REPRESENTATIVES Schuring, Jolivette, Hollister, Hagan, Cates, D. Miller, Calvert, Hartnett, Patton, Seitz, Britton, Willamowski, Otterman, Ogg, Perry, Allen, Collier, DePiero, Webster, Jones, Boccieri, Schaffer, Redfern, Damschroder, Metelsky, Coates, Aslanides, Lendrum, Kearns, Raga, Kilbane, Mason, Cirelli, Beatty, Williams, Schneider, Flowers, Buehrer, Metzger, Niehaus, Carey, Rhine, Flannery, Barrett, Sulzer, Krupinski, Carano, Key, Latta, Carmichael, Strahorn, Hoops, Stapleton, Fedor, DeBose, Clancy, Driehaus, Manning, Peterson, Core, G. Smith, Reidelbach, Faber, Widowfield, Hughes, McGregor, Young, Olman, Brown, Oakar, Sykes, Wolpert, Salerno, Setzer, Womer Benjamin, Roman, Woodard

To enact sections 3701.79, 3701.791, 3701.792, and

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3701.793 of the Revised Code to establish under

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the direction of the Director of Health 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 3701.79, 3701.791, 3701.792, and	6
3701.793 of the Revised Code be enacted to read as follows:	7

Sec. 3701.79. (A) As used in this section and in sections	8
3701.791, 3701.792, and 3701.793 of the Revised Code:	9

(1) "Nonprofit clinic" means a charitable nonprofit	10
corporation organized and operated pursuant to Chapter 1702. of	11
the Revised Code, or any charitable organization not organized and	12
not operated for profit, that provides health care services to	13
indigent and uninsured persons as defined in section 2305.234 of	14
the Revised Code. "Nonprofit clinic" does not include a hospital	15
as defined in section 3727.01 of the Revised Code, a facility	16
licensed under Chapter 3721. of the Revised Code, or a facility	17
that is operated for profit.	18

(2) "Prescription drug" means any drug to which the following	19
applies:	20

(a) Under the "Food, Drug, and Cosmetic Act," 52 Stat. 1040	21
(1938), 21 U.S.C.A. 301, as amended, the drug is required to bear	22
a label containing the legend, "Caution: Federal law prohibits	23
dispensing without prescription" or "Caution: Federal law	24
restricts this drug to use by or on the order of a licensed	25
veterinarian" or any similar restrictive statement, or the drug	26
may be dispensed only upon a prescription.	27

(b) Under Chapter 3715. or 3719. of the Revised Code, the	28
drug may be dispensed only upon a prescription.	29

(B) The director of health shall establish a drug repository	30
program to accept and dispense prescription drugs donated for the	31
purpose of being dispensed to individuals who meet eligibility	32
standards established in rules adopted by the state board of	33
pharmacy under section 3701.793 of the Revised Code. Only drugs	34
in their original sealed and tamper-evident unit dose packaging	35
may be accepted and dispensed. The packaging must be unopened,	36
except that drugs packaged in single unit doses may be accepted	37
and dispensed when the outside packaging is opened if the single	38
unit dose packaging is undisturbed. Drugs donated by individuals	39
bearing an expiration date that is less than six months from the	40
date the drug is donated shall not be accepted or dispensed. A	41
drug shall not be accepted or dispensed if there is reason to	42
believe that it is adulterated as described in section 3715.63 of	43
the Revised Code. Subject to the limitation specified in this	44
division, unused drugs dispensed for purposes of the medicaid	45
program may be accepted and dispensed under the drug repository	46
program.	47

Sec. 3701.791. (A) Any person, including a drug manufacturer	48
or any health care facility as defined in section 1337.11 of the	49
Revised Code, may donate prescription drugs to the drug repository	50
program. The drugs must be donated at a pharmacy or nonprofit	51
clinic that elects to participate in the drug repository program.	52
Participation in the program by pharmacies and nonprofit clinics	53
is voluntary. Nothing in this or any other section of the Revised	54
Code requires a pharmacy or nonprofit clinic to participate in the	55
program.	56

