3715.873 Adoption of rules.

In consultation with the director of health, the state board of pharmacy shall adopt rules governing the drug repository program that establish all of the following:

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

(B) Standards and procedures for accepting, safely storing, and dispensing drugs donated or given;

(C) With respect to drugs that are donated or given, other than orally administered cancer drugs described in division (C) of section 3715.87 of the Revised Code that are not in original sealed and tamper-evident unit dose packaging, standards and procedures for inspecting the drugs to determine that the original unit dose packaging is sealed and tamper-evident and that the drugs are unadulterated, safe, and suitable for dispensing;

(D) With respect to orally administered cancer drugs described in division (C) of section 3715.87 of the Revised Code that are not in original sealed and tamper-evident unit dose packaging, standards and procedures to determine based on a basic visual inspection that the drugs appear to be unadulterated, safe, and suitable for dispensing;

(E) Eligibility standards based on economic need for individuals to receive drugs;

(F) A means, such as an identification card, by which an individual who is eligible to receive drugs under the program may demonstrate eligibility to the pharmacy, hospital, or nonprofit clinic dispensing the drugs;

(G) A form that an individual receiving a drug under the program must sign before receiving the drug to confirm that the individual understands the immunity provisions of the program;

(H) A formula to determine the amount of a handling fee that pharmacies, hospitals, and nonprofit clinics may charge to drug recipients to cover restocking and dispensing costs;

(I) In addition, for drugs donated or given to the program by individuals:

(1) A list of drugs, arranged either by category or by individual drug, that the program will accept from individuals . The list shall include orally administered cancer drugs that are described in division (C) of section 3715.87 of the Revised Code.

(2) A list of drugs, arranged either by category or by individual drug, that the program will not accept from individuals. The list shall not include orally administered cancer drugs that are described in division (C) of section 3715.87 of the Revised Code. The list must include a statement as to why the drug is ineligible to be donated or given.

(3) A form each donor must sign stating that the donor is the owner of the drugs and intends to voluntarily donate them to the program.

(J) In addition, for drugs donated to the program by health care facilities:

(1) A list of drugs, arranged either by category or by individual drug, that the program will accept from health care facilities . The list shall include orally administered cancer drugs that are described in division (C) of section 3715.87 of the Revised Code.

(2) A list of drugs, arranged either by category or by individual drug, that the program will not accept from health care facilities. The list shall not include orally administered cancer drugs that are described in division (C) of section 3715.87 of the Revised Code. The list must include a statement as to why the drug is ineligible to be donated or given.

(K) Any other standards and procedures the board considers appropriate.

The rules shall be adopted in accordance with Chapter 119. of the Revised Code.

Cite as R.C. § 3715.873

History. Amended by 128th General AssemblyFile No.9, HB 1, §101.01, eff. 10/16/2009.

Effective Date: 04-07-2003; 2007 SB33 08-22-2007