WI Hazardous Pharmaceutical Rules
Highlights of WI Admin Codes 666.500-.510
Note that each state must adopt the EPA’s federal regulations around hazardous waste pharmaceuticals.
Below is a summary of Wisconsin’s adoption of the EPA’s new regulations around:
- Generator Improvements Rule
- Subpart P
- Nicotine Amendment
Answers to Commonly Asked Questions:
Does My WI Healthcare Facility Need to Comply with the New Rules?
Your Wisconsin healthcare facility must comply with the new regulations if it:
– Provides care/services/procedures that affects mental/physical condition of humans or animals
– Distributes, sells or dispenses medicines This pretty much covers all:
- Health Clinics
- Psychiatric and Substance Abuse Centers
- Ambulatory Services and Ambulatory Surgical Centers
- Physicians’ Offices
- Optical and Dental Providers
- Veterinary Clinics and Hospitals
- Long-Term Care Facilities (administer pharmaceuticals to one or more individuals there)
- Pharmacies (including Mail-Order and Long-Term Care)
- Retailers of Pharmaceuticals
- Wholesale Distributors
- Third Party Logistics Providers that serve as forward distributors
Ultimately, if you fall into one of three categories below, you required to operate under the EPA’s Subpart P program in Wisconsin:
- Large Quantity Generators (LQG): Generate more than 2,200 lbs. of hazardous waste per month.
- Small Quantity Generators (SQG): Generate more than 220 lbs. of hazardous waste, but less than 2,200 per month.
- Reverse Distributors: Those who receive or take back prescription pharmaceuticals from another organization to verify a manufacturer’s credit.
You can choose to opt in if you are a:
- Very Small Quantity Generators (VSQG), who generates less than 220 lbs. of hazardous waste each month.
VSQGs can continue to follow their previous way of handling their pharmaceuticals and acutely hazardous P waste. Otherwise, they may either opt into Subpart P, or they can send their hazardous waste pharmaceuticals off to an affiliate site that operates under Part 266 Subpart P.
Sewer Ban - No Flushing Hazardous Waste Pharmaceuticals
All hazardous pharmaceuticals can no longer be flushed down the drain or toilet
The nationwide Sewer Ban keeps hazardous pharmaceutical waste out of waterways. These five DEA controlled substances are also hazardous waste pharmaceuticals and must be managed in compliance with DEA regulations and destroyed to meet its non-retrievable standards:
- Chloral/Chloral Hydrate (Acetaldehyde, Trichloro, Aquachloral, Noctec, Somnote, Supprettes)
- Fentanyl sublingual spray (Subsys)
- Phenobarbital (Bellergal-S Donnatal Luminal)
- Testosterone gels/solutions (Androgel Axiron Foresta, Testim)
- Valium gel/injectable (Diazepam, Diastat)
For many MERI healthcare customers, this means that the material will have to be made non-recoverable following the DEA’s recommendations (i.e. witnessed destruction in a Cactus Sink or RX destroyer by a DEA registrant) before we can come and collect it for hazardous disposal.
What Does "RCRA Empty" Mean?
“RCRA Empty” Means That:
– A container is empty when all of the medicine is visible removed
– P-listed waste containers (Warfarin, Coumadin, etc.) must be disposed of as
non-credible, hazardous waste, no matter the amount of remaining residue.
– Non-acute pharma waste containers (syringes, IV bags, bottles, blister packs), can
be discarded in trash or other other facility protocol.
– Unused or Partially Used Inhalers should be managed as hazardous waste Empty, non-acute materials can go in the trash.
Nicotine Amendment: Do's and Don'ts
- Dispose of Nicotine as a P-Listed Hazardous Waste
- Follow your facility’s special disposal guidelines for Vape Pens and Cartridges
- Over the Counter Nicotine Patches, Gums and Wrappers can now be thrown in the trash
(Although, at MERI, we recommend they still be disposed of as hazardous waste)
New Standards For Managing Hazardous Waste Pharmaceuticals
WI Rules for Handling Hazardous Waste Pharmaceuticals For Those Operating Under Subchapter P:
– Employees Handling Hazardous Waste Must be Trained – Must have a Spill Response program that documents how you contain and manage it – Both hazardous and Non-hazardous can be managed as Hazardous waste that’s incinerated
– All sorting must take place at generator’s facility
– Credible or Potentially Credible Hazardous Waste Pharmaceuticals
– Must Be in Original Packaging (1 year expiry date) for Reverse Distributor
– No manifest or land band required, but must keep shipping records for 3 years
– Must follow DOT shipping requirements, with tracking, delivery confirmation
– Contact Reverse Distributor if not received paperwork after 35 days
– Non Credible Hazardous Waste Pharmaceuticals
– Don’t send non-credible waste to Reverse Distributor
– Containers must be structurally sound, compatible contents, secured, lid closed
– Containers Must be labeled “Hazardous Waste Pharmaceuticals”
– Mark start date on container (Dispose one year after first item was placed in the container)
– Maintain a log or inventory system
– No satellite accumulation area requirements for hazardous pharmaceuticals – Manifests initiated after Sept. 1, 2020 must use the “PHRM” waste code for non-creditable hazardous waste pharmaceuticals. If this waste code was not used, the manifests must be revised. This will prevent confusion and potential enforcement when evaluating e-manifest data against annual reporting. – This revision can be made by the generator in EPA’s e-manifest system. Go to the DNR manifest page for instructions on registering to use e-manifest.
