As Passed by the House

127th General Assembly
Regular Session
2007-2008
Sub. H. B. No. 283


Representative Webster 

Cosponsors: Representatives Setzer, Stebelton, Wagner, Williams, S., Schindel, McGregor, J., Fessler, Evans, Seitz, Latta, Yuko, Koziura, Coley, Combs, Collier, Fende, Peterson, Heard, Ujvagi, Hughes, Reinhard, Letson, Otterman, Williams, B., Uecker, Aslanides, Bacon, Batchelder, Brown, Budish, Chandler, Daniels, DeBose, Dodd, Domenick, Dyer, Flowers, Gibbs, Goodwin, Hagan, J., Huffman, Luckie, Patton, Schlichter, Schneider, Wachtmann, Wagoner, Yates, Zehringer 

A BILL
To amend sections 3715.521, 3715.55, and 3715.63 and 1
to enact sections 3715.88, 3715.89, 3715.90, 2
3715.91, and 3715.92 of the Revised Code to permit 3
pharmacy schools to accept for instructional 4
purposes donations of certain dangerous drugs, 5
including expired drugs.6


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

       Section 1. That sections 3715.521, 3715.55, and 3715.63 be 7
amended and sections 3715.88, 3715.89, 3715.90, 3715.91, and 8
3715.92 of the Revised Code be enacted to read as follows:9

       Sec. 3715.521.  No person shall sell, offer for sale, or 10
deliver at retail or to the consumer, any of the following:11

       (A) Any drug after the expiration date required by 21 C.F.R. 12
211.137 except pursuant to sections 3715.88 to 3715.92 of the 13
Revised Code;14

       (B) Any infant formula after the "use by" date required by 2115
C.F.R. 107.20;16

       (C) Any baby food after any expiration date, "use by" date, 17
or sale date required by state or federal law or marked on the 18
container by the manufacturer, processor, or packager.19

       Sec. 3715.55.  (A) As used in this section, "expired" means:20

       (1) In the case of a drug, that the expiration date required 21
by 21 C.F.R. 211.137 has passed;22

       (2) In the case of infant formula, the "use by" date required 23
by 21 C.F.R. 107.20 has passed;24

       (3) In the case of baby food, that any expiration date, "use 25
by" date, or sale date established by state or federal law or 26
marked on the container by the manufacturer, processor, or27
packager has passed.28

       (B) WheneverExcept as otherwise provided in this division, 29
whenever the director of agriculture or the state board of 30
pharmacy finds or has cause to believe, that any food, drug, 31
device, or cosmetic is adulterated, or so misbranded as to be 32
dangerous or fraudulent, within the meaning of sections 3715.01 33
and 3715.52 to 3715.72 of the Revised Code, or that a drug, infant 34
formula, or baby food is expired, the director or board shall 35
affix to the article a tag or other appropriate marking, giving 36
notice that the article is, or is suspected of being, adulterated, 37
misbranded, or expired and has been detained or embargoed, and 38
warning all persons not to remove or dispose of the article by 39
sale or otherwise until permission for removal or disposal is 40
given by the director or the board or the court. No person may 41
remove or dispose of a detained or embargoed article by sale or 42
otherwise without such permission. This division does not apply to 43
expired drugs donated pursuant to sections 3715.88 to 3715.92 of 44
the Revised Code.45

       (C) When an article detained or embargoed has been found by 46
the director or board to be adulterated, misbranded, or expired, 47
the director or board shall petition the municipal or county court 48
in whose jurisdiction the article is detained or embargoed for an49
order for condemnation of the article. When the director or the50
board has not found within ten days that an article so detained or 51
embargoed is adulterated, misbranded, or expired, the director or 52
board shall remove the tag or other marking.53

