Hazardous Drug Handling Protocol from USP <800>

The United States Pharmacopeia (USP) is a private, non-profit, organization although many standards issued by the USP are enforced at many regulatory agencies including the Joint Commission and individual state’s Boards of Pharmacy. The latest chapter, USP General Chapter <800>, provides standards for the safe handling of hazardous drugs in …

Getting Compliant with DEA Drug Disposal Regulations

The Drug Enforcement Agency (DEA) issues regulations regarding the handling and disposing of controlled substances to ensure safety to the environment and to prevent these types of drugs from falling into the wrong hands.  Healthcare facilities that must dispose of pharmaceuticals and controlled substances can face significant fines for improper …

Are Pharmaceutical Research Facilities Bound by DEA Regulations

Medical research laboratories often use controlled substances and many different pharmaceuticals during the course of research.  The Environmental Protection Agency (EPA) and the Drug Enforcement Administration (DEA) regulate safe and compliant medication waste.  The DEA has issued Code of Federal Regulations DEA 21 CFR related to compliance of medication disposal …

Do you Know What It Takes to Be DEA Compliant?

  Maintaining a drug disposal system that is compliant to all DEA regulations is critical for facilities to prevent environmental contamination and drug diversion.  All too frequently, healthcare workers are not properly trained on drug disposal practices that meet regulatory requirements and in some cases are even instructed to dispose …

EPA Subpart P Adoption Dates

The Environmental Protection Agency (EPA) outlines in the Code of Federal Regulations, CFR 40, standards such as Part 266 regarding the Management of Specific Types of Hazardous Waste Management Facilities with Subpart P relating specifically to Hazardous Waste Pharmaceuticals.  The final rule titled the Management Standards for Hazardous Waste Pharmaceuticals …

Challenges to Drug Management and Disposal in Prisons

Managing medications in jails and correctional facilities is a challenging task for nurses and medical staff.  Add to that the many prescriptions that are given to inmates to self-administer as Keep-on-Person (KOP) medications and correctional nurses face many additional challenges. KOP Medications and Tips for Correctional Facility Nurses Administering medications …

Segregating Pharmaceutical Waste In Long Term Care Facilities

Long-term care facilities can include a skilled nursing facility, an assisted living facility, a rehabilitation center, senior living, or hospice care.  These types of facilities can face challenges with properly segregating pharmaceutical waste for compliant medication waste disposal.  Long-term care facilities generate the same types of medical waste as hospitals …

How Should Dental Offices Dispose of Expired Controlled Substances?

Disposal of pharmaceutical waste in dental offices is regulated as medical waste which includes emergency drugs, patient prescriptions, partially used and expired over-the-counter medications.  Specific requirements vary in different states, although dental practices in California must abide by some of the strictest medical waste regulations which include the following record-keeping, …

Nursing Home Witness Signing for Destruction of Controlled Substances

Nursing homes, long-term care facilities and hospitals are the largest generators of pharmaceutical waste in the United States, generating more than 84,000 tons of medication waste each year, according to an article in Patient Safety and Quality Healthcare. Disposing of pharmaceutical waste and nursing homes can be complex and confusing …

What Is the Waste Profile Ticket and Regulations for Pharmaceutical Waste Compliance?

Many steps are required to safely and legally transport and dispose of hazardous pharmaceutical waste. Who Is Responsible for Pharmaceutical Waste Compliance? Properly completing a waste profile ticket is one of the most crucial steps in pharmaceutical waste compliance of both non-hazardous and hazardous waste disposal. The profile ticket lists …

Controlled Substance Disposal Policy and Procedures

An effective controlled substance disposal policy is mandatory to protect healthcare workers, patients and medical facilities. Healthcare workers are at an increased risk for drug diversion, a serious epidemic in the United States. Drug diversion in hospitals and healthcare facilities puts patients at risk when they do not receive the …

