As Introduced 1 123rd General Assembly 4 Regular Session S. B. No. 248 5 1999-2000 6 SENATOR DRAKE 8 _________________________________________________________________ 10 A B I L L To amend section 4729.01 and to enact section 12 4729.41 of the Revised Code to permit a 13 pharmacist who has completed a course in drug 14 administration approved by the State Board of Pharmacy to administer drugs. 15 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 17 Section 1. That section 4729.01 be amended and section 19 4729.41 of the Revised Code be enacted as follows: 20 Sec. 4729.01. As used in this chapter: 29 (A) "Pharmacy," except when used in a context that refers 31 to the practice of pharmacy, means any area, room, rooms, place 32 of business, department, or portion of any of the foregoing where 34 the practice of pharmacy is conducted. 36 (B) "Practice of pharmacy" means providing pharmacist care 38 requiring specialized knowledge, judgment, and skill derived from 40 the principles of biological, chemical, behavioral, social, 41 pharmaceutical, and clinical sciences. As used in this division, 42 "pharmacist care" includes the following: (1) Interpreting prescriptions; 44 (2) Compounding or dispensing drugs and dispensing drug 46 therapy related devices; 47 (3) Counseling individuals with regard to their drug 49 therapy, recommending drug therapy related devices, and assisting 51 in the selection of drugs and appliances for treatment of common 52 diseases and injuries and providing instruction in the proper use 54 of the drugs and appliances; 2 (4) Performing drug regimen reviews with individuals by 57 discussing all of the drugs that the individual is taking and explaining the interactions of the drugs; 58 (5) Performing drug utilization reviews with licensed 60 health professionals authorized to prescribe drugs when the 61 pharmacist determines that an individual with a prescription has 62 a drug regimen that warrants additional discussion with the 63 prescriber; 64 (6) Advising an individual and the health care 66 professionals treating an individual with regard to the 67 individual's drug therapy; 68 (7) Acting pursuant to a consult agreement with a 70 physician authorized under Chapter 4731. of the Revised Code to 74 practice medicine and surgery or osteopathic medicine and 75 surgery, if an agreement has been established with the physician; 76 (8) IF A PHARMACIST LICENSED UNDER THIS CHAPTER HAS MET 78 THE REQUIREMENTS OF SECTION 4729.41 OF THE REVISED CODE, 79 ADMINISTERING DRUGS PRESCRIBED BY A LICENSED HEALTH PROFESSIONAL 80 AUTHORIZED TO PRESCRIBE DRUGS. 81 (C) "Compounding" means the preparation, mixing, 84 assembling, packaging, and labeling of one or more drugs in any 85 of the following circumstances: 86 (1) Pursuant to a prescription issued by a licensed health 89 professional authorized to prescribe drugs; (2) Pursuant to the modification of a prescription made in 91 accordance with a consult agreement; 92 (3) As an incident to research, teaching activities, or 95 chemical analysis; (4) In anticipation of prescription drug orders based on 98 routine, regularly observed dispensing patterns. (D) "Consult agreement" means an agreement to manage an 100 individual's drug therapy that has been entered into by a 102 pharmacist and a physician authorized under Chapter 4731. of the 103 Revised Code to practice medicine and surgery or osteopathic 106 3 medicine and surgery. (E) "Drug" means: 108 (1) Any article recognized in the United States 110 pharmacopoeia and national formulary, or any supplement to them, 112 intended for use in the diagnosis, cure, mitigation, treatment, 113 or prevention of disease in humans or animals; 114 (2) Any other article intended for use in the diagnosis, 116 cure, mitigation, treatment, or prevention of disease in humans 118 or animals; (3) Any article, other than food, intended to affect the 120 structure or any function of the body of humans or animals; 122 (4) Any article intended for use as a component of any 124 article specified in division (C)(1), (2), or (3) of this 125 section; but does not include devices or their components, parts, 126 or accessories. 127 (F) "Dangerous drug" means any of the following: 129 (1) Any drug to which either of the following applies: 131 (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 134 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is 135 required to bear a label containing the legend "Caution: Federal 137 law prohibits dispensing without prescription" or "Caution: 138 Federal law restricts this drug to use by or on the order of a 139 licensed veterinarian" or any similar restrictive statement, or 140 the drug may be dispensed only upon a prescription; 141 (b) Under Chapter 3715. or 3719. of the Revised Code, the 143 drug may be dispensed only upon a prescription. 