SENATORS Prentiss, Wachtmann, Randy Gardner, Nein, Mead, Amstutz, Spada, White, Harris, Robert Gardner, Austria, Jacobson

To enact sections 3715.87, 3715.871, 3715.872, and

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3715.873 of the Revised Code to establish under the

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direction of the State Board of Pharmacy a drug

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repository program to accept and dispense donated

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prescription drugs.

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BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That sections 3715.87, 3715.871, 3715.872, and	6
3715.873 of the Revised Code be enacted to read as follows:	7

Sec. 3715.87. (A) As used in this section and in sections	8
3715.871, 3715.872, and 3715.873 of the Revised Code:	9

(1) "Hospital" has the same meaning as in section 3727.01 of	10
the Revised Code.	11

(2) "Nonprofit clinic" means a charitable nonprofit	12
corporation organized and operated pursuant to Chapter 1702. of	13
the Revised Code, or any charitable organization not organized and	14
not operated for profit, that provides health care services to	15
indigent and uninsured persons as defined in section 2305.234 of	16
the Revised Code. "Nonprofit clinic" does not include a hospital	17
as defined in section 3727.01 of the Revised Code, a facility	18
licensed under Chapter 3721. of the Revised Code, or a facility	19
that is operated for profit.	20

(3) "Prescription drug" means any drug to which the following	21
applies:	22

(a) Under the "Food, Drug, and Cosmetic Act," 52 Stat. 1040	23
(1938), 21 U.S.C.A. 301, as amended, the drug is required to bear	24
a label containing the legend, "Caution: Federal law prohibits	25
dispensing without prescription" or "Caution: Federal law	26
restricts this drug to use by or on the order of a licensed	27
veterinarian" or any similar restrictive statement, or the drug	28
may be dispensed only upon a prescription.	29

(b) Under Chapter 3715. or 3719. of the Revised Code, the	30
drug may be dispensed only upon a prescription.	31

(B) The state board of pharmacy shall establish a drug	32
repository program to accept and dispense prescription drugs	33
donated for the purpose of being dispensed to individuals who are	34
residents of this state and meet eligibility standards established	35
in rules adopted by the board under section 3715.873 of the	36
Revised Code. Only drugs in their original sealed and	37
tamper-evident unit dose packaging may be accepted and dispensed.	38
The packaging must be unopened, except that drugs packaged in	39
single unit doses may be accepted and dispensed when the outside	40
packaging is opened if the single unit dose packaging is	41
undisturbed. Drugs donated by individuals bearing an expiration	42
date that is less than six months from the date the drug is	43
donated shall not be accepted or dispensed. A drug shall not be	44
accepted or dispensed if there is reason to believe that it is	45
adulterated as described in section 3715.63 of the Revised Code.	46
Subject to the limitation specified in this division, unused drugs	47
dispensed for purposes of the medicaid program may be accepted and	48
dispensed under the drug repository program.	49

Sec. 3715.871. (A) Any person, including a drug manufacturer	50
or any health care facility as defined in section 1337.11 of the	51
Revised Code, may donate prescription drugs to the drug repository	52
program. The drugs must be donated at a pharmacy, hospital, or	53
nonprofit clinic that elects to participate in the drug repository	54
program and meets criteria for participation in the program	55
established in rules adopted by the state board of pharmacy under	56
section 3715.873 of the Revised Code. Participation in the program	57
by pharmacies, hospitals, and nonprofit clinics is voluntary.	58
Nothing in this or any other section of the Revised Code requires	59
a pharmacy, hospital, or nonprofit clinic to participate in the	60
program.	61

(B) A pharmacy, hospital, or nonprofit clinic eligible to	62
participate in the program shall dispense drugs donated under this	63
section to individuals who are residents of this state and meet	64
the eligibility standards established in rules adopted by the	65
board under section 3715.873 of the Revised Code or to other	66
government entities and nonprofit private entities to be dispensed	67
to individuals who meet the eligibility standards. A drug may be	68
dispensed only pursuant to a prescription issued by a licensed	69
health professional authorized to prescribe drugs, as defined in	70
section 4729.01 of the Revised Code. A pharmacy, hospital, or	71
nonprofit clinic that accepts donated drugs shall comply with all	72
applicable federal laws and laws of this state dealing with	73
storage and distribution of dangerous drugs and shall inspect all	74
drugs prior to dispensing them to determine that they are not	75
adulterated. The pharmacy, hospital, or nonprofit clinic may	76
charge individuals receiving donated drugs a handling fee	77
established in accordance with rules adopted by the board under	78
section 3715.873 of the Revised Code. Drugs donated to the	79
repository may not be resold.	80

