As Introduced

127th General Assembly
Regular Session
S. B. No. 58

Senator Coughlin 

Cosponsor: Senator Mumper 

To amend sections 4729.01, 4729.17, and 4729.41 of 1
the Revised Code to modify the authority of 2
pharmacists to administer immunizations and to 3
make changes in certain voting procedures of the 4
State Board of Pharmacy.5


       Section 1. That sections 4729.01, 4729.17, and 4729.41 of the 6
Revised Code be amended to read as follows:7

       Sec. 4729.01. As used in this chapter:8

       (A) "Pharmacy," except when used in a context that refers to 9
the practice of pharmacy, means any area, room, rooms, place of 10
business, department, or portion of any of the foregoing where the 11
practice of pharmacy is conducted.12

       (B) "Practice of pharmacy" means providing pharmacist care 13
requiring specialized knowledge, judgment, and skill derived from 14
the principles of biological, chemical, behavioral, social, 15
pharmaceutical, and clinical sciences. As used in this division, 16
"pharmacist care" includes the following:17

       (1) Interpreting prescriptions;18

       (2) Dispensing drugs and drug therapy related devices;19

       (3) Compounding drugs;20

       (4) Counseling individuals with regard to their drug therapy, 21
recommending drug therapy related devices, and assisting in the 22
selection of drugs and appliances for treatment of common diseases 23
and injuries and providing instruction in the proper use of the 24
drugs and appliances;25

       (5) Performing drug regimen reviews with individuals by 26
discussing all of the drugs that the individual is taking and 27
explaining the interactions of the drugs;28

       (6) Performing drug utilization reviews with licensed health 29
professionals authorized to prescribe drugs when the pharmacist 30
determines that an individual with a prescription has a drug 31
regimen that warrants additional discussion with the prescriber;32

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

       (8) Acting pursuant to a consult agreement with a physician 36
authorized under Chapter 4731. of the Revised Code to practice 37
medicine and surgery or osteopathic medicine and surgery, if an 38
agreement has been established with the physician;39

       (9) Administering the adultEngaging in the administration of40
immunizations specified into the extent authorized by section 41
4729.41 of the Revised Code, if the pharmacist has met the 42
requirements of that section.43

       (C) "Compounding" means the preparation, mixing, assembling, 44
packaging, and labeling of one or more drugs in any of the 45
following circumstances:46

       (1) Pursuant to a prescription issued by a licensed health 47
professional authorized to prescribe drugs;48

       (2) Pursuant to the modification of a prescription made in 49
accordance with a consult agreement;50

       (3) As an incident to research, teaching activities, or 51
chemical analysis;52

       (4) In anticipation of orders for drugs pursuant to 53
prescriptions, based on routine, regularly observed dispensing 54

       (5) Pursuant to a request made by a licensed health 56
professional authorized to prescribe drugs for a drug that is to 57
be used by the professional for the purpose of direct 58
administration to patients in the course of the professional's 59
practice, if all of the following apply:60

       (a) At the time the request is made, the drug is not 61
commercially available regardless of the reason that the drug is 62
not available, including the absence of a manufacturer for the 63
drug or the lack of a readily available supply of the drug from a 64

       (b) A limited quantity of the drug is compounded and provided 66
to the professional.67

       (c) The drug is compounded and provided to the professional 68
as an occasional exception to the normal practice of dispensing 69
drugs pursuant to patient-specific prescriptions.70

       (D) "Consult agreement" means an agreement to manage an 71
individual's drug therapy that has been entered into by a 72
pharmacist and a physician authorized under Chapter 4731. of the 73
Revised Code to practice medicine and surgery or osteopathic 74
medicine and surgery.75

       (E) "Drug" means:76

       (1) Any article recognized in the United States pharmacopoeia 77
and national formulary, or any supplement to them, intended for 78
use in the diagnosis, cure, mitigation, treatment, or prevention 79
of disease in humans or animals;80

