special handling fo r temperature such as refrigera tion. The pharmacy must remove any patient-specific information fr om the medication before donating.

If the facility answers “no” to any of the a bove questions, the pharmacy cannot reuse the unused medication. However, the pharmacy may accept returns of pharmaceuticals for credit or for proper disposal. To receive credit from the pharmaceutical manufacturer, pharmacies send the unused medication to a reverse distributor for potential credit and eventual disposal. The reverse
distributor determines which medications can re ceive credit from the manufacturer and then arranges for disposal of the unused and/or ex pired medications. Health care facilities and pharmacies should confer with state and/or local environmental agencies to ensure regulatory compliance when using reverse distributors.

If the health care facili ty cannot return the unused medicati on to the pharmacy and it must be discarded, the unused medication becomes waste and the facility must follow applicable federal, state, and local laws and ordi nances for waste disposal. The following subsections describe management options for unused pharmaceuti cals depending on their classification.

4.3 Identifying Hazardous Vs. Nonhazardous Waste

Federal hazardous waste law (the Resource Conservation and Recovery Act, or RCRA), its implementing regulations, and state regulations define hazardous wastes. Some state hazardous waste requirements may be broade r or more stringent than federal requirements. The discussion in this subsection is only for reference and is not intended to be used as a substitute for RCRA itself or its implementing regulations, contained in the Code of Federal Regulations (CFR). Finally, failing to comply with RCRA can result in the initiation of enforcement actions against the facility.

To be classified as a hazardous waste under RCRA, the waste must be listed in EPA regulations
at 40 CFR 261 or exhibit certain characteristics. Thus, a pharmaceutical waste may be considered
hazardous under RCRA if:

1. The pharmaceutical or its sole 6 

### active ingredient is specifically listed on

— The P List: Acutely Hazardous Waste (40 CFR 261.33(e)) or

— The U List: Discarded Commercial Chemical Products (40 CFR 261.33(f)); and/or

6 Many pharmaceuticals have more than one active ingred ient. If the pharmaceutical cont ains an active ingredient that is on the P List or U List AND the pharmaceutical has more than one active ingredient (i.e., not “sole” ingredient), then that phar maceutical waste does not meet RCRA’s defi nition of a listed hazardous waste. However, the pharmaceutical waste may still be hazardous waste if it exhibits characteristics of hazardous waste. Although pharmaceutical waste with more than on e active ingredient does not meet R CRA’s definition of a listed hazardous waste, EPA recommends that health care facilities still manage the waste as RCRA hazardous waste.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 14 August 26, 2010 

### 2. The waste exhibits one or more hazardous waste characteristic as defined in 40 CFR 261.21-24, (ignitability, corrosivity, reactivity, or toxicity).

Many health care facilities also use the Nationa l Institute for Occupati onal Safety and Health (NIOSH) list of hazardous materi als to identify additional unused pharmaceuticals that should be handled similarly to waste defined as hazardous under RCRA. Although RCRA does not require facilities to manage NIOSH listed hazardous mate rials the same as RCRA hazardous waste, EPA
recommends that the NIOSH-listed hazardous mate rials be managed using RCRA guidelines as a

BMP.

The P and U- Listings (40 CFR 261.33 (e) and (f))

A waste pharm aceutical can meet RCRA’s defin ition of hazardous waste if the pharmaceutical (including its generic name) or the sole activ e ingredient of the pharmaceutical is listed on
RCRA’s P List or U List. P-listed and U-listed wa stes fall under the hazardous waste definition included at 40 CFR 261.33, Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof . Once the decision is made to discard of the unused pharmaceutical, the health care facility must identify whether or not the pharmaceutical (including its generic name) or the pharmaceutical’s sole-active ingredient appears on the P-List
or U-List.

If the pharmaceutical (including its generic name) or its sole active ingredient is a P- or U-listed waste, then the health care fac ility must manage that waste pharmaceutical as a hazardous waste in accordance with all applicable federal, state and local environmental regulations 7



### .

Table 1 lists examples of P- and U-listed commercial chemical products that have pharmaceutical uses.

Table 1. Examples of Active Pharmaceutical Ingredients that are Considered Hazardous Under RCRA (P-Listed and U-Listed)

Pharmaceutical Name No. Pharmaceutical Name No.

P-Listed
Arsenic trioxide (chemotherapy drug) P012 Phentermine (controlled substance) P046
Epinephrine (a) P042 Physostigmine P204

Nicotine P075 Physostigmine salicylate P188
Nitroglycerin (b) P081 Warfarin >0.3% P001

U-Listed
Azaserine (chemotherapy dr ug) U015 Mitomycin C (chemotherapy drug) U010
Chloral hydrate (controlled substance) U034 Paraldehyde (controlled substance) U182
Chlorambucil (chemotherapy drug) U035 Phenacetin U187

Chloroform U044 Phenol U188
Cyclophosphamide (chemotherapy drug) U058 Reserpine U200
Daunomycin (chemotherapy drug) U059 Resorcinol U201

7 Note that the applicable regulations will depend on th e quantity of waste generated each month, as described in
Section 4.3.1.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 15 August 26, 2010



### Table 1. Examples of Active Pharmaceutical Ingredients that are Considered Hazardous Under RCRA (P-Listed and U-Listed)

Pharmaceutical Name No. Pharmaceutical Name No.

Dichlorodiflurom ethane U075 Saccharin U202
Diethylstilbestrol U089 Selenium sulfide U205
Hexachlorophene U132 Streptozotocin (chemotherapy drug) U206

Lindane U129 Trichloromonofluromethane U121
Melphalan (chemotherapy drug) U150 Uracil mustard (chemotherapy drug) U237

Mercury U151 Warfarin <0.3% U248

Source: Practice Greenhealth . 2008. Managing Pharmaceu tical Waste: A 10-Step Bl ueprint for Health Care Facilities in the United States. Revised August 2008. Accessed online at: http://www.practicegreenhealth.org/page_att ach ments/0000/0102/PharmWasteBlueprint.pdf ; Washington Depa rtment of Ecology Example RCRA Waste C odes for Pharmaceuticals. Accessed online at: http://www.ecy.wa.gov/programs/hwtr/ pharmaceuticals/pages/pu_m etals.html . For a complete listing of discarded

co mmercial chemical products found on RCRA’s P- and U-lis ts, please see 40 CFR 261.33(e) and (f), respectively,

at http://www.epa.g ov/wa stes/hazard/wastetypes/listed.htm

.

a – The Agency clarified its regulation at 40 CFR 261.33, explaining that epin ephrine salts are not included in the epinephrine P042 listing; therefore, the waste epinephrin e salt would be hazardous only if it exhibited one or more
of the hazardous waste characteristics. Please confer with state and/or local environmental regulatory authorities to determine if this clarification is accepte d in that state. (See “Scope of Haza rdous Waste Listing P042(Epinephrine),” October 15, 2007, RCRA Online# 14778: http://yosemite.epa.gov/osw/rcra.nsf/

0 c994248c239947e85256d090071175f/2f701627eb73b2ab852573d2005e0b4f!OpenDocument ).

b – Medicinal nitroglycerin may be excluded from the lis ting as it typically does not exhibit the characteristic of reactivity (for which nitroglycerin was listed). Please conf er with state and/or local environmental regulatory authorities to determine if this exclusion is accepted in that state. (See “Regulation of Nitroglycerin Under Revised Mixture and Derived-From Rules,” March 18, 2003, RCRA Online# 14654: http://yosemite.epa.gov/osw/rcra.nsf/

0 c994248c239947e85256d090071175f/7acfec572de8897f85256d1600748bcb!OpenDocument ).



