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To amend sections 3719.08, 4723.481, 4729.01, | 1 |
4729.071, 4729.29, 4729.51, 4729.54, 4729.541, | 2 |
4729.55, 4729.75, 4729.77, 4729.78, 4729.79, | 3 |
4729.80, 4729.81, 4729.82, 4729.83, 4729.99, | 4 |
4731.052, 4731.22, 4731.283, 4776.02, 4776.04, and | 5 |
5111.172; to amend, for the purpose of adopting | 6 |
new section numbers as indicated in parentheses, | 7 |
sections 4729.79 (4729.80), 4729.80 (4729.81), | 8 |
4729.81 (4729.82), 4729.82 (4729.83), 4729.83 | 9 |
(4729.84), and 4729.84 (4729.85); and to enact new | 10 |
section 4729.79 and sections 109.90, 3793.22, | 11 |
4729.291, 4729.552, 4729.561, 4729.571, 4729.69, | 12 |
4729.86, 4731.054, 4731.055, 4731.228, 4731.241, | 13 |
5111.179, and 5111.1710 of the Revised Code to | 14 |
establish and modify laws regarding the prevention | 15 |
of prescription drug abuse, development of | 16 |
information programs by the State Medical Board, | 17 |
and Medicaid coverage of prescription drugs. | 18 |
Section 1. That sections 3719.08, 4723.481, 4729.01, | 19 |
4729.071, 4729.29, 4729.51, 4729.54, 4729.541, 4729.55, 4729.75, | 20 |
4729.77, 4729.78, 4729.79, 4729.80, 4729.81, 4729.82, 4729.83, | 21 |
4729.99, 4731.052, 4731.22, 4731.283, 4776.02, 4776.04, and | 22 |
5111.172 be amended; sections 4729.79 (4729.80), 4729.80 | 23 |
(4729.81), 4729.81 (4729.82), 4729.82 (4729.83), 4729.83 | 24 |
(4729.84), and 4729.84 (4729.85) be amended, for the purpose of | 25 |
adopting new section numbers as indicated in parentheses; and new | 26 |
section 4729.79 and sections 109.90, 3793.22, 4729.291, 4729.552, | 27 |
4729.561, 4729.571, 4729.69, 4729.86, 4731.054, 4731.055, | 28 |
4731.228, 4731.241, 5111.179, and 5111.1710 of the Revised Code be | 29 |
enacted to read as follows: | 30 |
Sec. 109.90. The attorney general shall collaborate with the | 31 |
state board of pharmacy and director of alcohol and drug addiction | 32 |
services in the establishment and administration of a drug | 33 |
take-back program, as provided under section 4729.69 of the | 34 |
Revised Code. Any costs of the program shall be divided equally | 35 |
between the attorney general, state board of pharmacy, and | 36 |
department of alcohol and drug addiction services. | 37 |
Sec. 3719.08. (A) Whenever a manufacturer sells a controlled | 38 |
substance, and whenever a wholesaler sells a controlled substance | 39 |
in a package the wholesaler has prepared, the manufacturer or | 40 |
wholesaler shall securely affix to each package in which the | 41 |
controlled substance is contained a label showing in legible | 42 |
English the name and address of the vendor and the quantity, kind, | 43 |
and form of controlled substance contained therein. No person, | 44 |
except a pharmacist for the purpose of dispensing a controlled | 45 |
substance upon a prescription shall alter, deface, or remove any | 46 |
label so affixed. | 47 |
(B) Except as provided in division (C) of this section, when | 48 |
a pharmacist dispenses any controlled substance on a prescription | 49 |
for use by a patient, or supplies a controlled substance to a | 50 |
licensed health professional authorized to prescribe drugs for use | 51 |
by the professional in personally furnishing patients with | 52 |
controlled substances, the pharmacist shall affix to the container | 53 |
in which the controlled substance is dispensed or supplied a label | 54 |
showing the following: | 55 |
(1) The name and address of the pharmacy dispensing or | 56 |
supplying the controlled substance; | 57 |
(2) The name of the patient for whom the controlled substance | 58 |
is prescribed and, if the patient is an animal, the name of the | 59 |
owner and the species of the animal; | 60 |
(3) The name of the prescriber; | 61 |
(4) All directions for use stated on the prescription or | 62 |
provided by the prescriber; | 63 |
(5) The date on which the controlled substance was dispensed | 64 |
or supplied; | 65 |
(6) The name, quantity, and strength of the controlled | 66 |
substance and, if applicable, the name of the distributor or | 67 |
manufacturer. | 68 |
(C) The requirements of division (B) of this section do not | 69 |
apply when a controlled substance is prescribed or supplied for | 70 |
administration to an ultimate user who is institutionalized. | 71 |
(D) A licensed health professional authorized to prescribe | 72 |
drugs who personally furnishes a controlled substance to a patient | 73 |
shall comply with division | 74 |
the Revised Code with respect to labeling and packaging of the | 75 |
controlled substance. | 76 |
(E) No person shall alter, deface, or remove any label | 77 |
affixed pursuant to this section as long as any of the original | 78 |
contents remain. | 79 |
(F) Every label for a schedule II, III, or IV controlled | 80 |
substance shall contain the following warning: | 81 |
"Caution: federal law prohibits the transfer of this drug to | 82 |
any person other than the patient for whom it was prescribed." | 83 |
Sec. 3793.22. The director of alcohol and drug addiction | 84 |
services shall collaborate with the state board of pharmacy and | 85 |
attorney general in the establishment and administration of a drug | 86 |
take-back program, as provided under section 4729.69 of the | 87 |
Revised Code. Any costs of the program shall be divided equally | 88 |
between the department of alcohol and drug addiction services, | 89 |
state board of pharmacy, and attorney general. | 90 |
Sec. 4723.481. Under a certificate to prescribe issued under | 91 |
section 4723.48 of the Revised Code, a clinical nurse specialist, | 92 |
certified nurse-midwife, or certified nurse practitioner is | 93 |
subject to all of the following: | 94 |
(A) The nurse shall not prescribe any drug or therapeutic | 95 |
device that is not included in the types of drugs and devices | 96 |
listed on the formulary established in rules adopted under section | 97 |
4723.50 of the Revised Code. | 98 |
(B) The nurse's prescriptive authority shall not exceed the | 99 |
prescriptive authority of the collaborating physician or | 100 |
podiatrist and shall be in conformance with any rules adopted by | 101 |
the state medical board under Chapter 4731. of the Revised Code | 102 |
