EPA Final Rule: What Community Pharmacists Need to Know

Determine Generator Category

Less than 100 kg of hazardous pharmaceutical waste per month is considered a Very Small Quantity Generator (VSQG) and is not subject to the EPA’s Rule Subpart P.

VSQGs must still comply with sewer prohibition as outlined in the final rule.

Requirements for Subpart P

Determine if a hazardous waste pharmaceutical is potentially creditable or non-creditable before sending the pharmaceutical to a reverse distributor.

Definition of Creditability

Potentially creditable hazardous waste pharmaceuticals are defined in the EPA's rule as:

• In the original manufacturer’s packing (except when subject to recall)

• Not dispensed

• Unexpired, or less than 1 year past expiration date

If determined to be potentially creditable, it may be sent to a reverse distributor and must comply with all applicable U.S. Department of Transportation regulations in 49 C.F.R. §§ 171-180 for any hazardous waste material that meets definition under 49 C.F.R. § 171.8.

Non-creditable hazardous waste pharmaceuticals must be sent to a designated disposal facility. Shipping of non-creditable hazardous waste pharmaceuticals must follow very specific requirements pertaining to packaging, labeling, and marking as outlined in the EPA’s final rule.

OTC vs Prescription Medications

According to the NCPA, the EPA's rule makes a distinction between OTC and precription medications. 

Unexpired OTC products are not considered solid wastes at the pharmacy and can be sent to a reverse distributor as long the pharmacy has reasonable expectation that the OTC product could be legitimately used, reused, or reclaimed.

Prescription drugs are considered solid waste, thus subject to EPA’s streamlined regulations
Must determine creditability or non-creditability at the pharmacy store level.

Disposal Prohibition

Pharmacies are prohibited from disposing of hazardous waste pharmaceuticals in a sewer system that passes to publicly-owned treatment facilities.