Sub. S. B. No. 18 As Reported by the Senate Health, Human Services and Aging Committee

Senator Wachtmann

A BILL

To amend section 4729.01 of the Revised Code 1
regarding the compounding of drugs by pharmacists. 2

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

       Section 1. That section 4729.01 of the Revised Code be 3
amended to read as follows: 4

       Sec. 4729.01. As used in this chapter: 5

       (A) "Pharmacy," except when used in a context that refers to 6
the practice of pharmacy, means any area, room, rooms, place of 7
business, department, or portion of any of the foregoing where the 8
practice of pharmacy is conducted. 9

       (B) "Practice of pharmacy" means providing pharmacist care 10
requiring specialized knowledge, judgment, and skill derived from 11
the principles of biological, chemical, behavioral, social, 12
pharmaceutical, and clinical sciences. As used in this division, 13
"pharmacist care" includes the following: 14

       (1) Interpreting prescriptions; 15

       (2) ~~Compounding or dispensing~~Dispensing drugs and ~~dispensing~~ 16
drug therapy related devices; 17

       (3) Compounding drugs; 18

       (4) Counseling individuals with regard to their drug therapy, 19
recommending drug therapy related devices, and assisting in the 20
selection of drugs and appliances for treatment of common diseases 21
and injuries and providing instruction in the proper use of the 22
drugs and appliances; 23

       ~~(4)~~(5) Performing drug regimen reviews with individuals by 24
discussing all of the drugs that the individual is taking and 25
explaining the interactions of the drugs; 26

       ~~(5)~~(6) Performing drug utilization reviews with licensed 27
health professionals authorized to prescribe drugs when the 28
pharmacist determines that an individual with a prescription has a 29
drug regimen that warrants additional discussion with the 30
prescriber; 31

       ~~(6)~~(7) Advising an individual and the health care 32
professionals treating an individual with regard to the 33
individual's drug therapy; 34

       ~~(7)~~(8) Acting pursuant to a consult agreement with a 35
physician authorized under Chapter 4731. of the Revised Code to 36
practice medicine and surgery or osteopathic medicine and surgery, 37
if an agreement has been established with the physician; 38

       ~~(8)~~(9) Administering the adult immunizations specified in 39
section 4729.41 of the Revised Code, if the pharmacist has met the 40
requirements of that section. 41

       (C) "Compounding" means the preparation, mixing, assembling, 42
packaging, and labeling of one or more drugs in any of the 43
following circumstances: 44

       (1) Pursuant to a prescription issued by a licensed health 45
professional authorized to prescribe drugs; 46

       (2) Pursuant to the modification of a prescription made in 47
accordance with a consult agreement; 48

       (3) As an incident to research, teaching activities, or 49
chemical analysis; 50

       (4) In anticipation of ~~prescription drug~~ orders for drugs 51
pursuant to prescriptions, based on routine, regularly observed 52
dispensing patterns; 53

       (5) Pursuant to a request made by a licensed health 54
professional authorized to prescribe drugs for a drug that is to 55
be used by the professional for the purpose of direct 56
administration to patients in the course of the professional's 57
practice, if all of the following apply: 58

       (a) The drug is not commercially available. 59

       (b) A limited quantity of the drug is compounded and provided 60
to the professional. 61

       (c) The drug is compounded and provided to the professional 62
as an occasional exception to the normal practice of dispensing 63
drugs pursuant to patient-specific prescriptions. 64

       (D) "Consult agreement" means an agreement to manage an 65
individual's drug therapy that has been entered into by a 66
pharmacist and a physician authorized under Chapter 4731. of the 67
Revised Code to practice medicine and surgery or osteopathic 68
medicine and surgery. 69

       (E) "Drug" means: 70

       (1) Any article recognized in the United States pharmacopoeia 71
and national formulary, or any supplement to them, intended for 72
use in the diagnosis, cure, mitigation, treatment, or prevention 73
of disease in humans or animals; 74

       (2) Any other article intended for use in the diagnosis, 75
cure, mitigation, treatment, or prevention of disease in humans or 76
animals; 77

       (3) Any article, other than food, intended to affect the 78
structure or any function of the body of humans or animals; 79

       (4) Any article intended for use as a component of any 80
article specified in division (E)(1), (2), or (3) of this section; 81
but does not include devices or their components, parts, or 82
accessories. 83

       (F) "Dangerous drug" means any of the following: 84

       (1) Any drug to which either of the following applies: 85

       (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 86
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is 87
required to bear a label containing the legend "Caution: Federal 88
law prohibits dispensing without prescription" or "Caution: 89
Federal law restricts this drug to use by or on the order of a 90
licensed veterinarian" or any similar restrictive statement, or 91
the drug may be dispensed only upon a prescription; 92

       (b) Under Chapter 3715. or 3719. of the Revised Code, the 93
drug may be dispensed only upon a prescription. 94

       (2) Any drug that contains a schedule V controlled substance 95
and that is exempt from Chapter 3719. of the Revised Code or to 96
which that chapter does not apply; 97

       (3) Any drug intended for administration by injection into 98
the human body other than through a natural orifice of the human 99
body. 100

