New National Rules Governing Pharmaceutical Disposal Start August 21st

07/22/2019

The U.S. Environmental Protection Agency issued new rules for healthcare providers on handling hazardous waste pharmaceuticals on February 22, 2019. A provision that prohibits disposing pharmaceuticals down the drain becomes effective nationally on and after August 21, 2019. The rules were enacted to protect drinking water and surface water. They are expected to reduce the amount of hazardous waste pharmaceuticals entering U.S. waterways by as much as 2,300 tons annually.

Healthcare providers subject to the federal sewering prohibition include any person lawfully authorized to:

• provide preventative, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or

• distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.

Healthcare providers should talk with their current waste vendor or a vendor specializing in pharmaceutical waste handling and disposal to ensure they have provisions in place to properly handle unwanted pharmaceuticals. To learn more about Michigan’s pharmaceutical waste regulations and the new federal rule, visit www.Michigan.gov/EGLEDrugDisposal and review “Non-Household Drug Disposal” resources. For questions regarding these environmental regulations, please e-mail EGLE-DrugDisposal@michigan.gov.

Who is included?

Healthcare providers include, but are not limited to:

• Independent dental, veterinary, chiropractic, optical, and medical offices

• Medical, veterinary, and psychiatric hospitals

• Ambulance services

• Ambulatory surgical centers

• Health and outpatient care clinics

• Surgical clinics

• Chemotherapy clinics

• Veterinary clinics

• Long term care facilities

• Nursing care facilities

• Assisted living facilities with on-site nursing facilities

• Military medical logistics facilities

• Coroners offices

• Retail brick and mortar pharmacies

• Mail order pharmacies

• Compounding pharmacies

• Long term care pharmacies

• Wholesale pharmaceutical distributors

• Third-party logistics providers that serve as forward distributors

What is defined as a pharmaceutical?

Pharmaceuticals generally include most formulations that have a National Drug Code. They are specifically defined as chemical formulations intended to diagnosis, cure, mitigate, care for, treat, or prevent disease or injury. They also include products intended to affect the structure or function of the body of a human or animal. This includes prescription drugs, over-the-counter drugs and dietary supplements.

How do I manage controlled substances in Michigan?

The simplest way to manage controlled substances that cannot be sewered in Michigan is to manage them as a universal waste using a Drug Enforcement Administration (DEA) registered reverse distributor that specializes in hazardous waste pharmaceutical disposal.  Regardless of whether the collection container is used to accumulate unadministered partial doses of controlled substances (wastage), inventories of controlled substances in reverse distribution being evaluated for manufacturer credit (inventories), or discarded hazardous waste pharmaceuticals destined for disposal (hazardous waste), they can all be managed under Michigan’s streamlined universal waste regulation and sent for hazardous waste incineration through a DEA reverse distributor.

Wastage –  The wasting of leftover, unadministered partial doses of controlled substances, like a dose that remains in a vial, tube, transdermal patch, or syringe should be:

• witnessed and documented;

• wasted into containers that include absorbents or chemical reactants that bind or chemically alter the contents to prevent diversion and illicit use; and

• the containers should be secured.

Collected wastage is no longer regulated by DEA if the controlled substances were administered to patients and the leftover pharmaceutical wasting was witnessed and documented.  Consequently, wasting containers remain subject to hazardous waste regulation and can be managed as a universal waste in Michigan.

Controlled Substances Inventories Sent for Reverse Distribution – Inventories of controlled substances that can no longer be administered to a patient and are sent for manufacturer credit through reverse distribution remain subject to both DEA regulations and the hazardous waste regulations. They can be managed to meet the universal waste regulations in Michigan.  The transfer to the reverse distributor is considered a distribution under the DEA regulations and requires recordkeeping.   

Controlled Substances Sent for Hazardous Waste Disposal – Controlled substances that are a hazardous waste being disposed remain subject to both the DEA regulations and the hazardous waste regulations.  They can be managed to meet the universal waste regulations in Michigan.  The transfer to the reverse distributor is considered a distribution under the DEA regulations and requires recordkeeping.