       (2) Any other article intended for use in the diagnosis, 81
cure, mitigation, treatment, or prevention of disease in humans or 82

       (3) Any article, other than food, intended to affect the 84
structure or any function of the body of humans or animals;85

       (4) Any article intended for use as a component of any 86
article specified in division (E)(1), (2), or (3) of this section; 87
but does not include devices or their components, parts, or 88

       (F) "Dangerous drug" means any of the following:90

       (1) Any drug to which either of the following applies:91

       (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 92
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is 93
required to bear a label containing the legend "Caution: Federal 94
law prohibits dispensing without prescription" or "Caution: 95
Federal law restricts this drug to use by or on the order of a 96
licensed veterinarian" or any similar restrictive statement, or 97
the drug may be dispensed only upon a prescription;98

       (b) Under Chapter 3715. or 3719. of the Revised Code, the 99
drug may be dispensed only upon a prescription.100

       (2) Any drug that contains a schedule V controlled substance 101
and that is exempt from Chapter 3719. of the Revised Code or to 102
which that chapter does not apply;103

       (3) Any drug intended for administration by injection into 104
the human body other than through a natural orifice of the human 105

       (G) "Federal drug abuse control laws" has the same meaning as 107
in section 3719.01 of the Revised Code.108

       (H) "Prescription" means a written, electronic, or oral order 109
for drugs or combinations or mixtures of drugs to be used by a 110
particular individual or for treating a particular animal, issued 111
by a licensed health professional authorized to prescribe drugs.112

       (I) "Licensed health professional authorized to prescribe 113
drugs" or "prescriber" means an individual who is authorized by 114
law to prescribe drugs or dangerous drugs or drug therapy related 115
devices in the course of the individual's professional practice, 116
including only the following:117

       (1) A dentist licensed under Chapter 4715. of the Revised 118

        (2) A clinical nurse specialist, certified nurse-midwife, or 120
certified nurse practitioner who holds a certificate to prescribe 121
issued under section 4723.48 of the Revised Code;122

       (3) An optometrist licensed under Chapter 4725. of the 123
Revised Code to practice optometry under a therapeutic 124
pharmaceutical agents certificate;125

       (4) A physician authorized under Chapter 4731. of the Revised 126
Code to practice medicine and surgery, osteopathic medicine and 127
surgery, or podiatry;128

       (5) A physician assistant who holds a certificate to 129
prescribe issued under Chapter 4730. of the Revised Code;130

       (6) A veterinarian licensed under Chapter 4741. of the 131
Revised Code.132

       (J) "Sale" and "sell" include delivery, transfer, barter, 133
exchange, or gift, or offer therefor, and each such transaction 134
made by any person, whether as principal proprietor, agent, or 135

       (K) "Wholesale sale" and "sale at wholesale" mean any sale in 137
which the purpose of the purchaser is to resell the article 138
purchased or received by the purchaser.139

       (L) "Retail sale" and "sale at retail" mean any sale other 140
than a wholesale sale or sale at wholesale.141

       (M) "Retail seller" means any person that sells any dangerous 142
drug to consumers without assuming control over and responsibility 143
for its administration. Mere advice or instructions regarding 144
administration do not constitute control or establish 145

       (N) "Price information" means the price charged for a 147
prescription for a particular drug product and, in an easily 148
understandable manner, all of the following:149

       (1) The proprietary name of the drug product;150

       (2) The established (generic) name of the drug product;151

       (3) The strength of the drug product if the product contains 152
a single active ingredient or if the drug product contains more 153
than one active ingredient and a relevant strength can be 154
associated with the product without indicating each active 155
ingredient. The established name and quantity of each active 156
ingredient are required if such a relevant strength cannot be so 157
associated with a drug product containing more than one 158

