In August 2015, the Environmental Protection Agency (EPA) issued a proposal (Subpart P of 40 CFR 266) which highlighted new techniques for the management, storage, and disposal of hazardous pharmaceutical waste in healthcare facilities.
With the proposed regulation scheduled to take effect at some point in 2016, it’s vital to understand the impact it has on the way you handle pharmaceutical waste at your facility.
Before getting into the impact of the rule, let’s look at who is affected.
Who Is Affected?
The newly proposed regulations would directly influence the way employees at places like clinics, hospitals, nursing homes, pharmacies, and other similar sites that dispose of and manage pharmaceuticals.
Anyone working within these facilities, or anyone who handles pharmaceutical waste, will want to have a thorough understanding of Subpart P of 40 CFR 266 once the proposal is actually rolled out and put into effect, as it will be crucial to their job moving forward.
One major impact of the new regulation is that it would change the way employees disposed of hazardous pharmaceuticals.
When the regulation goes into effect, flushing pharmaceuticals that are on the EPA’s P and U lists—in addition to any others deemed hazardous—down the drain will no longer be an option. Items that fall into those categories, by EPA definition, are ones that are potentially corrosive, ignitable, reactive, or toxic, so it’s obvious why they shouldn’t be flushed.
Prior to this regulation going live, it may be wise to go through your inventory of pharmaceuticals and determine which drugs are deemed hazardous under the new proposal and which aren’t. This will help educate staff and ensure you’re fully knowledgeable on what to do with these items in your facility.
The aforementioned pharmaceuticals that fall into the hazardous category must then be handled just like any other hazardous waste, instead of being poured down the drain or flushed. However, if you are able to receive manufacturer’s credit for these drugs, you can certainly send them to a reverse distributor without having to produce the typical waste manifests you otherwise would need. At that point, it would be the responsibility of the reverse distributor to follow the new rules applying to them under this regulation.
Pharmaceutical Reverse Distributors
Speaking of reverse distributors, this new regulation will create a new category of hazardous waste facilities known as “pharmaceutical reverse distributors,” and these facilities will follow similar standards to large quantity generators with supplementary standards being added to address any concerns for current, or potential, stakeholders. According to the EPA, a pharmaceutical reverse distributor is any facility that can “accept potentially creditable pharmaceuticals for the purpose of determining a manufacturer’s credit.”
Under this regulation, pharmaceutical hazardous waste will not count towards a facility’s generator status if they are managed under the new, Subpart P of 40 CFR 266. Given these new circumstances, the new regulation may allow some facilities to become conditionally exempt or even drop down to smaller quantity generator status, which is great news if, in fact, your facility is able to downgrade itself.
Of course, any pharmaceutical hazardous waste that’s accumulated must be marked as such and disposed of in proper fashion.
Now let’s discuss the differences between creditable waste and non-creditable waste.
What is Considered Creditable Waste?
Simply put, pharmaceutical hazardous waste that is considered creditable is waste that can receive manufacturer’s credit when returned.
Alongside this regulation, the EPA is proposing that any creditable pharmaceutical waste be excluded from having to follow typical hazardous waste management standards. This would include being excluded from things like accumulation limits, labeling rules, and manifest requirements when that waste is compliant with Subpart P of 40 CFR 266. The EPA will also continue permitting healthcare facilities to send waste that could potentially be considered creditable hazardous waste to reverse distributors for manufacturer’s credit.
When is Pharmaceutical Waste Considered Non-Creditable?
Receiving credit for your pharmaceuticals is obviously the ideal situation. However, there are scenarios in which it could be deemed non-creditable. Some examples of reasons why pharmaceutical waste would be considered non-creditable are:
- It has been removed from original packaging and has been re-packaged
- More than one year past their label’s expiration date
- If it was generated while caring for a patient
- The patient refused the drug after an attempt to administer it was made
While the regulation is not currently in effect, it likely will be at some point during the 2016 calendar year. It’s important that employees and anyone who interacts with hazardous pharmaceutical waste be well-versed on these new rules for when that time comes.
Managing and disposing of these types of items properly can be confusing and stressful, but it doesn’t have to be. If your facility needs further help understanding regulatory changes or if you have any type of waste you need to get rid of, Hazardous Waste Experts is your choice for compliant, affordable, and fast services. Call us today at 888-681-8923 or visit our Request a Price Quote page to obtain a free, no obligation quote.