governing physician or podiatrist prescribing. | 103 |
(C) The nurse may prescribe a schedule II controlled | 104 |
substance as specified in division (A)(2) of section 3719.06 of | 105 |
the Revised Code, but shall not prescribe a schedule II controlled | 106 |
substance in collaboration with a podiatrist. | 107 |
(D) The nurse may personally furnish to a patient a sample of | 108 |
any drug or therapeutic device included in the types of drugs and | 109 |
devices listed on the formulary, subject to all of the following: | 110 |
(1) The amount of the sample furnished shall not exceed a | 111 |
seventy-two-hour supply, except when the minimum available | 112 |
quantity of the sample is packaged in an amount that is greater | 113 |
than a seventy-two-hour supply, in which case the nurse may | 114 |
furnish the sample in the packaged amount. | 115 |
(2) No charge may be imposed for the sample or for furnishing | 116 |
it. | 117 |
(3) Samples of controlled substances may not be personally | 118 |
furnished. | 119 |
(E) The nurse may personally furnish to a patient a complete | 120 |
or partial supply of a drug or therapeutic device included in the | 121 |
types of drugs and devices listed on the formulary, subject to all | 122 |
of the following: | 123 |
(1) The nurse shall personally furnish only antibiotics, | 124 |
antifungals, scabicides, contraceptives, prenatal vitamins, | 125 |
antihypertensives, drugs and devices used in the treatment of | 126 |
diabetes, drugs and devices used in the treatment of asthma, and | 127 |
drugs used in the treatment of dyslipidemia. | 128 |
(2) The nurse shall not furnish the drugs and devices in | 129 |
locations other than a health department operated by the board of | 130 |
health of a city or general health district or the authority | 131 |
having the duties of a board of health under section 3709.05 of | 132 |
the Revised Code, a federally funded comprehensive primary care | 133 |
clinic, or a nonprofit health care clinic or program. | 134 |
(3) The nurse shall comply with all safety standards for | 135 |
personally furnishing supplies of drugs and devices, as | 136 |
established in rules adopted under section 4723.50 of the Revised | 137 |
Code. | 138 |
Sec. 4729.01. As used in this chapter: | 139 |
(A) "Pharmacy," except when used in a context that refers to | 140 |
the practice of pharmacy, means any area, room, rooms, place of | 141 |
business, department, or portion of any of the foregoing where the | 142 |
practice of pharmacy is conducted. | 143 |
(B) "Practice of pharmacy" means providing pharmacist care | 144 |
requiring specialized knowledge, judgment, and skill derived from | 145 |
the principles of biological, chemical, behavioral, social, | 146 |
pharmaceutical, and clinical sciences. As used in this division, | 147 |
"pharmacist care" includes the following: | 148 |
(1) Interpreting prescriptions; | 149 |
(2) Dispensing drugs and drug therapy related devices; | 150 |
(3) Compounding drugs; | 151 |
(4) Counseling individuals with regard to their drug therapy, | 152 |
recommending drug therapy related devices, and assisting in the | 153 |
selection of drugs and appliances for treatment of common diseases | 154 |
and injuries and providing instruction in the proper use of the | 155 |
drugs and appliances; | 156 |
(5) Performing drug regimen reviews with individuals by | 157 |
discussing all of the drugs that the individual is taking and | 158 |
explaining the interactions of the drugs; | 159 |
(6) Performing drug utilization reviews with licensed health | 160 |
professionals authorized to prescribe drugs when the pharmacist | 161 |
determines that an individual with a prescription has a drug | 162 |
regimen that warrants additional discussion with the prescriber; | 163 |
(7) Advising an individual and the health care professionals | 164 |
treating an individual with regard to the individual's drug | 165 |
therapy; | 166 |
(8) Acting pursuant to a consult agreement with a physician | 167 |
authorized under Chapter 4731. of the Revised Code to practice | 168 |
medicine and surgery or osteopathic medicine and surgery, if an | 169 |
agreement has been established with the physician; | 170 |
(9) Engaging in the administration of immunizations to the | 171 |
extent authorized by section 4729.41 of the Revised Code. | 172 |
(C) "Compounding" means the preparation, mixing, assembling, | 173 |
packaging, and labeling of one or more drugs in any of the | 174 |
following circumstances: | 175 |
(1) Pursuant to a prescription issued by a licensed health | 176 |
professional authorized to prescribe drugs; | 177 |
(2) Pursuant to the modification of a prescription made in | 178 |
accordance with a consult agreement; | 179 |
(3) As an incident to research, teaching activities, or | 180 |
chemical analysis; | 181 |
(4) In anticipation of orders for drugs pursuant to | 182 |
prescriptions, based on routine, regularly observed dispensing | 183 |
patterns; | 184 |
(5) Pursuant to a request made by a licensed health | 185 |
professional authorized to prescribe drugs for a drug that is to | 186 |
be used by the professional for the purpose of direct | 187 |
administration to patients in the course of the professional's | 188 |
practice, if all of the following apply: | 189 |
(a) At the time the request is made, the drug is not | 190 |
commercially available regardless of the reason that the drug is | 191 |
not available, including the absence of a manufacturer for the | 192 |
drug or the lack of a readily available supply of the drug from a | 193 |
manufacturer. | 194 |
(b) A limited quantity of the drug is compounded and provided | 195 |
to the professional. | 196 |
(c) The drug is compounded and provided to the professional | 197 |
as an occasional exception to the normal practice of dispensing | 198 |
drugs pursuant to patient-specific prescriptions. | 199 |
(D) "Consult agreement" means an agreement to manage an | 200 |
individual's drug therapy that has been entered into by a | 201 |
pharmacist and a physician authorized under Chapter 4731. of the | 202 |
Revised Code to practice medicine and surgery or osteopathic | 203 |
medicine and surgery. | 204 |
(E) "Drug" means: | 205 |