       (4) The dosage form;160

       (5) The price charged for a specific quantity of the drug 161
product. The stated price shall include all charges to the 162
consumer, including, but not limited to, the cost of the drug 163
product, professional fees, handling fees, if any, and a statement 164
identifying professional services routinely furnished by the 165
pharmacy. Any mailing fees and delivery fees may be stated 166
separately without repetition. The information shall not be false 167
or misleading.168

       (O) "Wholesale distributor of dangerous drugs" means a person 169
engaged in the sale of dangerous drugs at wholesale and includes 170
any agent or employee of such a person authorized by the person to 171
engage in the sale of dangerous drugs at wholesale.172

       (P) "Manufacturer of dangerous drugs" means a person, other 173
than a pharmacist, who manufactures dangerous drugs and who is 174
engaged in the sale of those dangerous drugs within this state.175

       (Q) "Terminal distributor of dangerous drugs" means a person 176
who is engaged in the sale of dangerous drugs at retail, or any 177
person, other than a wholesale distributor or a pharmacist, who 178
has possession, custody, or control of dangerous drugs for any 179
purpose other than for that person's own use and consumption, and 180
includes pharmacies, hospitals, nursing homes, and laboratories 181
and all other persons who procure dangerous drugs for sale or 182
other distribution by or under the supervision of a pharmacist or 183
licensed health professional authorized to prescribe drugs.184

       (R) "Promote to the public" means disseminating a 185
representation to the public in any manner or by any means, other 186
than by labeling, for the purpose of inducing, or that is likely 187
to induce, directly or indirectly, the purchase of a dangerous 188
drug at retail.189

       (S) "Person" includes any individual, partnership, 190
association, limited liability company, or corporation, the state, 191
any political subdivision of the state, and any district, 192
department, or agency of the state or its political subdivisions.193

       (T) "Finished dosage form" has the same meaning as in section 194
3715.01 of the Revised Code.195

       (U) "Generically equivalent drug" has the same meaning as in 196
section 3715.01 of the Revised Code.197

       (V) "Animal shelter" means a facility operated by a humane 198
society or any society organized under Chapter 1717. of the 199
Revised Code or a dog pound operated pursuant to Chapter 955. of 200
the Revised Code.201

       (W) "Food" has the same meaning as in section 3715.01 of the 202
Revised Code.203

       Sec. 4729.17.  Any investigation, inquiry, or hearing, which 204
the state board of pharmacy is empowered to hold or undertake may 205
be held or undertaken by or before any member or members of the 206
board and the finding or order of such member or members shall be 207
deemed to be the order of said board when approved and confirmed 208
by a majority of the board members present and voting at a meeting 209
of the board at which there is a quorum.210

       Sec. 4729.41. (A)(1) A pharmacist licensed under this chapter211
who meets the requirements of division (B) of this section may 212
administer adultdo either or both of the following:213

       (a) Administer immunizations for influenza to individuals 214
fourteen years of age or older;215

       (b) Administer immunizations to individuals eighteen years of 216
age or older for any of the following:217

       (1) Influenza;218

       (2)(i) Pneumonia;219

       (3)(ii) Tetanus;220

       (4)(iii) Hepatitis A;221

       (5)(iv) Hepatitis B;222

       (v) Meningitis;223

       (vi) Diphtheria;224

       (vii) Pertussis.225

       (2) A pharmacy intern licensed under this chapter who meets 226
the requirements of division (B) of this section and is working 227
under the direct supervision of a pharmacist who meets the 228
requirements of that division may administer immunizations for 229
influenza to individuals eighteen years of age or older.230

       (3) As part of engaging in the administration of 231
immunizations or supervising a pharmacy intern's administration of 232
immunizations, a pharmacist may administer epinephrine or 233
diphenhydramine, or both, to individuals in emergency situations 234
resulting from adverse reactions to the immunizations administered 235
by the pharmacist or pharmacy intern.236

       (B) ToFor a pharmacist or pharmacy intern to be authorized 237
to administerengage in the adultadministration of immunizations238
as specified in division (A) of this section, athe pharmacist or 239
pharmacy intern shall do all of the following:240

