Stericycle’s EPA Knowledge Center

1. Small and Large Quantity Generators (SQG and LQGs) that meet the EPA’s new definition of a health care facility or reverse distributor must manage their hazardous waste pharmaceuticals under new subpart P. 2. Very Small Quantity Generators (VSQGs) that meet the EPA’s new definition of health care facility or reverse distributor have the option of managing hazardous waste pharmaceuticals under new subpart P. 3. Facilities have less stringent options to dispose of containers with residual hazardous waste and p-listed wastes. 4. Controlled substances that are hazardous waste are conditionally exempted from being managed as such.

The rule is intended to provide health care specific regulations for the management of hazardous waste pharmaceuticals and help keep pharmaceuticals from entering our waterways. These tailored standards strive to make it easier and safer for health care facilities to follow, rather than the industrial-oriented hazardous waste generator regulations.

As defined in the final rule, the new regulations cover most health care entities that manage pharmaceutical products and waste such as hospitals, pharmacies, dentists, nursing facilities or long-term care facilities (LTCF), clinics and reverse distributors. The final rule does not apply to pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.

Under the new Final Rule, pharmaceutical waste (including P-listed wastes) does not count toward generator status. Hazardous waste from other areas of health care facilities and reverse distributors, such as solvents and other nonpharmaceutical waste, (e.g., products and other retail waste) will still be used to determine generator status.

The Final Rule bans the flushing (also called “sewering”) of all hazardous waste pharmaceuticals, regardless of generator type. This ban does not affect nonhazardous pharmaceuticals. However, the EPA discourages flushing of any pharmaceuticals. See Stericycle’s infographic on the effects pharmaceutical waste has on the environment.

There are only a few controlled substances that are hazardous waste. These few drugs are conditionally exempted from hazardous waste regulations when managed in compliance with DEA regulations and incinerated at an authorized facility.

1. Stock, dispensing, and unit dose containers — this includes vials, blister packs, and dispensing bottles (not to exceed 1 liter or 10,000 pills). These items are considered empty when their contents have been removed by normal means and are not regulated as hazardous waste, even if they held P-listed wastes.

2. Syringes — syringes are considered empty and not regulated as hazardous waste pharmaceuticals when the plunger has been fully depressed. The empty syringe should be managed under applicable federal, state, and local requirements for medical waste and sharps.

3. Intravenous bags (IVs) — fully administered IV bags are considered empty and/or those that meet the current definition of RCRA empty.

4. Other containers, including delivery devices — this includes items such as inhalers, nebulizers, ointments, gels, and creams. These items are also considered empty when the current definition of RCRA empty is met.

Yes. The EPA amended the current listing for acutely hazardous nicotine and salts (P075) designating that FDA-approved, over-the-counter nicotine replacement therapies such as patches, gums and lozenges are no longer considered acutely hazardous waste.

This new exception applies to all generators of hazardous waste, not just healthcare facilities as it is outside of subpart P. Other nicotine containing products such as prescription replacement therapies and e-cigarettes are not excluded from the P075 listing and are still regulated as such. There is no requirement or timeline for state adoption.

Stay aware of your state's progress and potentially unique adoption of the Final Rule. It is very important to understand that all current RCRA regulations are being enforced until your state adopts. It is recommended that facilities potentially impacted by the Final Rule review the regulations.