(1) Any article recognized in the United States pharmacopoeia | 206 |
and national formulary, or any supplement to them, intended for | 207 |
use in the diagnosis, cure, mitigation, treatment, or prevention | 208 |
of disease in humans or animals; | 209 |
(2) Any other article intended for use in the diagnosis, | 210 |
cure, mitigation, treatment, or prevention of disease in humans or | 211 |
animals; | 212 |
(3) Any article, other than food, intended to affect the | 213 |
structure or any function of the body of humans or animals; | 214 |
(4) Any article intended for use as a component of any | 215 |
article specified in division (E)(1), (2), or (3) of this section; | 216 |
but does not include devices or their components, parts, or | 217 |
accessories. | 218 |
(F) "Dangerous drug" means any of the following: | 219 |
(1) Any drug to which either of the following applies: | 220 |
(a) Under the "Federal Food, Drug, and Cosmetic Act," 52 | 221 |
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is | 222 |
required to bear a label containing the legend "Caution: Federal | 223 |
law prohibits dispensing without prescription" or "Caution: | 224 |
Federal law restricts this drug to use by or on the order of a | 225 |
licensed veterinarian" or any similar restrictive statement, or | 226 |
the drug may be dispensed only upon a prescription; | 227 |
(b) Under Chapter 3715. or 3719. of the Revised Code, the | 228 |
drug may be dispensed only upon a prescription. | 229 |
(2) Any drug that contains a schedule V controlled substance | 230 |
and that is exempt from Chapter 3719. of the Revised Code or to | 231 |
which that chapter does not apply; | 232 |
(3) Any drug intended for administration by injection into | 233 |
the human body other than through a natural orifice of the human | 234 |
body. | 235 |
(G) "Federal drug abuse control laws" has the same meaning as | 236 |
in section 3719.01 of the Revised Code. | 237 |
(H) "Prescription" means a written, electronic, or oral order | 238 |
for drugs or combinations or mixtures of drugs to be used by a | 239 |
particular individual or for treating a particular animal, issued | 240 |
by a licensed health professional authorized to prescribe drugs. | 241 |
(I) "Licensed health professional authorized to prescribe | 242 |
drugs" or "prescriber" means an individual who is authorized by | 243 |
law to prescribe drugs or dangerous drugs or drug therapy related | 244 |
devices in the course of the individual's professional practice, | 245 |
including only the following: | 246 |
(1) A dentist licensed under Chapter 4715. of the Revised | 247 |
Code; | 248 |
(2) A clinical nurse specialist, certified nurse-midwife, or | 249 |
certified nurse practitioner who holds a certificate to prescribe | 250 |
issued under section 4723.48 of the Revised Code; | 251 |
(3) An optometrist licensed under Chapter 4725. of the | 252 |
Revised Code to practice optometry under a therapeutic | 253 |
pharmaceutical agents certificate; | 254 |
(4) A physician authorized under Chapter 4731. of the Revised | 255 |
Code to practice medicine and surgery, osteopathic medicine and | 256 |
surgery, or podiatry; | 257 |
(5) A physician assistant who holds a certificate to | 258 |
prescribe issued under Chapter 4730. of the Revised Code; | 259 |
(6) A veterinarian licensed under Chapter 4741. of the | 260 |
Revised Code. | 261 |
(J) "Sale" and "sell" include delivery, transfer, barter, | 262 |
exchange, or gift, or offer therefor, and each such transaction | 263 |
made by any person, whether as principal proprietor, agent, or | 264 |
employee. | 265 |
(K) "Wholesale sale" and "sale at wholesale" mean any sale in | 266 |
which the purpose of the purchaser is to resell the article | 267 |
purchased or received by the purchaser. | 268 |
(L) "Retail sale" and "sale at retail" mean any sale other | 269 |
than a wholesale sale or sale at wholesale. | 270 |
(M) "Retail seller" means any person that sells any dangerous | 271 |
drug to consumers without assuming control over and responsibility | 272 |
for its administration. Mere advice or instructions regarding | 273 |
administration do not constitute control or establish | 274 |
responsibility. | 275 |
(N) "Price information" means the price charged for a | 276 |
prescription for a particular drug product and, in an easily | 277 |
understandable manner, all of the following: | 278 |
(1) The proprietary name of the drug product; | 279 |
(2) The established (generic) name of the drug product; | 280 |
(3) The strength of the drug product if the product contains | 281 |
a single active ingredient or if the drug product contains more | 282 |
than one active ingredient and a relevant strength can be | 283 |
associated with the product without indicating each active | 284 |
ingredient. The established name and quantity of each active | 285 |
ingredient are required if such a relevant strength cannot be so | 286 |
associated with a drug product containing more than one | 287 |
ingredient. | 288 |
(4) The dosage form; | 289 |
(5) The price charged for a specific quantity of the drug | 290 |
product. The stated price shall include all charges to the | 291 |
consumer, including, but not limited to, the cost of the drug | 292 |
product, professional fees, handling fees, if any, and a statement | 293 |
identifying professional services routinely furnished by the | 294 |
pharmacy. Any mailing fees and delivery fees may be stated | 295 |
separately without repetition. The information shall not be false | 296 |
or misleading. | 297 |
(O) "Wholesale distributor of dangerous drugs" means a person | 298 |
engaged in the sale of dangerous drugs at wholesale and includes | 299 |
any agent or employee of such a person authorized by the person to | 300 |
engage in the sale of dangerous drugs at wholesale. | 301 |
(P) "Manufacturer of dangerous drugs" means a person, other | 302 |
than a pharmacist, who manufactures dangerous drugs and who is | 303 |
engaged in the sale of those dangerous drugs within this state. | 304 |
(Q) "Terminal distributor of dangerous drugs" means a person | 305 |
who is engaged in the sale of dangerous drugs at retail, or any | 306 |
person, other than a wholesale distributor or a pharmacist, who | 307 |
