SB 152 — Allow wild animal rehab facility to get euthanasia drug permit

but does not include devices or their components, parts, or accessories.

"Drug" does not include "hemp" or a "hemp product" as those terms are defined in section 928.01 of the Revised Code.

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

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

(a) Under the "Federal Food, Drug, and Cosmetic Act," 52 Stat.

1040 (1938), 21 U.S.C.A.

301, as amended, the drug is required to bear a label containing the legend "Caution:

Federal law prohibits dispensing without prescription" or "Caution:

Federal law restricts this drug to use by or on Am.

S.

152 Page136th 3G.A. As Passed by the Senate of the following circumstances:

46the (1)order Pursuantof to a prescriptionlicensed issuedveterinarian" byor aany licensedsimilar healthrestrictive 47statement, professionalor authorizedthe todrug prescribemay drugs;be dispensed only upon a prescription;

48(b) (2)Under PursuantChapter to3715. 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 patterns;

55 (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 64 a manufacturer.

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

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

70 (D) "Consult agreement" means an agreement that has been 71 entered into under section 4729.39 of the Revised Code.

72 S.

B.

No.

152 Page 4 As Passed by the Senate (E) "Drug" means:

73 (1) Any article recognized in the United States 74 pharmacopoeia and national formulary, or any supplement to them, 75 intended for use in the diagnosis, cure, mitigation, treatment, 76 or prevention of disease in humans or animals;

77 (2) Any other article intended for use in the diagnosis, 78 cure, mitigation, treatment, or prevention of disease in humans 79 or animals;

80 (3) Any article, other than food, intended to affect the 81 structure or any function of the body of humans or animals;

82 (4) Any article intended for use as a component of any 83 article specified in division (E)(1), (2), or (3) of this 84 section;

but does not include devices or their components, 85 parts, or accessories.

86 "Drug" does not include "hemp" or a "hemp product" as 87 those terms are defined in section 928.01 of the Revised Code.

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

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

90 (a) Under the "Federal Food, Drug, and Cosmetic Act," 52 91 Stat.

1040 (1938), 21 U.S.C.A.

301, as amended, the drug is 92 required to bear a label containing the legend "Caution:

Federal 93 law prohibits dispensing without prescription" or "Caution:

94 Federal law restricts this drug to use by or on the order of a 95 licensed veterinarian" or any similar restrictive statement, or 96 the drug may be dispensed only upon a prescription;

97 (b) Under Chapter 3715.

of the Revised Code, the 98 drug may be dispensed only upon a prescription.

99(2) S.Any drug that contains a schedule V controlled substance and that is exempt from Chapter 3719.

of the Revised Code or to which that chapter does not apply;

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

(4) Any drug that is a biological product, as defined in section 3715.01 of the Revised Code.

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

(H) "Prescription" means all of the following:

(1) A written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treating a particular animal, issued by a licensed health professional authorized to prescribe drugs;

(2) For purposes of sections 4723.4810, 4729.282, 4730.432, and 4731.93 of the Revised Code, a written, electronic, or oral order for a drug to treat chlamydia, gonorrhea, or trichomoniasis issued to and in the name of a patient who is not the intended user of the drug but is the sexual partner of the intended user;

(3) For purposes of sections 3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 4723.483, 4729.88, 4730.433, 4731.96, and 5101.76 of the Revised Code, a written, electronic, or oral order for an epinephrine autoinjector issued to and in the name of a school, school district, or camp;

(4) For purposes of Chapter 3728.

and sections 4723.483, 4729.88, 4730.433, and 4731.96 of the Revised Code, a written, electronic, or oral order for an epinephrine autoinjector issued to and in the name of a qualified entity, as defined in section 3728.01 of the Revised Code;

(5) For purposes of sections 3313.7115, 3313.7116, 3314.147, 3326.60, 3328.38, 4723.4811, 4730.437, 4731.92, and 5101.78 of the Revised Code, a written, electronic, or oral order for injectable or nasally administered glucagon in the name of a school, school district, or camp.

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

(1) A dentist licensed under Chapter 4715.

of the Revised Code;

(2) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid license issued under Chapter 4723.

of the Revised Code to practice nursing as an advanced practice registered nurse;

(3) A certified registered nurse anesthetist who holds a current, valid license issued under Chapter 4723.

of the Revised Code to practice nursing as an advanced practice registered nurse, but only to the extent of the nurse's authority under sections 4723.43 and 4723.434 of the Revised Code;

Am.

S.

152 Page136th 5G.A. As Passed by the Senate (2) Any drug that contains a schedule V controlled 100 substance and that is exempt from Chapter 3719.

of(4) theAn Revisedoptometrist 101licensed Codeunder orChapter to4725. which that chapter does not apply;

102of (3) Any drug intended for administration by injection into 103 the humanRevised bodyCode otherto thanpractice throughoptometry; a natural orifice of the human 104 body;

105(5) (4)A Anyphysician drugauthorized thatunder isChapter a4731. biological product, as defined in 106 section 3715.01 of the Revised Code.

107of (G)the "FederalRevised drugCode abuseto controlpractice laws"medicine hasand thesurgery, sameosteopathic meaningmedicine 108and assurgery, inor sectionpodiatric 3719.01medicine ofand thesurgery; Revised Code.

109(6) (H)A "Prescription"physician meansassistant allwho ofholds thea following:license to practice as a physician assistant issued under Chapter 4730.

110 (1) A written, electronic, or oral order for drugs or 111 combinations or mixtures of drugsthe toRevised beCode, usedholds by a particularvalid 112prescriber individualnumber or for treating a particular animal, issued by athe 113state licensedmedical healthboard, professionaland authorizedhas tobeen prescribegranted drugs;physician-delegated prescriptive authority;

114(7) (2)A Forveterinarian purposeslicensed ofunder sectionsChapter 4723.4810,4741. 4729.282, 115 4730.432, and 4731.93 of the Revised Code, a written, 116 electronic, or oral order for a drug to treat chlamydia, 117 gonorrhea, or trichomoniasis issued to and in the name of a 118 patient who is not the intended user of the drug but is the 119 sexual partner of the intended user;

120 (3) For purposes of sections 3313.7110, 3313.7111, 121 3314.143, 3326.28, 3328.29, 4723.483, 4729.88, 4730.433, 122 4731.96, and 5101.76 of the Revised Code,Code; a written, electronic, 123 or oral order for an epinephrine autoinjector issued to and in 124 the name of a school, school district, or camp;

125(8) (4)A Forcertified purposesmental ofhealth assistant licensed under Chapter 3728.4772.

andof sectionsthe 4723.483,Revised 126Code 4729.88,who 4730.433,has andbeen 4731.96granted ofphysician-delegated prescriptive authority by the Revisedphysician Code,supervising athe written,certified 127mental S.health assistant.

