Frequently asked questions about pharmaceutical waste

There are two significant differences between the EPA’s standards and ours:

• We include state-only dangerous waste pharmaceuticals in addition to federal hazardous waste pharmaceuticals.
• We require long-term care facilities to determine if the special requirements apply to them based on the amount of dangerous waste they generate.

No. The special requirements do not apply to:

• Nonpharmaceutical dangerous waste generated by a health care facility.
• Pharmaceuticals that are legitimately used, reused, donated, or reclaimed.
• Pharmaceutical waste from households.

Noncreditable dangerous waste pharmaceuticals:

• Have no expectation of credit,
  OR
• Are partially administered.

Biomedical waste, also known as regulated medical waste, is:

• Defined under the Solid Waste regulations (RCW 70A.228.010).
• Regulated by local health departments or districts.

Occupational Safety and Health Administration (OSHA) and U.S. Department of Transportation (DOT) requirements are similar, but they do not replace or supersede the biomedical waste distinction or the dangerous waste designation.

• OSHA has bloodborne pathogens guidelines that cover safe practices for employees to reduce the risk of transmitting diseases.
• DOT also has special requirements for the transport of infectious or potentially infectious materials.

Dual waste is dangerous waste that also meets the definition of a biomedical waste.

Dual waste must be managed in accordance with any handling and transportation requirements for both:

• Biomedical waste
  AND
• Dangerous waste regulations.

Contact your waste vendor to ensure proper management.

After you have designated your waste, determine whether your dangerous waste pharmaceuticals fall under the 2.2 lb QEL or the 220 lb QEL.

What is a QEL?

A quantity exclusion limit (QEL) is a monthly weight limit based on the type of waste you are counting:

• Most dangerous wastes have a QEL of 220 pounds.
• Dangerous wastes that are extremely toxic in small amounts have a QEL of 2.2 pounds. This includes:
  • P-listed wastes
    OR
  • State-only toxic wastes with the waste code of WT01.

How to find the weight of your dangerous waste pharmaceuticals

It is difficult to find the actual weight of dangerous waste pharmaceuticals.

You can choose one of the following options:

1. Do twice monthly weigh-ins and count the difference:
   • Weigh a waste container at the beginning of the month. Record the weight (A).
   • Weigh the container at the end of the month. Record the weight (B).
   • Subtract A from B.
   • This is the weight of the dangerous waste pharmaceuticals you generated over one month.
     NOTE: This will result in an overcount since the individual packaging weights are included.
      
2. Keep a log of each waste amount generated. This method results in a more accurate count since the packaging weight is not counted, but is more time intensive for staff to log:
   • Track the individual volume or weight of dangerous waste pharmaceuticals every time you add to your waste container. 
     For example: If only half of a 1 mL prefilled syringe of epinephrine is administered, track 0.5 mL on your log when the whole syringe is added to your waste container.
   • Total these individual amounts at the end of the month.
   • This is your dangerous waste pharmaceutical count (in pounds) for the month. If you are tracking by volume, convert to pounds.

Yes. Health care facilities must count all dangerous waste. This includes potentially creditable dangerous waste pharmaceuticals.

Potentially creditable dangerous waste pharmaceuticals are waste even if you receive a manufacturer credit.

Yes. Health care facilities must count all dangerous waste each calendar month to determine if the special requirements apply.

This includes:

• Dangerous waste pharmaceuticals, such as:
  • Any non-empty pharmaceutical containers.
  • Partial doses.
  • Dropped pills.
  • Expired medications.
• Potentially creditable dangerous waste pharmaceuticals sent to a reverse distributor.
• Nonpharmaceutical dangerous waste, such as:
  • Cleaning supplies.
  • Disinfectants.
  • Lab chemicals.
  • X-ray fixer.
  • Paint. 
  • Solvents, including accumulated solvents prior to distilling.

No, you cannot take a waste shipment weight and divide by the number of months to determine the count.

• You must count your dangerous waste each month.
• You cannot average multiple months over time.

If you are managing dangerous waste pharmaceuticals under the special requirements (WAC 173-303-555 (10)), you may send the waste to a permitted treatment, storage, and disposal (TSD) facility or an alternate disposal facility.