has possession, custody, or control of dangerous drugs for any | 308 |
purpose other than for that person's own use and consumption, and | 309 |
includes pharmacies, hospitals, nursing homes, and laboratories | 310 |
and all other persons who procure dangerous drugs for sale or | 311 |
other distribution by or under the supervision of a pharmacist or | 312 |
licensed health professional authorized to prescribe drugs. | 313 |
(R) "Promote to the public" means disseminating a | 314 |
representation to the public in any manner or by any means, other | 315 |
than by labeling, for the purpose of inducing, or that is likely | 316 |
to induce, directly or indirectly, the purchase of a dangerous | 317 |
drug at retail. | 318 |
(S) "Person" includes any individual, partnership, | 319 |
association, limited liability company, or corporation, the state, | 320 |
any political subdivision of the state, and any district, | 321 |
department, or agency of the state or its political subdivisions. | 322 |
(T) "Finished dosage form" has the same meaning as in section | 323 |
3715.01 of the Revised Code. | 324 |
(U) "Generically equivalent drug" has the same meaning as in | 325 |
section 3715.01 of the Revised Code. | 326 |
(V) "Animal shelter" means a facility operated by a humane | 327 |
society or any society organized under Chapter 1717. of the | 328 |
Revised Code or a dog pound operated pursuant to Chapter 955. of | 329 |
the Revised Code. | 330 |
(W) "Food" has the same meaning as in section 3715.01 of the | 331 |
Revised Code. | 332 |
(X) "Pain management clinic" has the same meaning as in | 333 |
section 4731.054 of the Revised Code. | 334 |
Sec. 4729.071. (A) As used in this section, "license" and | 335 |
"applicant for an initial license" have the same meanings as in | 336 |
section 4776.01 of the Revised Code, except that "license" as used | 337 |
in both of those terms refers to the types of authorizations | 338 |
otherwise issued or conferred under this chapter. | 339 |
(B) In addition to any other eligibility requirement set | 340 |
forth in this chapter, each applicant for an initial license shall | 341 |
comply with sections 4776.01 to 4776.04 of the Revised Code. The | 342 |
state board of pharmacy shall not grant a license to an applicant | 343 |
for an initial license unless the applicant complies with sections | 344 |
4776.01 to 4776.04 of the Revised Code and the board, in its | 345 |
discretion, decides that the results of the criminal records check | 346 |
do not make the applicant ineligible for a license issued pursuant | 347 |
to section 4729.08, 4729.09, | 348 |
Revised Code. | 349 |
Sec. 4729.29. | 350 |
and section 4729.28 of the Revised Code do not do | 351 |
the following: | 352 |
| 353 |
prescribe drugs | 354 |
scope of professional practice; | 355 |
(B) Prevent a prescriber from personally furnishing the | 356 |
prescriber's patients with drugs, within the prescriber's scope of | 357 |
professional practice, that seem proper to the prescriber | 358 |
| 359 |
section 4729.291 of the Revised Code; | 360 |
(C) Apply to the sale of oxygen, peritoneal dialysis | 361 |
solutions, or the sale of drugs that are not dangerous drugs by a | 362 |
retail dealer, in original packages when labeled as required by | 363 |
the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), | 364 |
21 U.S.C.A. 301, as amended. | 365 |
| 366 |
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| 374 |
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378 |
Sec. 4729.291. (A) When a licensed health professional | 379 |
authorized to prescribe drugs personally furnishes drugs to a | 380 |
patient pursuant to division (B) of section 4729.29 of the Revised | 381 |
Code, the prescriber shall ensure that the drugs are labeled and | 382 |
packaged in accordance with state and federal drug laws and any | 383 |
rules and regulations adopted pursuant to those laws. Records of | 384 |
purchase and disposition of all drugs personally furnished to | 385 |
patients shall be maintained by the prescriber in accordance with | 386 |
state and federal drug statutes and any rules adopted pursuant to | 387 |
those statutes. | 388 |
(B) When personally furnishing to a patient RU-486 | 389 |
(mifepristone), a prescriber is subject to section 2919.123 of the | 390 |
Revised Code. A prescription for RU-486 (mifepristone) shall be in | 391 |
writing and in accordance with section 2919.123 of the Revised | 392 |
Code. | 393 |
(C) Except in the case of a veterinarian, a prescriber may | 394 |
not do either of the following: | 395 |
(1) In any thirty-day period, personally furnish an amount of | 396 |
all controlled substances combined that exceeds a total of two | 397 |
thousand five hundred dosage units; | 398 |
(2) In any twenty-four-hour period, personally furnish to or | 399 |
for a patient an amount of a controlled substance that exceeds the | 400 |
amount necessary for the patient's use in a twenty-four-hour | 401 |
period. | 402 |
Sec. 4729.51. (A) No person other than a registered | 403 |
wholesale distributor of dangerous drugs shall possess for sale, | 404 |
sell, distribute, or deliver, at wholesale, dangerous drugs, | 405 |
except as follows: | 406 |
(1) A pharmacist who is a licensed terminal distributor of | 407 |
dangerous drugs or who is employed by a licensed terminal | 408 |
distributor of dangerous drugs may make occasional sales of | 409 |
dangerous drugs at wholesale; | 410 |
(2) A licensed terminal distributor of dangerous drugs having | 411 |
more than one establishment or place may transfer or deliver | 412 |
dangerous drugs from one establishment or place for which a | 413 |
license has been issued to the terminal distributor to another | 414 |
establishment or place for which a license has been issued to the | 415 |
terminal distributor if the license issued for each establishment | 416 |
or place is in effect at the time of the transfer or delivery. | 417 |
(B)(1) No registered wholesale distributor of dangerous drugs | 418 |
shall possess for sale, or sell, at wholesale, dangerous drugs to | 419 |
any person other than the following: | 420 |
(a) | 421 |
a licensed health professional authorized to prescribe drugs; | 422 |
(b) An optometrist licensed under Chapter 4725. of the | 423 |