(J) "Sale" or "sell" includes any transaction made by any person, whether as principal proprietor, agent, or employee, to do or offer to do any of the following:

deliver, distribute, broker, exchange, gift or otherwise give away, or transfer, whether the transfer is by passage of title, physical movement, or both.

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

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

(M) "Retail seller" means any person that sells any dangerous drug to consumers without assuming control over and responsibility for its administration.

Mere advice or instructions regarding administration do not constitute control or establish responsibility.

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

(1) The proprietary name of the drug product;

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

(3) The strength of the drug product if the product contains a single active ingredient or if the drug product contains more than one active ingredient and a relevant strength can be associated with the product without indicating each active ingredient.

The established name and quantity of each active ingredient are required if such a relevant strength cannot be so associated with a drug product containing more than one ingredient.

(4) The dosage form;

(5) The price charged for a specific quantity of the drug product.

The stated price shall include all charges to the consumer, including, but not limited to, the cost of the drug product, professional fees, handling fees, if any, and a statement identifying professional services routinely furnished by the pharmacy.

Any mailing fees and delivery fees may be stated separately without repetition.

The information shall not be false or misleading.

(O) "Wholesale distributor of dangerous drugs" or "wholesale distributor" means a person engaged in the sale of dangerous drugs at wholesale and includes any agent or employee of such a Am.

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152 Page136th 6G.A. As Passed by the Senate electronic, or oral order for an epinephrine autoinjector issued 128 to and in the name of a qualified entity, as defined in section 129 3728.01 of the Revised Code;

130person (5)authorized Forby purposes of sections 3313.7115, 3313.7116, 131 3314.147, 3326.60, 3328.38, 4723.4811, 4730.437, 4731.92, and 132 5101.78 of the Revisedperson Code,to aengage written, electronic, or oral 133 order for injectable or nasally administered glucagon in the 134sale name of adangerous school,drugs schoolat district,wholesale. or camp.

135(P) (I)"Manufacturer "Licensedof healthdangerous professional authorized to prescribe 136 drugs" or "prescriber""manufacturer" means ana individualperson, whoother isthan authorizeda bypharmacist 137or lawprescriber, towho prescribemanufactures drugs or dangerous drugs orand drugwho therapyis 138engaged related devices in the coursesale of thethose individual'sdangerous professionaldrugs. 139 practice, including only the following:

140(Q) (1)"Terminal Adistributor dentistof licenseddangerous underdrugs" Chapteror 4715."terminal distributor" means a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a manufacturer, repackager, outsourcing facility, third-party logistics provider, wholesale distributor, or pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption.

"Terminal distributor" includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist, licensed health professional authorized to prescribe drugs, or other person authorized by the Revisedstate 141board Code;of pharmacy.

142(R) (2)"Promote Ato clinicalthe nursepublic" specialist,means certifieddisseminating nurse-midwife,a 143representation to the public in any manner or certifiedby nurseany practitionermeans, whoother holdsthan aby current,labeling, validfor 144the licensepurpose issuedof underinducing, Chapteror 4723.that is likely to induce, directly or indirectly, the purchase of a dangerous drug at retail.

(S) "Person" includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the Revisedstate, Codeand toany 145district, practicedepartment, nursingor asagency anof advancedthe practicestate registeredor nurse;its political subdivisions.

146(T)(1) (3)"Animal Ashelter" certifiedmeans registereda nursefacility anesthetistoperated whoby holds a 147humane current,society validor licenseany issuedsociety organized under Chapter 4723.1717.

of the Revised 148 Code toor practicea nursingdog aspound anoperated advancedpursuant practice registered 149 nurse, but only to theChapter extent955. of the nurse's authority under 150 sections 4723.43 and 4723.434 of the Revised Code;

151 (4) An optometrist licensed under Chapter 4725.

of the 152 Revised Code to practice optometry;

153 (5) A physician authorized under Chapter 4731.

of the 154 Revised Code to practice medicine and surgery, osteopathic 155 medicine and surgery, or podiatric medicine and surgery;

156 S.

B.

No.

152 Page 7 As Passed by the Senate (6) A physician assistant who holds a license to practice 157 as a physician assistant issued under Chapter 4730.

of the 158 Revised Code, holds a valid prescriber number issued by the 159 state medical board, and has been granted physician-delegated 160 prescriptive authority;

161 (7) A veterinarian licensed under Chapter 4741.

of the 162 Revised Code;

163 (8) A certified mental health assistant licensed under 164 Chapter 4772.

of the Revised Code who has been granted 165 physician-delegated prescriptive authority by the physician 166 supervising the certified mental health assistant.

167 (J) "Sale" or "sell" includes any transaction made by any 168 person, whether as principal proprietor, agent, or employee, to 169 do or offer to do any of the following:

deliver, distribute, 170 broker, exchange, gift or otherwise give away, or transfer, 171 whether the transfer is by passage of title, physical movement, 172 or both.

173 (K) "Wholesale sale" and "sale at wholesale" mean any sale 174 in which the purpose of the purchaser is to resell the article 175 purchased or received by the purchaser.

176 (L) "Retail sale" and "sale at retail" mean any sale other 177 than a wholesale sale or sale at wholesale.

178 (M) "Retail seller" means any person that sells any 179 dangerous drug to consumers without assuming control over and 180 responsibility for its administration.

Mere advice or 181 instructions regarding administration do not constitute control 182 or establish responsibility.

183 (N) "Price information" means the price charged for a 184 prescription for a particular drug product and, in an easily 185 S.

B.

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152 Page 8 As Passed by the Senate understandable manner, all of the following:

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

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

188 (3) The strength of the drug product if the product 189 contains a single active ingredient or if the drug product 190 contains more than one active ingredient and a relevant strength 191 can be associated with the product without indicating each 192 active ingredient.

The established name and quantity of each 193 active ingredient are required if such a relevant strength 194 cannot be so associated with a drug product containing more than 195 one ingredient.

196 (4) The dosage form;

197 (5) The price charged for a specific quantity of the drug 198 product.

The stated price shall include all charges to the 199 consumer, including, but not limited to, the cost of the drug 200 product, professional fees, handling fees, if any, and a 201 statement identifying professional services routinely furnished 202 by the pharmacy.

Any mailing fees and delivery fees may be 203 stated separately without repetition.

The information shall not 204 be false or misleading.

205 (O) "Wholesale distributor of dangerous drugs" or 206 "wholesale distributor" means a person engaged in the sale of 207 dangerous drugs at wholesale and includes any agent or employee 208 of such a person authorized by the person to engage in the sale 209 of dangerous drugs at wholesale.

