196.984. Administrative rules, authority to promulgate. - Missouri Statutes

Administrative rules, authority to promulgate.

196.984. 1. In consultation with the board of pharmacy, the directorof the department of health and senior services shall adopt and promulgaterules to implement the prescription drug repository program. Such rulesshall include:

(1) Eligibility criteria for pharmacies, hospitals, and nonprofitclinics to receive and dispense donated prescription drugs under theprogram;

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

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

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

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

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

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

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

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

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

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

(10) Any other standards and procedures the department deemsappropriate or necessary to implement the provisions of sections 196.970 to196.984.

2. Any rule or portion of a rule, as that term is defined in section536.010, RSMo, that is created under the authority delegated in sections196.970 to 196.984 shall become effective only if it complies with and issubject to all of the provisions of chapter 536, RSMo, and, if applicable,section 536.028, RSMo. Sections 196.970 to 196.984 and chapter 536, RSMo,are nonseverable and if any of the powers vested with the general assemblypursuant to chapter 536, RSMo, to review, to delay the effective date, orto disapprove and annul a rule are subsequently held unconstitutional, thenthe grant of rulemaking authority and any rule proposed or adopted afterAugust 28, 2004, shall be invalid and void.

(L. 2004 S.B. 1160)

*Word "establish" appears in original rolls.