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Controlled_Substances

How to Dispose of Controlled Substances

There is a lot of confusion about the proper and legal disposal of Drug Enforcement Agency (DEA) controlled substances in a clinical setting. Controlled substances are drugs that have the potential for abuse or dependence, and are regulated by the DEA to help prevent misuse. The Controlled Substances Act (CSA) divides controlled substance drugs into five categories called schedules:

  • Schedule I includes drugs that have no accepted medical use, such as heroin.
  • Schedule II drugs are used medically but have high abuse potential, such as morphine. Their purchase, storage and usage are strictly monitored.
  • Schedules III through V drugs have decreased abuse potential and range from sedatives to cough suppressants, such as codeine.

What Constitutes Proper Disposal of DEA Controlled Substances

Disposal generally refers to a wide range of activities that result in a controlled substance being rendered unavailable for further use. A controlled substance can be disposed of by destruction, return, recall, sale or through the manufacturing process.

When disposing of by destruction, the drug must be rendered non-retrievable. Non-retrievable means to permanently alter the controlled substance’s physical or chemical condition through irreversible means, making it unavailable and unusable for all practical purposes. Incineration is the only method currently accepted by the DEA to render a drug non-retrievable. Sewering (pouring down the drain) and landfill disposal (mixing with kitty litter, coffee grounds, etc.) does not meet the DEA’s non-retrievable standards.

In a clinical setting, this means controlled substances should not be simply placed into a sharps container or non-hazardous pharmaceutical waste container. That’s because these methods could allow the controlled substance to be poured out and used, making them retrievable.

In Arizona, regulations prohibit medication disposal into sewers unless specific permission has been granted by the wastewater treatment authority. The DEA intends to allow public and private entities to develop a variety of destruction methods that are secure, convenient and responsible — however, they must also meet all other applicable federal, state, tribal and local laws.

How to Stay DEA Compliant

Although the DEA states that it seeks to determine a variety of destruction methods, the only acceptable method of destruction for pharmaceutical wastage (i.e., drugs dispensed to a patient and not fully used, such as a single dose vial or syringe with remaining controlled substance) at this time is incineration. Therefore, the only method that currently meets the DEA requirement for both the non-retrievable and destruction standards involves a two-part process:

  • Wasting the medication into a suitable neutralizing media, such as a Cactus Smart Sink or an Rx Destroyer. A solidifier can also be used for liquid only waste.
  • Placing the neutralized container into a non-hazardous pharmaceutical waste container that will be sent out for incineration.

Wastage is no longer required to be recorded on DEA Form 41. However, this change is for the DEA only, and it doesn’t necessarily apply to state, local or accrediting bodies. As a result, it is strongly encouraged to maintain double signatures for wastage.

Proper disposal of unused, out-of-date, damaged or otherwise unusable or unwanted controlled substances, including samples, should involve transferring them to a registrant authorized to receive such materials. These registrants are referred to as “Authorized Reverse Distributors.” Schedule I and II controlled substances should be transferred using DEA Form 222, while Schedule III through V compounds may be transferred via invoice. You should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.

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Transferring Your Medical Waste Disposal Service: What to Consider

When your medical waste disposal service contract is coming to an end, there’s a lot to think about. Should you select a new provider or stick with your current one? If you’re experiencing rising costs and unsatisfactory service, it could be time to change things up. But where do you start? What sorts of questions should you ask during the process and what should the contract include? Follow these tips to make the process easier.

Contract Essentials

Transferring your medical waste disposal services to another vendor means signing a new contract. Here’s what should be in it.

  • A service contract should be required. Never enter into an agreement without the terms spelled out on paper. A waste acceptance policy should always be included.
  • The contract should outline the medical waste disposal provider’s roles and responsibilities for the scope of service, and identify its liabilities if an accident occurs.
  • It should also spell out the total price to be charged. Watch out for hidden fees, such as fuel charges, environmental fees or container surcharges. Be sure to ask about these costs as they aren’t always disclosed upfront.
  • The length of the contract should be clear, and any cancellation provisions should be included.

Questions to Ask When Hiring a Medical Waste Service Provider

As part of your due diligence when selecting a new medical waste provider, make sure to ask these questions.

