Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule

Question: What is the definition of healthcare facility under the proposed rule and what is a pharmaceutical reverse distributor?

Answer: EPA is proposing healthcare facility to mean any person that:

  1. provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
  2. sells or dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but is not limited to, healthcare facilities include hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.

Pharmaceutical reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need. Reverse distributors generally have contracts with healthcare facilities to help the healthcare facility manage its unused and sometimes expired waste pharmaceuticals.

Healthcare facilities send their unused pharmaceuticals to a reverse distributor they have a contract with and the reverse distributor reviews the unused pharmaceuticals received and works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then the pharmaceutical reverse distributor sends the waste pharmaceuticals for disposal.

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