144 (2) Any drug that contains a schedule V controlled 146 substance and that is exempt from Chapter 3719. of the Revised 147 Code or to which that chapter does not apply; 148 (3) Any drug intended for administration by injection into 150 the human body other than through a natural orifice of the human 151 body. 152 (G) "Federal drug abuse control laws" has the same meaning 154 as in section 3719.01 of the Revised Code. 155 4 (H) "Prescription" means a written, electronic, or oral 160 order for drugs or combinations or mixtures of drugs to be used 161 by a particular individual or for treating a particular animal, 162 issued by a licensed health professional authorized to prescribe 165 drugs. (I) "Licensed health professional authorized to prescribe 168 drugs" or "prescriber" means an individual who is authorized by 170 law to prescribe drugs or dangerous drugs or drug therapy related 174 devices in the course of the individual's professional practice, 175 including only the following: 176 (1) A dentist licensed under Chapter 4715. of the Revised 179 Code; (2) An advanced practice nurse approved under section 182 4723.56 of the Revised Code to prescribe drugs and therapeutic 183 devices; 184 (3) An optometrist licensed under Chapter 4725. of the 187 Revised Code to practice optometry under a therapeutic 190 pharmaceutical agents certificate; (4) A physician authorized under Chapter 4731. of the 193 Revised Code to practice medicine and surgery, osteopathic 196 medicine and surgery, or podiatry; (5) A veterinarian licensed under Chapter 4741. of the 198 Revised Code. 199 (J) "Sale" and "sell" include delivery, transfer, barter, 201 exchange, or gift, or offer therefor, and each such transaction 202 made by any person, whether as principal proprietor, agent, or 203 employee. 204 (K) "Wholesale sale" and "sale at wholesale" mean any sale 206 in which the purpose of the purchaser is to resell the article 207 purchased or received by the purchaser. 208 (L) "Retail sale" and "sale at retail" mean any sale other 210 than a wholesale sale or sale at wholesale. 211 (M) "Retail seller" means any person that sells any 213 dangerous drug to consumers without assuming control over and 214 5 responsibility for its administration. Mere advice or 215 instructions regarding administration do not constitute control 216 or establish responsibility. 217 (N) "Price information" means the price charged for a 219 prescription for a particular drug product and, in an easily 220 understandable manner, all of the following: 221 (1) The proprietary name of the drug product; 223 (2) The established (generic) name of the drug product; 225 (3) The strength of the drug product if the product 227 contains a single active ingredient or if the drug product 228 contains more than one active ingredient and a relevant strength 229 can be associated with the product without indicating each active 230 ingredient. The established name and quantity of each active 231 ingredient are required if such a relevant strength cannot be so 232 associated with a drug product containing more than one 233 ingredient. 234 (4) The dosage form; 236 (5) The price charged for a specific quantity of the drug 238 product. The stated price shall include all charges to the 239 consumer, including, but not limited to, the cost of the drug 240 product, professional fees, handling fees, if any, and a 241 statement identifying professional services routinely furnished 242 by the pharmacy. Any mailing fees and delivery fees may be 243 stated separately without repetition. The information shall not 244 be false or misleading. 245 (O) "Wholesale distributor of dangerous drugs" means a 247 person engaged in the sale of dangerous drugs at wholesale and 248 includes any agent or employee of such a person authorized by the 250 person to engage in the sale of dangerous drugs at wholesale. 251 (P) "Manufacturer of dangerous drugs" means a person, 253 other than a pharmacist, who manufactures dangerous drugs and who 254 is engaged in the sale of those dangerous drugs within this 255 state. 256 (Q) "Terminal distributor of dangerous drugs" means a 258 6 person who is engaged in the sale of dangerous drugs at retail, 260 or any person, other than a wholesale distributor or a 261 pharmacist, who has possession, custody, or control of dangerous 263 drugs for any purpose other than for that person's own use and 265 consumption, and includes pharmacies, hospitals, nursing homes, 266 and laboratories and all other persons who procure dangerous 267 drugs for sale or other distribution by or under the supervision 268 of a pharmacist or licensed health professional authorized to 269 prescribe drugs. (R) "Promote to the public" means disseminating a 271 representation to the public in any manner or by any means, other 272 than by labeling, for the purpose of inducing, or that is likely 273 to induce, directly or indirectly, the purchase of a dangerous 274 drug at retail. 275 (S) "Person" includes any individual, partnership, 277 association, limited liability company, or corporation, the 278 state, any political subdivision of the state, and any district, 279 department, or agency of the state or its political subdivisions. 280 (T) "Finished dosage form" has the same meaning as in 282 section 3715.01 of the Revised Code. 283 (U) "Generically equivalent drug" has the same meaning as 285 in section 3715.01 of the Revised Code. 286 (V) "Animal shelter" means a facility operated by a humane 288 society or any society organized under Chapter 1717. of the 289 Revised Code or a dog pound operated pursuant to Chapter 955. of 290 the Revised Code. 291 (W) "Food" has the same meaning as in section 3715.01 of 294 the Revised Code. (X) "ADMINISTER" HAS THE SAME MEANING AS IN SECTION 296 3719.01 OF THE REVISED CODE. 297 Sec. 4729.41. A PHARMACIST LICENSED UNDER THIS CHAPTER WHO 299 HAS SUCCESSFULLY COMPLETED A COURSE APPROVED BY THE STATE BOARD 300 OF PHARMACY IN ADMINISTRATION OF DRUGS MAY ADMINISTER DRUGS 301 PRESCRIBED BY A LICENSED HEALTH PROFESSIONAL AUTHORIZED TO 302 7 PRESCRIBE DRUGS. PROOF OF SUCCESSFULLY COMPLETING THE COURSE 303 SHALL BE MAINTAINED BY THE PHARMACIST AT THE PHARMACIST'S PLACE 304 OF EMPLOYMENT, SUBJECT TO INSPECTION BY THE BOARD OR THE BOARD'S 305 DESIGNEE. THE BOARD SHALL APPROVE COURSES FOR THE PURPOSES OF THIS 307 SECTION. Section 2. That existing section 4729.01 of the Revised 309 Code is hereby repealed. 310