  • What is the price increase notification process? If one occurs, does the contract give you the option of getting out of it or limit the price increase to a predetermined amount?
  • Does the company have appropriate regulatory licenses?
  • Are its employees given background checks? If so, how often?
  • Are its employees properly trained in hazardous materials transportation, OSHA bloodborne pathogens, OSHA hazard communication and HIPAA? Do they participate in continuing education courses?
  • Does the company have the appropriate insurance coverages, including general liability, environmental pollution, auto and worker’s compensation?
  • Is the company able to handle the reach and logistics of your business? Some companies may be able to handle a single location practice, but are not equipped to handle bigger or multi-location operations, like medical groups or surgical centers.
  • Are there customer references you can contact? This is the best way to determine how the company will perform in the future.

US Bio-Clean provides low cost medical waste management services to a variety of businesses and industries throughout Arizona. There are never any hidden fees or automatic price increases. Get a free quote.

Beautiful female medical intern shakes hands with a medical professional. She is wearing a lab coat and is holding a clipboard.

Q&A: DOT Regulated Medical Waste Training

As someone who oversees the disposal of regulated medical waste, you’re familiar with the acronyms of a host of regulatory agencies, including the EPA, OSHA and ADEQ. But there’s one more acronym that often gets forgotten when it comes to regulated medical waste compliance: the U.S. Department of Transportation, or DOT.

The DOT regulates the transportation of nine classes of hazardous materials, including regulated medical waste, and it’s your organization’s responsibility to be in compliance with the department’s regulations, even if you aren’t the ones transporting it. That means completing DOT training. Here we answer common questions about this training, including how often it’s needed.

What is it?

DOT regulated medical waste training teaches employees how to segregate, package and properly prepare regulated medical waste for transportation and disposal. The training ends in an exam that employees must pass in order for the organization to maintain compliance.

Who is it for?

DOT training is required for any employee who has any part in preparing regulated medical waste for shipment, whether that be packaging, labeling or signing the manifest prior to transportation.

When is it required?

DOT regulations require new employees to complete the training within 90 days of employment. Employees must also repeat the training every three years. It is the sole responsibility of the employer to ensure employees complete and maintain certification in a timely manner.

Why should I do it?

DOT training outlines how regulated medical waste must be segregated, packaged and labeled to protect the environment and the public from hazardous waste. It is a requirement, just as trainings mandated by HIPAA and OSHA. Not completing the training or failing to recertify every three years opens your organization up to audit and significant penalties. DOT training also may be a necessary step when applying for accreditation from medical associations, such as the Joint Commission or the Accreditation Association for Ambulatory Health Care.

How can I get the training?

US Bio-Clean offers a suite of compliance training, which includes DOT training.

nurse shows other trainees how to use the IV drip

The Right Way to Handle Bulk vs. Trace Chemotherapy Waste

There is a great deal of confusion surrounding the handling and disposal of bulk and trace chemotherapy waste. The Resource Conservation and Recovery Act (RCRA) was enacted by the EPA to mandate the disposal of waste deemed hazardous. Neither RCRA or most states specifically define trace chemotherapy, however, the EPA has recently recognized trace chemotherapy waste as empty IV bags, tubings, vials, gowns, gloves and other items that may be contaminated with chemotherapy pharmaceuticals. And in Arizona, chemotherapy waste is defined as any discarded material that has come in contact with an agent that kills or prevents the reproduction of malignant cells. This includes antineoplastic drugs.

To further muddy the waters, the RCRA lists just nine chemotherapy agents. That’s because the regulations were written years ago and have not been updated since the approval of over 100 new drugs now on the market.

Let us try to clear up some of the confusion.

The Difference Between Bulk and Trace Chemotherapy Waste

Healthcare facilities generate trace chemotherapy waste (also known as yellow bag/container waste) and hazardous chemotherapy waste (sometimes called bulk chemotherapy waste). For items such as vials and IV bags to be considered “trace,” they must meet the RCRA definition of empty. All contents must be removed that can be removed through normal means, and there can be no more than 3 percent by weight remaining.

Bulk chemotherapy waste generally refers to chemotherapy drugs that do not meet the RCRA definition of empty. Other bulk waste may include items used to clean up chemotherapy waste spills or visibly contaminated personal protective equipment.

