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To amend section 4729.01 of the Revised Code | 1 |
regarding the compounding of drugs by pharmacists. | 2 |
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) | 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 |
| 24 |
discussing all of the drugs that the individual is taking and | 25 |
explaining the interactions of the drugs; | 26 |
| 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 |
| 32 |
professionals treating an individual with regard to the | 33 |
individual's drug therapy; | 34 |
| 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 |
| 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 | 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 | 81 |
section; but does not include devices or their components, parts, | 82 |
or 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) Until January 17, 2000, an advanced practice nurse | 114 |
approved under section 4723.56 of the Revised Code to prescribe | 115 |
drugs and therapeutic devices; | 116 |
(3) A clinical nurse specialist, certified nurse-midwife, or | 117 |
certified nurse practitioner who holds a certificate to prescribe | 118 |
issued under section 4723.48 of the Revised Code; | 119 |
(4) An optometrist licensed under Chapter 4725. of the | 120 |
Revised Code to practice optometry under a therapeutic | 121 |
pharmaceutical agents certificate; | 122 |
(5) A physician authorized under Chapter 4731. of the Revised | 123 |
Code to practice medicine and surgery, osteopathic medicine and | 124 |
surgery, or podiatry; | 125 |
(6) A veterinarian licensed under Chapter 4741. of the | 126 |
Revised Code. | 127 |
(J) "Sale" and "sell" include delivery, transfer, barter, | 128 |
exchange, or gift, or offer therefor, and each such transaction | 129 |
made by any person, whether as principal proprietor, agent, or | 130 |
employee. | 131 |
(K) "Wholesale sale" and "sale at wholesale" mean any sale in | 132 |
which the purpose of the purchaser is to resell the article | 133 |
purchased or received by the purchaser. | 134 |
(L) "Retail sale" and "sale at retail" mean any sale other | 135 |
than a wholesale sale or sale at wholesale. | 136 |
(M) "Retail seller" means any person that sells any dangerous | 137 |
drug to consumers without assuming control over and responsibility | 138 |
for its administration. Mere advice or instructions regarding | 139 |
administration do not constitute control or establish | 140 |
responsibility. | 141 |
(N) "Price information" means the price charged for a | 142 |
prescription for a particular drug product and, in an easily | 143 |
understandable manner, all of the following: | 144 |
(1) The proprietary name of the drug product; | 145 |
(2) The established (generic) name of the drug product; | 146 |
(3) The strength of the drug product if the product contains | 147 |
a single active ingredient or if the drug product contains more | 148 |
than one active ingredient and a relevant strength can be | 149 |
associated with the product without indicating each active | 150 |
ingredient. The established name and quantity of each active | 151 |
ingredient are required if such a relevant strength cannot be so | 152 |
associated with a drug product containing more than one | 153 |
ingredient. | 154 |
(4) The dosage form; | 155 |
(5) The price charged for a specific quantity of the drug | 156 |
product. The stated price shall include all charges to the | 157 |
consumer, including, but not limited to, the cost of the drug | 158 |
product, professional fees, handling fees, if any, and a statement | 159 |
identifying professional services routinely furnished by the | 160 |
pharmacy. Any mailing fees and delivery fees may be stated | 161 |
separately without repetition. The information shall not be false | 162 |
or misleading. | 163 |
(O) "Wholesale distributor of dangerous drugs" means a person | 164 |
engaged in the sale of dangerous drugs at wholesale and includes | 165 |
any agent or employee of such a person authorized by the person to | 166 |
engage in the sale of dangerous drugs at wholesale. | 167 |
(P) "Manufacturer of dangerous drugs" means a person, other | 168 |
than a pharmacist, who manufactures dangerous drugs and who is | 169 |
engaged in the sale of those dangerous drugs within this state. | 170 |
(Q) "Terminal distributor of dangerous drugs" means a person | 171 |
who is engaged in the sale of dangerous drugs at retail, or any | 172 |
person, other than a wholesale distributor or a pharmacist, who | 173 |
has possession, custody, or control of dangerous drugs for any | 174 |
purpose other than for that person's own use and consumption, and | 175 |
includes pharmacies, hospitals, nursing homes, and laboratories | 176 |
and all other persons who procure dangerous drugs for sale or | 177 |
other distribution by or under the supervision of a pharmacist or | 178 |
licensed health professional authorized to prescribe drugs. | 179 |
(R) "Promote to the public" means disseminating a | 180 |
representation to the public in any manner or by any means, other | 181 |
than by labeling, for the purpose of inducing, or that is likely | 182 |
to induce, directly or indirectly, the purchase of a dangerous | 183 |
drug at retail. | 184 |
(S) "Person" includes any individual, partnership, | 185 |
association, limited liability company, or corporation, the state, | 186 |
any political subdivision of the state, and any district, | 187 |
department, or agency of the state or its political subdivisions. | 188 |
(T) "Finished dosage form" has the same meaning as in section | 189 |
3715.01 of the Revised Code. | 190 |
(U) "Generically equivalent drug" has the same meaning as in | 191 |
section 3715.01 of the Revised Code. | 192 |
(V) "Animal shelter" means a facility operated by a humane | 193 |
society or any society organized under Chapter 1717. of the | 194 |
Revised Code or a dog pound operated pursuant to Chapter 955. of | 195 |
the Revised Code. | 196 |
(W) "Food" has the same meaning as in section 3715.01 of the | 197 |
Revised Code. | 198 |
Section 2. That existing section 4729.01 of the Revised Code | 199 |
is hereby repealed. | 200 |