Comments from manufacturers expressed concerns, among many others, about the definition of pharmaceutical, waste determination, and reverse distribution.
Definition of pharmaceutical. The EPA has proposed to include dietary supplements and over-the-counter drugs (OTC drugs) that are required by the Food and Drug Administration to include “Drug Facts” in the definition of “pharmaceutical.” Some manufacturers expressed concern that the expansion of the definition to include dietary supplements could create substantial confusion in managing what substances are returned to what reverse distributors, with the result that more materials will be inadvertently shipped incorrectly to a reverse distributor that is not responsible for that product.
In addition, some say that EPA’s decision to include certain OTC drugs is inconsistent with the definition of “drug” in the Food, Drug, and Cosmetic Act.
Waste determination. The EPA has proposed that pharmaceuticals generated at healthcare facilities that are sent to reverse distributors be considered discarded and, therefore, solid waste. Commenters say that such pharmaceuticals have not been discarded and remain products with monetary value.
Reverse distribution. Reverse distribution, as applicable to this proposed rule, is the practice of managing unused and/or expired hazardous waste pharmaceuticals by returning them to the supplier or manufacturer. EPA’s proposals concerning reverse distribution are perhaps the most contentious for both manufacturers and retailers. Most concerning are:
- That reverse distributors that don’t comply with the new regulations would be considered treatment, storage, and disposal facilities (TSDFs) and subject to all the permitting and other requirements for TSDFs under RCRA. Commenters contend that requiring reverse distributors to become full-fledged TSDFs for minor cases of noncompliance, including those with no environmental or health impact, is not authorized by RCRA.
- That many pharmaceutical manufacturers that do not operate as reverse distributors often receive returned products. Therefore, commenters ask that the EPA specifically exclude pharmaceutical manufacturers from the rule’s requirements for reverse distributors.
The retail industry’s major problem with the proposed rule for the management of hazardous waste pharmaceuticals has to do with products in reverse distribution. Commenters pointed out, similar to manufacturers, that reverse distribution of prescription pharmaceuticals, OTC drugs, and dietary supplements are essential business components of the retail sector and not waste management activities.
Follow the progression of EPA’s proposed Management Standards for Hazardous Waste Pharmaceuticals on Enviro.BLR.com® where you will find information and tools for managing medical waste at your facility.