Although several drug deactivation products are marketed for pharmaceutical waste disposal in home and clinical settings, none have been reviewed or approved by the Drug Enforcement Agency (DEA) or Environmental Protection Agency (EPA). Disposing of drugs in the trash (even after treatment with a drug decomposition product) may violate state and/or local regulations. Federal guidelines from the DEA, EPA, and FDA for consumer disposal of household medicines recommend take-back programs as the best disposal option.
Unlike ultimate users, regulated generators of pharmaceutical waste – including hospitals, veterinarians, and long-term care facilities, to name a few – must comply with strict regulatory requirements for collecting, transporting, tracking, and treating regulated medical wastes, pharmaceutical wastes, and hazardous wastes.
Regulatory Compliance Issues with Drug Decomposition Products
Regulated medical, pharmaceutical, and hazardous waste disposal regulations are complex and detailed, but facilities that use drug deactivation products for medication disposal face additional training and compliance difficulties. Many states impose restrictions on methods of drug disposal. For example – Colorado prohibits the trash disposal of activated carbon-based decomposition products, and California requires the incineration of all Rx wastes (including used charcoal-based products).
Other concerns include:
- State prohibitions on trash disposal: Although the main selling point for drug decomposition products is the ease of trash disposal, businesses’ use of such products results in a regulated business waste. This waste would be prohibited from trash disposal in most states unless extensive waste characterizations are performed to prove the mixtures are not hazardous.
- DEA irretrievable standard: Most drug decomposition products rely on activated carbon or charcoal to deactivate the medications. Users must follow the directions exactly for the processes to work correctly. In addition, many such products include a disclaimer that they are incapable of entirely dissolving capsule shells and patches. The DEA’s non-retrievable standard requires destruction methods to render all controlled substances non-retrievable, even mixtures where any controlled substance is likely to be present.
- Product limitations: Generators using these products must perform waste characterization on each bottle/batch and exercise care when combining different medications for treatment. If any individual medicine added to the disposal product has a federal hazardous waste designation, then all the resulting product-drug mixture must be managed as hazardous waste, according to the EPA’s Final Rule. Mixing of medications for treatment can raise disposal costs and/or incur regulatory penalties.
- Safety and shipping issues: Businesses generating both hazardous and non-hazardous pharmaceutical waste would need to implement separate disposal solutions for hazardous waste pharmaceuticals and multiple other drug categories prohibited by the product itself. For instance:
- Bio-based drugs, which can lead to mold growth in the bottle
- “Gas-causing” items or antacids, which can result in off-gassing
All drug decomposition/deactivation products require the user to mix medications with a chemical solution. This raises the possibility of accidental exposure in case of spills or overfilling.
Additionally, the following restrictions also apply:
- Bottles must be kept in controlled and secure locations and cannot necessarily be distributed throughout a facility for convenient access.
- Most products should be used within one year – or sooner if additives are bio-based.
- Mailback systems require the use of liquid hardeners to make them compliant for shipping by common carrier. However, some medications may not be compatible with the hardener.
- Some mailback systems are labeled using the expired DOT classification of ORM-D, as well issues with hardeners could lead to fines from UPS or DOT if spills result.
Costs Associated with Drug Decomposition/Deactivation Products
Waste generators can face high costs from using these products.
- Waste segregation: Salaried staff must spend time identifying and segregating wastes to determine what can and can’t be mixed with decomposition products.
- Training: The FDA approved seven new drugs in July 2021 and 12 in June 2021. Generators who use drug decomposition/deactivation products must ensure that staffers responsible for using the products receive updated information and training whenever any new drugs are used in the facility.
- Labor: Many medications are stored in blister packs as both a safety precaution and medication compliance aid. Many children can easily open a “child-proof” cap, but even many adults have difficulty removing a pill from a blister package. Consider how much time it will take for staff to empty vials, remove pills from packaging, and mix the medications with the product’s chemicals.
A 2019 survey conducted by Sharps Compliance among a large U.S.-based long-term care (LTC) provider found that nurses spent an average of 12 hours a month removing pills from their containers for disposal. Implementing drug disposal programs utilizing collection receptacles or mailback packages allows staffers to spend more time on patient care. These programs potentially save up to $10,000 annually for the time it takes two RNs to prepare medications for disposal via a multi-step process compared to placing wastes in a collection receptacle.
Regulatory Compliant Alternatives to Deactivation Products
Consolidation of medication disposal options – both hazardous and non-hazardous pharmaceuticals – into a single solution can help waste generators control costs and more easily comply with federal, state, and local regulations.
Our DEA-compliant MedSafe collection kiosk streamlines the disposal of unwanted, unused, and expired medications. It’s a full-service medication collection and disposal solution that meets the DEA Controlled Substances Act requirements.
- Comingled collection of controlled and non-controlled pharmaceuticals
- Inner liners returned prepaid via common carrier
- Online shipment tracking
- Proof of destruction using incineration to meet the DEA’s non-retrievable standard for controlled drugs
MedSafe medication collection kiosks help generators control costs.
- Reduce the time required for waste segregation and training
- Spend less time preparing medications for disposal
- No additional costs or extra fees for compliant handling and treatment of hazardous waste pharmaceuticals
Many LTC communities have found that MedSafe is a better alternative to decomposition products. Use of the collection kiosks offers savings of up to $12,000 a year per community and easier regulatory compliance.
Contact us to learn more about how Sharps Compliance can help your facility manage your regulated medical, pharmaceutical, and hazardous waste compliance and training. There are never any hidden fees, and we work with you to develop a custom regulated waste disposal solution that meets your needs and budget.