Revised Code who holds a topical ocular pharmaceutical agents | 424 |
certificate; | 425 |
(c) A registered wholesale distributor of dangerous drugs; | 426 |
(d) A manufacturer of dangerous drugs; | 427 |
(e) | 428 |
terminal distributor of dangerous drugs | 429 |
430 |
(f) Carriers or warehousers for the purpose of carriage or | 431 |
storage; | 432 |
(g) Terminal or wholesale distributors of dangerous drugs who | 433 |
are not engaged in the sale of dangerous drugs within this state; | 434 |
(h) An individual who holds a current license, certificate, | 435 |
or registration issued under Title 47 of the Revised Code and has | 436 |
been certified to conduct diabetes education by a national | 437 |
certifying body specified in rules adopted by the state board of | 438 |
pharmacy under section 4729.68 of the Revised Code, but only with | 439 |
respect to insulin that will be used for the purpose of diabetes | 440 |
education and only if diabetes education is within the | 441 |
individual's scope of practice under statutes and rules regulating | 442 |
the individual's profession; | 443 |
(i) An individual who holds a valid certificate issued by a | 444 |
nationally recognized S.C.U.B.A. diving certifying organization | 445 |
approved by the state board of pharmacy | 446 |
with respect to medical oxygen that will be used for the purpose | 447 |
of emergency care or treatment at the scene of a diving emergency; | 448 |
(j) | 449 |
a business entity that is a corporation formed under division (B) | 450 |
of section 1701.03 of the Revised Code, a limited liability | 451 |
company formed under Chapter 1705. of the Revised Code, or a | 452 |
professional association formed under Chapter 1785. of the Revised | 453 |
Code if the entity has a sole shareholder who is a licensed health | 454 |
professional authorized to prescribe drugs and is authorized to | 455 |
provide the professional services being offered by the entity; | 456 |
(k) | 457 |
a business entity that is a corporation formed under division (B) | 458 |
of section 1701.03 of the Revised Code, a limited liability | 459 |
company formed under Chapter 1705. of the Revised Code, a | 460 |
partnership or a limited liability partnership formed under | 461 |
Chapter 1775. of the Revised Code, or a professional association | 462 |
formed under Chapter 1785. of the Revised Code, if, to be a | 463 |
shareholder, member, or partner, an individual is required to be | 464 |
licensed, certified, or otherwise legally authorized under Title | 465 |
XLVII of the Revised Code to perform the professional service | 466 |
provided by the entity and each such individual is a licensed | 467 |
health professional authorized to prescribe drugs. | 468 |
(2) No registered wholesaler of dangerous drugs shall possess | 469 |
for sale, or sell, at wholesale, dangerous drugs to any of the | 470 |
following: | 471 |
(a) A prescriber who is employed by a pain management clinic | 472 |
that is not licensed as a terminal distributor of dangerous drugs | 473 |
with a pain management clinic classification issued under section | 474 |
4729.552 of the Revised Code; | 475 |
(b) A business entity described in division (B)(1)(j) of this | 476 |
section that is, or is operating, a pain management clinic without | 477 |
a license as a terminal distributor of dangerous drugs with a pain | 478 |
management clinic classification issued under section 4729.552 of | 479 |
the Revised Code; | 480 |
(c) A business entity described in division (B)(1)(k) of this | 481 |
section that is, or is operating, a pain management clinic without | 482 |
a license as a terminal distributor of dangerous drugs with a pain | 483 |
management clinic classification issued under section 4729.552 of | 484 |
the Revised Code. | 485 |
(3) No registered wholesale distributor of dangerous drugs | 486 |
shall possess dangerous drugs for sale at wholesale, or sell such | 487 |
drugs at wholesale, to a licensed terminal distributor of | 488 |
dangerous drugs, except | 489 |
(a) | 490 |
category I license, only dangerous drugs described in category I, | 491 |
as defined in division (A)(1) of section 4729.54 of the Revised | 492 |
Code; | 493 |
(b) | 494 |
category II license, only dangerous drugs described in category I | 495 |
and category II, as defined in divisions (A)(1) and (2) of section | 496 |
4729.54 of the Revised Code; | 497 |
(c) | 498 |
category III license, dangerous drugs described in category I, | 499 |
category II, and category III, as defined in divisions (A)(1), | 500 |
(2), and (3) of section 4729.54 of the Revised Code; | 501 |
(d) | 502 |
limited category I, II, or III license, only the dangerous drugs | 503 |
specified in the certificate furnished by the terminal distributor | 504 |
in accordance with section 4729.60 of the Revised Code. | 505 |
(C)(1) Except as provided in division (C)(4) of this section, | 506 |
no person shall sell, at retail, dangerous drugs. | 507 |
(2) Except as provided in division (C)(4) of this section, no | 508 |
person shall possess for sale, at retail, dangerous drugs. | 509 |
(3) Except as provided in division (C)(4) of this section, no | 510 |
person shall possess dangerous drugs. | 511 |
(4) Divisions (C)(1), (2), and (3) of this section do not | 512 |
apply to a registered wholesale distributor of dangerous drugs, a | 513 |
licensed terminal distributor of dangerous drugs, or a person who | 514 |
possesses, or possesses for sale or sells, at retail, a dangerous | 515 |
drug in accordance with Chapters 3719., 4715., 4723., 4725., | 516 |
4729., 4730., 4731., and 4741. of the Revised Code. | 517 |
Divisions (C)(1), (2), and (3) of this section do not apply | 518 |
to an individual who holds a current license, certificate, or | 519 |
registration issued under Title XLVII of the Revised Code and has | 520 |
been certified to conduct diabetes education by a national | 521 |
certifying body specified in rules adopted by the state board of | 522 |
pharmacy under section 4729.68 of the Revised Code, but only to | 523 |
the extent that the individual possesses insulin or personally | 524 |
supplies insulin solely for the purpose of diabetes education and | 525 |