210 (P) "Manufacturer of dangerous drugs" or "manufacturer" 211 means a person, other than a pharmacist or prescriber, who 212 manufactures dangerous drugs and who is engaged in the sale of 213 those dangerous drugs.

214 S.

B.

No.

152 Page 9 As Passed by the Senate (Q) "Terminal distributor of dangerous drugs" or "terminal 215 distributor" means a person who is engaged in the sale of 216 dangerous drugs at retail, or any person, other than a 217 manufacturer, repackager, outsourcing facility, third-party 218 logistics provider, wholesale distributor, or pharmacist, who 219 has possession, custody, or control of dangerous drugs for any 220 purpose other than for that person's own use and consumption.

221 "Terminal distributor" includes pharmacies, hospitals, nursing 222 homes, and laboratories and all other persons who procure 223 dangerous drugs for sale or other distribution by or under the 224 supervision of a pharmacist, licensed health professional 225 authorized to prescribe drugs, or other person authorized by the 226 state board of pharmacy.

227 (R) "Promote to the public" means disseminating a 228 representation to the public in any manner or by any means, 229 other than by labeling, for the purpose of inducing, or that is 230 likely to induce, directly or indirectly, the purchase of a 231 dangerous drug at retail.

232 (S) "Person" includes any individual, partnership, 233 association, limited liability company, or corporation, the 234 state, any political subdivision of the state, and any district, 235 department, or agency of the state or its political 236 subdivisions.

237 (T)(1) "Animal shelter" means a facility operated by a 238 humane society or any society organized under Chapter 1717.

of 239 the Revised Code or a dog pound operated pursuant to Chapter 240 955.

241 (2) "County dog warden" means a dog warden or deputy dog 242 warden appointed or employed under section 955.12 of the Revised 243 Code.

244(3) S."Wild animal rehabilitation facility" means a facility that holds a permit issued by the chief of the division of wildlife for rehabilitation purposes in accordance with section 1533.08 of the Revised Code or rules adopted by the chief.

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

(V) "Pain management clinic" has the same meaning as in section 4731.054 of the Revised Code.

(W) "Investigational drug or product" means a drug or product that has successfully completed phase one of the United States food and drug administration clinical trials and remains under clinical trial, but has not been approved for general use by the United States food and drug administration.

"Investigational drug or product" does not include controlled substances in schedule I, as defined in section 3719.01 of the Revised Code.

(X) "Product," when used in reference to an investigational drug or product, means a biological product, other than a drug, that is made from a natural human, animal, or microorganism source and is intended to treat a disease or medical condition.

(Y) "Third-party logistics provider" means a person that provides or coordinates Am.

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152 Page136th 10G.A. As Passed by the Senate (3) "Wild animal rehabilitation facility" means a facility 245 that holds a permit issued by the chief of the division of 246 wildlife for rehabilitation purposes in accordance with section 247 1533.08 of the Revised Code or rules adopted by the chief.

248warehousing (U)or "Food"other haslogistics theservices samepertaining meaningto asdangerous indrugs sectionincluding 3715.01distribution, on behalf of 249a manufacturer, wholesale distributor, or terminal distributor of dangerous drugs, but does not take ownership of the Reviseddrugs Code.or have responsibility to direct the sale or disposition of the drugs.

250(Z) (V)"Repackager "Painof managementdangerous clinic"drugs" hasor the"repackager" samemeans meaninga asperson inthat 251repacks sectionand 4731.054relabels ofdangerous thedrugs Revisedfor Code.sale or distribution.

252(AA) (W)"Outsourcing "Investigationalfacility" drug or product" means a drugfacility or 253 product that hasis successfullyengaged completedin phase one of the Unitedcompounding 254 States food and drugsale administrationof clinicalsterile trialsdrugs and remainsis 255registered underas clinicalan trial,outsourcing butfacility haswith not been approved for general use 256 by the United States food and drug administration.

257(BB) "Investigational"Laboratory" drugmeans ora product"laboratory doeslicensed notunder includethis controlledchapter 258as substancesa interminal scheduledistributor I,of asdangerous defineddrugs inand sectionentrusted 3719.01to have custody of any of the 259following Reviseddrugs Code.and to use the drugs for scientific and clinical purposes and for purposes of instruction:

260dangerous (X)drugs "Product," when used in reference to an 261 investigational drug or product, means a biological product, 262 other than a drug, that isare madenot fromcontrolled asubstances, naturalas human,defined animal,in orsection 2633719.01 microorganismof sourcethe andRevised isCode; intended to treat a disease or 264 medical condition.

265 (Y) "Third-party logistics provider" means a person that 266 provides or coordinates warehousing or other logistics services 267 pertaining to dangerous drugs includingthat distribution,are oncontrolled behalfsubstances, 268as ofdefined ain manufacturer,that wholesalesection; distributor, or terminal 269 distributor of dangerous drugs, but does not take ownership of 270 the drugs or have responsibility to direct the sale or 271 disposition of the drugs.

272and (Z)controlled "Repackagersubstances ofin dangerousschedule drugs"I, oras "repackager"defined meansin 273that S.section.

B.(CC) "Overdose reversal drug" means both of the following:

No.(1) Naloxone;

152(2) PageAny 11other Asdrug Passedthat by the Senatestate aboard personof thatpharmacy, repacksthrough andrules relabelsadopted dangerousin drugsaccordance forwith saleChapter or119. 274 distribution.

275of (AA)the "OutsourcingRevised facility"Code, meansdesignates as a facilitydrug that is 276approved engagedby in the compoundingfederal andfood sale of sterile drugs and isdrug 277administration registeredfor as an outsourcing facility with the Unitedreversal Statesof 278a foodknown andor drugsuspected administration.opioid-related overdose.

279Sec. (BB) "Laboratory" means a laboratory licensed under this 280 chapter as a terminal distributor of dangerous drugs and 281 entrusted to have custody of any of the following drugs and to 282 use the drugs for scientific and clinical purposes and for 283 purposes of instruction:

dangerous4729.36. drugs that are not controlled 284 substances, as defined in section 3719.01 of the Revised Code;

285(A) No place except a pharmacy licensed as a terminal distributor of dangerous drugs thatand areno controlledperson substances,except asa definedlicensed pharmacist shall knowingly display any sign or advertise in 286any fashion, using the words "pharmacy," "drugs," "drug store," "drug store supplies," "pharmacist," "druggist," "pharmaceutical chemist," "apothecary," "drug sundries," or "medicine," or knowingly use any of these words or their equivalent, of those words in any manner that section;would lead or tend to lead the public to believe that the place is a pharmacy or the person is a pharmacist.

and(B) controlledA substancespharmacy inmaking scheduleretail I,sales asmay 287advertise definedby name or therapeutic class the availability for sale or dispensing of any dangerous drug provided that the advertising includes the price information specified in the definition of that section.term in section 4729.01 of the Revised Code.