### RCRA Hazardous Waste Charac teristics (40 CFR 261. 21-24)

If it is d etermined that the waste pharmaceutical is not a listed hazardous wa ste, then the health care facility must determine if that waste pharm aceutical meets one of RCRA’s hazardous waste characteristics. The generator of the waste can either use a sta ndardized test method or apply general knowledge of the waste’s properties in making this determination. Examples of RCRA hazardous waste characteristics exhibited by pharmaceutical wastes include the following 8 

### :

 

### Ignitability (D001): the presence of a flammable solvent is the most common reason pharmaceuticals meet this charac teristic. For alcohol, RCRA sets a threshold limit of 24% (i.e., if the formul ation contains more than 24% alcohol,
then the waste is considered hazardous waste). Strong oxidizers, such as silver nitrate and potassium permanganate, in pharmaceutical formulations may also meet the definition of ignitability.

8 Source: Healthcare Environmental Reso urces Center, Pharmaceutical Wastes in Health Care Facilities. Accessed
online at: http://www.hercenter.o rg /hazmat/pharma.cfmBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 16 August 26, 2010  

### Corrosivity (D002): applie s to strong acids (pH ≤ 2) or strong bases (pH ≥ 12.5). In pharmaceutical compounding, glacial acetic acid and concentrated sodium hydroxide might be used. Their wastes are corrosive and thus considered
hazardous.

 

### Reactivity (D003): nitroglycerin, a P-listed hazardous waste, would fall into this category if used in bulk. However, dosage forms typically do not exhibit characteristics of reactivity 9 

### :

 

### Toxicity (D004 to D043): The toxicity char acteristic (TC) identifies wastes that are likely to leach concentrations of a ny one of 40 different toxic chemicals in amounts above the specified regulatory le vels. Examples of TC chemicals/heavy metals that have pharmaceutical uses a nd their toxicity threshold levels are:

— Arsenic (D004): 5.0 mg/L;

— Barium (D005): 100.0 mg/L;

— Cadmium (D006): 1.0 mg/L;

— Chloroform (D022): 6.0 mg/L;

— Chromium (D007): 5.0 mg/L;

— m-Cresol (D024): 200 mg/L;

— Lindane (D013): 0.4 mg/L;

— Mercury (D009): 0.2 mg/L;

— Selenium (D010): 1.0 mg/L; and

— Silver (D011): 5.0 mg/L.

4.3.1 Requirements for Managing Hazardous Waste

Any facility that gen erates a h azardous pharmaceutical waste is subject to the RCRA generator regulations at 40 CFR 262. 10 

### Under the federal program ther e are three RCRA hazardous waste generator categories, and the extent of the requi rements for each generator category is defined by the amount of hazardous waste generated in a calendar month. A facility that generates 1000 kilograms (kg) or more of hazardous waste in a month, or greater than 1 kg of acute (P list) hazardous waste in a month is a large quantity generator (LQG). LQGs are subject to the full extent of the RCRA generator regulations (see 40 CFR 262). For example, LQGs must:

 

### Obtain an EPA identification number;

 

### Can store waste for only 90 days (accumul ation requirement) or otherwise obtain a RCRA permit;

 

### Meet manifest and reporting requirements; and

 

### Comply with certain training requirements.

9 If a listed hazardous waste is listed solely because it exhi bits the characteristics of ignitability, corrosivity and/or reactivity, and the waste at its point of generation no longer exhibits the characteristic for which it was listed, then it is not a hazardous waste (66 FR 27286, May 16, 2001). Since local and state regulations may be broader or more stringent than the federal regulations, EPA recommends th e regulated community contact their local regulatory authorities to determine if this exemption applies in their states.

10 For more information regarding the va rious federal RCRA generator requirements, please see the following links: http://www.epa.gov/epawaste/h azard/ge neration/summary.htm and http://www.epa.gov/epawaste /hazard/downl oads/tool.pdfBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 17 August 26, 2010 

### If a facility generates more than 100 kg but less than 1000 kg of hazardous waste in a month, then it is a small quantity generator (SQG). SQGs are subject to fewer requirements than LQGs. For example, SQGs do not need to complete a biennial report, and SQGs have fewer personnel training and contingency pl anning requirements than LQGs (see 40 CFR 262.34(d)(5)). Moreover, SQGs must meet th e 180 day (rather than the 90 days for LQGs) accumulation requirements or otherwis e obtain a RCRA permit.

A facility generating no more than 100 kg of h azardous waste in a month, or no more than 1 kg of acutely hazardous waste (P list) in a month, is a conditionally-exempt small quantity generator (CESQG) under the federal program. CESQGs ha ve the least stringent requirements of all generators (see 40 CFR 261.5). For example, CE SQGs are not required to obtain an EPA identification number, manifest wast e sent off-site for disposal, or meet any storage time limits. In addition, under the federal regul ations, CESQGs can send hazardous wastes to either a stateapproved solid waste facility or to a hazardous waste disposal f acility. States authorized to implement the RCRA hazardous waste program may have broader or more stringent generator requirements than the federal RCRA program, so facilities should contact their state environmental regulatory agency to ensure full compliance.

The discussion on handling hazardous waste in this document assumes the health care facility is a SQG or LQG. Some health care facilities will fall into the CE SQG category and certain federal RCRA hazardous waste requirements will not appl y. For example, under federal regulations, a CESQG can send hazardous waste to certain nonhazardous waste facilities 11 

### . This document provides suggestions on how to best handle unus ed pharmaceuticals that are hazardous wastes, regardless of the generator size.

Federal regulations also require that hazardous wa stes from SQGs and LQGs be transported in approved containers by an authorized hazardous waste transporter and transported to permitted hazardous waste treatment, storage, and disposal facilities. RCRA also prohibits health care facilities that qualify as small quantity or larg e quantity generators of hazardous waste from disposing of hazardous pharmaceutical waste in so lid waste landfills, solid waste incinerators, or hospital/medical/infectious wast e incinerators (40 CFR 268). Hazardous waste from SQGs and LQGs cannot be collected with biohazardous (red bag) waste for sterilization as the sterilized waste is disposed in solid waste landfills. As a BMP, EPA recommends that all health care facilities, regardle ss of generator size, should not dispose of hazardous waste with red bag waste. Also, some states require hazardous waste that is also biohazardous (infectious) to be disposed of as “dual” wast es. Health care facili ties should check state hazardous waste requirements as they may be br oader or more stringent than the federal requirements.

