As Passed by the House

125th General Assembly
Regular Session
2003-2004
Sub. H. B. No. 454


REPRESENTATIVES White, Seitz, Clancy, McGregor, Raga, Schmidt, Setzer, Chandler, Kearns, Schaffer, Webster, Miller, Perry, Distel, Strahorn, Hollister, Price, Cirelli, G. Smith, Reidelbach, Hoops, Harwood, Slaby, Combs, Beatty, Barrett, Allen, Aslanides, Brown, Buehrer, Carano, Carmichael, Collier, DeBose, DeGeeter, Domenick, Driehaus, C. Evans, D. Evans, Fessler, Flowers, Hagan, Hughes, Husted, Key, Kilbane, Niehaus, Olman, Otterman, S. Patton, T. Patton, Schlichter, S. Smith, D. Stewart, J. Stewart, Sykes, Taylor, Widener, Willamowski



A BILL
To amend section 3719.81 and to enact sections 1
3719.811, 3719.812, and 3719.813 of the Revised 2
Code regarding the distribution of sample drugs by 3
and to charitable pharmacies.4


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

       Section 1. That section 3719.81 be amended and sections 5
3719.811, 3719.812, and 3719.813 of the Revised Code be enacted to 6
read as follows:7

       Sec. 3719.81.  (A) As used in this section, "sample drug" has 8
the same meaning as in section 2925.01 of the Revised Code.9

        (B) A person may furnish another a sample of any drug of 10
abuse, or of any drug or pharmaceutical preparation that would be 11
hazardous to health or safety if used without the supervision of a 12
licensed health professional authorized to prescribe drugs, if all 13
of the following apply:14

       (1) The sample drug is furnished free of charge by a 15
manufacturer, manufacturer's representative, or wholesale dealer 16
in pharmaceuticals to a licensed health professional authorized to 17
prescribe drugs, or is furnished free of charge by such a18
professional to a patient for use as medication;19

       (2) The sample drug is in the original container in which it 20
was placed by the manufacturer, and the container is plainly21
marked as a sample;22

       (3) Prior to its being furnished, the sample drug sample has 23
been stored under the proper conditions to prevent its 24
deterioration or contamination;25

       (4) If the sample drug is of a type which deteriorates with 26
time, the sample container is plainly marked with the date beyond 27
which the sample drug sample is unsafe to use, and the date has 28
not expired on the sample furnished. Compliance with the labeling29
requirements of the "Federal Food, Drug, and Cosmetic Act," 52 30
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, shall be deemed 31
compliance with this section.32

       (5) The sample drug is distributed, stored, or discarded in 33
such a way that the sample drug sample may not be acquired or used 34
by any unauthorized person, or by any person, including a child, 35
for whom it may present a health or safety hazard.36

       (B)(C) Division (A)(B) of this section does not do any of the37
following:38

       (1) Apply to or restrict the furnishing of any sample of a39
nonnarcotic substance if the substance may, under the "Federal 40
Food, Drug, and Cosmetic Act" and under the laws of this state, 41
otherwise be lawfully sold over the counter without a 42
prescription;43

       (2) Authorize a licensed health professional authorized to 44
prescribe drugs who is a clinical nurse specialist, certified 45
nurse-midwife, certified nurse practitioner, or advanced practice 46
nurse to furnish a sample of a drug that is not a drug the nurse 47
is authorized to prescribe;48

       (3) Authorize an optometrist to furnish a sample of a drug 49
that is not a drug the optometrist is authorized to prescribe.50

       (4) Prohibit a licensed health professional authorized to 51
prescribe drugs, manufacturer of dangerous drugs, wholesale 52
distributor of dangerous drugs, or representative of a 53
manufacturer of dangerous drugs from furnishing a sample drug to a 54
charitable pharmacy in accordance with section 3719.811 of the 55
Revised Code.56

        (5) Prohibit a pharmacist working, whether or not for 57
compensation, in a charitable pharmacy from dispensing a sample 58
drug to a person in accordance with section 3719.811 of the 59
Revised Code.60

       (C)(D) The state board of pharmacy shall, in accordance with61
Chapter 119. of the Revised Code, adopt rules as necessary to give 62
effect to this section.63

       Sec. 3719.811. (A) As used in this section:64

        (1) "Charitable pharmacy" means a pharmacy that meets all of 65
the following requirements:66

       (a) Holds a terminal distributor of dangerous drugs license 67
under section 4729.54 of the Revised Code.68

        (b) Is exempt from federal taxation pursuant to 26 U.S.C. 69
501(a) and (c)(3).70

        (c) Is not a hospital as defined in section 3727.01 of the 71
Revised Code.72

        (2) "Prescription" has the same meaning as in section 4729.01 73
of the Revised Code.74