How to Dispose of Bulk and Trace Chemotherapy Waste

In Arizona, trace chemotherapy waste is placed in yellow containers and must be picked up by a licensed medical waste transporter and disposed of via medical waste incineration.

Bulk chemotherapy waste and containers that are not “RCRA empty” must be managed in accordance with applicable hazardous waste regulations. While not all chemotherapy waste may be regulated as hazardous under the federal RCRA regulations, the EPA recommends that facilities manage all unused bulk chemotherapy pharmaceuticals as hazardous waste as a best management practice.

Arizona regulations require that all chemotherapy waste must be treated by incineration in an approved facility. Bulk waste must be sent to a RCRA-approved incinerator. But trace waste — with one exception — may be sent to a medical waste incinerator. These incinerators have less stringent transportation and documentation requirements, and thus cost significantly less to dispose of than bulk waste.

The Exception: Arsenic Trioxide

Of the nine chemotherapy drugs listed under RCRA, the exception is arsenic trioxide, a P-listed (acutely toxic) hazardous waste. To be “RCRA empty,” all the contents must be removed and it must be triple rinsed. This is not possible in most healthcare settings, so it is to be considered bulk waste. There is one exception to this exception (no wonder people are confused!): The EPA does allow a used arsenic trioxide syringe to be discarded as trace chemotherapy.

Still Confused?

Get help from a licensed, experienced medical waste disposal company like US Bio-Clean. We can create a fully compliant chemotherapy waste disposal plan that fits your specific needs.

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What Is Non-Hazardous Pharmaceutical Waste and What Should You Do with It?

Non-hazardous pharmaceutical waste sounds benign enough. After all, it’s got “non-hazardous” in the name. And if it’s non-hazardous, it can be disposed of along with the regular trash, right? Not so fast.

Classifying Non-Hazardous Pharmaceutical Waste

Non-hazardous pharmaceutical waste is a bit of a misnomer in that it’s not as harmless as it sounds. It still poses health risks to the environment. Better terminology is non-RCRA pharmaceutical waste. RCRA stands for Resource Conservation and Recovery Act, the legislation through which the Environmental Protection Agency governs how hazardous waste must be treated and disposed of.

Non-hazardous or non-RCRA waste is waste that is not governed by RCRA laws. But it still must be disposed of properly in order to protect our communities and comply with other state and federal regulations.

Non-RCRA pharmaceutical waste accounts for about 85 percent of all hospital pharmacy inventory waste, and includes:

Disposing of Non-Hazardous Pharmaceutical Waste

The best way to keep non-RCRA pharmaceutical waste out of our landfills and water supply is to segregate it and have it incinerated. Non-RCRA pharmaceutical waste often is disposed of in white containers with blue lids. Pharmaceutical waste containers should be clearly labeled “for incineration.” It’s important to train all staff on what should be disposed of in this way versus RCRA hazardous waste and biohazardous waste containers.

As a reminder, all medical waste should be housed in a secure area away from the public. Non-RCRA pharmaceutical waste, hazardous waste and biohazardous waste should be collected and disposed of by a state- and federally-compliant pharmaceutical waste disposal service.

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5 Things You Need to Know About Pharmaceutical Waste Disposal

The Resource Conservation and Recovery Act (RCRA) was written by legislators — and it shows. While the act outlines endless “don’ts,” it can be difficult to determine how you should handle pharmaceutical waste. Fortunately, you’ve come to the right place. Here’s how to dispose of pharmaceutical waste.

1. All Pharmaceutical Waste Isn’t Created Equal

Hazardous (RCRA), non-hazardous, trace chemotherapy and controlled substances — it all has to be handled separately and properly according to its classification. It’s also subject to the rules of a number of regulatory agencies. Some (but not all) pharmaceutical waste must be treated as hazardous waste and handled accordingly.

2. Biohazardous Waste and Pharmaceutical Waste Must Be Treated Differently

Some assume that treating pharmaceutical waste as biohazardous waste is the appropriate thing to do, but that’s not the case. Biohazardous waste is sterilized to remove the infectious potential and then delivered to a landfill for final disposal. When you dispose of pharmaceutical waste with biohazardous waste, it will ultimately end up in a landfill and seep into our water supply (or end up in surface water). Because of this, pharma waste needs to be segregated properly and treated by incineration. This breaks down the complex chemicals to render them safe.