The DEA and Controlled Substance Waste

The Drug Enforcement Administration, DEA, is responsible for governing the regulations related to controlled substance (CS) disposal by ultimate users and registrants.  21 Code of Federal Regulations, CFR, outlines the rules for compliant CS waste procedures in 21 CFR Parts: 1300, 1301, 1304, 1305,1307, and 1317.  Institutions both public and …

CS Chain of Custody: Ensuring That Waste Is Not the Weakest Link

Healthcare providers are faced with unique challenges when it comes to handling and disposing of pharmaceutical waste. Nurses and healthcare workers handling controlled substances have responsibilities under the Controlled Substances Act (CSA) including maintaining a properly documented chain of custody.  The Drug Enforcement Administration (DEA) is tasked with enforcing the …

Are All Chemotherapy Agents Classified as Pharmaceutical Waste?

Disposing of chemotherapy waste raises a lot of questions even for those experienced in the industry. Questions always arise as to whether chemotherapy waste is considered hazardous waste or medical waste. With chemotherapy agents, there is not just one waste stream. There are chemotherapy agents classified as pharmaceutical waste and …

What Are the Implications for CS Waste in Medical Research

Pharmaceuticals and controlled substances are often used in medical research laboratories, requiring proper controls and disposal methods. The Drug Enforcement Administration (DEA) and the Environmental Protection Agency (EPA) have issued Code of Federal Regulations regarding compliance to pharmaceutical waste disposal. These regulations apply to pharmaceutical waste from any industry including …

Financial Considerations for an Effective CS Waste Program

effective cs waste program

Properly disposing of expired medications is the main focus of any controlled substance (CS) waste program.  Hospitals must have policies and procedures in place for the safe management and disposal of pharmaceutical waste for expired, discontinued or leftover medications.  It is estimated that hospitals in the U.S. produce nearly 5.9 billion tons of medical waste each year.

Read more“Financial Considerations for an Effective CS Waste Program”

USP General Chapter <800> Compliance

The United States Pharmacopeia (USP) is a non-profit, private organization with standards enforced throughout various regulatory agencies such as individual state’s Boards of Pharmacy and the Joint Commission.  The USP’s latest chapter on managing hazardous drugs in the healthcare industry, USP<800>, provides comprehensive guidelines on managing the entire life cycle …

Does Your CS Waste Program Meet Joint Commission Requirements?

The Joint Commission is an independent, nonprofit organization that was founded in 1951 with a focus on continually improving health care for the public.  The Joint Commission is the oldest and largest standards-setting, accrediting body in health care in the United States.  Approximately 4,500 general, long-term acute, rehabilitation, children’s, psychiatric …

Proper Documentation of CS Waste Program

A controlled substance (CS) waste program which meets DEA compliance must adhere to the Code of Federal Regulations (CFR) 21, 40 and 42 pertaining to the regulations for drug waste disposal.  Each registrant, facility, distributor and reverse distributor must ensure that they meet all facility, local, tribal, state and federal …

DEA Medication Disposal Compliance: What’s the Real Cost?

The laws under compliant DEA medication disposal regulations have changed considerably in recent years.  In August of 2019, 40 CFR, the Code of Federal Regulations, went into effect which amends the Resource Conservation and Recovery Act, RCRA.  Prior to the 2019, 40 CFR ruling, flushing of hazardous pharmaceutical waste down …

Are You Compliant with FDA Medication Disposal?

Educating medical staff in various healthcare facilities and settings is critical for FDA medication disposal compliance.  All too often, healthcare workers are not trained on the proper procedures for disposing of pharmaceuticals and simply throw leftover medications in the trash or are told to flush down a drain.  There are …

CS Waste Compliance: Easier Said than Done

The need for health care facilities to manage their controlled substance waste with compliance to DEA regulations has never been greater.  With heightened awareness to the opioid epidemic and drug diversion, properly disposing of controlled substance (CS) waste effectively and safely is critical.  Many health care facilities find CS waste …

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