        (3) "Sample drug" has the same meaning as in section 2925.01 75
of the Revised Code.76

        (B) A manufacturer of dangerous drugs or wholesale 77
distributor of dangerous drugs may furnish a sample drug to a 78
charitable pharmacy if all of the following apply:79

       (1) The sample drug is in the original container in which it 80
was placed by its manufacturer and the container is plainly marked 81
as a sample.82

        (2) Prior to its being furnished, the sample drug has been 83
stored under the proper conditions to prevent its deterioration or 84
contamination.85

        (3) If the sample drug is of a type that deteriorates with 86
time, the container in which the sample drug is stored is plainly 87
marked with the date beyond which the sample drug is unsafe to 88
use, and the date has not expired on the sample drug furnished. 89
Compliance with the labeling requirements of the "Federal Food, 90
Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301, as 91
amended, constitutes compliance with division (B)(3) of this 92
section.93

        (4) The sample drug is distributed, stored, or discarded in 94
such a way that the sample drug may not be acquired or used by any 95
unauthorized person, or by any person, including a child, for whom 96
it may present a health or safety hazard.97

       (5) The sample drug is furnished free of charge.98

       (6) The sample drug is not a controlled substance.99

        (C) A representative of a manufacturer of dangerous drugs or 100
a licensed health professional authorized to prescribe drugs may 101
furnish a sample drug to a charitable pharmacy if all of the 102
following apply:103

        (1) The state board of pharmacy has adopted rules under 104
division (F) of this section to permit such a representative or 105
health professional to furnish a sample drug to a charitable 106
pharmacy.107

       (2) The representative or health professional complies with 108
standards and procedures established in rules adopted under 109
division (F) of this section.110

       (3) The requirements in divisions (B)(1) to (6) of this 111
section are satisfied.112

        (D) A pharmacist working, whether or not for compensation, in 113
a charitable pharmacy may dispense a sample drug to a person if 114
all of the following apply:115

        (1) The person to whom the sample drug is dispensed is 116
eligible for the sample drug under standards established by the 117
body responsible for the charitable pharmacy's general management.118

        (2) The person to whom the sample is dispensed presents to 119
the pharmacist a valid prescription for the sample drug.120

       (3) The sample drug is dispensed free of charge.121

       (4) The requirements in divisions (B)(1) to (4) and (6) of 122
this section are satisfied.123

        (E) Divisions (B), (C), and (D) of this section do not do 124
either of the following:125

        (1) Apply to or restrict the furnishing of any sample of a 126
nonnarcotic substance if the substance may, under the "Federal 127
Food, Drug, and Cosmetic Act" and under the law of this state, 128
otherwise be lawfully sold over the counter without a 129
prescription.130

        (2) Authorize a pharmacist working, whether or not for 131
compensation, in a charitable pharmacy to dispense a sample drug 132
that the charitable pharmacy is unauthorized to possess, have 133
custody or control of, or distribute.134

       (F) The state board of pharmacy shall, in accordance with 135
Chapter 119. of the Revised Code, adopt rules as necessary to give 136
effect to this section. The rules may permit representatives of 137
manufacturers of dangerous drugs to furnish sample drugs to 138
charitable pharmacies under this section. If they do so, the rules 139
shall establish standards and procedures for the representatives 140
to furnish the sample drugs.141

       Sec. 3719.812. The state board of pharmacy; any person that 142
donates a sample drug as permitted under section 3719.811 of the 143
Revised Code; any charitable pharmacy or pharmacist working in a 144
charitable pharmacy that accepts or dispenses sample drugs as 145
permitted under section 3719.811 of the Revised Code; and any 146
licensed health professional authorized to prescribe drugs who 147
accepts delivery of a sample drug on behalf of a charitable 148
pharmacy as permitted under section 3719.811 of the Revised Code 149
shall not, in the absence of bad faith, be subject to any of the 150
following for matters related to donating, accepting, or 151
dispensing sample drugs under section 3719.811 of the Revised 152
Code: criminal prosecution; liability in tort or other civil 153
action for injury, death, or loss to person or property; or 154
professional disciplinary action.155

       Sec. 3719.813. A drug manufacturer shall not, in the absence 156
of bad faith, be subject to criminal prosecution or liability in 157
tort or other civil action for injury, death, or loss to person or 158
property for matters related to the donation, acceptance, or 159
dispensing of a drug manufactured by the drug manufacturer that is 160
donated by any person as permitted under section 3719.811 of the 161
Revised Code, including but not limited to liability for failure 162
to transfer or communicate product or consumer information or the 163
expiration date of the donated drug.164

       Section 2. That existing section 3719.81 of the Revised Code 165
is hereby repealed.166