(a) In general.- 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) Requirements.- 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 donated prescription drugs and medical supplies under the Program;
(5) Standards and procedures for accepting, safely storing, dispensing, shipping, and if necessary, 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. 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.
(a) In general.- 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) Requirements.- 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 donated prescription drugs and medical supplies under the Program;
(5) Standards and procedures for accepting, safely storing, dispensing, shipping, and if necessary, 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. 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.
(a) In general.- 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) Requirements.- 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 donated prescription drugs and medical supplies under the Program;
(5) Standards and procedures for accepting, safely storing, dispensing, shipping, and if necessary, 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. 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.
