REPRESENTATIVES White, Seitz, Clancy, McGregor, Raga, Schmidt, Setzer, Chandler, Kearns, Schaffer, Webster, Miller, Perry, Distel, Strahorn

To amend section 3719.81 and to enact section

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3719.811 of the Revised Code regarding the

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distribution of sample drugs by and to charitable

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pharmacies.

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

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

Sec. 3719.81.  (A) As used in this section, "sample drug" has	7
the same meaning as in section 2925.01 of the Revised Code.	8

(B) A person may furnish another a sample of any drug of	9
abuse, or of any drug or pharmaceutical preparation that would be	10
hazardous to health or safety if used without the supervision of a	11
licensed health professional authorized to prescribe drugs, if all	12
of the following apply:	13

(1) The sample drug is furnished free of charge by a	14
manufacturer, manufacturer's representative, or wholesale dealer	15
in pharmaceuticals to a licensed health professional authorized to	16
prescribe drugs, or is furnished free of charge by such a	17
professional to a patient for use as medication;	18

(2) The sample drug is in the original container in which it	19
was placed by the manufacturer, and the container is plainly	20
marked as a sample;	21

(3) Prior to its being furnished, the sample drug sample has	22
been stored under the proper conditions to prevent its	23
deterioration or contamination;	24

(4) If the sample drug is of a type which deteriorates with	25
time, the sample container is plainly marked with the date beyond	26
which the sample drug sample is unsafe to use, and the date has	27
not expired on the sample furnished. Compliance with the labeling	28
requirements of the "Federal Food, Drug, and Cosmetic Act," 52	29
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, shall be deemed	30
compliance with this section.	31

(5) The sample drug is distributed, stored, or discarded in	32
such a way that the sample drug sample may not be acquired or used	33
by any unauthorized person, or by any person, including a child,	34
for whom it may present a health or safety hazard.	35

(B)(C) Division (A)(B) of this section does not do any of the	36
following:	37

(1) Apply to or restrict the furnishing of any sample of a	38
nonnarcotic substance if the substance may, under the "Federal	39
Food, Drug, and Cosmetic Act" and under the laws of this state,	40
otherwise be lawfully sold over the counter without a	41
prescription;	42

(2) Authorize a licensed health professional authorized to	43
prescribe drugs who is a clinical nurse specialist, certified	44
nurse-midwife, certified nurse practitioner, or advanced practice	45
nurse to furnish a sample of a drug that is not a drug the nurse	46
is authorized to prescribe;	47

(3) Authorize an optometrist to furnish a sample of a drug	48
that is not a drug the optometrist is authorized to prescribe.	49

(4) Prohibit a manufacturer of dangerous drugs, wholesale	50
distributor of dangerous drugs, or representative of a	51
manufacturer of dangerous drugs from furnishing a sample drug to a	52
charitable pharmacy in accordance with section 3719.811 of the	53
Revised Code.	54

(5) Prohibit a pharmacist acting on behalf of a charitable	55
pharmacy from dispensing a sample drug to a person in accordance	56
with section 3719.811 of the Revised Code.	57

(C)(D) The state board of pharmacy shall, in accordance with	58
Chapter 119. of the Revised Code, adopt rules as necessary to give	59
effect to this section.	60

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

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(1) "Charitable pharmacy" means a pharmacy that meets all of	62
the following requirements:	63

(a) Holds a terminal distributor of dangerous drugs license	64
under section 4729.54 of the Revised Code.	65

(b) Is exempt from federal taxation pursuant to 26 U.S.C.	66
501(a) and (c)(3).	67

(c) Is not a hospital as defined in section 3727.01 of the	68
Revised Code.	69

(2) "Prescription" has the same meaning as in section 4729.01	70
of the Revised Code.	71

(3) "Sample drug" means a dangerous drug, other than a	72
controlled substance, that, at one time, had been placed in a	73
container plainly marked as a sample by a manufacturer.	74

(B) A manufacturer of dangerous drugs or wholesale	75
distributor of dangerous drugs may furnish a sample drug to a	76
charitable pharmacy if all of the following apply:	77

(1) The sample drug is in the original container in which it	78
was placed by its manufacturer and the container is plainly marked	79
as a sample.	80

(2) Prior to its being furnished, the sample drug has been	81
stored under the proper conditions to prevent its deterioration or	82
contamination.	83

(3) If the sample drug is of a type that deteriorates with	84
time, the container in which the sample drug is stored is plainly	85
marked with the date beyond which the sample drug is unsafe to	86
use, and the date has not expired on the sample drug furnished.	87
Compliance with the labeling requirements of the "Federal Food,	88
Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301, as	89
amended, constitutes compliance with division (B)(3) of this	90
section.	91

(4) The sample drug is distributed, stored, or discarded in	92
such a way that the sample drug may not be acquired or used by any	93
unauthorized person, or by any person, including a child, for whom	94
it may present a health or safety hazard.	95

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

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(C) A representative of a manufacturer of dangerous drugs may	97
furnish a sample drug to a charitable pharmacy if all of the	98
following apply:	99

(1) The state board of pharmacy has adopted rules under	100
division (F) of this section to permit such a representative to	101
furnish a sample drug to a charitable pharmacy.	102

(2) The representative complies with standards and procedures	103
established in rules adopted under division (F) of this section.	104

(3) The requirements in divisions (B)(1) to (5) of this	105
section are satisfied.	106

(D) A pharmacist acting on behalf of a charitable pharmacy	107
may dispense a sample drug to a person if all of the following	108
apply:	109

(1) The person to whom the sample drug is dispensed is	110
eligible for the sample drug under standards established by the	111
body responsible for the charitable pharmacy's general management.	112

(2) The person to whom the sample is dispensed presents to	113
the pharmacist a valid prescription for the sample drug.	114

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

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(4) The requirements in divisions (B)(1) to (4) of this	116
section are satisfied.	117

(E) Divisions (B), (C), and (D) of this section do not do	118
either of the following:	119

(1) Apply to or restrict the furnishing of any sample of a	120
nonnarcotic substance if the substance may, under the "Federal	121
Food, Drug, and Cosmetic Act" and under the law of this state,	122
otherwise be lawfully sold over the counter without a	123
prescription.	124

(2) Authorize a pharmacist acting on behalf of a charitable	125
pharmacy to dispense a sample drug that the charitable pharmacy is	126
unauthorized to possess, have custody or control of, or	127
distribute.	128

(F) The state board of pharmacy shall, in accordance with	129
Chapter 119. of the Revised Code, adopt rules as necessary to give	130
effect to this section. The rules may permit representatives of	131
manufacturers of dangerous drugs to furnish sample drugs to	132
charitable pharmacies under this section. If they do so, the rules	133
shall establish standards and procedures for the representatives	134
to furnish the sample drugs.	135

Section 2. That existing section 3719.81 of the Revised Code	136
is hereby repealed.	137