(a) (1) A charitable clinic may accept for redispensing prescription drugs obtained from a nursing facility by the clinic pharmacy for relabeling and dispensing free of charge and pursuant to a valid prescription order to an indigent patient.
(2) The donor patient shall be considered to be the owner of the prescription drug and entitled to donate the prescription drug for use by a charitable clinic.
(b) (1) (A) (i) Any nursing home may enter into a contract with any charitable clinic for the transfer of prescription drugs under this section.
(ii) No prescription drugs may be transferred without a contract.
(B) A contract entered into under subdivision (b)(1)(A) of this section shall:
(i) Be approved by the Arkansas State Board of Pharmacy, in cooperation with the Department of Health and the Department of Human Services; and
(ii) Set out procedures for ensuring a safe chain of custody to protect the safety of all transferred drugs.
(C) The contract may specify that the charitable clinic will:
(i) Define a specified set of prescription drugs that will be transferred from the nursing home to the charitable clinic;
(ii) Request from time to time the transfer of particular prescription drugs;
(iii) Receive all the prescription drugs that the nursing home is authorized to transfer under this section; or
(iv) Make such other provisions as may be approved by the board.
(2) The pharmacist-in-charge at the charitable clinic shall be responsible for determining the description of the prescription drugs that will be included in the contract.
(c) Donations of prescription drugs to a charitable clinic pharmacy shall meet the following requirements:
(1) (A) The charitable clinic pharmacy accepts the prescription drugs only in their original sealed and tamper-evident packaging.
(B) However, the charitable clinic pharmacy may accept prescription drugs packaged in single-unit doses or blister packs with the outside packaging opened if the single-unit dose packaging remains intact;
(2) A pharmacist of the charitable clinic pharmacy determines that the prescription drug is not adulterated or misbranded and is safe to dispense;
(3) No product of which the integrity cannot be assured is accepted for redispensing by the pharmacist of the charitable clinic pharmacy;
(4) The prescription drugs are physically transferred from the nursing facility to a charitable clinic pharmacy by a person authorized by the board to pick up the prescription drugs for the charitable clinic;
(5) (A) The donor executes a form stating that the donor is authorized to donate the prescription drugs and intends to voluntarily donate them to a charitable clinic pharmacy.
(B) The nursing facility retains the donor form along with other acquisition records;
(6) The donor patient's name, prescription number, and any other identifying marks are obliterated from the packaging before the nursing facility sends the prescription drug to the charitable clinic;
(7) The drug name, strength, and expiration date remain on the prescription drug package label;
(8) The redispensed prescription drug is assigned the same expiration date as on the original package;
(9) Expired prescription drugs accepted by a charitable clinic pharmacy are not redispensed and are destroyed according to the charitable clinic pharmacy's destruction procedures; and
(10) The charitable clinic pharmacy accepts no controlled substances.
(d) (1) If a nursing facility that releases prescription drugs to a charitable clinic receives notice from a pharmacy that a prescription drug has been recalled, the nursing facility shall inform the clinic of the recall.
(2) If a charitable clinic receives a recall notification from a nursing facility, the clinic shall perform a uniform destruction of all of the recalled prescription drug in the facility.
(e) No prescription drug dispensed through a charitable clinic pharmacy shall be eligible for reimbursement from the state Medicaid program.
(f) Indigent patients receiving prescription drugs through the prescription drug redispensing program shall sign a waiver form releasing the nursing facility, the donor, and the donor's estate from liability.
(g) The board shall promulgate rules to develop:
(1) Forms and procedures for authorizations and certifications required under subdivision (c)(4) of this section;
(2) The donor consent form required under subdivision (c)(5) of this section;
(3) The waiver forms required under subsection (f) of this section; and
(4) (A) Specific requirements for a charitable clinic pharmacy or other specialty pharmacy for the medically indigent as defined by rules of the board to qualify for participation in and to participate in the prescription drug redispensing program.
(B) On request, the board shall provide the information required under subdivision (g)(4)(A) of this section to charitable clinics.
(h) (1) The following persons and entities that participate in the prescription drug redispensing program shall not be subject to any professional disciplinary action or criminal prosecution for actions taken under the prescription drug redispensing program:
(A) The donor and the donor's estate;
(B) A nursing facility;
(C) The prescribing physician, physician's assistant, registered nurse, advanced practice nurse, or nurse practitioner;
(D) Pharmacists and pharmacy technicians except when the board has promulgated regulations dealing specifically with the prescription drug redispensing program;
(E) The charitable clinic;
(F) The Department of Health;
(G) The Department of Human Services; or
(H) The board.
(2) Participation in the prescription drug redispensing program shall not be used as an independent basis for a claim of liability in tort or other civil action against any person or entity, including, but not limited to:
(A) The donor and the donor's estate;
(B) A nursing facility;
(C) The prescribing physician, physician's assistant, nurse practitioner, or nurse;
(D) The charitable clinic;
(E) The charitable clinic pharmacy acting in conformity with board regulations;
(F) The pharmacist who originally dispensed the donated prescription drugs acting in conformity with board regulations;
(G) A pharmacist dispensing donated prescription drugs acting in conformity with board regulations;
(H) The Department of Health;
(I) The Department of Human Services; or
(J) The board.
(3) (A) In the absence of bad faith, a prescription drug manufacturer shall not be subject to criminal prosecution or liability in tort or other civil action for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a prescription drug manufactured by the prescription drug manufacturer that is donated by any person under the prescription drug redispensing program, including, but not limited to, liability for failure to provide:
(i) Product or consumer package insert information; or
(ii) The expiration date of the donated prescription drug.
(B) Subdivision (h)(3)(A) of this section does not apply to a previously undisclosed product defect.
Section: Previous 17-92-1102 17-92-1103 17-92-1104 17-92-1105 17-92-1106 17-92-1107 NextLast modified: November 15, 2016