288Sec. (CC) "Overdose reversal drug" means both of the following:

289 (1) Naloxone;

290 (2) Any other drug that the state board of pharmacy, 291 through rules adopted in accordance with Chapter 119.

of the 292 Revised Code, designates as a drug that is approved by the 293 federal food and drug administration for the reversal of a known 294 or suspected opioid-related overdose.

295 Sec.

(A) The state board of pharmacy may issue a 296 limited license to an animal shelter, a wild animal 297 rehabilitation facility, or county dog warden solely for the 298 purpose of purchasing, possessing, and administering drugs that 299 are distributed in a manufactured dosage form as described in 300 section 4729.532 of the Revised Code.

Unless otherwise approved 301 by the board, no such license shall authorize or permit the 302distribution S.of these drugs to any person other than the originating wholesale distributor of the drugs.

B.An application for licensure shall include the information the board requires by rule under this section.

No.If the application meets the requirements of the rules adopted under this section, the board shall issue the license.

152(B) PageThe 12board, Asin Passedaccordance bywith theChapter Senate119. distribution of these drugs to any person other than the 303 originating wholesale distributor of the drugs.

Anof applicationthe 304Revised forCode, licensure shall includeadopt theany informationrules thenecessary boardto requiresadminister 305and byenforce rule under this section.

If the application meets the 306 requirements of the rules adopted under this section, the board 307 shall issue the license.

308 (B) The board, in accordance with Chapter 119.

of the 309 Revised Code, shall adopt any rules necessary to administer and 310 enforce this section.

311Am. (1) Require as a condition of licensure that an agent or 312 employee of an animal shelter or wild animal rehabilitation 313 facility or an agent or employee of a county dog warden, other 314 than a registered veterinary technician as defined in section 315 4741.01 of the Revised Code, has successfully completed a 316 euthanasia technician certification course described in section 317 4729.532 of the Revised Code;

318S. (2) Specify the information the animal shelter, wild 319 animal rehabilitation facility, or county dog warden must 320 provide the board for issuance or renewal of a license;

321 (3) Address any other matters the board considers 322 necessary or appropriate for the administration and enforcement 323 of this section.

324 Sec.

4729.532.

(A) No agent or employee of an animal 325 shelter, no agent or employee of a wild animal rehabilitation 326 facility, and no county dog warden or agent or employee of a 327 county dog warden shall perform euthanasia by means of lethal 328 injection on an animal by use of any substance other than a 329 substance in a manufactured dosage form that the state 330 veterinary medical licensing board, in consultation with the 331 S.

152 Page136th 13G.A. As Passed by the Senate state board of pharmacy, approves by rule adopted in accordance 332 with Chapter 119.

(1) Require as a condition of licensure that an agent or employee of an animal shelter or wild animal rehabilitation facility or an agent or employee of a county dog warden, other than a registered veterinary technician as defined in section 4741.01 of the Revised Code, has successfully completed a euthanasia technician certification course described in section 4729.532 of the Revised Code;

(2) Specify the information the animal shelter, wild animal rehabilitation facility, or county dog warden must provide the board for issuance or renewal of a license;

(3) Address any other matters the board considers necessary or appropriate for the administration and enforcement of this section.

Sec.

4729.532.

(A) No agent or employee of an animal shelter, no agent or employee of a wild animal rehabilitation facility, and no county dog warden or agent or employee of a county dog warden shall perform euthanasia by means of lethal injection on an animal by use of any substance other than a substance in a manufactured dosage form that the state veterinary medical licensing board, in consultation with the state board of pharmacy, approves by rule adopted in accordance with Chapter 119.

333 The agent or employee of an animal shelter or wild animal 334 rehabilitation facility, county dog warden, or agent or employee 335 of a county dog warden when using a lethal solution to perform 336 euthanasia on an animal shall use the solution in accordance 337 with the following methods:

338 (1) Intravenous injection by hypodermic needle;

339 (2) Intraperitoneal injection by hypodermic needle;

340 (3) Intracardial injection by hypodermic needle, but only 341 on an animal verified to be unconscious;

342 (4) Oral administration of solution or powder.

343 (B) Before euthanasia, a euthanasia technician may 344 administer a solution of one or more drugs exclusively for the 345 purpose of inducing anesthesia, sedation, or unconsciousness 346 prior to euthanasia.

Only those drugs that have been approved by 347 rule adopted in accordance with Chapter 119.

of the Revised Code 348 by the state board of pharmacy, in consultation with the state 349 veterinary medical licensing board, may be used.

350 (C) No agent or employee of an animal shelter or wild 351 animal rehabilitation facility and no county dog warden or agent 352 or employee of a county dog warden, other than a registered 353 veterinary technician as defined in section 4741.01 of the 354 Revised Code, shall perform euthanasia by means of lethal 355 injection on an animal or administer pre-euthanasia drugs that 356 induce anesthesia, sedation, or unconsciousness unless the agent 357 or employee or county dog warden has received certification 358 after successfully completing a euthanasia technician 359 certification course as described in this division.

360The S.curriculum for a euthanasia technician certification course shall be one that has been approved by the state veterinary medical licensing board, shall be at least sixteen hours in length, and shall include information in at least all of the following areas:

(1) The pharmacology, proper administration, and storage of euthanasia, sedation, and anesthesia solutions;

Am.

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152 Page136th 14G.A. As Passed by the Senate The curriculum for a euthanasia technician certification 361 course shall be one that has been approved by the state 362 veterinary medical licensing board, shall be at least sixteen 363 hours in length, and shall include information in at least all 364 of the following areas:

365(2) (1)Federal Theand pharmacology,state properlaws administration,regulating andthe storage 366and accountability of euthanasia, sedation, and anesthesia solutions;

367(3) (2)Euthanasia Federaltechnician andstress statemanagement; laws regulating the storage and 368 accountability of euthanasia, sedation, and anesthesia 369 solutions;

370(4) (3)Proper Euthanasiadisposal technicianof stresseuthanized management;animals.

371(D)(1) (4)No Properagent disposalor employee of euthanizedan animals.animal shelter or wild animal rehabilitation facility shall perform euthanasia by means of lethal injection on animals or administer pre-euthanasia drugs that induce anesthesia, sedation, or unconsciousness under this section unless the facility in which the agent or employee works or is employed is licensed with the state board of pharmacy under section 4729.531 of the Revised Code.

