This bill revises various provisions of the prescription drug donation repository program, including the following: (1) Present law authorizes the department of health, in cooperation with the board of pharmacy, to promulgate rules to establish and enforce a prescription drug donation repository program under which a person or organization may donate prescription drugs and supplies for use by a 501(c)(3) organization and that meets eligibility criteria specified by rule for administering the program. This bill transfers authority to create such program from the department of health to the board of pharmacy. This bill also provides for the drugs being used by "an individual" instead of a 501(c)(3) organization. Under this bill, the board, in cooperation with the department of health, may establish and maintain a prescription drug donation repository program under which a person may donate prescription drugs and supplies for use by an individual who meets eligibility criteria. This bill authorizes the board to contract with a third party to implement and administer the program. (2) This bill adds that a pharmacy or medical facility may elect to participate in the program by providing written notification to the department of the following: (A) The name, street address, and telephone number of the pharmacy or medical facility, and a state issued license or registration number issued to the pharmacy or medical facility, including the name of the issuing agency; (B) The name and telephone number of the responsible pharmacist, physician, physician's assistant, or nurse practitioner who is employed by or under contract with the pharmacy or medical facility; and (C) A statement, signed and dated by the responsible pharmacist, physician, physician's assistant, or nurse practitioner, indicating that the pharmacy or medical facility meets the eligibility requirements and will comply with the program. (3) This bill redefines "donor" for purposes of a program. Under present law, a donor is a person, a pharmacy, or medical facility as well as any drug manufacturer or wholesaler licensed by the board of pharmacy, who donates prescription drugs to an approved repository program. This bill redefines donor to specifically include an individual member of the public and an entity legally authorized to possess medicine in the state in which it is located with a license or permit in good standing. (4) This bill removes a requirement for organizations that administer a program to annually submit certain data to the department. (5) Under present law, a prescription drug or supplies may be accepted and dispensed under the program if all of the following conditions are met: (A) The prescription drug is in its original sealed and tamper-evident packaging. However, a prescription drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit dose packaging remains intact; (B) The prescription drug or supplies are inspected before the prescription drug or supplies are dispensed by a licensed pharmacist employed by or under contract with the medical facility or pharmacy, and the licensed pharmacist determines that the prescription drug or supplies are not adulterated or misbranded; and (C) The prescription drug or supplies are prescribed by a healthcare practitioner for use by an eligible individual and are dispensed by a pharmacist. This bill revises the above provisions to instead provide the following: (A) Except as provided below in (C), the drugs must be in their original sealed and tamper-evident unit dose packaging. The packaging must be unopened. However, the drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed; (B) The program must develop and implement standards and procedures to determine, based on a basic visual inspection, that the drugs appear to be unadulterated, safe, and suitable for dispensing; and (C) High value specialty medications, including, but not limited to, cancer drugs, that are not in original sealed and tamper-evident unit dose packaging may be donated to a drug repository program. (6) This bill adds priority for dispensing donated prescriptions and supplies, which will be as follows: (A) First, to an indigent patient; (B) Second, to a patient who has no prescription drug insurance or cannot afford the out-of-pocket expenses for the drug prescribed; and (C) Lastly, to another individual if an indigent, uninsured, or underinsured patient is unavailable. (7) Present law authorizes a medical facility or pharmacy to charge an individual who receives a prescription drug or supplies a handling fee that does not exceed an amount established by rule. This bill revises the fee provision to instead provide the following: (A) An eligible recipient will not charge or collect fees from an eligible patient for prescriptions or supplies dispensed pursuant to the program. However, an eligible recipient may charge a handling fee for each donated drug or supply that is dispensed; and (B) An eligible recipient may charge fees, including, but not limited to, a usual and customary charge, to donors, eligible recipients, health plans, pharmacy benefit managers, and other entities. The fee must not exceed the reasonable cost of educating and providing technical support to donors and patients, shipping and handling, labor, storage, licensing, insurance, utilities, advertising, technology, supplies, and equipment. (8) This bill specifies in detail requirements for accepting and dispensing donated drugs and supplies, such as inspections to determine suitability for dispensing; storage requirements; and disposal of products not suitable for being dispensed. (9) This bill revises the immunity provisions to remove references to the provisions not applying when there is gross negligence or willful misconduct. This bill retains the present law provisions whereby immunity does not apply to acts or omissions that are not performed reasonably and in good faith or to acts or omissions outside the scope of the program.

Statutes affected:
Introduced: 43-6-502, 49-4-204, 49-4-301, 49-4-302, 49-4-303, 49-4-304, 49-4-306, 49-4-705, 49-4-903(b), 49-4-903, 49-4-913(a), 49-4-913, 49-4-919, 49-4-933(d)(2), 49-4-933, 49-4-943(c)(1)(A), 49-4-943, 49-7-112(e), 49-7-112, 49-7-121, 49-7-202(r), 49-7-202, 49-7-204(d), 49-7-204, 49-7-210(e), 49-7-210, 49-7-1310(c)(3), 49-7-1310, 49-7-2004(a), 49-7-2004, 49-7-2701, 49-8-1401, 49-9-301