       (G) "Federal drug abuse control laws" has the same meaning as 101
in section 3719.01 of the Revised Code. 102

       (H) "Prescription" means a written, electronic, or oral order 103
for drugs or combinations or mixtures of drugs to be used by a 104
particular individual or for treating a particular animal, issued 105
by a licensed health professional authorized to prescribe drugs. 106

       (I) "Licensed health professional authorized to prescribe 107
drugs" or "prescriber" means an individual who is authorized by 108
law to prescribe drugs or dangerous drugs or drug therapy related 109
devices in the course of the individual's professional practice, 110
including only the following: 111

       (1) A dentist licensed under Chapter 4715. of the Revised 112
Code; 113

        (2) A clinical nurse specialist, certified nurse-midwife, or 114
certified nurse practitioner who holds a certificate to prescribe 115
issued under section 4723.48 of the Revised Code; 116

       (3) An optometrist licensed under Chapter 4725. of the 117
Revised Code to practice optometry under a therapeutic 118
pharmaceutical agents certificate; 119

       (4) A physician authorized under Chapter 4731. of the Revised 120
Code to practice medicine and surgery, osteopathic medicine and 121
surgery, or podiatry; 122

       (5) A veterinarian licensed under Chapter 4741. of the 123
Revised Code. 124

       (J) "Sale" and "sell" include delivery, transfer, barter, 125
exchange, or gift, or offer therefor, and each such transaction 126
made by any person, whether as principal proprietor, agent, or 127
employee. 128

       (K) "Wholesale sale" and "sale at wholesale" mean any sale in 129
which the purpose of the purchaser is to resell the article 130
purchased or received by the purchaser. 131

       (L) "Retail sale" and "sale at retail" mean any sale other 132
than a wholesale sale or sale at wholesale. 133

       (M) "Retail seller" means any person that sells any dangerous 134
drug to consumers without assuming control over and responsibility 135
for its administration. Mere advice or instructions regarding 136
administration do not constitute control or establish 137
responsibility. 138

       (N) "Price information" means the price charged for a 139
prescription for a particular drug product and, in an easily 140
understandable manner, all of the following: 141

       (1) The proprietary name of the drug product; 142

       (2) The established (generic) name of the drug product; 143

       (3) The strength of the drug product if the product contains 144
a single active ingredient or if the drug product contains more 145
than one active ingredient and a relevant strength can be 146
associated with the product without indicating each active 147
ingredient. The established name and quantity of each active 148
ingredient are required if such a relevant strength cannot be so 149
associated with a drug product containing more than one 150
ingredient. 151

       (4) The dosage form; 152

       (5) The price charged for a specific quantity of the drug 153
product. The stated price shall include all charges to the 154
consumer, including, but not limited to, the cost of the drug 155
product, professional fees, handling fees, if any, and a statement 156
identifying professional services routinely furnished by the 157
pharmacy. Any mailing fees and delivery fees may be stated 158
separately without repetition. The information shall not be false 159
or misleading. 160

       (O) "Wholesale distributor of dangerous drugs" means a person 161
engaged in the sale of dangerous drugs at wholesale and includes 162
any agent or employee of such a person authorized by the person to 163
engage in the sale of dangerous drugs at wholesale. 164

       (P) "Manufacturer of dangerous drugs" means a person, other 165
than a pharmacist, who manufactures dangerous drugs and who is 166
engaged in the sale of those dangerous drugs within this state. 167

       (Q) "Terminal distributor of dangerous drugs" means a person 168
who is engaged in the sale of dangerous drugs at retail, or any 169
person, other than a wholesale distributor or a pharmacist, who 170
has possession, custody, or control of dangerous drugs for any 171
purpose other than for that person's own use and consumption, and 172
includes pharmacies, hospitals, nursing homes, and laboratories 173
and all other persons who procure dangerous drugs for sale or 174
other distribution by or under the supervision of a pharmacist or 175
licensed health professional authorized to prescribe drugs. 176

       (R) "Promote to the public" means disseminating a 177
representation to the public in any manner or by any means, other 178
than by labeling, for the purpose of inducing, or that is likely 179
to induce, directly or indirectly, the purchase of a dangerous 180
drug at retail. 181

       (S) "Person" includes any individual, partnership, 182
association, limited liability company, or corporation, the state, 183
any political subdivision of the state, and any district, 184
department, or agency of the state or its political subdivisions. 185

       (T) "Finished dosage form" has the same meaning as in section 186
3715.01 of the Revised Code. 187

       (U) "Generically equivalent drug" has the same meaning as in 188
section 3715.01 of the Revised Code. 189

       (V) "Animal shelter" means a facility operated by a humane 190
society or any society organized under Chapter 1717. of the 191
Revised Code or a dog pound operated pursuant to Chapter 955. of 192
the Revised Code. 193

       (W) "Food" has the same meaning as in section 3715.01 of the 194
Revised Code. 195

       Section 2. That existing section 4729.01 of the Revised Code 196
is hereby repealed. 197

Section 1. That section 4729.01 of the Revised Code be	3
amended to read as follows:	4