372 (D)(1) No agent or employee of ana animalcounty shelterdog orwarden wild 373 animal rehabilitation facility shall perform euthanasia by means 374 of lethal injection on animals or administer pre-euthanasia 375 drugs that induce anesthesia, sedation, or unconsciousness under 376 this section unless the facilitycounty indog whichwarden the agent or employee 377 works or is employed is licensed with the state board of 378 pharmacy under section 4729.531 of the Revised Code.

No(2) Any agent or 379 employee of aan animal shelter or wild animal rehabilitation facility or county dog warden shallperforming perform euthanasia by 380 means of lethal injection on animals or administeradministering pre- 381 euthanasia drugs that induce anesthesia, sedation, or 382 unconsciousness undershall thisdo sectionso unlessonly thein countya doghumane wardenand 383proficient manner that is licensedin underconformity sectionwith 4729.531the methods described in divisions (A) and (B) of thethis Revisedsection Code.and not in violation of Chapter 959.

384 (2) Any agent or employee of an animal shelter or wild 385 animal rehabilitation facility or county dog warden performing 386 euthanasia by means of lethal injection or administering pre- 387 euthanasia drugs that induce anesthesia, sedation, or 388 unconsciousness shall do so only in a humane and proficient 389 S.

B.

No.

152 Page 15 As Passed by the Senate manner that is in conformity with the methods described in 390 divisions (A) and (B) of this section and not in violation of 391 Chapter 959.

392 (E) Nothing in this section precludes a licensed 393 veterinarian or registered veterinary technician as defined in 394 section 4741.01 of the Revised Code from engaging in the 395 practice of veterinary medicine as authorized in Chapter 4741.

396 of the Revised Code.

397 Sec.

398 (1) "Category II" means any dangerous drug that is not 399 included in category III.

400 (2) "Category III" means any controlled substance that is 401 contained in schedule I, II, III, IV, or V.

402 (3) "Emergency medical service organization" has the same 403 meaning as in section 4765.01 of the Revised Code.

404 (4) "Emergency medical service organization satellite" 405 means a location where dangerous drugs are stored that is 406 separate from, but associated with, the headquarters of an 407 emergency medical service organization.

"Emergency medical 408 service organization satellite" does not include the units under 409 the control of the emergency medical service organization.

410 (5) "Person" includes an emergency medical service 411 organization or an emergency medical service organization 412 satellite.

413 (6) "Schedule I," "schedule II," "schedule III," "schedule 414 IV," and "schedule V" have the same meanings as in section 415 3719.01 of the Revised Code.

416 (B)(1) A person seeking to be licensed as a terminal 417distributor S.of dangerous drugs shall file with the executive director of the state board of pharmacy a verified application.

After it is filed, the application may not be withdrawn without approval of the board.

(2) An application shall contain all the following that apply in the applicant's case:

Am.

S.

152 Page136th 16G.A. As Passed by the Senate distributor of dangerous drugs shall file with the executive 418 director of the state board of pharmacy a verified application.

419(a) AfterInformation itthat isthe filed,board requires relative to the applicationqualifications mayof nota beterminal withdrawndistributor withoutof 420dangerous approvaldrugs set forth in section 4729.55 of the board.Revised Code;

421(b) (2)A Anstatement applicationas shallto containwhether all the followingperson thatis 422seeking applyto inbe thelicensed applicant'sas case:a category II, category III, limited category II, or limited category III terminal distributor of dangerous drugs;

423(c) (a)If Information that the boardperson requiresis relativeseeking to thebe 424licensed qualificationsas of a limited category II or limited category III terminal distributor of dangerous drugs, a list of the dangerous drugs setthat 425the forthperson inis sectionseeking 4729.55to ofpossess, have custody or control of, and distribute, which list shall also specify the Revisedpurpose Code;for which those drugs will be used and their source;

426(d) (b)If Athe statementperson asis toan whetheremergency medical service organization, the personinformation that is seekingspecified toin bedivisions 427(C)(1) licensedand as(2) aof categorythis II,section, categoryand III,if limitedthe categoryperson II,is oran 428emergency limitedmedical categoryservice IIIorganization terminalsatellite, distributorthe information required under division (D) of dangerousthis drugs;section;

429(e) (c)Except Ifwith therespect person is seeking to bethe licensedunits asunder athe limitedcontrol 430of categoryan IIemergency ormedical limitedservice categoryorganization, IIIthe terminalidentity distributor of 431the dangerousone drugs,establishment aor listplace ofat which the dangerousperson drugsintends thatto theengage personin 432the issale seekingor toother possess,distribution haveof custodydangerous ordrugs controlat of,retail, and 433maintain distribute,possession, whichcustody, listor shallcontrol alsoof specifydangerous thedrugs purpose for whichpurposes 434other thosethan drugsthe willperson's beown useduse andor theirconsumption; source;

435(f) (d) If the personapplication ispertains anto emergencya medicalpain servicemanagement 436clinic, organization, the information that isdemonstrates, specifiedto inthe divisionssatisfaction (C) 437 (1) and (2) of this section, and if the personboard, iscompliance anwith emergencydivision 438(A) medicalof servicesection organization4729.552 satellite,of the informationRevised requiredCode. 439 under division (D) of this section;

440(C)(1) (e)Each Except with respect to the units under the control of 441 an emergency medical service organization,organization thethat identityapplies offor thea 442terminal onedistributor establishment or place at which the person intends to engage 443 in the sale or other distribution of dangerous drugs atlicense retail,shall 444submit andwith maintainits possession,application custody,all or control of dangerous drugs 445 for purposes other than the person'sfollowing: own use or consumption;

446(a) S.A copy of its standing orders or protocol, which orders or protocol shall be signed by a physician;

B.(b) A list of the dangerous drugs that the units under its control may carry, expressed in standard dose units, which shall be signed by a physician;

No.(c) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765.

152 Page 17 As Passed by the Senate (f) If the application pertains to a pain management 447 clinic, information that demonstrates, to the satisfaction of 448 the board, compliance with division (A) of section 4729.552 of 449 the Revised Code.

450 (C)(1) Each emergency medical service organization that 451 applies for a terminal distributor of dangerous drugs license 452 shall submit with its application all of the following:

453 (a) A copy of its standing orders or protocol, which 454 orders or protocol shall be signed by a physician;

455 (b) A list of the dangerous drugs that the units under its 456 control may carry, expressed in standard dose units, which shall 457 be signed by a physician;

458 (c) A list of the personnel employed or used by the 459 organization to provide emergency medical services in accordance 460 with Chapter 4765.

461 In accordance with Chapter 119.

of the Revised Code, the 462 board shall adopt rules specifying when an emergency medical 463 service organization that is licensed as a terminal distributor 464 must notify the board of any changes in its documentation 465 submitted pursuant to division (C)(1) of this section.