4.3.2 Recommended Management of Hazardous Pharmaceutical Waste

Health care facilities m ust comp ly with RCRA requirements for the management and disposal of hazardous pharmaceutical waste. Waste may be dis posed of via incineration at a hazardous waste
incinerator or in a hazardous waste landfill after the waste is treated under the Land Disposal Restrictions program (see http://www.epa.gov/epawaste/haz ard/tsd/ldr/resource.h tm ). Hazardous

11 The EPA CESQG Landfill/Municipal Solid Waste Landfill re gulations do not require state approval of a facility. The regulations apply to all facilities without state action, a lthough in practice most states have permitting programs in place.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 18 August 26, 2010 

### pharmaceutical waste is most commonly treated by hazardous waste incineration, with the resulting incinerator ash disposed in a pe rmitted hazardous waste landfill. EPA recommends segregation of hazardous waste (rather than ha ndling all waste as hazardous). Because only approximately 5% of all pharmaceutical waste is hazardous, it may be more expensive to dispose of all pharmaceutical waste (hazardous and nonh azardous) as hazardous wast e. Facilities should then follow the applicable federal and stat e regulations for proper disposal. EPA also
recommends that health care f acilities collect, store, and pack age hazardous waste oxidizers separately from other hazardous waste. Links to state waste programs are available at: http://www.epa.gov/epawaste/wyl/stateprograms.htm

.

4.3.3 Definition of RCRA- Em pty Containers

Under 40 CFR 261.7, empty containers of hazardous waste are not subject to hazardous waste regulations under RCRA (40 CFR 261 thr ough 265, 267, 268, 270, or to the notification requirements of section 3010). However, if the c ontainer does not meet th e definition of “RCRAempty,” the container must be disposed of as a hazardous waste and meet all the RCRA requirements. Table 2 presents the defin ition of “empty containers” under RCRA.

Table 2. RCRA Definition of “Empty Containers”

Type of RCRA Waste RCRA Definition of Empty Container
Acute Hazardous Waste (e.g., PListed) (i) The container or inner liner has been triple rinsed using a solvent capable of removing the commercial chemical product or manufacturing
chemical intermediate a ;

(ii) The container or inner liner has been cleaned by another method that has been shown in the scientific literature, or by tests conducted by the generator, to achieve equivalent removal; or

(iii) In the case of a container, the in ner liner that prevented contact of the commercial chemical product or manufact uring chemical intermediate with
the container has been removed.
Toxic Waste (U-Listed and Characteristic Hazardous Wastes) (i) All wastes have been removed that can be removed using the practices commonly employed to remove materials from that type of container, e.g., pouring, pumping, and aspirating, and

(ii) No more than 2.5 centimeters (one inch) of residue remain on the bottom of the container or inner liner, or

(iii)(A) No more than 3 percent by weight of the total capacity of the
container remains in the container or inner liner if the container is less than or equal to 119 gallons in size; or

(B) No more than 0.3 percent by weight of the total capacity of the container remains in the container or inner liner if the container is greater than 119 gallons in size.
Compressed Gas Containers A contai ner that has held a hazardous waste that is a compressed gas is empty when the pressure in the co ntainer approaches atmospheric.

Source: 40 CFR 261.7 a – The rinsates from the triple-rinsing of containers which have held commercial chemical products listed in 40 CFR 261.33(e) are also RCRA hazardous wastes (see 40 CFR 261.3(a)(2)(iv)).



### Triple rinsing at health care facilities is not alwa ys practical. Therefore, f acilities often dispose of all vials, IVs, and other contai ners that have held P-listed pharmaceuticals as hazardous wastesBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 19 August 26, 2010 

### even if “empty.” Some states ex clude certain containers from inclusion as hazardous waste. These containers may include those that held so lid pharmaceutical doses (i.e., tablets, capsules, and patches) and empty warfarin st ock bottles and unit-dose packaging.

For syringes containing P-listed or U-listed pha rmaceuticals, used syringes do not need to be handled as hazardous waste as long as no characteristic hazard remains (i.e., ignitability, corrosivity, reactivity, or toxic ity). EPA issued this interpre tation in 1994 for the P-listed pharmaceutical epinephrine. In an April 2008 letter 12 

### , EPA extended this interpretation to all Plisted or U-listed pharmaceuticals.

4.3.4 Proposed Universal Waste Rule

In Decem ber 2008, EPA proposed adding hazardous pharmaceutical wastes to the Universal Waste Rule in order to provide an alternate system for management of hazardous pharmaceutical wastes that is protective of pub lic health and the environment. The proposed addition is intended to make it easier for generators to collect and properly dispose of these items as hazardous wastes, resulting in a simpler and more stream lined waste management system. This proposed rule would apply to pharmacies, hospitals, doctors’ offices, dentists’ offices, outpatient care centers, ambulatory health care services, residentia l care facilities, veterinary clinics, and other facilities that generate ha zardous pharmaceutical wastes.

Under the proposed universal waste program, generators of hazardous pharmaceutical wastes will have the option of managing these wastes as “ universal wastes.” If the facility chooses to manage its hazardous pharmaceutical waste under the proposed universal waste option once the rule is finalized and adopted by its state, th en the facility will become a “handler” of pharmaceutical universal waste, rather than a “generator” of hazardous pharmaceutical waste. Compared to a generator of hazardous pharmaceu tical waste, as a handler of pharmaceutical universal waste, the facility will have the fo llowing benefits: 1) an increased accumulation volume threshold for small quantity handlers; 2) an increased on-site accumulation time limit; 3) no manifest requirement; and 4) si mplified training requirements.

Currently, EPA is reviewing public comments r eceived on the proposed rule. EPA expects that this rule will be finalized in 2011. This draft guidance document wi ll be updated to reflect the
final rule.

12 Available online at: http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/

6 A5DEDF2FBA24FE68525744B0045B4AF/$file/14788.pdfBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water



### 4.4 Recommended Management of Nonha z ardous Unused Pharmaceuticals

DRAFT 

### 20 August 26, 2010 

### Red Bags/Sharps Containers Should Not

Be Used

As a best management practice, unused pharmaceuticals should not be disposed of with biohazardous waste or red bag waste. Biohazardous waste is typically sterilized (e.g., in an autoclave) prior to disposal in landfills. The temperature achieved during autoclaving is insufficient to destroy most pharmaceutical ingredients. During sterilization, wastewater potentially containing pharmaceuticals may be generated and discharged to the sewer, through which it reaches waterways. EPA’s goal is to keep pharmaceuticals out
of U.S. waters. Nonhazardo us 13 

### pharmaceuticals include both
controlled and non-controlled substances.
Section 4.5 outlines how EPA recommends that health care facilities manage controlled
substances that are not hazardous waste under
RCRA. For unused non-controlled pharmaceuticals, EPA recommends that health
care facilities send the pharmaceuticals to a reverse distributor for potential credit and proper disposal 14 

### . For unused non-controlled pharmaceuticals that cannot be sent to a reverse distributor, EPA recomme nds that the facility segregate the nonhazardous pharmaceutical
wastes from other solid wastes. Nonhazardous pharmaceutical waste should not be sewered, but rather should be disposed in a solid waste landfill
or incinerated in a solid waste incinerator 15



### . When commingling nonhazardous pharmaceutical waste with other solid wast e, EPA recomm

Use of Specialty Waste Haulers by Hospitals

The hospital pharmacies that EPA visited used specialty waste haulers for their segregated nonhazardous pharmaceutical waste. ends that the facility:

1. Take the medication out of the original containers.

2. Mix medication, either liquid or solid, with an undesirable substance. Undesirable substances include sand, coffee grounds, kitty litter, or other absorbent materials.

3. Place the waste mixture in a sealable bag, empty can, or other container to prevent leakage.

4. Dispose with the solid waste (i.e., regular trash).

EPA also recognizes that there ar e drug disposal kits and drug re moval technologies available for use by health care facilities. EPA does not recomme nd or endorse a particul ar product for health
care facilities. EPA does ac knowledge that these technol ogies may be effective.

