Effective 28 Aug 2004

196.984. Administrative rules, authority to promulgate. — 1. In consultation with the board of pharmacy, the director of the department of health and senior services shall adopt and promulgate rules to implement the prescription drug repository program. Such rules shall include:

(1) Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to receive and dispense donated prescription drugs under the program;

(2) Standards and procedures for accepting, safely storing, and dispensing donated prescription drugs;

(3) Standards and procedures for inspecting donated prescription drugs to determine that the original single-unit-dose packaging is sealed and tamper-evident and that the prescription drugs are unadulterated, safe, and suitable for dispensing;

(4) Eligibility requirements for recipients in the program shall be based on economic need for persons to receive prescription drugs under the program. For purposes of this subdivision, "economic need" means a net family income below three hundred percent of the federal poverty level;

(5) An identification card by which a person who is eligible to receive donated prescription drugs under the program may demonstrate eligibility to the pharmacy, hospital, or nonprofit clinic;

(6) A form that a person receiving a prescription drug from the program must sign before receiving the drug to confirm that such person understands the criminal and civil immunity from liability provisions of the program;

(7) Establishing* a maximum handling fee that pharmacies, hospitals, and nonprofit clinics may charge to drug recipients to cover restocking and dispensing costs;

(8) For prescription drugs donated to the program by individuals:

(a) A list of prescription drugs, arranged by category or by individual drug, that the program will and will not accept from individuals. If a drug is ineligible for donation, the list must include a statement as to the reason the drug is ineligible for donation; and

(b) A form each donor must sign stating that the donor is the owner of the prescription drugs and intends to voluntarily donate such drugs to the program;

(9) For prescription drugs donated to the program by health care facilities, a list of prescription drugs, arranged by category or by individual drug, that the program will and will not accept from health care facilities. If a drug is ineligible for donation, the list must include a statement as to the reason the drug is ineligible for donation; and

(10) Any other standards and procedures the department deems appropriate or necessary to implement the provisions of sections 196.970 to 196.984.

2. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in sections 196.970 to 196.984 shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. Sections 196.970 to 196.984 and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2004, shall be invalid and void.

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(L. 2004 S.B. 1160)

*Word "establish" appears in original rolls.