This is not an exclusion and all other special requirements still apply.

Alternate disposal facilities include:

• Permitted municipal combustors or incinerators.
• Permitted hospital, medical, and infectious waste incinerators.
• Permitted commercial and industrial solid waste incinerators.
• Permitted dangerous waste incinerators.

To use an alternate disposal facility, you must:

• Have a letter demonstrating this alternate disposal facility can accept your state-only dangerous waste pharmaceuticals.
• Follow all other applicable regulations in the special requirements.

We do not recommend accepting expired or unused pharmaceuticals from patients.

We recommend you:

• Direct patients to Washington's Safe Medication Return program. They can request a free mail-back container or find take-back kiosks near them.
• Host a medication return kiosk. Your health care facility may apply to host a kiosk or provide mail-back packages.

If you do choose to accept expired or unused pharmaceuticals from patients, you must either:

• Manage and count them with your facility’s dangerous waste pharmaceuticals,
  OR
• Manage them separately as household hazardous waste. In this case, you do not need to count household hazardous waste with your facility’s generated dangerous waste pharmaceuticals.

No. We do not require any specific types or colors of containers, but they must be:

• Compatible with the wastes.
• Structurally sound.

Some vendors may prefer to use specific containers or a color-coding system for different types of waste, but this is not required.

Yes. Keep noncreditable dangerous waste pharmaceutical containers closed when not actively placing waste into the container.

No. Hazard labels are not required on noncreditable dangerous waste pharmaceutical accumulation containers. But, they must be labeled with the words:

• “Dangerous Waste Pharmaceuticals” or “Hazardous Waste Pharmaceuticals”
  AND
• An accumulation start date (or some other method of tracking how long the waste has been accumulating on-site).

Note:

• This does not supersede any DOT regulations.
• A hazard class label may be required for shipment.

You must ensure that pharmaceuticals are:

• Undispensed.
• In their original packaging.
• Within 1 year of expiration.

You must also:

• Respond to spills of any potentially creditable dangerous waste pharmaceuticals.
• Manage any spill materials and cleanup as noncreditable dangerous waste pharmaceuticals.

Best management practices for accumulation:

• Label containers to identify contents and prevent mixing with wastes.
• Use non-leaking containers that are compatible with the materials.
• Keep containers closed when not actively in use.

You must maintain the following records for at least 5 years:

• Shipping papers.
• Confirmation of delivery to a reverse distributor within 35 days of shipment.
• Any potentially creditable dangerous waste pharmaceuticals received from off-site true SQGs (WAC 173-303-555(4)(b)).

We recommend maintaining records from your reverse distributor to show a reasonable expectation of credit such as:

• Invoices showing credit received in the past.
• Communication from the reverse distributor about previously uncredited pharmaceuticals that will be credited in the future.

Yes, as long as the receiving facility is managing under Subpart P or the equivalent.

• See a list of states that have adopted Subpart P.

To consolidate dangerous waste pharmaceuticals, the:

• Generating health care facility must:
  • Be a “true SQG.”
  • Manage dangerous waste pharmaceuticals under the requirements for generators of dangerous waste (WAC 173-303-170(2)(a)(i) and -171) or the equivalent in their state.
• Receiving facility must:
  • Manage dangerous waste pharmaceuticals under the special requirements, Subpart P, or the equivalent in their state.

FDA-approved investigational drugs are regulated under the FDA and cannot be regulated under the special requirements until:

• FDA investigation is complete.
• Drug wastes are discarded by a health care facility or reverse distributor.

Waste from laboratories developing or researching new drugs cannot be managed under the special requirements.

No. Law enforcement agencies are not considered health care facilities. Any dangerous waste drugs held as evidence must be managed under the Dangerous Waste Regulations.

Law enforcement agencies can use the:

• Conditional exclusion for state-only dangerous waste drugs in WAC 173-303-071(3)(nn).
• Focus on: Pharmaceutical Waste Conditional Exclusion for Washington Law Enforcement publication for more information.

Correction and detention facilities that are managed by a law enforcement agency may qualify as a health care facility if the dangerous waste pharmaceuticals are used for the care of the clients or residents.