only if diabetes education is within the individual's scope of | 526 |
practice under statutes and rules regulating the individual's | 527 |
profession. | 528 |
Divisions (C)(1), (2), and (3) of this section do not apply | 529 |
to an individual who holds a valid certificate issued by a | 530 |
nationally recognized S.C.U.B.A. diving certifying organization | 531 |
approved by the state board of pharmacy | 532 |
the extent that the individual possesses medical oxygen or | 533 |
personally supplies medical oxygen for the purpose of emergency | 534 |
care or treatment at the scene of a diving emergency. | 535 |
(D) No licensed terminal distributor of dangerous drugs shall | 536 |
purchase for the purpose of resale dangerous drugs from any person | 537 |
other than a registered wholesale distributor of dangerous drugs, | 538 |
except as follows: | 539 |
(1) A licensed terminal distributor of dangerous drugs may | 540 |
make occasional purchases of dangerous drugs for resale from a | 541 |
pharmacist who is a licensed terminal distributor of dangerous | 542 |
drugs or who is employed by a licensed terminal distributor of | 543 |
dangerous drugs; | 544 |
(2) A licensed terminal distributor of dangerous drugs having | 545 |
more than one establishment or place may transfer or receive | 546 |
dangerous drugs from one establishment or place for which a | 547 |
license has been issued to the terminal distributor to another | 548 |
establishment or place for which a license has been issued to the | 549 |
terminal distributor if the license issued for each establishment | 550 |
or place is in effect at the time of the transfer or receipt. | 551 |
(E) No licensed terminal distributor of dangerous drugs shall | 552 |
engage in the sale or other distribution of dangerous drugs at | 553 |
retail or maintain possession, custody, or control of dangerous | 554 |
drugs for any purpose other than the distributor's personal use or | 555 |
consumption, at any establishment or place other than that or | 556 |
those described in the license issued by the state board of | 557 |
pharmacy to such terminal distributor. | 558 |
(F) Nothing in this section shall be construed to interfere | 559 |
with the performance of official duties by any law enforcement | 560 |
official authorized by municipal, county, state, or federal law to | 561 |
collect samples of any drug, regardless of its nature or in whose | 562 |
possession it may be. | 563 |
Sec. 4729.54. (A) As used in this section and section | 564 |
4729.541 of the Revised Code: | 565 |
(1) "Category I" means single-dose injections of intravenous | 566 |
fluids, including saline, Ringer's lactate, five per cent dextrose | 567 |
and distilled water, and other intravenous fluids or parenteral | 568 |
solutions included in this category by rule of the state board of | 569 |
pharmacy, that have a volume of one hundred milliliters or more | 570 |
and that contain no added substances, or single-dose injections of | 571 |
epinephrine to be administered pursuant to sections 4765.38 and | 572 |
4765.39 of the Revised Code. | 573 |
(2) "Category II" means any dangerous drug that is not | 574 |
included in category I or III. | 575 |
(3) "Category III" means any controlled substance that is | 576 |
contained in schedule I, II, III, IV, or V. | 577 |
(4) "Emergency medical service organization" has the same | 578 |
meaning as in section 4765.01 of the Revised Code. | 579 |
(5) "Person" includes an emergency medical service | 580 |
organization. | 581 |
(6) "Schedule I, schedule II, schedule III, schedule IV, and | 582 |
schedule V" mean controlled substance schedules I, II, III, IV, | 583 |
and V, respectively, as established pursuant to section 3719.41 of | 584 |
the Revised Code and as amended. | 585 |
(B)(1) A person who desires to be licensed as a terminal | 586 |
distributor of dangerous drugs shall file with the executive | 587 |
director of the state board of pharmacy a verified application | 588 |
589 | |
withdrawn without approval of the board. | 590 |
(2) An application shall contain all the following that apply | 591 |
in the applicant's case: | 592 |
| 593 |
qualifications of a terminal distributor of dangerous drugs set | 594 |
forth in section 4729.55 of the Revised Code; | 595 |
| 596 |
category I, category II, category III, limited category I, limited | 597 |
category II, or limited category III terminal distributor of | 598 |
dangerous drugs; | 599 |
| 600 |
category I, limited category II, or limited category III terminal | 601 |
distributor of dangerous drugs, a notarized list of the dangerous | 602 |
drugs that the person wishes to possess, have custody or control | 603 |
of, and distribute, which list shall also specify the purpose for | 604 |
which those drugs will be used and their source; | 605 |
| 606 |
organization, the information that is specified in division (C)(1) | 607 |
of this section; | 608 |
| 609 |
the identity of the one establishment or place at which the person | 610 |
intends to engage in the sale or other distribution of dangerous | 611 |
drugs at retail, and maintain possession, custody, or control of | 612 |
dangerous drugs for purposes other than the person's own use or | 613 |
consumption; | 614 |
(f) If the application pertains to a pain management clinic, | 615 |
information that demonstrates, to the satisfaction of the board, | 616 |
compliance with division (A) of section 4729.552 of the Revised | 617 |
Code. | 618 |
(C)(1) An emergency medical service organization that wishes | 619 |
to be licensed as a terminal distributor of dangerous drugs shall | 620 |
list in its application for licensure the following additional | 621 |
information: | 622 |
(a) The units under its control that the organization | 623 |
determines will possess dangerous drugs for the purpose of | 624 |
administering emergency medical services in accordance with | 625 |
Chapter 4765. of the Revised Code; | 626 |
(b) With respect to each such unit, whether the dangerous | 627 |
drugs that the organization determines the unit will possess are | 628 |
in category I, II, or III. | 629 |
(2) An emergency medical service organization that is | 630 |
licensed as a terminal distributor of dangerous drugs shall file a | 631 |