(B) A pharmacy or nonprofit clinic shall dispense drugs	57
donated under this section to individuals who meet the eligibility	58
standards established in rules adopted by the state board of	59
pharmacy under section 3701.793 of the Revised Code or to other	60
government entities and nonprofit private entities to be dispensed	61
to individuals who meet the eligibility standards. A drug may be	62
dispensed only pursuant to a prescription issued by a licensed	63
health professional authorized to prescribe drugs, as defined in	64
section 4729.01 of the Revised Code. A pharmacy or nonprofit	65
clinic that accepts donated drugs shall comply with all applicable	66
federal laws and laws of this state dealing with storage and	67
distribution of dangerous drugs and shall inspect all drugs prior	68
to dispensing them to determine that they are not adulterated. The	69
pharmacy or nonprofit clinic may charge individuals receiving	70
donated drugs a handling fee established in accordance with rules	71
adopted by the state board of pharmacy under section 3701.793 of	72
the Revised Code. Drugs donated to the repository may not be	73
resold.	74

Sec. 3701.792. (A) As used in this section, "health care	75
professional" means any of the following who provide medical,	76
dental, or other health-related diagnosis, care, or treatment:	77

(1) Individuals authorized under Chapter 4731. of the	78
Revised Code to practice medicine and surgery, osteopathic	79
medicine and surgery, or podiatric medicine and surgery;	80

(2) Registered nurses and licensed practical nurses licensed	81
under Chapter 4723. of the Revised Code;	82

(3) Physician assistants authorized to practice under Chapter	83
4730. of the Revised Code;	84

(4) Dentists and dental hygienists licensed under Chapter	85
4715. of the Revised Code;	86

(5) Optometrists licensed under Chapter 4725. of the Revised	87
Code;	88

(6) Pharmacists licensed under Chapter 4729. of the Revised	89
Code.	90

(B) The director of health; any person, including a drug	91
manufacturer, or government entity that donates drugs to the	92
repository program; any pharmacy, nonprofit clinic, or health care	93
professional that accepts or dispenses drugs under the program;	94
and any pharmacy or nonprofit clinic that employs a health care	95
professional who accepts or dispenses drugs under the program	96
shall not, in the absence of bad faith, be subject to any of the	97
following for matters related to donating, accepting, or	98
dispensing drugs under the program: criminal prosecution;	99
liability in tort or other civil action for injury, death, or loss	100
to person or property; or professional disciplinary action.	101

Sec. 3701.793. In consultation with the director of health,	102
the state board of pharmacy shall adopt rules governing the drug	103
repository program that establish all of the following:	104

(A) Standards and procedures for accepting, safely storing,	105
and dispensing donated drugs;	106

(B) Standards and procedures for inspecting donated drugs	107
to determine that the original unit dose packaging is sealed and	108
tamper-evident and that the drugs are unadulterated, safe, and	109
suitable for dispensing;	110

(C) Eligibility standards based on economic need for	111
individuals to receive drugs;	112

(D) A means, such as an identification card, by which an	113
individual who is eligible to receive donated drugs may	114
demonstrate eligibility to the pharmacy or nonprofit clinic	115
dispensing the drugs;	116

(E) A form that an individual receiving a drug from the	117
repository must sign before receiving the drug to confirm that the	118
individual understands the immunity provisions of the program;	119

(F) A formula to determine the amount of a handling fee that	120
pharmacies and nonprofit clinics may charge to drug recipients to	121
cover restocking and dispensing costs;	122

(G) In addition, for drugs donated to the repository by	123
individuals:	124

(1) A list of drugs, arranged either by category or by	125
individual drug, that the repository will accept from individuals;	126

(2) A list of drugs, arranged either by category or by	127
individual drug, that the repository will not accept from	128
individuals. The list must include a statement as to why the drug	129
is ineligible for donation.	130

(3) A form each donor must sign stating that the donor is	131
the owner of the drugs and intends to voluntarily donate them to	132
the repository.	133

(H) In addition, for drugs donated to the repository by	134
health care facilities:	135

(1) A list of drugs, arranged either by category or by	136
individual drug, that the repository will accept from health care	137
facilities;	138

(2) A list of drugs, arranged either by category or by	139
individual drug, that the repository will not accept from health	140
care facilities. The list must include a statement as to why the	141
drug is ineligible for donation.	142

(I) Any other standards and procedures the board considers	143
appropriate.	144

The rules shall be adopted in accordance with Chapter 119.	145
of the Revised Code.	146

Section 2. Sections 3701.79, 3701.791, and 3701.792 of the	147
Revised Code as enacted by this act shall take effect one year	148
after the effective date of this act.	149

Section 3. The State Board of Pharmacy shall adopt the rules	150
required by section 3701.793 of the Revised Code not later than	151
nine months after the effective date of this act.	152