3. Fines Aren’t the Only Thing to Worry About

Regulatory angencies often publicize waste disposal violators, so be sure to consider how negative headlines could harm your business when deciding how to dispose of pharmaceutical waste.

4. Chemotherapy Waste Must Be Kept Separate and Treated Appropriately

Chemotherapy waste must be segregated and disposed of separately from biohazardous waste and pharmaceutical waste. Miscategorizing it is not only against Arizona regulations, but ADEQ requires chemotherapy waste to be incinerated or disposed of at either an approved solid waste or hazardous waste disposal facility.

5. Disposal of Controlled Substances Must Meet the Stringent Requirements of the DEA

The United States Drug Enforcement Agency requires that all expired and/or unused controlled substances be returned to the manufacturer or destroyed at a DEA/EPA-licensed incinerator. Both processes require using a DEA-licensed reverse distributor to transport the pharmaceuticals and file the required paperwork.

Save Yourself from Regulatory Headaches

Proper pharmaceutical waste disposal is complex, and there’s a ton of bad information out there. Working with an experienced pharmaceutical waste disposal company like US Bio-Clean can keep your business in compliance with federal and state regulations, and out of hot water with the ADEQ, EPA, USDOT and the DEA.

Beautiful girl at the dentist getting a check up on her teeth - pediatrics dental care concepts

Dental Waste Disposal: How to Handle 6 Types of Dental Waste

A dental office is a busy place. Patients coming and going throughout the day. Cleanings, X-rays, fillings, crowns, root canals. All of that activity makes for a challenging logistical problem — what to do with the resulting hazardous waste.

Here, we offer advice on how to dispose of the six most common types of dental waste so you can keep your patients safe, the environment clean and your business compliant.

1. Mercury Amalgam Waste

Amalgam is a combination of metals chemically bonded by mercury, a toxic element that can enter the environment through waste water, vapors or scrap. Never dispose of dental amalgam in the garbage, in a sharps container or down the drain — this dental waste should always be managed by amalgam removal specialists.

In December 2016, the Environmental Protection Agency issued a federal regulation requiring amalgam separators in dental offices. These devices can increase the capture of dental amalgam waste from 80 percent to 95 percent. Check the American Dental Association’s best management practices for amalgam waste.

2. Silver-Containing Wastes

With its high silver content, used X-ray fixer should not be washed down the drain. Instead, you can install an in-house silver recovery unit, which allows you to salvage the silver. Or the waste can be collected by a biomedical waste disposer. Many practices now avoid the challenges of X-ray fixer waste disposal by using digital imaging equipment.

3. Lead-Containing Wastes

X-ray packets and lead aprons contain lead foil, which has a leachable toxin that can contaminate soil and groundwater if sent to landfills. To avoid this issue, lead disposal should be handled by a licensed hazardous waste disposal company.

4. Blood-Soaked Gauze

For this biohazardous medical waste, proper disposal steps include packaging it in a leak- and puncture-resistant red disposable plastic bag or a leak-proof reusable container with a universal biohazard symbol. Learn more about the rules for dealing with bloodborne pathogens.

5. Sharps

Sharps containers must be appropriately labeled, puncture resistant and leak-proof. The container should be visible and easily reachable by the person using the sharps, and not placed in high-traffic areas, under sinks, inside cabinets or near light switches.

6. Chemicals, Disinfectants and Sterilizing Agents

Some of these substances are federally regulated and must be treated as hazardous waste because they can also have a detrimental effect on the environment. If possible, sterilize instruments with steam or dry heat. And ask your biomedical waste provider for guidance on the proper disposal of all chemicals used in your dental office.

Need Some Help?

As a partner of the Arizona Dental Association, US Bio-Clean can provide cost-effective disposal solutions for your dental office.

Blood sampling in the medical laboratory

OSHA and Bloodborne Pathogens: 7 Must-Know Rules

If you’re responsible for handling medical waste as part of your job, you’ve probably come across the OSHA Bloodborne Pathogens standard. The regulation is meant to protect employees who have occupational exposure to blood or other potentially infectious materials (OPIM).