Operating under Subchapter P
Operating Under Subchapter P
– While need to account for all hazardous waste in facility, hazardous pharmaceutical waste
will not be counted toward your status if you are following Subchapter P
– Must notify WI DNR if following Subchapter P, by using form 8700-12 and submit annual report
– Can Accumulate up to 1 year
SQG/LQG Required to Operate Under Subchapter P
– Small Quantity Generators – SQG (less than 2,200 lbs. hazardous month, 2.2 lbs P-waste)
– Because hazardous waste pharmaceuticals no longer counted toward your status, you may drop to a VSQG
– Large Quantity Generators – LQG (no limited on hazardous waste)
– Because hazardous waste pharmaceuticals no longer counted toward status,
you may drop to SQG or VSQG if opting into Subchapter P
VSQG Can Opt into Subchapter P
– Very Small Quantity Generators – VSQG – (less than 220 lbs. hazardous waste/mo; 2.2 lbs. P-waste)
– Can send both credible and non-credible to SQG or LQG that is under control
of the same owner operating under Subchapter P
– Can decide not to opt into Subchapter P, but must follow NR 662, and have hazardous waste
pharmaceuticals count toward totals.
– Long Term Care Facilities – Follow 666.504-.506
– 20 or fewer beds presumed to be VSQG
– Allows for on-site receptacle from authorized DEA collector
– Drug Collection Devices (i.e. Drug Buster, RX Destroyer) Must Be Incinerated,
Not Thrown in the Trash When Full
What's a Solid Waste According to WI Regulations?
WI Solid Waste Rule
Here’s how the WI DNR defines a solid waste: If you can no longer use a material for its intended purpose, and it is being discarded by being abandoned, recycled or deemed inherently waste-like, the material is a solid waste. In Wisconsin this is defined under NR 661.02. Items that are excluded from being a solid waste, are those which are recycled, as listed in both NR 661.02 and NR 661.04. Note that items which are legitimately recycled, rather than disposed of, must be documented.
Disposing Solid Waste
Solid wastes and recyclables are the most common types of waste in the healthcare industry. These include things like non-contaminated PPE, which end up in a landfill, or packaging materials, which often end up at a recycling facility.
You should work closely with your waste hauler and disposal facility to determine how to evaluate, profile and deliver solid waste generated at your facility.
What’s Not a Solid Waste
Infectious, radiological, hazardous or universal wastes are not classified as solid wastes. They must first be sent to licensed facilities for treatment before disposal.
Deciphering your Waste
Is the waste generated at your facility a solid waste? Biohazard or infectious waste? Hazardous waste? Your facility must determine its waste classification before disposal.
The WI DNR recommends that nonhazardous pharmaceuticals should be disposed of by appropriately authorized incineration. This is regardless of their classification as hazardous or solid waste.
For more info: read our blog: https://www.meriinc.com/defining-wisconsins-solid-waste-rule/
Link to WI DNR Hazardous Waste Webinars
Link to EPA 8700-12
Here’s the link to RCRAinfo.epa.gov …and here are the instructions on how to complete the EPA’s 8700-12 form to notify them you’ll be operating under Subpart P:
Small and Large Quantity Generators
If you’ve yet to do so, notify the EPA you are a healthcare facility (form 8700-12) on RCRAinfo.epa.gov. This information will be captured in your WI hazardous waste annual report (Due March 1). A healthcare facility is not required to fill box 10.B “Waste codes for federally regulated hazardous wastes” with respect to hazardous waste pharmaceuticals. However, you do need to fill out this box for other hazardous waste generated onsite. In section D, question number 1 fill in “Yes” and Select “A” as a healthcare facility.
Very Small Quantity Generators:
Healthcare facilities can send both credible and non-credible waste to SQG and LQG if it is under control of the same owner operating under Subpart P To opt in, fill out form 8700-12 on RCRAinfo.epa.gov. In section D, question number 1 fill in “Yes”. Select “A” as a healthcare facility. Soon after, you will receive an EPA ID number from the EPA to include on manifests and labels.
EPA Link: Very Small Quantity Generators
EPA Requirements for Very Small Quantity Generators of Hazardous Waste
EPA Link: Small Quantity Generators
EPA Requirements for Small Quantity Generators of Hazardous Waste
EPA Link: Requirements for Large Quantity Generators
Requirements for Large Quantity Generators of Hazardous