§ 15-608. Regulations.

MD Health-Gen Code § 15-608 (2019) (N/A)
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(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.