       (1) Successfully complete a course in the administration of241
adult immunizations that has been approved by the state board of242
pharmacy as meeting the standards established for such courses by243
the centers for disease control and prevention in the public244
health service of the United States department of health and human245

       (2) Receive and maintain certification to perform basic247
life-support procedures by successfully completing a basic248
life-support training course certified by the American red cross249
or American heart association;250

       (3) Practice in accordance with a definitive set of treatment 251
guidelines specified in a protocol established by a physician and 252
approved by the state board of pharmacy. The253

       (C) The protocol required by division (B)(3) of this section254
shall include provisions requiring that the pharmacist do bothfor 255
implementation of the following requirements:256

       (a) Observe an individual who has been immunized by the(1) 257
The pharmacist or pharmacy intern who administers an immunization 258
shall observe the individual who receives the immunization to 259
determine whether the individual has an adverse reaction to the 260
immunization. The length of time and location of the observation 261
shall becomply with the standards and procedures specified in 262
rules adopted by the state board of pharmacy under division (D)263
(E) of this section. The protocol shall specify procedures to be 264
followed by a pharmacist when administering epinephrine, 265
diphenhydramine, or both, to an individual who has an adverse 266
reaction to an immunization administered by the pharmacist or a 267
pharmacy intern.268

       (b) Not later than thirty days after administering an adult269
immunization to an individual,(2) For each immunization 270
administered to an individual by a pharmacist, other than an 271
immunization for influenza administered to an individual eighteen 272
years of age or older, the pharmacist shall notify the 273
individual's family physician or, if the individual has no family 274
physician, the board of health of the health district in which the 275
individual resides or the authority having the duties of a board 276
of health for that district under section 3709.05 of the Revised 277
Code. The notice shall be given not later than thirty days after 278
the immunization is administered.279

        (3) For each immunization for influenza administered by a 280
pharmacist to an individual who is fourteen years of age or older 281
but younger than eighteen years of age, the pharmacist or a 282
pharmacy intern shall obtain permission from the individual's 283
parent or legal guardian in accordance with the procedures 284
specified in rules adopted under division (E) of this section.285

       (C)(D)(1) No pharmacist shall do either of the following:286

       (1)(a) Engage in the administration of adult immunizations by287
injection unless the requirements of division (B) of this section288
have been met;289

       (2)(b) Delegate to any person the pharmacist's authority to290
administer adultengage in or supervise the administration of291

       (2) No pharmacy intern shall engage in the administration of 293
immunizations for influenza unless the requirements of division 294
(B) of this section have been met.295

       (D)(E)(1) The state board of pharmacy shall adopt rules to296
implement this section, including rules for approval. The rules 297
shall be adopted in accordance with Chapter 119. of the Revised 298
Code and shall include provisions for the following:299

       (a) Approval of courses in administration of adult300
immunizations and approval;301

       (b) Approval of protocols to be followed by pharmacists and 302
pharmacy interns in administering adultengaging in the 303
administration of immunizations;304

       (c) Procedures to be followed by pharmacists and pharmacy 305
interns in obtaining from the individual's parent or legal 306
guardian permission to administer influenza immunizations to an 307
individual younger than eighteen years of age pursuant to division 308
(A)(1)(a) of this section;309

       (d) Identification of the locations at which a pharmacist or 310
a pharmacy intern may engage in the administration of 311
immunizations. Prior312

       (2) Prior to adopting the rules regarding approval of 313
protocols to be followed by pharmacists and pharmacy interns in 314
engaging in the administration of immunizations, the state board 315
of pharmacy shall consult with the state medical board and the 316
board of nursing. The rules shall be adopted in accordance with 317
Chapter 119. of the Revised Code.318

       Section 2.  That existing sections 4729.01, 4729.17, and 319
4729.41 of the Revised Code are hereby repealed.320