2013 Maryland Code
HEALTH - GENERAL
§ 15-608 - Regulations.

§15-608.

(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. 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.