HIPAA & FACTA File Management

How to Avoid Fines for HIPAA & FACTA File Management Non-Compliance

Pharmaceuticals are an essential component of modern healthcare. They help patients recover more quickly and painlessly and are frequently used to better manage chronic medical conditions. Safe pharmaceutical handling and disposal are key to proper pharma waste management, which is governed by strict and sometimes confusing regulations.

These guidelines help ensure your pharma waste labeling and disposal practices preserve staff, patient, and environmental safety while protecting you against financial, licensing, and reputational harm. Here’s how to make sure your pharma waste management program is compliant.

Follow the EPA Pharmaceutical Waste Rule

In February 2019, the EPA published its new management standards for hazardous waste pharmaceuticals to streamline compliance for healthcare facilities and pharmaceutical distributors. But that doesn’t mean you can simply toss non-hazardous pharma waste in the trash bin. For while it’s true that non-hazardous waste doesn’t meet federal or state classifications of ignitable, toxic, corrosive, or reactive, it isn’t as harmless as the name makes it sound.

Specific regulations are set out in the agency’s Labeling Standards on Containers for Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals.

Pharma waste generators must follow strict guidelines when segregating and labeling all pharmaceutical waste:

  • Place waste in structurally sound containers that are compatible with their contents and lack evidence of spillage, leakage, or damage that could cause leaking.
  • Manage containers so they don’t generate extreme heat or pressure, produce uncontrolled flammable fumes or gases, or threaten human health or the environment.
  • Keep containers closed and secured to prevent unauthorized access to their contents.
  • Label or clearly mark each container with the phrase “Hazardous Waste Pharmaceuticals” as well as the date it became waste. Containers should also be clearly labeled “for incineration.”

Non-Hazardous Pharmaceutical Waste

Non-hazardous pharma waste still poses significant health risks to people, animals, and the environment. In reality, a better way to define it is non-RCRA (Resource Conservation and Recovery Act) pharmaceutical waste.

To protect our planet at large, non-hazardous pharma waste, including trace chemo waste, must be disposed of in accordance with state and federal regulations.

Non-RCRA pharma waste includes:

The best solution for keeping hazardous and non-hazardous pharma waste out of our landfills and water supplies is to segregate, label, and incinerate it properly. Managing pharmaceuticals requires thorough staff training on what waste must be disposed of in this way, versus disposal of hazardous and biohazardous waste.

The Importance of Properly Segregating and Labeling Pharmaceutical Waste

Even though only ten percent or less of the pharmaceutical products in a hospital are classified as hazardous waste, state and federal regulations require all pharma waste, including non-hazardous and trace chemo waste, to be appropriately segregated, labeled, and incinerated.

To avoid doing harm or incurring penalties, those responsible for labeling pharma waste must be aware of the risks associated with improper pharmaceutical waste disposal:

  • Dangerous chemicals can leach into the surrounding environment and contaminate groundwater and plant and animal life.
  • Health risks to the community via contaminated drinking water.
  • Expired drugs can end up in the wrong hands.

The fines for improper pharma waste disposal can often be huge. For instance, a D.C. hospital agreed to pay a $108,304 penalty to settle alleged violations of hazardous waste regulations including failure to label and date hazardous waste containers. And it isn’t just federal agencies like the EPA that levy these penalties. State agencies, including those in Alabama and Tennessee, also impose penalties for everything from improper labeling to failure to provide hazardous waste training for personnel. Obviously, maintaining a compliant pharma waste management program can only help benefit an organization’s bottom line.

Choosing the Right Pharmaceutical Waste Disposal Services

When choosing a provider for your facility’s pharmaceutical waste disposal, it’s critical to choose one that’s licensed to handle the disposal of pharmaceutical waste. When you do, you’re ensured of working with a waste management company that’s up-to-date on all state and federal regulations concerning medical waste, including the labeling and disposal of pharma waste.

TriHaz is a highly qualified licensed contractor for the disposal of hazardous and non-hazardous pharma waste. We’re here to help your facility improve the reliability and safety of its pharmaceutical waste management program. We also offer staff compliance training for OSHA, DOT, and HIPAA, including how to properly segregate waste. Contact us today to learn more about our pharmaceutical waste disposal services.


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