Published by the Occupational Safety and Health Administration (OSHA), the bloodborne pathogens standard is a maze of definitions, prohibitions and mandates that can make your head spin. But noncompliance can put people at risk and subject your business to citations and penalties. To help you get a handle on things, here are some of the standard’s key requirements.

1. Have a Plan

An exposure control plan details in writing the steps an employer will take to eliminate or minimize exposure to blood or OPIM. This includes a list of job categories in which all employees have exposure and a list of job categories in which some employees have exposure. Employers must seek input for this plan from frontline workers.

2. Assume It’s All Infectious and Implement Controls

Under OSHA’s concept of universal precautions, all human blood and OPIM should be treated as if they contain bloodborne pathogens. Engineering and work practice controls must be implemented, such as safer medical devices, sharps disposal containers and hand hygiene.

3. Provide PPE

Personal protective equipment (PPE) is specialized clothing that includes gloves, gowns, lab coats, face shields or masks, eye protection, mouthpieces and resuscitation bags. Employers must provide and maintain this equipment at their own expense.

4. Offer Vaccinations

The hepatitis B vaccination must be offered to all occupationally exposed employees within 10 working days of initial assignment, after they complete the mandated bloodborne pathogens training.

5. Evaluate and Follow Up

Following an incident, an employer must make immediately available a confidential medical evaluation and follow-up (at the employer’s expense) that includes documentation of the circumstances surrounding the exposure.

6. Affix Labels

Warning labels are required on certain items, including containers of regulated waste and contaminated reusable sharps, as well as refrigerators and freezers housing blood or OPIM.

7. Keep Employees in the Know

Workers must undergo annual training on the standard’s requirements, including ways to control exposure, medical evaluation and follow-up protocols. Also, the employer must keep a sharps injury log, unless otherwise exempt.

US Bio-Clean provides streamlined, cost-effective disposal solutions that take the worry out of OSHA compliance. We also offer an online OSHA healthcare compliance system that gives users the ability to complete Bloodborne Pathogens training in less than an hour. Additionally, the system guides administrators through a step-by-step process to create a fully compliant exposure control plan.

A doctor putting a syringe in a toxic bin

How to Prepare Biohazardous Medical Waste for Off-Site Treatment

In order to stay legal, you need to follow the guidelines for medical waste transportation when having your medical waste taken to a treatment facility. The first step is to package medical waste according to standards, such as using red bags, puncture-resistant containers for sharps and secondary containers as necessary. Also, waste must be transported by a licensed biohazardous medical waste transporter. Transporters of medical waste must provide generators with a copy of a tracking document that shows acceptance of the waste.

This document must be retained for one year and contain the following:

  • Name and address of the transporter, generator and the facility for medical waste treatment, storage, transfer or disposal.
  • Quantity of the medical waste, including weight, volume and number of containers.
  • The identification number attached to the bags or containers.
  • The date of medical waste collection.

Packaging Biohazardous Medical Waste for Disposal

Follow these guidelines when packaging biohazardous medical waste for collection for treatment or disposal:

  • Red bags must be leak-resistant, impervious to moisture, sealable and sufficiently strong enough to prevent tearing or bursting under normal use.
  • When packaging sharps, red bags must be puncture-resistant and placed in a secondary container that prevent breakage of bags during storage and handling.
  • The secondary container can be either disposable or reusable, and must bear a conspicuous biohazard symbol.
  • The secondary container, if reusable, must be completely leak-proof, closable with a fitted lid, cleanable and resistant to corrosion.
  • Secondary containers must never be used for purposes other than storing biohazardous medical waste.
  • Liners, red bags and other disposable packaging must never be reused and must be disposed as biohazardous medical waste.

Additional Guidelines to Follow When Preparing Medical Waste for Transport

In addition to the above regulations, there are specific rules for handling certain types of medical waste, such as cultures and stocks, human pathologic waste, waste containing chemotherapy agents and waste generated from experimental or research animals.

Cultures and Stocks

  • When shipped off-site for disposal or treatment, cultures and stocks must be placed in a primary container with absorbent lining. This container must be placed inside a secondary container, which then must be placed inside an outer container.
  • If federal and state laws prescribe specific requirements for packaging and transporting cultures and stock waste, the treatment facility must comply with those laws.
  • Cultures and stocks must be incinerated, autoclaved or treated with an Arizona Department of Environmental Quality-approved (ADEQ) alternative medical waste treatment method.

