The Environmental Protection Agency’s new rule regarding disposal of hazardous pharmaceutical waste takes effect in August 2019. The rule is intended to improve how pharmaceutical waste is managed by the health care sector, which should result in better protection for humans and the environment.
In part 1 of this 3-part series, we shared some basic information about the new rule. Here, in Part 2, we explain why the new rules were created and what the term “pharmaceuticals” actually means under the new rule. In Part 3, we will discuss who is affected by the new rule and the penalty for non-compliance.
First of all, why were these new rules created? According to the EPA, healthcare workers and retail pharmacy employees are often unfamiliar with, or confused by, RCRA hazardous waste management requirements. So, they often (incorrectly) dispose of hazardous pharmaceuticals as municipal waste or as medical waste.
The new rule simplifies the regulations, making it easier to manage wasted and expired medications. By making things simpler, a much larger percentage of hazardous pharmaceutical waste should be managed properly. The rule also decreases the regulatory burden for many hazardous pharmaceutical waste generators. However, the rule does not focus exclusively on reducing regulations. It also strengthens what had been a long-standing policy of “discouraging” the flushing of pharmaceuticals down the drain and now prohibits the “sewering” of hazardous waste pharmaceuticals.
So, what is a “pharmaceutical” under the new rule, and are all pharmaceuticals hazardous?
According to the final rule, the term pharmaceutical is quite broad. It includes any drug or dietary supplement for use by humans or other animals, such as:
- dietary supplements
- prescription drugs
- over-the-counter drugs
- homeopathic drugs
- compounded drugs
- investigational new drugs
- pharmaceuticals that remain in non-empty containers
- personal protective equipment contaminated with pharmaceuticals
- clean-up material from spills of pharmaceuticals
Not all of these pharmaceuticals are classified as hazardous!
Pharmaceutical waste is considered hazardous waste if it meets a listing, or exhibits a characteristic, described in title 40 of the Code of Federal Regulations Part 261. In addition, waste pharmaceuticals are hazardous if they exhibit one or more of these four characteristics: ignitability, corrosivity, reactivity and toxicity. Bottom line: even though the new rule streamlines regulations, it is still important to know what is, and what is not considered hazardous pharmaceutical waste.
But wait, there’s more…
Nicotine-related products – Vape shops, take note! The new definition of pharmaceutical also includes electronic nicotine delivery systems, such as e-cigarettes and vaping pens, AND liquid nicotine packaged for retail sale and intended for use in an electronic nicotine delivery system, such as pre-filled cartridges or vials. So, the regulations extend beyond health care facilities to vape shops and other retailers: if you sell any of these items, you must treat them as hazardous waste when disposing of them.
On the other hand, health care facilities and retail stores will no longer be required to treat FDA-approved over-the-counter nicotine replacement therapies (such as patches, gums and lozenges) as a RCRA hazardous waste. Note: this provision of the final rule must be in effect in your state for facilities to use this exemption.
- Part 1: The basics: Unpacking the EPA’s new rule
- Part 3: Who is Affected by the New Rule
United Medical Waste Management helps health-care facilities manage their hazardous waste from cradle-to-grave, in complete compliance with the regulations. Contact us for a free waste audit and facility evaluation.