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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) At the time the request is made, the drug is not | 59 |
| commercially available regardless of the reason that the drug is | 60 |
| not available, including the absence of a manufacturer for the | 61 |
| drug or the lack of a readily available supply of the drug from a | 62 |
| manufacturer. | 63 |
| (b) A limited quantity of the drug is compounded and provided | 64 |
| to the professional. | 65 |
| (c) The drug is compounded and provided to the professional | 66 |
| as an occasional exception to the normal practice of dispensing | 67 |
| drugs pursuant to patient-specific prescriptions. | 68 |
| (D) "Consult agreement" means an agreement to manage an | 69 |
| individual's drug therapy that has been entered into by a | 70 |
| pharmacist and a physician authorized under Chapter 4731. of the | 71 |
| Revised Code to practice medicine and surgery or osteopathic | 72 |
| medicine and surgery. | 73 |
| (E) "Drug" means: | 74 |
| (1) Any article recognized in the United States pharmacopoeia | 75 |
| and national formulary, or any supplement to them, intended for | 76 |
| use in the diagnosis, cure, mitigation, treatment, or prevention | 77 |
| of disease in humans or animals; | 78 |
| (2) Any other article intended for use in the diagnosis, | 79 |
| cure, mitigation, treatment, or prevention of disease in humans or | 80 |
| animals; | 81 |
| (3) Any article, other than food, intended to affect the | 82 |
| structure or any function of the body of humans or animals; | 83 |
| (4) Any article intended for use as a component of any | 84 |
| article specified in division (E)(1), (2), or (3) of this section; | 85 |
| but does not include devices or their components, parts, or | 86 |
| accessories. | 87 |
| (F) "Dangerous drug" means any of the following: | 88 |
| (1) Any drug to which either of the following applies: | 89 |
| (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 | 90 |
| Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is | 91 |
| required to bear a label containing the legend "Caution: Federal | 92 |
| law prohibits dispensing without prescription" or "Caution: | 93 |
| Federal law restricts this drug to use by or on the order of a | 94 |
| licensed veterinarian" or any similar restrictive statement, or | 95 |
| the drug may be dispensed only upon a prescription; | 96 |
| (b) Under Chapter 3715. or 3719. of the Revised Code, the | 97 |
| drug may be dispensed only upon a prescription. | 98 |
| (2) Any drug that contains a schedule V controlled substance | 99 |
| and that is exempt from Chapter 3719. of the Revised Code or to | 100 |
| which that chapter does not apply; | 101 |
| (3) Any drug intended for administration by injection into | 102 |
| the human body other than through a natural orifice of the human | 103 |
| body. | 104 |
| (G) "Federal drug abuse control laws" has the same meaning as | 105 |
| in section 3719.01 of the Revised Code. | 106 |
| (H) "Prescription" means a written, electronic, or oral order | 107 |
| for drugs or combinations or mixtures of drugs to be used by a | 108 |
| particular individual or for treating a particular animal, issued | 109 |
| by a licensed health professional authorized to prescribe drugs. | 110 |
| (I) "Licensed health professional authorized to prescribe | 111 |
| drugs" or "prescriber" means an individual who is authorized by | 112 |
| law to prescribe drugs or dangerous drugs or drug therapy related | 113 |
| devices in the course of the individual's professional practice, | 114 |
| including only the following: | 115 |
| (1) A dentist licensed under Chapter 4715. of the Revised | 116 |
| Code; | 117 |
| (2) A clinical nurse specialist, certified nurse-midwife, or | 118 |
| certified nurse practitioner who holds a certificate to prescribe | 119 |
| issued under section 4723.48 of the Revised Code; | 120 |
| (3) An optometrist licensed under Chapter 4725. of the | 121 |
| Revised Code to practice optometry under a therapeutic | 122 |
| pharmaceutical agents certificate; | 123 |
| (4) A physician authorized under Chapter 4731. of the Revised | 124 |
| Code to practice medicine and surgery, osteopathic medicine and | 125 |
| surgery, or podiatry; | 126 |
| (5) A veterinarian licensed under Chapter 4741. of the | 127 |
| Revised Code. | 128 |
| (J) "Sale" and "sell" include delivery, transfer, barter, | 129 |
| exchange, or gift, or offer therefor, and each such transaction | 130 |