If the facility segregates and manages its unus ed pharmaceuticals separately from other solid wastes and uses a specialty waste hauler for the pharmaceutical waste, the facility may not need
to mix medication with an undesirable substan ce. Any waste identified as hazardous should be disposed as discussed in Section 4.3.

13 Nonhazardous: not a federally-listed or state-listed hazard ous waste and does not meet a federal or state hazardous
waste characteristic.

14 EPA strongly recommends that the state regulatory agen cy is consulted to ensure compliance with all state environmental regulations when unused pharm aceuticals are sent to reverse distributors.

15 Nonhazardous wastes (or solid wastes) are regulated at the state or local le vel. Please contact the state regulatory agency for restrictions on the di sposal of nonhazardous ph armaceutical wastes in solid waste landfills.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 21 August 26, 2010 

### 4.4.1 Chemotherapy Pharmaceuticals

Health care facilities g enera te trace chemotherapy waste (yellow bag waste), hazardous chemotherapy waste (sometimes referred to as bulk chemotherapy waste), and nonhazardous chemotherapy waste. Trace chemotherapy waste in cludes empty IV bags, tubings, gowns, etc. that may be contaminated with nonhazardous ch emotherapy pharmaceuticals. Yellow bags with trace chemotherapy waste are typically picked up by a specialty waste hauler and disposed of via
medical waste incineration. Hazardous wast e from chemotherapy treatment and non-RCRAempty 16 

### containers that once contained hazardous chemotherapy pharmaceuticals must be managed in accordance with applicable hazardous waste regulations, as described in Section 4.3.

While not all chemotherapy pharmaceutical waste may be regulated as hazardous under the federal RCRA regulations, EPA recommends that facilities manage all unused chemotherapy pharmaceuticals as hazardous waste as a best management practice.

4.4.2 Radioactive Pharmaceuticals

Collect and store radio active pharmaceutical wa ste in accordance with NRC regulations (10 CFR Part 20). Radioactive pharmaceuticals that are al so RCRA hazardous wastes when disposed (i.e., mixed wastes) are regulated by multiple agencies. The hazardous portion is regulated by EPA or the authorized state, while the radioactive compon ent of the waste is regulated under the Atomic Energy Act (AEA) by either the NRC or the Department of Energy (DOE). 17 

### Section 1006 of RCRA states that if RCRA regul ations are inconsistent with the AEA requirements, then the RCRA regulations do not apply. Therefore, if a facility managing a mixed hazardous pharmaceutical waste under RCRA subtitle C encounters RCRA requirements that are inconsistent with the AEA requirements, the AEA requirements apply. However, as discussed in the Joint NRC/EPA Guidance on Testing Require ments for Mixed Radioactive and Hazardous Waste (62 FR 62079, 62085; November 20, 1997), an inconsistency occurs when compliance with one statute or set of regul ations would necessarily cause non-compliance with the other and relief from an inconsistency would be limited to that specific RCRA re quirement, and that the determination of inconsistency would not relieve the generator from all other RCRA requirements.

4.5 Identifying Controlled Substances

The Drug Enforcement Administration (DEA) regul ates the distribution, shipping, and transfer
of controlled substances. The Controlled S ubstances Act (CSA) includes requirements for transferring (recordkeeping) controlled substances (e.g., narcotic s, opiates, and stimulants). For a list of controlled substances, go to the follo wing DEA Office of Diversion Control website: http://www.deadiversion.usdoj.gov/schedules/inde x.html. Some example pharmaceuticals on the
controlled substance list include the following:

 

### Codeine;

 

### Diazepam;

 

### Dextropropoxyphene dosage forms (e.g., propoxyphene);

16 See Section 4.3.2 for the definition of RCRA-empty.

17 The NRC regulates radioactive wastes generated by commercial entities or non-DOE facilities, whereas DOE regulates radioactive wastes generated by DOE facilities.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 22 August 26, 2010  

### Fentanyl;

 

### Hydrocodone;

 

### Hydromorphone and Hydrocodone combination product;

 

### Lorazepam;

 

### Morphine; and

 

### Oxycodone.

4.5.1 Requirements for Managing Controlled Substances

The CSA ha s specific requirements on how to handle controlled pharmaceuticals. These requirements prohibit the transfer or shipping of controlled substanc es from health care facilities to any other entity, unless the transfer occurs betw een DEA registrants. As a result, a health care facility can send unused stock of controlled s ubstance pharmaceuticals to another facility for reuse or disposal if both faci lities are DEA registrants.

If the facility is a DEA registrant, such as a pha rmacy, hospital, or a practitioner, the facility has options for disposing of an unused controll ed substance. It may destroy the unused pharmaceutical in accordance with state guidance a nd with appropriate documentation; or send the waste to a DEA-regist ered reverse distributor 18



### .

If the facility is a non-DEA registrant, such as a long-term care facility, it must directly dispose of controlled substances, except that DEA allo ws returns when the storage, dispensing, and returning occurs using an automated dispensi ng system (ADS) operated by a DEA-registered pharmacy.

A health care facility cannot retu rn patient dispensed (even unit dos ing) controlled substances. If pharmaceuticals have been dispensed under a pres cription, the controlled substance cannot be sent to a registrant. Non-DEA re gistrants may dispose of contro lled substances upon instruction by DEA Special Agents in Charge. This procedure involves the non-DEA registrant submitting a letter to the local DEA Special Agent in Charge. The letter must include:

 

### Name and address of the person;

 

### Name and quantity of each controlled substance to be disposed of;

 

### How the applicant obtained the controlled substance, if known; and

 

### Name, address, and registration num ber of the person who possessed the controlled substance prior to the applicant, if known.

Provided such disposal is permissible under th e CSA, the Special Agent in Charge shall
authorize and instruct th e applicant to dispose of the cont rolled substance through any of the following methods: 1) transfer of the substan ce to a person registered under the CSA and authorized to possess the substance; 2) delivery to an agent of the Administration or to the nearest office of the Administration; 3) by dest ruction in the presence of an agent of the
Administration or other authorized person; or 4) by such other means as the Special Agent in Charge may determine to ensure that the substa nce does not become ava ilable to unauthorized persons. Though this is an option curre ntly available to end users, it is used in extremely limited
circumstances.

18 Please confer with state and/or local environmental agencies to ensure regulatory compliance when using reverse
distributors.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 23 August 26, 2010 

### Typically, the facility ne eds to destroy the unused controlled substances on site, witnessed by two health care p rofessionals , generally a pharmacist
and a nurse or two nurses. Two-witness destruction practices that EPA identified in use at health care facilities include disposal down the drain and crushing and mixing the controlled substances with an undesirable material (e.g., absorbent material such as kitty litter, sand, or coffee grounds). For personnel safety reasons, EPA does not recommend that pharmaceuticals
be crushed and recommends that medications be disposed of unaltered. Red Bags/Sharps Containers Should Not

Be Used

As a best management practice, unused pharmaceuticals should not be disposed of with biohazardous waste or red bag waste. Biohazardous waste is typically sterilized (e.g., in an autoclave) prior disposal in landfills. The temperature achieved during autoclaving is insufficient to destroy most pharmaceutical ingredients. During sterilization, wastewater potentially containing pharmaceuticals may be generated and discharged to the sewer, through which it reaches waterways. EPA’s goal is to keep pharmaceuticals out
of U.S. waters. Facilities may use disposal down the drain sewer (or flushing) as an acceptable destruction option
for controlled substances. However, EPA
recommends that health care facilities use other destruction options (see below).