       (D) If the court finds that a detained or embargoed article 54
is adulterated, misbranded, or expired, the article shall, after55
entry of the decree, be destroyed at the expense of the claimant56
thereof, under the supervision of the director or the board, and 57
all court costs, fees, storage, and other proper expenses shall be 58
taxed against the claimant of the article or the claimant's agent; 59
provided, that when the adulteration or misbranding can be 60
corrected by proper labeling or processing of the article, the 61
court, after entry of the decree and after such costs, fees, and 62
expenses have been paid and a good and sufficient bond,63
conditioned that the article shall be so labeled or processed, has 64
been executed, may by order direct that the article be delivered 65
to the claimant thereof for labeling or processing under the 66
supervision of the director or the board. The expense of 67
supervision shall be paid by the claimant. The bond shall be68
returned to the claimant of the article on representation to the 69
court by the director or the board that the article is no longer 70
in violation of sections 3715.01 and 3715.52 to 3715.72 of the 71
Revised Code, and that the expenses of supervision have been paid.72

       (E) Whenever the director finds in any room, building,73
vehicle of transportation, or other structure, any meat, sea food74
seafood, poultry, vegetable, fruit, or other perishable articles75
that are unsound, or contain any filthy, decomposed, or putrid76
substance, or that may be poisonous or deleterious to health or77
otherwise unsafe, the articles are declared to be a nuisance, and 78
the director shall forthwith condemn or destroy the articles, or79
in any other manner render the articles unsalable as human food.80

       Sec. 3715.63. (A) A drug or device is adulterated within the 81
meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised 82
Code, if any of the following apply:83

       (A)(1) It consists, in whole or in part, of any filthy, 84
putrid, or decomposed substance.85

       (B)(2) It has been produced, processed, prepared, packed, or 86
held under unsanitary conditions whereby it may have been87
contaminated with filth, or whereby it may have been rendered 88
injurious to health.89

       (C)(3) It is a drug and its container is composed, in whole 90
or in part, of any poisonous or deleterious substance that may 91
render the contents injurious to health.92

       (D)(4) It is a drug and it bears or contains, for purposes of 93
coloring only, a coal-tar color other than one from a batch 94
certified under authority of the "Federal Food, Drug, and Cosmetic95
Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.96

       (E)(5) It purports to be or is represented as a drug the name 97
of which is recognized in the United States pharmacopoeia and 98
national formulary, or any supplement to them, and its strength 99
differs from or its quality or purity falls below the standard set 100
forth in those compendiums. A determination as to strength, 101
quality, or purity shall be made in accordance with the tests or 102
methods of assay set forth in the compendiums, or in the absence 103
or inadequacy of such tests or methods of assay, those prescribed104
under the authority of the "Federal Food, Drug, and Cosmetic Act." 105
A drug recognized in the compendiums is not adulterated under this106
division because it differs from the standard of strength, 107
quality, or purity set forth for that drug in the compendiums, if 108
the difference in strength, quality, or purity is plainly stated 109
on its label. Whenever a drug is recognized in both the 110
homoeopathic pharmacopoeia of the United States and in the United 111
States pharmacopoeia and national formulary, including their 112
supplements, it shall be subject to the requirements of the United 113
States pharmacopoeia and national formulary unless it is labeled 114
and offered for sale as a homoeopathic drug, in which case it 115
shall be subject to the provisions of the homoeopathic116
pharmacopoeia of the United States and not to those of the United 117
States pharmacopoeia and national formulary.118

       (F)(6) It is not subject to the provisions of division 119
(E)(A)(5) of this section, and its strength differs from or its 120
purity or quality falls below that which it purports or is 121
represented to possess.122

       (G)(7) It is a drug and any substance has been:123

       (1)(a) Mixed or packed with the drug so as to reduce the 124
drug's quality or strength;125

       (2)(b) Substituted wholly or in part for the drug.126

       (B) An expired drug is not adulterated within the meaning of 127
sections 3715.01 and 3715.52 to 3715.72 of the Revised Code if the 128
drug is donated pursuant to sections 3715.88 to 3715.92 of the 129
Revised Code.130

