When discarded, some pharmaceutical drugs meet the US EPA’s definition of a hazardous waste. This happens when the drugs’ ingredients appear on one of EPA’s RCRA lists (i.e., the P list or the U list) or because of the drugs’ hazardous characteristics.
On August 31, after years of regulatory activity and comments from stakeholders in the healthcare and pharmaceutical industries, EPA has proposed mandatory management standards for hazardous waste pharmaceuticals. A pre-publication of EPA’s new Management Standards for Hazardous Waste Pharmaceuticals is now available
Under the long-awaited proposed rule, EPA will add a Subpart P to 40 CFR 266 – Standards for the Management of Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities.
Under the new rule, both small quantity and large quantity generators (SQGs and LQGs) will be required to manage hazardous waste pharmaceuticals under the new 40 CFR 266, Subpart P rules and not the rules for other generators at 40 CFR 262. Conditionally exempt small quantity generators will not be affected by this rulemaking. Who’s Affected by These New RCRA Rules?
The rule will affect generators of waste pharmaceuticals in the following NAICS industry sectors:
Pharmacies, vet clinics, physicians’ offices, dentists’ offices, chiropractors, outpatient care centers, other ambulatory healthcare services, hospitals, nursing care facilities, continuing care retirement communities, some medical examiners and coroners’ offices, and various NAICS pharmaceutical reverse distributors. One-time Notification for Healthcare Facilities
The proposed rule will require non-CESQG healthcare facilities to file a one-time notification with the EPA Regional Administrator. CESQG sites can choose to follow these new standards, including submitting the notification. New Facility Category: Pharmaceutical Reverse Distributors
EPA‘s proposed rule creates a new category of hazardous waste facility, “pharmaceutical reverse distributors,” that must follow standards similar to those for large quantity generators with supplementary standards added to address concerns from stakeholders. This includes, but is not limited to, annual training for personnel who handle evaluated hazardous waste pharmaceuticals in on-site accumulation areas. [40 CFR 265.16]
EPA’s RCRA definition of a pharmaceutical reverse distributor should not be confused with the Drug Enforcement Agency’s definition of “reverse distributor”. Under EPA rules, a pharmaceutical reverse distributor is “a facility that can accept potentially creditable pharmaceuticals for the purpose of determining a manufacturer’s credit.” Counting Hazardous Waste Pharmaceuticals
Under the proposed rule, hazardous waste pharmaceuticals will no longer count toward healthcare facilities’ generators status, provided they are managed under the new 40 CFR 266, Subpart P requirements. This rule change may allow some facilities to “move down” to small quantity or even conditionally exempt status. RCRA Training Requirements for Healthcare Facilities
Because EPA feels that the training requirements for large quantity generators are “excessive” for healthcare workers who only sporadically generate pharmaceutical hazardous waste, the hazardous waste training requirement for these employees (or personnel, as they’re called in RCRA
) will be closer to the small quantity generator standard. [40 CFR 262.34(b)]
In the words of the SQG training requirement, facilities must ensure personnel who generate and/or manage hazardous waste pharmaceuticals are “thoroughly familiar” with proper handling and emergency response procedures appropriate to their responsibilities during normal facility operations and emergencies.
The normal RCRA training requirements will continue to apply to personnel who generate and/or manage other types of hazardous waste on site. EPA may require documentation of training for healthcare facilities in its final rule. Making Hazardous Waste Determinations for Pharmaceutical Hazardous Waste
In the 2008 Universal Waste proposal, EPA made an assumption—that pharmaceuticals returned to manufacturers may be reused or recycled in order to extract value. This led EPA to decide that it was the manufacturers’ responsibility to make a solid waste determination at the time they receive the returned product. Commenters of the 2008 rule made it clear that EPA’s assumption was off base.
In the words of one commenter to the rule, “EPA’s belief that reverse distributors first arrange to transport and receive the drugs, and then determine whether the drugs are useful products or wastes is pure fiction.”
Due to economic and safety constraints, manufactures rarely re-use or recycle returned pharmaceuticals. So, EPA has proposed to make it the healthcare facility’s responsibility to make a hazardous waste determination when the decision is made to return pharmaceutical products.
When a pharmaceutical waste is determined to be a RCRA hazardous waste, it must be managed under the newly proposed standards. That said, EPA also allows for healthcare facilities to skip the determination step by managing all pharmaceutical waste as hazardous. Creditable vs. Non-creditable Hazardous Waste Pharmaceuticals
In the proposed rule, EPA splits pharmaceutical wastes into two distinct categories: ”creditable” and “non-creditable” pharmaceuticals.
Creditable pharmaceuticals are those for which the generator can receive manufacturer’s credit upon return.
EPA is proposing to exclude creditable pharmaceutical hazardous waste from the RCRA hazardous waste management standards, including accumulation limits, labeling rules, and manifest requirements, when the waste is managed in conformance with the new 40 CFR 266, Subpart P. EPA will continue to allow healthcare facilities to send potentially creditable hazardous waste pharmaceuticals to reverse distributors for processing manufacturers’ credits. Creditable pharmaceutical hazardous waste can be shipped without a manifest and without a hazardous waste transporter.
US DOT hazmat shipping regulations still apply to these shipments. Managing Non-creditable Hazardous Waste Pharmaceuticals
Under the newly proposed standards, non-creditable hazardous waste pharmaceuticals must be managed under new 40 CFR 266, Subpart P standards, which are similar to those proposed in EPA’s 2008 Universal Waste proposal (73 FR 73520, December 2, 2008).
A pharmaceutical waste may be considered “uncreditable” if it is not expected to be eligible for manufacturer’s credit. Pharmaceuticals can be deemed “uncreditable” when, for example:
• the pharmaceutical has been removed from the original container and re-packaged for dispensing purposes;
• an attempt was made to administer, but the patient refused to take it;
• the hazardous waste pharmaceutical was generated during patient care;
• a pharmacy receives a return of a dispensed pharmaceutical for which they already received compensation (from, for example, a health insurance provider); or
• the pharmaceutical is more than one year past the expiration date.
Accumulating Non-creditable Hazardous Waste Pharmaceuticals
Newly proposed management standards for non-creditable hazardous waste pharmaceuticals include:
- Training requirements for healthcare personnel who accumulate and/or manage the waste;
- Unique container requirements and accumulation time limits;
- Unique rules for labeling containers of hazardous waste pharmaceuticals;
- Rules for meeting LDRs, segregating organic and non-organic waste;
- Standards for off-site shipments and dealing with rejected shipments;
- Industry-specific RCRA reporting requirements;
- Manifest standards for off-site shipments, including exceptions, rejected shipments rules, but excluding waste code requirements; and
- Allowances for long-term care facilities.
To help healthcare industry professionals identify hazardous waste pharmaceuticals, EPA has set up a Hazardous Waste Pharmaceuticals Wiki page here
. More Updates on the Way!
Lion will post more information about the specifics of the new management standards later this week. Follow us on social media—@LionTechnology
on twitter and on LinkedIn
for more updates!