4.5.2 Recommended Management of Controlled Substances

For unused contro lled pharmaceuticals, EPA recomm ends that health care facilities send the pharmaceuticals to a reverse distributor for potential credit and proper disposal 19 

### . Facilities may also send the unused stock of controlled pharmaceuticals back to their pharmacy for proper disposal. If the facility is not a DEA registrant, it can check with the regional DEA and state board of pharmacy to request approval to send co ntrolled substances back to the pharmacy for disposal. How non-DEA re gistrants handle controlled substan ces may change based on an ongoing review by DEA (see 74 FR 3480, January 21, 2009).

If the facility cannot send unused controlled su bstances back to the pharmacy or to a reverse distributor, follow the steps outlined below.

Controlled Substances that are RCRA Hazardous

EPA strongly discourag es the practice of sewer di sposal for pharmaceuticals wastes that are both
hazardous wastes under RCRA and controlled substa nces. Any controlled substance identified as hazardous should be managed in accordance with federal, state, and local hazardous waste regulations as well as th e Controlled Substances Act and DEA regulations.

Controlled Substances that are Nonhazardous

For unused, nonhazardo us controlled pharmaceuticals that cannot be sent to a reverse distributor or pharmacy for disposal (because the reverse di stributor or pharmacy will not accept it), EPA recommends that the facility dispose of with solid waste (i.e., regular trash). For disposal with regular trash, EPA recommends that the facility:

19 EPA strongly recommends that facilities consult with their state regulatory agency to ensure compliance with all state environmental regulations when unused pharmaceuticals are sent to reverse distributors.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 24 August 26, 2010 

### 1. Take the medication out of the original containers.

2. Mix medication, either liquid or solid, with an undesirable substance. Undesirable substances include sand, coffee grounds, kitty litter, or other absorbent materials.

3. Place the waste mixture in a sealable bag, empty can, or other container to prevent leakage.

4. Dispose with the solid wa ste (i.e., regular trash).

If the facility segregates controlled substan ces that are nonhazardous pharmaceuticals from other solid wastes, the mixing with an undesirable subs tance may not be necessary, but the waste must be managed in accordance with the Controll ed Substances Act and DEA regulations.

4.6 Additional Resources for Identifying Waste Types

The U.S. EPA’s hazardous waste website, http://www.epa.gov/osw/hazard/index.htm can help
health care f acilities correctly identify unused pharmaceutical types and proper disposal requirements. Other publications and websites ma y also provide assistance, such as Practice
Greenhealth’s Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities
in the United States and the Healthcare Environmental Re source Center (HERC). See Section 6
for websites and other resources . Facilities can also purchas e proprietary databases from commercial services (for example, PharmE cology’s PharmE® Inventory Analysis or PharmWaste Technology, Inc.’s Pharmaceutical Waste-ID SystemsTM) 20



### .

20 EPA does not endorse any of these services but has provided them as an additional resource.

### 25Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of WaterDRAFTAugust 26, 2010Table 3. Recommended Management of Unused PharmaceuticalsBest Management Practices, Listed in Order of Preference(X – Recommended by EPA for type and form of pharmaceutical)UnusedPharmaceuticalStreamPharmaceuticalTypeMedication FormDonationaReverseDistributionbManagement asHazardous WastecSolid WasteIncinerationdDisposal in Solid WasteLandfill After Mixing withUndesirable SubstanceSolid (tablet, capsule)XXXXLiquid (IV, vials, drops)XXXXGels, creams, and lotions)XXXXPatchesXXEPA requests inputon BMPsEPA requests input on BMPsNon-ControlledSubstanceOrally inhaled and nasaldrug productsXXX (if pharmaceuticalis a RCRAhazardous waste)EPA requests inputon BMPsEPA requests input on BMPsSolidXXXXLiquidXXXXGels, creams, and lotions)XXXXPatchesXXEPA requests inputon BMPsEPA requests input on BMPsControlledSubstanceeOrally inhaled and nasaldrug productsXXX (if pharmaceuticalis a RCRAhazardous waste)EPA requests inputon BMPsEPA requests input on BMPsChemotherapyPharmaceuticalAllXXXSyringe contentsfXXBiohazardousEPA requests input on anyother formXXSyringe contentsfXUnopened/not yetexpiredHazardous andbiohazardous“dual” wasteEPA requests input on anyother formX

### 26Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of WaterDRAFTAugust 26, 2010Table 3. Recommended Management of Unused PharmaceuticalsBest Management Practices, Listed in Order of Preference(X – Recommended by EPA for type and form of pharmaceutical)UnusedPharmaceuticalStreamPharmaceuticalTypeMedication FormDonationaReverseDistributionbManagement asHazardous WastecSolid WasteIncinerationdDisposal in Solid WasteLandfill After Mixing withUndesirable SubstanceSolidXXXLiquidXXXGels, creams, and lotions)XXXPatchesXEPA requests inputon BMPsEPA requests input on BMPsNon-ControlledSubstanceOrally inhaled and nasaldrug productsXX (if pharmaceuticalis a RCRAhazardous waste)EPA requests inputon BMPsEPA requests input on BMPsSolidXXXLiquidXXXGels, creams, and lotions)XXXPatchesXEPA requests inputon BMPsEPA requests input on BMPsControlledSubstanceeOrally inhaled and nasaldrug productsXX (if pharmaceuticalis a RCRAhazardous waste)EPA requests inputon BMPsEPA requests input on BMPsChemotherapyPharmaceuticalAllXXSyringe contentsfXXBiohazardousEPA requests input on anyother formXXSyringe contentsfXUnopened/expiredHazardous andbiohazardous“dual” wasteEPA requests input on anyother formX

### 27Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of WaterDRAFTAugust 26, 2010Table 3. Recommended Management of Unused PharmaceuticalsBest Management Practices, Listed in Order of Preference(X – Recommended by EPA for type and form of pharmaceutical)UnusedPharmaceuticalStreamPharmaceuticalTypeMedication FormDonationaReverseDistributionbManagement asHazardous WastecSolid WasteIncinerationdDisposal in Solid WasteLandfill After Mixing withUndesirable SubstanceSolidXXLiquidXXGels, creams, and lotions)XXPatchesEPA requests inputon BMPsEPA requests input on BMPsNon-ControlledSubstanceOrally inhaled and nasaldrug productsX(if pharmaceutical isa RCRA hazardouswaste)EPA requests inputon BMPsEPA requests input on BMPsSolidXXLiquidXXGels, creams, and lotions)XXPatchesEPA requests inputon BMPsEPA requests input on BMPsControlledSubstanceeOrally inhaled and nasaldrug productsX (if pharmaceuticalis a RCRAhazardous waste)EPA requests inputon BMPsEPA requests input on BMPsChemotherapyPharmaceuticalAllXSyringe contentsfXXBiohazardousEPA requests input on anyother formXXSyringe contentsfXOpenedHazardous andbiohazardous“dual” wasteEPA requests input on anyother formXa – If allowed by the state.b – Reverse distribution of controlled substances is only permissible by 1) DEA registrants; or 2) with special permission fromthe state. EPA stronglyrecommends that facilitiescontact their state regulatory agency to ensure compliance withall state environmental regulations when unused pharmaceuticalsare sent to reverse distributors.c – RCRA hazardous waste requirements depend onthe quantity of waste generated in a month. If the facility qualifies as a conditionally-exempt small quantity generator(CESQG), the waste may not need to be disposed of at a RCRA-permitted hazardous waste facility.d – Solid waste incineration includes incineration in units that are subject to 40 CFR 60 subpart Cb, Eb, AAAA, BBBB, CCCC, DDDD, EEEE, and FFFF.e – Dispose in accordance with the Controlled Substances Act and DEA requirements.f – Empty syringe contents; dispose of empty syringe in red sharps container.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 28 August 26, 2010 