466 (2) An emergency medical service organization seeking to 467 be licensed as a terminal distributor of dangerous drugs shall 468 list in its application for licensure the following additional 469 information:

470 (a) The units under its control that the organization 471 determines will possess dangerous drugs for the purpose of 472 administering emergency medical services in accordance with 473 Chapter 4765.

474(b) S.With respect to each such unit, whether the dangerous drugs that the organization determines the unit will possess are in category II or III.

(3) An emergency medical service organization that is licensed as a terminal distributor of Am.

S.

152 Page136th 18G.A. As Passed by the Senate (b) With respect to each such unit, whether the dangerous 475 drugs that the organization determines the unit will possess are 476 in category II or III.

477 (3) An emergency medical service organization that is 478 licensed as a terminal distributor of dangerous drugs shall file 479 a new application for such licensure if there is any change in 480 the number or location of any of its units or if there is any 481 change in the category of the dangerous drugs that any unit will 482 possess.

483 (4) A unit listed in an application for licensure pursuant 484 to division (C)(2) of this section may obtain the dangerous 485 drugs it is authorized to possess from its emergency medical 486 service organization or, on a replacement basis, from a hospital 487 pharmacy.

If units will obtain dangerous drugs from a hospital 488 pharmacy, the organization shall file, and maintain in current 489 form, the following items with the pharmacist who is responsible 490 for the hospital's terminal distributor of dangerous drugs 491 license:

492 (a) A copy of its standing orders or protocol;

493 (b) A list of the personnel employed or used by the 494 organization to provide emergency medical services in accordance 495 with Chapter 4765.

of the Revised Code, who are authorized to 496 possess the drugs, which list also shall indicate the personnel 497 who are authorized to administer the drugs.

498 (D) Each emergency medical service organization satellite 499 that applies for a terminal distributor of dangerous drugs 500 license shall submit with its application all of the information 501 that the board requires to be submitted with the application, as 502 specified in rules the board shall adopt in accordance with 503Chapter S.119.

B.

No.

152 Page 19 As Passed by the Senate Chapter 119.

504 (E) There shall be four categories of terminal distributor 505 of dangerous drugs licenses.

506 (1) Category II license.

A person who obtains this license 507 may possess, have custody or control of, and distribute only the 508 dangerous drugs described in category II.

509 (2) Limited category II license.

A person who obtains this 510 license may possess, have custody or control of, and distribute 511 only the dangerous drugs described in category II that were 512 listed in the application for licensure.

513 (3) Category III license, which may include a pain 514 management clinic classification issued under section 4729.552 515 of the Revised Code.

A person who obtains this license may 516 possess, have custody or control of, and distribute the 517 dangerous drugs described in category II and category III.

If 518 the license includes a pain management clinic classification, 519 the person may operate a pain management clinic.

520 (4) Limited category III license.

A person who obtains 521 this license may possess, have custody or control of, and 522 distribute only the dangerous drugs described in category II or 523 category III that were listed in the application for licensure.

524 (F) Except for an application made by a county dog warden 525 or on behalf of an animal shelter or wild animal rehabilitation 526 facility, if an applicant for a limited category II license or 527 limited category III license intends to administer dangerous 528 drugs to a person or animal, the applicant shall submit, with 529 the application, a copy of its protocol or standing orders.

The 530 protocol or orders shall be signed by a licensed health 531 professional authorized to prescribe drugs, specify the 532dangerous S.drugs Am.

S.

152 Page136th 20G.A. As Passed by the Senate dangerous drugs to be administered, and list personnel who are 533 authorized to administer the dangerous drugs in accordance with 534 federal law or the law of this state.

535 An application made by a county dog warden or on behalf of 536 an animal shelter or wild animal rehabilitation facility shall 537 include a list of the dangerous drugs to be administeredadministered, to 538 animals and thelist personnel who are authorized to administer the 539dangerous drugs to animals in accordance with sectionfederal 4729.532law ofor the 540law Revisedof Code.this state.

541An Inapplication made by a county dog warden or on behalf of an animal shelter or wild animal rehabilitation facility shall include a list of the dangerous drugs to be administered to animals and the personnel who are authorized to administer the drugs to animals in accordance with Chaptersection 119.4729.532 of the Revised Code.

ofIn theaccordance Revisedwith Code,Chapter the119. 542 board shall adopt rules specifying when a licensee must notify 543 the board of any changes in its documentation submitted pursuant 544 to this division.

545of (G)(1)the ExceptRevised asCode, providedthe inboard divisionshall (G)(3)adopt ofrules thisspecifying 546when section,a eachlicensee applicantmust fornotify licensurethe asboard a terminal distributor 547 of dangerousany drugschanges shallin submit,its withdocumentation thesubmitted application,pursuant ato licensethis 548division. fee.

The(G)(1) amountExcept assessedas shallprovided notin bedivision returned(G)(3) toof thethis section, each applicant 549for iflicensure theas applicanta failsterminal todistributor qualifyof fordangerous drugs shall submit, with the license.application, a license fee.

550The (2)amount Theassessed followingshall feesnot applybe underreturned divisionto (G)(1)the ofapplicant thisif 551the section:applicant fails to qualify for the license.

552(2) (a)The Exceptfollowing asfees providedapply inunder division (G)(2)(b)(G)(1) of this 553 section:

554(a) (i)Except Threeas hundredprovided twentyin dollarsdivision for(G)(2)(b) aof categorythis IIsection: or 555 limited category II license;

556(i) (ii)Three Four hundred fortytwenty dollars for a category IIIII 557 license, including a license with a pain management clinic 558 classification issued under section 4729.552 of the Revised 559 Code, or a limited category IIIII license.license;

560(ii) S.Four hundred forty dollars for a category III license, including a license with a pain management clinic classification issued under section 4729.552 of the Revised Code, or a limited category III license.

(b) One hundred twenty dollars for all of the following:

(i) A person who is required to hold a license as a terminal distributor of dangerous drugs pursuant to division (C) of section 4729.541 of the Revised Code;

(ii) A professional association, corporation, partnership, or limited liability company organized for the purpose of practicing veterinary medicine that is not included in division (G)(2)(b) (i) of this section;

(iii) An emergency medical service organization satellite.

(3) No fee applies for a license issued to a charitable pharmacy, as defined in section 3719.811 of the Revised Code, if the charitable pharmacy is participating in the drug repository program established under section 3715.87 of the Revised Code.

(H)(1) The board shall issue a terminal distributor of dangerous drugs license to each person who submits an application for such licensure in accordance with this section, pays the required license fee, is determined by the board to meet the requirements set forth in section 4729.55 of the Revised Code, and satisfies any other applicable requirements of this section.