       Sec. 3715.88. As used in this section and in sections 3715.89 131
to 3715.92 of the Revised Code:132

       (A) "Expired" has the same meaning as in section 3715.55 of 133
the Revised Code.134

        (B) "National drug code number" means the number registered 135
for a drug pursuant to the listing system established by the 136
United States food and drug administration under the "Drug Listing 137
Act of 1972," 86 Stat. 559, 21 U.S.C. 360, as amended.138

        (C) "Pharmacy school" means a school, college, university, or 139
other educational institution that operates a pharmacy program 140
recognized and approved by the state board of pharmacy.141

       (D) "Controlled substance" has the same meaning as in section 142
3719.01 of the Revised Code.143

       (E) "Manufacturer of dangerous drugs," "terminal distributor 144
of dangerous drugs," and "wholesale distributor of dangerous 145
drugs" have the same meanings as in section 4729.01 of the Revised 146
Code.147

       Sec. 3715.89. (A) Subject to divisions (B) and (C) of this 148
section, any manufacturer of dangerous drugs, terminal distributor 149
of dangerous drugs, or wholesale distributor of dangerous drugs 150
may donate a dangerous drug, including a dangerous drug that has 151
expired, to a pharmacy school.152

       (B) A dangerous drug donation to a pharmacy school shall meet 153
all of the following requirements:154

       (1) The dangerous drug is not a controlled substance.155

       (2) Each container in which a dangerous drug is donated 156
contains a single national drug code number of that drug and no 157
other drugs.158

       (3) If the dangerous drug is of a type that deteriorates with 159
time, the container in which the drug is contained is plainly 160
marked with the drug's expiration date.161

       (C) A dangerous drug donation to a pharmacy school shall be 162
accompanied by a form signed by a representative of the 163
manufacturer, terminal distributor, or wholesale distributor 164
donating the drug. On delivery, a representative of the pharmacy 165
school accepting the drug donation shall also sign the form. The 166
form shall do both of the following:167

       (1) Confirm the acceptance of the dangerous drug donation by 168
the pharmacy school;169

       (2) Confirm that both the manufacturer, terminal distributor, 170
or wholesale distributor donating the dangerous drug and the 171
pharmacy school accepting the donation understand the immunity 172
provisions of section 3719.92 of the Revised Code.173

       Sec. 3715.90. (A) A pharmacy school may accept a donation of 174
a dangerous drug if the donation is made in accordance with 175
section 3715.89 of the Revised Code.176

        (B) All of the following apply to a dangerous drug donated to 177
a pharmacy school:178

        (1) The dangerous drug shall be used solely for instructional 179
purposes.180

       (2) The dangerous drug shall not be sold or transferred for 181
consideration of any kind.182

        (3) In accordance with 21 C.F.R. 201.125, the dangerous drug 183
shall not be used for a clinical use. "Clinical use" includes the 184
drug being furnished to a human or animal with the intent or 185
understanding that the human or animal will ingest or otherwise 186
absorb the drug into the human's or animal's body.187

       Sec. 3715.91. The state board of pharmacy shall, in 188
accordance with Chapter 119. of the Revised Code, adopt rules as 189
necessary to give effect to sections 3715.89 and 3715.90 of the 190
Revised Code.191

       Sec. 3715.92. The state board of pharmacy, any manufacturer 192
of dangerous drugs, terminal distributor of dangerous drugs, or 193
wholesale distributor of dangerous drugs that in good faith 194
donates a dangerous drug under section 3715.89 of the Revised 195
Code, and any pharmacy school that accepts a dangerous drug 196
donation under section 3715.90 of the Revised Code, shall not, in 197
the absence of bad faith, be subject to any of the following for 198
matters related to the donation or acceptance of the drug: 199
criminal prosecution; liability in tort or other civil action for 200
injury, death, or loss to person or property; or professional 201
liability.202

       Section 2. That existing sections 3715.521, 3715.55, and 203
3715.63 of the Revised Code are hereby repealed.204