### 5. S TARTING 

### A W ASTE 

### M ANAGEMENT 

### P ROGRAM



### EPA recommends that health care facilities implement a waste management program that includes waste segregation to ensure that facilities meet all applicable regulations and potentially minimize costs. For example, by separating the nonhazardous pharmaceutical waste from hazardous pharmaceutical waste, fa cilities may minimize cost and st ill comply with applicable federal regulations. Another important part of the waste management program is to communicate with staff so all pharmaceuticals are disposed properly.

5.1 Waste Segregation

The waste management plan should include a pr ocess to segregate pharmaceutical waste by how the facility plans to dispose of them. The pr ocess can identify the type of pharmaceutical (controlled or non-controlled, hazardous or nonhazardous, chemotherapy) either at time of delivery or when waste is collected. For example, some facilities find it useful after delivery and during stocking, to apply color-c oded stickers on supplies that match the disposal bin color placed at their facility to collect and segregate various types of waste (e.g., black color indicates hazardous waste).

5.2 Training Staff in Pr oper Disposal Methods

After developing a waste management plan, the f acility should train staff (pharmacy personnel, nurses on the patient floors, and others who w ill manage unused pharmaceuticals) to recognize the type of unused pharmaceutical and its prop er disposal. The staff should recognize when unused pharmaceuticals should be returned to the pha rmacy and when they should be disposed of and how. Training should be revisited to update and refresh staff on proper unused pharmaceutical management and waste handling. Staff can also provide feedback on how the program is working and ways to improve the process.

Posters and signs should also be pl aced near disposal ar eas to remind staff of disposal policies. During periodic pharmaceutical stock inventory, cons ider auditing waste disposal practices to determine how well facility staff is following the waste management plan. With the audit findings, the facility can identify wh ere additional training is needed.Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 29 August 26, 2010 

### 6. O THER 

### R ESOURCES



### U.S. Drug Enforcement Admi nistration (DEA) website: http://www.deadiversion.usdoj.gov

U.S. EPA RCRA hazardous waste website: http://www.epa.gov/osw/hazard/

The following is a list of various RCRA docu ments that pertain to pharmaceutical wastes. These documents are publicly availabl e in the RCRA Online database: http://www.epa.gov/epawaste/i nforesources/online/index.htm

 

### Scope of P042 (epinephrine) listing memo (RCRA Online #14778): http://yosemite.epa.gov/osw/ rcra.nsf/0c994248c239947e85256d090071175f/2F 70

1627EB73B2AB852573D2005E 0B4F/$file/14778.pdf

 

### Epinephrine residue in a syringe is not P042 (RCRA Online #13718): http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/1 C1 DEB3648A62A868525670F006BCCD2/$file/13718.pdf

 

### Syringes containing P- or U-listed residues are not hazardous waste (RCRA Online #14788): http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/6 A5 DEDF2FBA24FE68525744B0045B4AF/$file/14788.pdf

 

### Regulation of medicinal nitrog lycerine (RCRA Online #14654): http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7AC FEC572DE8897F85256D1600748BCB/$file/14654.pdf

 

### Hazardous Waste Generator Regulations: A User-Friendly Reference Document (RCRA Online #51186): http://www.epa.gov/epawaste /hazard/downloads/tool.pdf

 

### Hazardous Waste Listings: A User-Friendly Reference Document: http://www.epa.gov/epawaste/hazar d/wastetypes/pdfs /listing-ref.pdf

NIOSH Pocket Guide to Chemical Hazards: http://www.cdc.gov/niosh/npg/default.html

U.S. Departm ent of Health and Human Services – HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/

National Association of Boards of Pharm acy: http://www.nabp.net/

Am erican Society of Consultant Pharmacists: http://www.ascp.com/

Am erican Society of Health-System Pharmacists: http://www.ashp.org/

State W aste Programs, includi ng hazardous waste (links): http://www.epa.gov/epawaste/wyl/stateprograms.htmBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### 30 August 26, 2010 

### State Medical Waste Programs and Regulations (links): http://www.epa.gov/osw/nonhaz/indu strial/m edical/programs.htm

Example of State Guidance:

 

### Minnesota Technical Assistance Program (MNTAP): http://www.mntap.umn.edu/

 

### Kansas’ Disposal Options for Expired or Surplus Medications/Pharmaceuticals : http://www.kdheks.gov/waste/techguide/sw07-01.pdf

Healthcare Environm ental Resource Center: http://www.hercenter.org/index.cfm

 

### State program locator for hazardous waste ( http://www.hercenter.org/hz.cfm )

 

### State medical waste locator ( http://www.hercenter.or g /rmw/rmwlocator.cfm )

 

### State universal waste programs ( http://www.hercenter.org/uw.cfm )

Practice Greenhealth (form erly Hosp itals for a Healthy Environment): http://www.practiceg reenhealth.org/

Practice Greenhealth’s 10-Step Blueprint (updated August 2008): http://www.practicegreenhea lth.org/tools/toolkit/guides/Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-1 August 26, 2010 

### APPENDIX A: S TATE 

### L AWS AND 

### L OCAL 

### O RDINANCES



### State regulations on the management of unused pharmaceuticals vary from no regulation, to encouragement to “follow all applicable laws ,” to specific destruc tion and recordkeeping requirements. Practices are regulat ed by a variety of state entities including departments of health and environment, boards of pharmacy, and licensing agencies. In addition, state rules can vary by type of facility.

State Donation Programs

Som e states have programs in place to allow the reuse of unused pharmaceuticals through state repository programs. Typically, these programs allow the reuse of unopened medications (e.g., still in tamper-proof packaging or packaged as unit doses) that are non-controlled substances. Other common requirements incl ude that the medication is properly maintained (e.g., under control by the facility or pharmacy) and expiration date is be yond six months at time of donation.

Before use, the state requires that the unopened medication be in spected or reviewed, often by a pharmacist, to determine if the product is reus able. The type of pharmaceuticals, who can donate, and who can accept the donation varies by state as described in Table A-1. The federal government does not oversee the state programs; a ll programs listed in the table are managed at
the state level.