new application for such licensure if there is any change in the | 632 |
number, or location of, any of its units or any change in the | 633 |
category of the dangerous drugs that any unit will possess. | 634 |
(3) A unit listed in an application for licensure pursuant to | 635 |
division (C)(1) of this section may obtain the dangerous drugs it | 636 |
is authorized to possess from its emergency medical service | 637 |
organization or, on a replacement basis, from a hospital pharmacy. | 638 |
If units will obtain dangerous drugs from a hospital pharmacy, the | 639 |
organization shall file, and maintain in current form, the | 640 |
following items with the pharmacist who is responsible for the | 641 |
hospital's terminal distributor of dangerous drugs license: | 642 |
(a) A copy of its standing orders or protocol; | 643 |
(b) A list of the personnel employed or used by the | 644 |
organization to provide emergency medical services in accordance | 645 |
with Chapter 4765. of the Revised Code, who are authorized to | 646 |
possess the drugs, which list also shall indicate the personnel | 647 |
who are authorized to administer the drugs. | 648 |
(D) Each emergency medical service organization that applies | 649 |
for a terminal distributor of dangerous drugs license shall submit | 650 |
with its application the following: | 651 |
(1) A notarized copy of its standing orders or protocol, | 652 |
which orders or protocol shall be signed by a physician and | 653 |
specify the dangerous drugs that its units may carry, expressed in | 654 |
standard dose units; | 655 |
(2) A list of the personnel employed or used by the | 656 |
organization to provide emergency medical services in accordance | 657 |
with Chapter 4765. of the Revised Code. | 658 |
An emergency medical service organization that is licensed as | 659 |
a terminal distributor shall notify the board immediately of any | 660 |
changes in its standing orders or protocol. | 661 |
(E) There shall be six categories of terminal distributor of | 662 |
dangerous drugs licenses, which categories shall be as follows: | 663 |
(1) Category I license. A person who obtains this license may | 664 |
possess, have custody or control of, and distribute only the | 665 |
dangerous drugs described in category I. | 666 |
(2) Limited category I license. A person who obtains this | 667 |
license may possess, have custody or control of, and distribute | 668 |
only the dangerous drugs described in category I that were listed | 669 |
in the application for licensure. | 670 |
(3) Category II license. A person who obtains this license | 671 |
may possess, have custody or control of, and distribute only the | 672 |
dangerous drugs described in category I and category II. | 673 |
(4) Limited category II license. A person who obtains this | 674 |
license may possess, have custody or control of, and distribute | 675 |
only the dangerous drugs described in category I or category II | 676 |
that were listed in the application for licensure. | 677 |
(5) Category III license, which may include a pain management | 678 |
clinic classification issued under section 4729.552 of the Revised | 679 |
Code. A person who obtains this license may possess, have custody | 680 |
or control of, and distribute the dangerous drugs described in | 681 |
category I, category II, and category III. | 682 |
(6) Limited category III license. A person who obtains this | 683 |
license may possess, have custody or control of, and distribute | 684 |
only the dangerous drugs described in category I, category II, or | 685 |
category III that were listed in the application for licensure. | 686 |
(F) Except for an application made on behalf of an animal | 687 |
shelter, if an applicant for licensure as a limited category I, | 688 |
II, or III terminal distributor of dangerous drugs intends to | 689 |
administer dangerous drugs to a person or animal, the applicant | 690 |
shall submit, with the application, a notarized copy of its | 691 |
protocol or standing orders, which protocol or orders shall be | 692 |
signed by a licensed health professional authorized to prescribe | 693 |
drugs, specify the dangerous drugs to be administered, and list | 694 |
personnel who are authorized to administer the dangerous drugs in | 695 |
accordance with federal law or the law of this state. An | 696 |
application made on behalf of an animal shelter shall include a | 697 |
notarized list of the dangerous drugs to be administered to | 698 |
animals and the personnel who are authorized to administer the | 699 |
drugs to animals in accordance with section 4729.532 of the | 700 |
Revised Code. After obtaining a terminal distributor license, a | 701 |
licensee shall notify the board immediately of any changes in its | 702 |
protocol or standing orders, or in such personnel. | 703 |
(G)(1) Except as provided in division (G)(2) of this section, | 704 |
each applicant for licensure as a terminal distributor of | 705 |
dangerous drugs shall submit, with the application, a license fee | 706 |
determined as follows: | 707 |
(a) For a category I or limited category I license, | 708 |
forty-five dollars; | 709 |
(b) For a category II or limited category II license, one | 710 |
hundred twelve dollars and fifty cents; | 711 |
(c) For a category III license, including a license with a | 712 |
pain management clinic classification issued under section | 713 |
4729.552 of the Revised Code, or a limited category III license, | 714 |
one hundred fifty dollars. | 715 |
(2) For a professional association, corporation, partnership, | 716 |
or limited liability company organized for the purpose of | 717 |
practicing veterinary medicine, the fee shall be forty dollars. | 718 |
(3) Fees assessed under divisions (G)(1) and (2) of this | 719 |
section shall not be returned if the applicant fails to qualify | 720 |
for registration. | 721 |
(H)(1) The board shall issue a terminal distributor of | 722 |
dangerous drugs license to each person who submits an application | 723 |
for such licensure in accordance with this section, pays the | 724 |
required license fee, is determined by the board to meet the | 725 |
requirements set forth in section 4729.55 of the Revised Code, and | 726 |
