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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 |
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
| 10 |
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12 | |
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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 a | 18 |
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 plainly | 21 |
marked as a sample; | 22 |
(3) Prior to its being furnished, the sample drug | 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 | 28 |
not expired on the sample furnished. Compliance with the labeling | 29 |
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 | 34 |
by any unauthorized person, or by any person, including a child, | 35 |
for whom it may present a health or safety hazard. | 36 |
| 37 |
following: | 38 |
(1) Apply to or restrict the furnishing of any sample of a | 39 |
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 | 47 |
is authorized to prescribe; | 48 |
(3) Authorize an optometrist to furnish a sample | 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 |
| 61 |
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 |