Table A-1. Summary of State Donation Programs

State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

Arizona Legislative (HB 2382) Rx Board will
issue list of unacceptable products Individuals, manufacturers, or
health care institutions Volunteer participants: pharmacies, hospitals, or nonprofit
clinics Effective 6/6/2008; not operational as
of 8/2009

Arkansas Legislative (HB 1031) Non-controlled
substances Nursing facilities by clinic pharmacies Charitable
clinic pharmacies Signed 2/15/2005; program is currently in operation

California Legislative (SB 798) Prescription drugs Licensed health care facilities, licensed pharmacies, and drug
manufacturers Established by
counties Signed 9/30/2005; not operational as
of 8/2009

Colorado Legislative (SB 07-231) Chemotherapeutic drugs and medical
devices Cancer patients or
their families Volunteer participants: pharmacies or
health care
facilities Effective 8/8/2007; program is currently in operation

Connecticut Legislative (HB 6002) Non-controlled
substances Long-term care
facilities Vendor pharmacies or Department of
Social
Services Signed 6/21/2000; program is currently in operationBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-2 August 26, 2010 State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

Florida Legislative (SB 22A and HB 371) Chemotherapeutic drugs and supplies Any entity including individuals, health care facilities, pharmacies, manufacturers, or
wholesalers Volunteer participants: pharmacies or
health care
facilities Effective 7/1/2006; program is currently in operation Georgia Legislative (HB 430) Non-controlled, prescription drugs Any individual or entity including a drug
manufacturers or
health care facilities Volunteer participants: pharmacies, hospitals, or nonprofit
clinics Required to be implemented
no later than
1/1/2007

Guam Legislative (Chapter 5,
Sections 5103 and 5104) Not limited except
to meet standards established by
Guam or the U.S. Health care facilities, pharmacies, manufacturers, wholesalers, or
charitable institutions Medicine Bank, created at Community
Health
Centers and
various
institutional
facilities that

are government owned and operated Signed in

2004

Hawaii Legislative (HB 2005 final) Prescription drugs previously dispensed or
distributed at an
institutional facility Health care facilities (initiated by patients or facility personnel) Institutional
facilities or repositories in
the state Effective 7/1/2004; not operational as
of 8/2009

Indiana Legislative (HB 1251) Unused
medication Health care facilities Pharmacy/ pharmacist that dispensed prescription Effective 7/1/2004; not in operation as of 8/2009; requires the
office of
Medicaid policy and planning to
review the

process
Iowa Legislative (HF 724) Prescription drugs Patients Volunteer participants: pharmacies or
medical
facilities Signed 5/3/2005; program is currently in operationBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-3 August 26, 2010 State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

Kansas Legislative (HB 2578) Non-controlled substances;
donated from a controlled storage
unit of the donating entity; excludes drugs purchased under
Medicaid or State
Children’s Health Insurance Program (SCHIP) Long-term care residents, donating entities (e.g., health care facilities) Qualifying
medical

centers or clinics in
consultation
with pharmacists Signed 3/20/2008; program is currently in operation

Kentucky Legislative (SB 23) Chemotherapeutic (prescription) drugs andsupplies; noncontrolled
substances Health care facilities, pharmacies Volunteer participants: pharmacies or
health care
facilities Effective 3/18/2005; not in operation as
of 8/2009

Legislative (HB 1402) Prescription drugs Any individual or entity, including drug manufacturers, health care facilities, or government entities Charitable pharmacies Effective
8/15/2004 Louisiana

Legislative (SB 19) Prescription drugs Health care facilities or government entities
enrolled in Medicaid

program Charitable pharmacies Effective 6/29/2006; program is currently in operation

Maine Legislative (HP 105 and
HP 327/LD 411) Prescription drugs Health care facilities, manufacturers, or
wholesalers Pharmacies
and certain
health care
facilities HP 105
effective 5/31/2005; HP
327/ LD 411 provided $300,000 forpilot mailback program (signed 6/27/2007) Maryland Legislative (SB 1059) Non-controlled, prescription drugs Individuals Boardapproved drop-off sites
and repositories Effective 7/1/2006; program is currently in operation

Massachusett

s Legislative (Chapter 111, Section 25l) Unused
medication Residents or consultant pharmacists in health
care facilities Health care
facilities Signed in 2004; program is currently in operation Michigan Legislative (Public Act 329 of 2004) Unused
medication from the Department of
Corrections Michigan Department of Corrections Effective 2004Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-4 August 26, 2010 State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

Minnesota Legislative (Statute 151.55) Chemotherapeutic drugs and supplies Pharmacies, medical facilities, manufacturers, or wholesalers;
individuals over 18 Volunteer participants: pharmacies or
medical
facilities on the premises Effective 2007; program is currently in operation

Mississippi Legislative (State Code
Section 43- 13-503) Prescription drugs Any individual or entity, including drug manufacturers, health care facilities, or government entities;
the State Board of Pharmacy; the State Department of Health;
and the Division of
Medicaid Pharmacies, hospitals, nonprofit clinics, or
health care professionals Was to be implemented by 7/1/2005;
not in operation as
of 8/2009

Legislative (HB 898, SB 1160) Prescription drugs Any individual or entity Effective 8/28/2004; program is currently in operation Missouri

Legislative (HB 1687) Prescription drugs Any individual or entity, including but
not limited to
manufacturers or
health care facilities Volunteer participants: hospitals, pharmacies, nonprofit
clinics Approved 7/12/2006; not in operation as
of 4/2009

Montana Legislative (SB 288) Non-controlled, prescription drugs Long-term care
facilities Provisional community pharmacies Effective 10/1/2001; program is currently in operation

Nebraska Legislative (LB 756 and LB 1116) Chemotherapeutic drugs Any individual or entity, including but
not limited to
manufacturers or
health care facilities Volunteer participants: physician’s offices, pharmacies, hospitals, or
health clinics Effective
9/15/2003 and
clarified in 2006; program is currently in operation

Nevada Legislative (SB 327) Non-controlled, prescription drugs (unit dose, sealed individual dose, or sealed bottle) Public or private
mental health facilities Dispensing pharmacies Effective 7/1/2003; program is currently in operation

New Hampshire Legislative (State law,

NH RSA
Section 318.58) No details No details No details Authorizes

reuse program; not in operation as
of 12/2009. New Jersey Legislative (Title 24) Prescription drugs Licensed health care
facilities Same licensed
health care
facilities Not operational as
of 8/2009Best Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-5 August 26, 2010 State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

New Mexico Legislative (SN 82) Prescription drugs Corrections facilities with a registered or
licensed nurse Pharmacies operated by or
under contract
with the
Corrections Department Signed 4/7/2009; program is currently in operation

New York Legislative (S 2803-e) Unused
medication Residential health care facilities (by a resident, consultant pharmacist, or designee) Dispensing pharmacies Referred to
New York
Health Department
on 1/9/2008

North
Carolina Specific guidelines are being developed for a drug repository/return program b

North Dakota Legislative (HB 1256) Prescription drugs Any individual or entity Volunteer participants: practitioners or pharmacies Signed 4/2007; program is currently in operation

Ohio Legislative (HB 221) Prescription drugs Any individual, including
manufacturers or
health care facilities Volunteer participants: pharmacies, hospitals, or nonprofit
clinics Signed
1/6/2003. Program is currently in operation.

