Section 15-608 - Regulations

(a) On or before January 1, 2007, and in consideration of the recommendations of the Task Force on the Establishment of a Prescription Drug Repository Program, the Board shall adopt regulations governing the Program. (b) The regulations shall include: (1) Categories of drugs that a repository will not accept, including a statement as to why the drug is ineligible for donation; (2) A standard form each donor must sign stating that the donor is the owner of the drugs and intends to voluntarily donate them to the Program; (3) Requirements for designation of drop–off sites to accept donated prescription drugs and medical supplies under the Program; (4) Requirements for designation of repositories to dispense or dispose of donated prescription drugs and medical supplies under the Program; (5) Standards and procedures for accepting, safely storing, dispensing, shipping, and disposing of donated prescription drugs and medical supplies; (6) Standards and procedures for inspecting donated prescription drugs and medical supplies intended for dispensing to determine that: (i) The original packaging is: 1. Sealed and tamper–evident; and 2.

Standards and procedures for inspecting donated prescription drugs and medical supplies intended for dispensing to determine that: (i) The original packaging is: 1. Sealed and tamper–evident; and 2. In the case of prescription drugs, in the undisturbed single unit dose packaging; and (ii) The prescription drugs and medical supplies are unadulterated, safe, and suitable for dispensing; (7) A standard form for health care practitioners to submit to a repository to indicate a patient’s need for the Program; (8) A standard form that an individual receiving a prescription drug or medical supply from the Program must sign before receiving the drug or supply to confirm that the individual understands that: (i) The individual is receiving prescription drugs or medical supplies that have been donated to the Program; and (ii) Entities involved in the Program have certain immunity from liability; (9) Record keeping and reporting requirements for a repository; and (10) Any other standards and procedures the Board considers appropriate.