| made by any person, whether as principal proprietor, agent, or | 131 |
| employee. | 132 |
| (K) "Wholesale sale" and "sale at wholesale" mean any sale in | 133 |
| which the purpose of the purchaser is to resell the article | 134 |
| purchased or received by the purchaser. | 135 |
| (L) "Retail sale" and "sale at retail" mean any sale other | 136 |
| than a wholesale sale or sale at wholesale. | 137 |
| (M) "Retail seller" means any person that sells any dangerous | 138 |
| drug to consumers without assuming control over and responsibility | 139 |
| for its administration. Mere advice or instructions regarding | 140 |
| administration do not constitute control or establish | 141 |
| responsibility. | 142 |
| (N) "Price information" means the price charged for a | 143 |
| prescription for a particular drug product and, in an easily | 144 |
| understandable manner, all of the following: | 145 |
| (1) The proprietary name of the drug product; | 146 |
| (2) The established (generic) name of the drug product; | 147 |
| (3) The strength of the drug product if the product contains | 148 |
| a single active ingredient or if the drug product contains more | 149 |
| than one active ingredient and a relevant strength can be | 150 |
| associated with the product without indicating each active | 151 |
| ingredient. The established name and quantity of each active | 152 |
| ingredient are required if such a relevant strength cannot be so | 153 |
| associated with a drug product containing more than one | 154 |
| ingredient. | 155 |
| (4) The dosage form; | 156 |
| (5) The price charged for a specific quantity of the drug | 157 |
| product. The stated price shall include all charges to the | 158 |
| consumer, including, but not limited to, the cost of the drug | 159 |
| product, professional fees, handling fees, if any, and a statement | 160 |
| identifying professional services routinely furnished by the | 161 |
| pharmacy. Any mailing fees and delivery fees may be stated | 162 |
| separately without repetition. The information shall not be false | 163 |
| or misleading. | 164 |
| (O) "Wholesale distributor of dangerous drugs" means a person | 165 |
| engaged in the sale of dangerous drugs at wholesale and includes | 166 |
| any agent or employee of such a person authorized by the person to | 167 |
| engage in the sale of dangerous drugs at wholesale. | 168 |
| (P) "Manufacturer of dangerous drugs" means a person, other | 169 |
| than a pharmacist, who manufactures dangerous drugs and who is | 170 |
| engaged in the sale of those dangerous drugs within this state. | 171 |
| (Q) "Terminal distributor of dangerous drugs" means a person | 172 |
| who is engaged in the sale of dangerous drugs at retail, or any | 173 |
| person, other than a wholesale distributor or a pharmacist, who | 174 |
| has possession, custody, or control of dangerous drugs for any | 175 |
| purpose other than for that person's own use and consumption, and | 176 |
| includes pharmacies, hospitals, nursing homes, and laboratories | 177 |
| and all other persons who procure dangerous drugs for sale or | 178 |
| other distribution by or under the supervision of a pharmacist or | 179 |
| licensed health professional authorized to prescribe drugs. | 180 |
| (R) "Promote to the public" means disseminating a | 181 |
| representation to the public in any manner or by any means, other | 182 |
| than by labeling, for the purpose of inducing, or that is likely | 183 |
| to induce, directly or indirectly, the purchase of a dangerous | 184 |
| drug at retail. | 185 |
| (S) "Person" includes any individual, partnership, | 186 |
| association, limited liability company, or corporation, the state, | 187 |
| any political subdivision of the state, and any district, | 188 |
| department, or agency of the state or its political subdivisions. | 189 |
| (T) "Finished dosage form" has the same meaning as in section | 190 |
| 3715.01 of the Revised Code. | 191 |
| (U) "Generically equivalent drug" has the same meaning as in | 192 |
| section 3715.01 of the Revised Code. | 193 |
| (V) "Animal shelter" means a facility operated by a humane | 194 |
| society or any society organized under Chapter 1717. of the | 195 |
| Revised Code or a dog pound operated pursuant to Chapter 955. of | 196 |
| the Revised Code. | 197 |
| (W) "Food" has the same meaning as in section 3715.01 of the | 198 |
| Revised Code. | 199 |
| Section 2. That existing section 4729.01 of the Revised Code | 200 |
| is hereby repealed. | 201 |