(2) Except for the license of a county dog warden, the license shall describe the one establishment or place at which the licensee may engage in the sale or other distribution of dangerous drugs at retail and maintain possession, custody, or control of dangerous drugs for purposes other than the licensee's own use or consumption.

The one establishment or place shall be that which is identified in the application for licensure.

No such license shall authorize or permit the terminal distributor of dangerous drugs named Am.

S.

152 Page136th 21G.A. As Passed by the Senate (b) One hundred twenty dollars for all of the following:

561in (i)it Ato personengage whoin isthe requiredsale toor holdother adistribution licenseof asdangerous adrugs 562at terminalretail distributoror to maintain possession, custody, or control of dangerous drugs pursuantfor toany divisionpurpose (C)other 563than the distributor's own use or consumption, at any establishment or place other than that described in the license, except that an agent or employee of an animal shelter or wild animal rehabilitation facility or county dog warden may possess and use dangerous drugs in the course of business as provided in section 4729.5414729.532 of the Revised Code;Code.

564(3) (ii)The Alicense professionalof association,an corporation,emergency partnership,medical 565service ororganization limitedshall liabilitycover companythe organizedorganization's forheadquarters theand, purposein ofaddition, 566shall practicingcover veterinaryand medicinedescribe thatall isthe notunits includedof inthe divisionorganization 567listed (G)(2)(b)(i)in ofits thisapplication section;for licensure.

568(I)(1) (iii)All Anlicenses emergencyissued medicalor servicerenewed organizationpursuant satellite.to this section shall be effective for a period specified by the board in rules adopted under section 4729.26 of the Revised Code.

569The (3)effective Noperiod fee applies for aan licenseinitial issuedor torenewed alicense charitableshall 570not pharmacy,exceed astwenty-four definedmonths inunless section 3719.811 of the Revisedboard Code,extends if 571 the charitableperiod pharmacy is participating in therules drugto repositoryadjust 572license programrenewal establishedschedules. under section 3715.87 of the Revised Code.

573A (H)(1)license The board shall issuebe arenewed terminal distributor of 574 dangerous drugs license to each person who submits an 575 application for such licensure in accordance with this section, 576 pays the required license fee, is determined by the board according to 577 meet the requirementsprovisions setof forththis insection, section 4729.55 of the 578standard Revisedrenewal Code,procedure and satisfies any other applicable requirements of 579Chapter this4745. section.

580 (2) Except for the license of a county dog warden, the 581Revised licenseCode, shalland describerules theadopted oneby establishment or place at which 582 the licenseeboard mayunder engagesection in4729.26 the sale or other distribution of 583 dangerous drugs at retail and maintain possession, custody, or 584 control of dangerous drugs for purposes other than the 585Revised licensee'sCode. own use or consumption.

TheA oneperson establishmentseeking orto 586renew placea license shall besubmit thatan whichapplication isfor identifiedrenewal and pay the required fee on or before the date specified in the applicationrules foradopted 587by licensure.the board.

588The Nofee suchrequired for the renewal of a license shall authorizebe orthe permitsame as the terminallicense 589fee S.that applies under division (G)(2) of this section.

(2)(a) Subject to division (I)(2)(b) of this section, a license that has not been renewed by the date specified in rules adopted by the board may be reinstated only upon payment of the required renewal fee and a penalty fee of one hundred ten dollars.

(b) If an application for renewal has not been submitted by the sixty-first day after the renewal date specified in rules adopted by the board, the license is considered void and cannot be renewed, but the license holder may reapply for licensure.

(3) A terminal distributor of dangerous drugs that fails to renew licensure in accordance with this section and rules adopted by the board is prohibited from engaging in the retail sale, possession, or distribution of dangerous drugs until a valid license is issued by the board.

(J)(1) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (C)(1), (3), or (4) of this section.

(2) No licensed terminal distributor of dangerous drugs shall possess, have custody or control of, or distribute dangerous drugs that the terminal distributor is not entitled to possess, have custody or control of, or distribute by virtue of its category of licensure.

(3) No licensee that is required by division (F) of this section to notify the board of changes in its protocol or standing orders, or in personnel, shall fail to comply with that division.

(K) The board may enter into agreements with other states, federal agencies, and other entities to exchange information concerning licensing and inspection of terminal distributors of dangerous drugs located within or outside this state and to investigate alleged violations of the laws and rules governing distribution of drugs by terminal distributors.

Any information received Am.

S.

152 Page136th 22G.A. As Passed by the Senate distributor of dangerous drugs named in it to engage in the sale 590 or other distribution of dangerous drugs at retail or to 591 maintain possession, custody, or control of dangerous drugs for 592 any purpose other than the distributor's own use or consumption, 593 at any establishment or place other than that described in the 594 license, except that an agent or employee of an animal shelter 595 or wild animal rehabilitation facility or county dog warden may 596 possess and use dangerous drugs in the course of business as 597 provided in section 4729.532 of the Revised Code.

598pursuant (3)to Thesuch licensean ofagreement anis emergencysubject medicalto servicethe 599same organizationconfidentiality shallrequirements coverapplicable to the organization'sagency headquartersor and,entity infrom 600which addition,it shallwas coverreceived and describeshall allnot thebe unitsreleased ofwithout theprior 601authorization organizationfrom listedthat inagency itsor applicationentity. for licensure.

602Sec. (I)(1) All licenses issued or renewed pursuant to this 603 section shall be effective for a period specified by the board 604 in rules adopted under section 4729.26 of the Revised Code.

The4729.55. 605 effective period for an initial or renewed license shall not 606 exceed twenty-four months unless the board extends the period in 607 rules to adjust license renewal schedules.

ANo license shall be 608issued renewedto byan theapplicant boardfor accordinglicensure toas thea provisionsterminal distributor of thisdangerous 609drugs section,unless the standardapplicant renewalhas procedurefurnished satisfactory proof to the state board of Chapterpharmacy 4745.that:

of(A) theThe 610applicant Revisedis Code,equipped as to land, buildings, and rulesequipment adoptedto byproperly carry on the boardbusiness underof sectiona 611terminal 4729.26distributor of dangerous drugs within the Revisedcategory Code.of licensure approved by the board.

A(B) personOne seekingof tothe renewfollowing awill licensemaintain 612supervision shalland submitcontrol anover applicationthe forpossession renewal and paycustody theof requireddangerous feedrugs 613and oncontrolled orsubstances beforethat themay datebe specifiedacquired inby theor ruleson adoptedbehalf byof the 614applicant: board.

The(1) feeA requiredpharmacist, forlicensed thehealth renewalprofessional ofauthorized ato licenseprescribe shalldrugs, beor 615other theperson sameauthorized asby the licenseboard,; fee that applies under division (G)(2) 616 of this section.