(A) "Pharmacy," except when used in a context that refers to	6
the practice of pharmacy, means any area, room, rooms, place of	7
business, department, or portion of any of the foregoing where the	8
practice of pharmacy is conducted.	9

(B) "Practice of pharmacy" means providing pharmacist care	10
requiring specialized knowledge, judgment, and skill derived from	11
the principles of biological, chemical, behavioral, social,	12
pharmaceutical, and clinical sciences. As used in this division,	13
"pharmacist care" includes the following:	14

(2) ~~Compounding or dispensing~~Dispensing drugs and ~~dispensing~~	16
drug therapy related devices;	17

(4) Counseling individuals with regard to their drug therapy,	19
recommending drug therapy related devices, and assisting in the	20
selection of drugs and appliances for treatment of common diseases	21
and injuries and providing instruction in the proper use of the	22
drugs and appliances;	23

~~(4)~~(5) Performing drug regimen reviews with individuals by	24
discussing all of the drugs that the individual is taking and	25
explaining the interactions of the drugs;	26

~~(5)~~(6) Performing drug utilization reviews with licensed	27
health professionals authorized to prescribe drugs when the	28
pharmacist determines that an individual with a prescription has a	29
drug regimen that warrants additional discussion with the	30
prescriber;	31

~~(6)~~(7) Advising an individual and the health care	32
professionals treating an individual with regard to the	33
individual's drug therapy;	34

~~(7)~~(8) Acting pursuant to a consult agreement with a	35
physician authorized under Chapter 4731. of the Revised Code to	36
practice medicine and surgery or osteopathic medicine and surgery,	37
if an agreement has been established with the physician;	38

~~(8)~~(9) Administering the adult immunizations specified in	39
section 4729.41 of the Revised Code, if the pharmacist has met the	40
requirements of that section.	41

(C) "Compounding" means the preparation, mixing, assembling,	42
packaging, and labeling of one or more drugs in any of the	43
following circumstances:	44

(1) Pursuant to a prescription issued by a licensed health	45
professional authorized to prescribe drugs;	46

(2) Pursuant to the modification of a prescription made in	47
accordance with a consult agreement;	48

(3) As an incident to research, teaching activities, or	49
chemical analysis;	50

(4) In anticipation of ~~prescription drug~~ orders for drugs	51
pursuant to prescriptions, based on routine, regularly observed	52
dispensing patterns;	53

(5) Pursuant to a request made by a licensed health	54
professional authorized to prescribe drugs for a drug that is to	55
be used by the professional for the purpose of direct	56
administration to patients in the course of the professional's	57
practice, if all of the following apply:	58

(b) A limited quantity of the drug is compounded and provided	60
to the professional.	61

(c) The drug is compounded and provided to the professional	62
as an occasional exception to the normal practice of dispensing	63
drugs pursuant to patient-specific prescriptions.	64

(D) "Consult agreement" means an agreement to manage an	65
individual's drug therapy that has been entered into by a	66
pharmacist and a physician authorized under Chapter 4731. of the	67
Revised Code to practice medicine and surgery or osteopathic	68
medicine and surgery.	69

(1) Any article recognized in the United States pharmacopoeia	71
and national formulary, or any supplement to them, intended for	72
use in the diagnosis, cure, mitigation, treatment, or prevention	73
of disease in humans or animals;	74

(2) Any other article intended for use in the diagnosis,	75
cure, mitigation, treatment, or prevention of disease in humans or	76
animals;	77

(3) Any article, other than food, intended to affect the	78
structure or any function of the body of humans or animals;	79

(4) Any article intended for use as a component of any	80
article specified in division (E)(1), (2), or (3) of this section;	81
but does not include devices or their components, parts, or	82
accessories.	83

(a) Under the "Federal Food, Drug, and Cosmetic Act," 52	86
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is	87
required to bear a label containing the legend "Caution: Federal	88
law prohibits dispensing without prescription" or "Caution:	89
Federal law restricts this drug to use by or on the order of a	90
licensed veterinarian" or any similar restrictive statement, or	91
the drug may be dispensed only upon a prescription;	92

(b) Under Chapter 3715. or 3719. of the Revised Code, the	93
drug may be dispensed only upon a prescription.	94

(2) Any drug that contains a schedule V controlled substance	95
and that is exempt from Chapter 3719. of the Revised Code or to	96
which that chapter does not apply;	97

(3) Any drug intended for administration by injection into	98
the human body other than through a natural orifice of the human	99
body.	100

(G) "Federal drug abuse control laws" has the same meaning as	101
in section 3719.01 of the Revised Code.	102

(H) "Prescription" means a written, electronic, or oral order	103
for drugs or combinations or mixtures of drugs to be used by a	104
particular individual or for treating a particular animal, issued	105
by a licensed health professional authorized to prescribe drugs.	106

(I) "Licensed health professional authorized to prescribe	107
drugs" or "prescriber" means an individual who is authorized by	108
law to prescribe drugs or dangerous drugs or drug therapy related	109
devices in the course of the individual's professional practice,	110
including only the following:	111