Environmental Briefing: New EPA Laws Ban Flushing of Opioids & Other Hazardous Pharmaceuticals

On Aug. 21, a new federal rule took effect banning labs and other healthcare facilities from flushing hazardous waste pharmaceuticals into the sewer system. If you haven’t already done so, you’ll need to establish protocols and procedures to ensure compliance and avoid stiff penalties.  

The New Anti-Flushing Law

The new rule is part of an existing piece of federal environmental legislation called the Resource Conservation and Recovery Act (RCRA), which regulates the treatment, storage and disposal of hazardous wastes. In February, the U.S. Environmental Protection Agency (EPA) published a new Final Rule (Final Rule) extending RCRA to hazardous drugs that harm the environment by, among other things, prohibiting the disposal of hazardous waste pharmaceuticals down the drain.

Who Must Comply?

The new hazardous pharmaceuticals restrictions apply to “healthcare facilities,” including:  

  • Pharmacies;
  • Veterinary clinics;
  • Physicians’ offices;
  • Optical and dental providers;
  • Outpatient care centers;
  • Chiropractors;
  • Hospitals;
  • Surgical centers;
  • Nursing care facilities; and
  • Medical examiners, and coroners’ offices.

Although clinical labs aren’t on the list, they could still be subject to the flushing rules if they’re part of a hospital, physician’s office or other named facility or if they generate 100 kilograms or less per month of hazardous waste or one kilogram or less per month of acutely hazardous waste.

Facilities that are not subject to the Final Rule include:

  • Pharmaceutical manufacturers;
  • Production facilities; and
  • Other types of generators of hazardous waste pharmaceuticals, including households, farmers, ranchers and fisheries.

The Final Rule also applies to what are called “reverse distributors,” i.e., entities such as forward distributors and third-party logistics providers that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that are no longer needed.

Takeaway: The maximum fine for violating the new rules is $70,000 dollars per violation, per day. That makes it imperative to establish protocol providing for compliance with requirements for, among other things:

  • Personnel training;
  • Containers, labeling and handling shipments of hazardous pharmaceuticals;
  • Reporting incidents involving spills or disposals of hazardous pharmaceuticals; and
  • Recordkeeping.

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