617(2) (2)(a)An Subjectanimal toshelter, divisionwild (I)(2)(b)animal ofrehabilitation thisfacility, section,or acounty 618dog licensewarden thatlicensed hasunder notsection been4729.531 renewedof by the dateRevised specifiedCode, inor rules; 619 S.

(3) A laboratory will maintain supervision and control over the possession and custody of dangerous drugs and controlled substances that may be acquired by or on behalf of the applicant.

(C) Adequate safeguards are assured to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs.

(D) Adequate safeguards are assured that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner.

(E) If the applicant, or any agent or employee of the applicant, has been found guilty of violating section 4729.51 of the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 Stat.

(1938), 21 U.S.C.A.

301, the federal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729.

of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the recurrence of the violation.

(F) If the application is made on behalf of an animal shelter, wild animal rehabilitation facility, or county dog warden, at least one of the agents or employees of the animal shelter or county dog warden is certified in compliance with section 4729.532 of the Revised Code.

(G) In the case of an applicant who is a retail seller of peritoneal dialysis solutions in original packages labeled as required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat.

1040 (1938), U.S.C.A.

301, the applicant will maintain supervision and control over the possession, custody, and retail sale of the peritoneal dialysis solutions.

(H) In the case of an applicant who is a pain management clinic, the applicant meets the requirements to receive a license with a pain management clinic classification issued under section Am.

S.

152 Page136th 23G.A. As Passed by the Senate adopted by the board may be reinstated only upon payment of the 620 required renewal fee and a penalty fee of one hundred ten 621 dollars.

6224729.552 (b)of If an application for renewal has not been submitted 623 by the sixty-firstRevised dayCode. after the renewal date specified in rules 624 adopted by the board, the license is considered void and cannot 625 be renewed, but the license holder may reapply for licensure.

626SECTION (3)2. A terminal distributor of dangerous drugs that fails 627 to renew licensure in accordance with this section and rules 628 adopted by the board is prohibited from engaging in the retail 629 sale, possession, or distribution of dangerous drugs until a 630 valid license is issued by the board.

631That (J)(1)existing Nosections emergency4729.01, medical4729.36, service4729.531, organization4729.532, that4729.54, isand 6324729.55 licensed as a terminal distributor of dangerousthe drugsRevised shallCode failare 633hereby torepealed. comply with division (C)(1), (3), or (4) of this section.

634Am. (2) No licensed terminal distributor of dangerous drugs 635 shall possess, have custody or control of, or distribute 636 dangerous drugs that the terminal distributor is not entitled to 637 possess, have custody or control of, or distribute by virtue of 638 its category of licensure.

639S. (3) No licensee that is required by division (F) of this 640 section to notify the board of changes in its protocol or 641 standing orders, or in personnel, shall fail to comply with that 642 division.

643 (K) The board may enter into agreements with other states, 644 federal agencies, and other entities to exchange information 645 concerning licensing and inspection of terminal distributors of 646 dangerous drugs located within or outside this state and to 647 investigate alleged violations of the laws and rules governing 648 S.

152 Page136th 24G.A. As Passed by the Senate distribution of drugs by terminal distributors.

AnySpeaker information___________________ 649of received pursuant to such an agreement is subject to the sameHouse 650of confidentialityRepresentatives. requirements applicable to the agency or entity 651 from which it was received and shall not be released without 652 prior authorization from that agency or entity.

653President Sec.___________________ of the Senate.

4729.55.Passed ________________________, 20____ Approved ________________________, 20____ Governor.

NoAm. license shall be issued to an applicant 654 for licensure as a terminal distributor of dangerous drugs 655 unless the applicant has furnished satisfactory proof to the 656 state board of pharmacy that:

657S. (A) The applicant is equipped as to land, buildings, and 658 equipment to properly carry on the business of a terminal 659 distributor of dangerous drugs within the category of licensure 660 approved by the board.

661 (B) One of the following will maintain supervision and 662 control over the possession and custody of dangerous drugs and 663 controlled substances that may be acquired by or on behalf of 664 the applicant:

665 (1) A pharmacist, licensed health professional authorized 666 to prescribe drugs, or other person authorized by the board,;

667 (2) An animal shelter, wild animal rehabilitation 668 facility, or county dog warden licensed under section 4729.531 669 of the Revised Code, or ;

670 (3) A laboratory will maintain supervision and control 671 over the possession and custody of dangerous drugs and 672 controlled substances that may be acquired by or on behalf of 673 the applicant.

674 (C) Adequate safeguards are assured to prevent the sale or 675 other distribution of dangerous drugs by any person other than a 676 pharmacist or licensed health professional authorized to 677 S.

152 Page136th 25G.A. As Passed by the Senate prescribe drugs.

678The (D)section Adequatenumbering safeguards are assured that the applicant 679 will carry on the business of alaw terminal distributor of 680 dangerous drugs in a mannergeneral that allows pharmacists and pharmacypermanent 681nature internsis employedcomplete byand the terminal distributor to practice 682 pharmacy in aconformity safewith andthe effectiveRevised manner.Code.

683Director, (E)Legislative IfService theCommission. applicant, or any agent or employee of the 684 applicant, has been found guilty of violating section 4729.51 of 685 the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 686 Stat.

1040Filed (1938),in 21the U.S.C.A.office of the Secretary of State at Columbus, Ohio, on the ____ day of ___________,A.

301,D. the federal drug abuse 687 control laws, Chapter 2925., 3715., 3719., or 4729.

of20____. the 688 Revised Code, or any rule of the board, adequate safeguards are 689 assured to prevent the recurrence of the violation.

690Secretary (F) If the application is made on behalf of anState. animal 691 shelter, wild animal rehabilitation facility, or county dog 692 warden, at least one of the agents or employees of the animal 693 shelter or county dog warden is certified in compliance with 694 section 4729.532 of the Revised Code.

695File (G)No. In the case of an applicant who is a retail seller of 696 peritoneal dialysis solutions in original packages labeled as 697 required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat.

698_________ (1938),Effective 21Date U.S.C.A.___________________

301, the applicant will maintain 699 supervision and control over the possession, custody, and retail 700 sale of the peritoneal dialysis solutions.

701 (H) In the case of an applicant who is a pain management 702 clinic, the applicant meets the requirements to receive a 703 license with a pain management clinic classification issued 704 under section 4729.552 of the Revised Code.

705 Section 2.

That existing sections 4729.01, 4729.531, 706 S.

B.

No.

152 Page 26 As Passed by the Senate 4729.532, 4729.54, and 4729.55 of the Revised Code are hereby 707 repealed.

708