Sec. 3715.872. (A) As used in this section, "health care	81
professional" means any of the following who provide medical,	82
dental, or other health-related diagnosis, care, or treatment:	83

(1) Individuals authorized under Chapter 4731. of the	84
Revised Code to practice medicine and surgery, osteopathic	85
medicine and surgery, or podiatric medicine and surgery;	86

(2) Registered nurses and licensed practical nurses licensed	87
under Chapter 4723. of the Revised Code;	88

(3) Physician assistants authorized to practice under Chapter	89
4730. of the Revised Code;	90

(4) Dentists and dental hygienists licensed under Chapter	91
4715. of the Revised Code;	92

(5) Optometrists licensed under Chapter 4725. of the Revised	93
Code;	94

(6) Pharmacists licensed under Chapter 4729. of the Revised	95
Code.	96

(B) The state board of pharmacy; the director of health; any	97
person, including a drug manufacturer, or government entity that	98
donates drugs to the repository program; any pharmacy, hospital,	99
nonprofit clinic, or health care professional that accepts or	100
dispenses drugs under the program; and any pharmacy, hospital, or	101
nonprofit clinic that employs a health care professional who	102
accepts or dispenses drugs under the program shall not, in the	103
absence of bad faith, be subject to any of the following for	104
matters related to donating, accepting, or dispensing drugs under	105
the program: criminal prosecution; liability in tort or other	106
civil action for injury, death, or loss to person or property; or	107
professional disciplinary action.	108

A drug manufacturer shall not, in the absence of bad faith,	109
be subject to criminal prosecution or liability in tort or other	110
civil action for injury, death, or loss to person or property for	111
matters related to the donation, acceptance, or dispensing of a	112
drug manufactured by the drug manufacturer that is donated by any	113
person under the program, including but not limited to liability	114
for failure to transfer or communicate product or consumer	115
information or the expiration date of the donated drug.	116

Sec. 3715.873. In consultation with the director of health,	117
the state board of pharmacy shall adopt rules governing the drug	118
repository program that establish all of the following:	119

(A) Eligibility criteria for pharmacies, hospitals, and	120
nonprofit clinics to receive and dispense donated drugs under the	121
program;	122

(B) Standards and procedures for accepting, safely storing,	123
and dispensing donated drugs;	124

(C) Standards and procedures for inspecting donated drugs	125
to determine that the original unit dose packaging is sealed and	126
tamper-evident and that the drugs are unadulterated, safe, and	127
suitable for dispensing;	128

(D) Eligibility standards based on economic need for	129
individuals to receive drugs;	130

(E) A means, such as an identification card, by which an	131
individual who is eligible to receive donated drugs may	132
demonstrate eligibility to the pharmacy, hospital, or nonprofit	133
clinic dispensing the drugs;	134

(F) A form that an individual receiving a drug from the	135
repository must sign before receiving the drug to confirm that the	136
individual understands the immunity provisions of the program;	137

(G) A formula to determine the amount of a handling fee that	138
pharmacies, hospitals, and nonprofit clinics may charge to drug	139
recipients to cover restocking and dispensing costs;	140

(H) In addition, for drugs donated to the repository by	141
individuals:	142

(1) A list of drugs, arranged either by category or by	143
individual drug, that the repository will accept from individuals;	144

(2) A list of drugs, arranged either by category or by	145
individual drug, that the repository will not accept from	146
individuals. The list must include a statement as to why the drug	147
is ineligible for donation.	148

(3) A form each donor must sign stating that the donor is	149
the owner of the drugs and intends to voluntarily donate them to	150
the repository.	151

(I) In addition, for drugs donated to the repository by	152
health care facilities:	153

(1) A list of drugs, arranged either by category or by	154
individual drug, that the repository will accept from health care	155
facilities;	156

(2) A list of drugs, arranged either by category or by	157
individual drug, that the repository will not accept from health	158
care facilities. The list must include a statement as to why the	159
drug is ineligible for donation.	160

(J) Any other standards and procedures the board considers	161
appropriate.	162

The rules shall be adopted in accordance with Chapter 119.	163
of the Revised Code.	164

Section 2. Sections 3715.87, 3715.871, and 3715.872 of the	165
Revised Code as enacted by this act shall take effect one year	166
after the effective date of this section.	167

Section 3. The State Board of Pharmacy shall adopt the rules	168
required by section 3715.873 of the Revised Code not later than	169
nine months after the effective date of this section.	170