Human Pathologic Waste

  • This type of waste must be packaged in a covered, labeled and leak-proof container.
  • Human pathologic waste must be incinerated, autoclaved or treated with an ADEQ-approved alternative medical waste treatment method.
  • If not treated by incineration, the waste must be preprocessed by grinding and treated in compliance with ADEQ standards.
  • If the waste is processed by a combination of grinding and alternative treatment methods, grinding must be done in a closed system that prevents release of the waste into the environment.

Waste Containing Chemotherapy Agents

  • The waste must be packaged in a covered, labeled and leak-proof container.
  • Medical waste containing chemotherapy agents must be incinerated or disposed of in either an approved solid waste or hazardous waste disposal facility.

Experimental or Animal Research Waste

Waste from experimental sources or from animal research can be incinerated, autoclaved or packaged for off-site treatment or for land-filling. Complete animal carcasses must be incinerated for treatment in compliance with one of the following:

  • The waste must be packaged in a covered, labeled and leak-proof container, and sent to an incinerator or an ADEQ-approved landfill.
  • If not treated by incineration, the waste must be preprocessed by grinding and treated in compliance with ADEQ standards.

General Guidelines for Grinding Waste

If the waste is processed by a combination of grinding and alternative treatment methods, grinding must be done in a closed system that prevents release of the waste into the environment. Also, medical sharps processed by grinding must be done in a way that renders the waste incapable of creating a stick hazard.

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Is Nitroglycerin Hazardous Waste?

It’s easy to get confused about the proper disposal of medicinal nitroglycerin due to the categorization of the drug. By definition, nitroglycerin is listed specifically as hazardous waste under the EPA Resource Conservation and Recovery Act (RCRA). It is further categorized as P-listed (P081) or Acutely Toxic.

But there is some good news regarding the proper disposal of medicinal nitroglycerin. The EPA has classified most if not all of the nitroglycerin used in healthcare settings as non-hazardous. In fact, in 2003 the EPA issued a guidance letter to clear up the hazardous waste listing for this product. The response confirmed under the revised mixture and derived-from rules [40 CFR 261.3(g)(1)], which went into effect February 1, 2002, that a waste that has been listed solely for the characteristic of ignitability, corrosivity or reactivity is not regulated as a hazardous waste if it does not exhibit any hazardous waste characteristic. Moreover, if the waste does not exhibit a characteristic at the point of generation, it is considered to have never been a hazardous waste and does not need to meet land disposal restrictions (LDRs) (66 FR 27286, May 16, 2001). The EPA determined that the scope of the P081 listing does not include medicinal forms of nitroglycerin. 

Until this clarification, nitroglycerin was classified and handled as RCRA hazardous waste. The new rules took immediate effect in states that have not been authorized to carry out the base hazardous waste program. However, because the revised mixture and derived-from rules are less stringent than the existing federal requirements, states which are authorized for the base RCRA program are not required to adopt them [40 CFR 271.1(i)]. The regulatory authority in Arizona (ADEQ) has adopted the federal position. Since this clarification, best management practices dictate that nitroglycerin be handled as non-hazardous pharmaceutical waste and sent to a medical waste incinerator or municipal incinerator for treatment.

Many medical waste disposal companies still advise their customers to treat nitroglycerin as a P-Listed RCRA waste. But this practice can be considerably more expensive given the more extensive manifesting and labeling requirements, not to mention the increase in final disposal costs.

One other consideration is that any facility producing 1kg (2.2 lbs.) of P-listed waste in a calendar month is categorized by the EPA as a large quantity hazardous waste generator. Large quantity generators must follow additional requirements specific to proper management of waste, time and storage limits, training, preparedness and prevention, contingency plans, and reporting to regulatory agencies. These facilities must also pay increased fees to regulatory agencies. US Bio-Clean, an Arizona medical waste disposal company, provides professional guidance in the proper categorization, segregation and disposal of pharmaceutical waste, including nitroglycerin.

Are You Compliant With State and Federal Laws? Get the 2016 Definitive Guide to Arizona Medical Waste Disposal and Find Out!

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