Oklahoma Legislative (HB1297 and SB 1640) Non-controlled, prescription drugs Long-term care facilities, public
intermediate care facilities for people
with mental retardation (ICF/MR), or
manufacturers Certain pharmacies or
charitable
clinics Effective 11/1/2006; program is currently in operation

Oregon Repository/donations not permitted; return an d reuse of medications allowed only in long-term care pharmacies where drugs have not been disp ensed (remain in control of facility staff) b
Pennsylvania Legislative (SB 638) Chemotherapeutic drugs Health care facilities or pharmacies Authorized, participant pharmacies Signed 5/13/2008; not in operation as
of 8/2009

Rhode Island Legislative (HB 5107 and HB 5850) Prescription drugs, including chemotherapeutic drugs Nursing home, assisted living center, and drug
manufacturer Authorized, participant pharmacy Not operational as
of 8/2009

South
Carolina Repository/donations not permitted; return and reuse of medications allowed based on pharmacist’s professional judgment b

South Dakota Legislative (HB 1165) Unit-dose
medications Patients in hospice programs, nursing facilities, or assisted living facilities Hospice

programs, nursing or assisted living
facilities Signed 2/19/2004; not in operation as
of 8/2009

Tennessee Legislative (HB 3560 and SB 3660) Non-controlled, prescription drugs Nursing home or hospice services Charitable
clinic pharmacies Effective 7/1/2006; program is currently in operationBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-6 August 26, 2010 State Program Type Types of
Pharmaceuticals Who Can Donate? a Who Can Accept? Notes

Texas Legislative (SB 1896) Non-controlled
substances Pharmacists who practice in or consult
with a health care facility; licensed health care professionals responsible for administration of drugs in a penal institution Pharmacies Signed 6/15/2007; program is currently in operation

Utah Legislative (58-17b-503) Non-controlled, prescription drugs Pharmacists receiving return; drug must have been prescribed to a patient in a nursing care facility, ICFMR, state prison, county jail, or state hospital Dispensing pharmacy Effective 7/1/2005; not in operation as
of 8/2009

Vermont Legislative (H. 711) Prescription drugs (unsold or unused) Health care facilities
or wholesale
distributors Volunteer participants: pharmacies, hospitals, or nonprofit
clinics No details

Virginia Legislative (HB 154, HB 1854, and HB 2682) Prescription drugs Hospitals (medications dispensed to patients but not used) Pharmacies, clinics (2005), or hospitals (2009) Signed
4/6/2002 and 3/24/2005; program is currently in operation West Virginia Return of unit-dosed , non-controlled substances allowed b
Legislative (SB 56) Prescription drugs State prison pharmacies State prison pharmacies Approved
8/20/2003 Wisconsin

Legislative (AB 845 and AB 197) Chemotherapeutic drugs and supplies; prescription drugs
for all other
chronic diseases (e.g., diabetes) Any individual or entity Volunteer participants:
medical
facilities or pharmacies Enacted 4/6/2004; expanded in

2005

Wyoming Legislative (HB 194) Prescription drugs Any individual or entity, including but
not limited to manufacturers, physicians, or health
care facilities Volunteer participants: pharmacies, physicians, or
health care
facilities Signed 3/2/2005; program is currently in operation

Source: National Conference of State Legislatures (NCSL), State Prescripti on Drug Return, Reuse and Recycling Laws (website), http://www.ncsl.org/programs/health/rx-reuse.htm . Accessed July 1, 2010.

a – Health care facility may include hospitals, long-term care facilities, medical clinics, physician offices, et al. Check the state program’s definition of health care facility.

b – National Association of Boards of Pharmacy, 2009 Survey of Pharmacy Law



### State Regulations for the Dispos al of Unused Pharmaceuticals

States g enerally do not specifically regulate the disposal of unused pharmaceuticals, but some regulate pharmaceutical management and disposal options, or they provide guidance. Some states require unused pharmaceuticals to be destroyed but do not specify the process ofBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### A-7 August 26, 2010 

### destruction; however, many states have require ments for the types of personnel required to conduct and oversee the destruction, especially for controlled subs tances. States may also have more stringent requirements than EPA for the dis posal of hazardous waste. Check with the state environmental management agency for more details. To identify state requirements, facilities can check the state links provided at the following website: http://www.epa.gov/osw/nonhaz/indu strial/m edical/programs.htm or the state program locators

at http://www.hercenter.org/regs andstandards/stateandlocal.cfm

.

### B-1Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of WaterDRAFTAugust 26, 2010APPENDIXB:SAMPLEUNUSEDPHARMACEUTICALTRACKINGSHEETLocationDatePharmaceuticalNameFormStrengthAmountWastedDisposal MethodReason WastedNotesExample:Pharmacy01/01/2010HydrocodoneTablet5 mg25 tabletsReverse distributionExpiredExample:Room 51201/01/2010HydrocodoneTablet5 mg1 tabletDrainPatient refusedExample:Med sta 301/01/2010AmoxicillinLiquid125 mg/5mL15 mLTrash canPatient dischargedOpened bottleLocation: Nurses station number or pharmacyForm: tablet, capsule, vial, IV, cream, gel, emulsion, inhalant, etc.Amount wasted: number of items or liquid volumeBest Management Practices for Unused Pharmaceu ticals at Health Care Facilities EPA Office of Water

DRAFT 

### C-1 August 26, 2010 

### APPENDIX C: C ONSIDERATIONS 

### W HEN 

### C ONTRACTING WITH A 

### S PECIALTY 

### W ASTE 

### H AULER



### Your facility might want to consider the fo llowing factors when choosing a specialty waste hauler. Remember: you are hiring a company to transp ort your waste, but the waste is still yours and is still your responsibility.

Confirm that the specialty waste hauler is fam iliar with all regulations that apply to your facility

. Your specialty waste hauler should be aware of all federal, state, and local pharmaceutical disposal, storage, and transport laws. If you are not familiar with the regulations, ask the specialty waste hauler for a list of regulations and have them explain to you what laws apply. Federal agencies that may regulate wa ste disposal include the following:

 

### U.S. Environmental Protection Agency (EPA): http://www.epa.gov/ ;

 

### Occupational Safety and Hea lth Administration (OSHA): http://www.osha.gov/ ;

 

### U.S. Department of Transportation (DOT): http://www.dot.gov/ ;

 

### Nuclear Regulatory Commission (NRC): http://www.nrc.gov/ ;

 

### Centers for Medicare and Me dicaid Services (CMS): http://www.cms.hhs.gov/ ; and

 

### Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/

.

Other regulations m ay be required by state heal th departments, environmental boards, and Medicaid programs and local health departments.

Confirm that the hauler dedicates resou rces to keep current with regulations , such as an environmental regulations department. Regulat ions are updated often, and you will want your hauler to be familiar with the latest requirements.

Get to know the hauler staff.

 

### Have they been properly trained? Are th ey familiar with the laws governing waste handling, transport, and storage of the types of waste your facility generates?

 

### Can they handle emergencies, such as natural disasters and spills?

Get to know the company. Where do they take your waste? How does it get there? Does your hauler deliver it directly to a landfill or incinerator? Does your hauler operate the landfill or incinerator? Are they licensed to do so? Does your hauler transport your waste to another hauler? Do they provide you adequate records, such as waste manifests? Can they provide proof of training for hauler employees and hauler insurance?

Request full service. Request training for you and your staff on waste management. Make sure proper transport and disposal records are provided to you. At a minimum, you should receive a waste manifest identifying the types and quantities of waste and their destination 21 

### . Will they provide assistance with drug inventories?

21 RCRA includes manifest requirements for large quantity and small quantity generators (LQGs and SQGs).