satisfies any other applicable requirements of this section. | 727 |
(2) The license of a person other than an emergency medical | 728 |
service organization shall describe the one establishment or place | 729 |
at which the licensee may engage in the sale or other distribution | 730 |
of dangerous drugs at retail and maintain possession, custody, or | 731 |
control of dangerous drugs for purposes other than the licensee's | 732 |
own use or consumption. The one establishment or place shall be | 733 |
that which is described in the application for licensure. | 734 |
No such license shall authorize or permit the terminal | 735 |
distributor of dangerous drugs named in it to engage in the sale | 736 |
or other distribution of dangerous drugs at retail or to maintain | 737 |
possession, custody, or control of dangerous drugs for any purpose | 738 |
other than the distributor's own use or consumption, at any | 739 |
establishment or place other than that described in the license, | 740 |
except that an agent or employee of an animal shelter may possess | 741 |
and use dangerous drugs in the course of business as provided in | 742 |
division (D) of section 4729.532 of the Revised Code. | 743 |
(3) The license of an emergency medical service organization | 744 |
shall cover and describe all the units of the organization listed | 745 |
in its application for licensure. | 746 |
(4) The license of every terminal distributor of dangerous | 747 |
drugs shall indicate, on its face, the category of licensure. If | 748 |
the license is a limited category I, II, or III license, it shall | 749 |
specify, and shall authorize the licensee to possess, have custody | 750 |
or control of, and distribute only, the dangerous drugs that were | 751 |
listed in the application for licensure. | 752 |
(I) All licenses issued pursuant to this section shall be | 753 |
effective for a period of twelve months from the first day of | 754 |
January of each year. A license shall be renewed by the board for | 755 |
a like period, annually, according to the provisions of this | 756 |
section, and the standard renewal procedure of Chapter 4745. of | 757 |
the Revised Code. A person who desires to renew a license shall | 758 |
submit an application for renewal and pay the required fee on or | 759 |
before the thirty-first day of December each year. The fee | 760 |
required for the renewal of a license shall be the same as the fee | 761 |
paid for the license being renewed, and shall accompany the | 762 |
application for renewal. | 763 |
A license that has not been renewed during December in any | 764 |
year and by the first day of February of the following year may be | 765 |
reinstated only upon payment of the required renewal fee and a | 766 |
penalty fee of fifty-five dollars. | 767 |
(J)(1) No emergency medical service organization that is | 768 |
licensed as a terminal distributor of dangerous drugs shall fail | 769 |
to comply with division (C)(2) or (3) of this section. | 770 |
(2) No emergency medical service organization that is | 771 |
licensed as a terminal distributor of dangerous drugs shall fail | 772 |
to comply with division (D) of this section. | 773 |
(3) No licensed terminal distributor of dangerous drugs shall | 774 |
possess, have custody or control of, or distribute dangerous drugs | 775 |
that the terminal distributor is not entitled to possess, have | 776 |
custody or control of, or distribute by virtue of its category of | 777 |
licensure. | 778 |
(4) No licensee that is required by division (F) of this | 779 |
section to notify the board of changes in its protocol or standing | 780 |
orders, or in personnel, shall fail to comply with that division. | 781 |
Sec. 4729.541. | 782 |
(B) of this section, a business entity described in division | 783 |
(B)(1)(j) or (k) of section 4729.51 of the Revised Code may | 784 |
possess, have custody or control of, and distribute the dangerous | 785 |
drugs in category I, category II, and category III of section | 786 |
4729.54 of the Revised Code without holding a terminal distributor | 787 |
of dangerous drugs license issued under that section. | 788 |
(B) If a business entity described in division (B)(1)(j) or | 789 |
(k) of section 4729.51 of the Revised Code is a pain management | 790 |
clinic or is operating a pain management clinic, the entity shall | 791 |
hold a license as a terminal distributor of dangerous drugs with a | 792 |
pain management clinic classification issued under section | 793 |
4729.552 of the Revised Code. | 794 |
Sec. 4729.55. No license shall be issued to an applicant for | 795 |
licensure as a terminal distributor of dangerous drugs unless the | 796 |
applicant has furnished satisfactory proof to the state board of | 797 |
pharmacy that: | 798 |
(A) The applicant is equipped as to land, buildings, and | 799 |
equipment to properly carry on the business of a terminal | 800 |
distributor of dangerous drugs within the category of licensure | 801 |
approved by the board. | 802 |
(B) A pharmacist, licensed health professional authorized to | 803 |
prescribe drugs, animal shelter licensed with the state board of | 804 |
pharmacy under section 4729.531 of the Revised Code, or a | 805 |
laboratory as defined in section 3719.01 of the Revised Code will | 806 |
maintain supervision and control over the possession and custody | 807 |
of dangerous drugs that may be acquired by or on behalf of the | 808 |
applicant. | 809 |
(C) Adequate safeguards are assured to prevent the sale or | 810 |
other distribution of dangerous drugs by any person other than a | 811 |
pharmacist or licensed health professional authorized to prescribe | 812 |
drugs. | 813 |
(D) Adequate safeguards are assured that the applicant will | 814 |
carry on the business of a terminal distributor of dangerous drugs | 815 |
in a manner that allows pharmacists and pharmacy interns employed | 816 |
by the terminal distributor to practice pharmacy in a safe and | 817 |
effective manner. | 818 |
(E) If the applicant, or any agent or employee of the | 819 |
applicant, has been found guilty of violating section 4729.51 of | 820 |
the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 | 821 |
Stat. 1040 (1938), 21 U.S.C.A. 301, the federal drug abuse control | 822 |
laws, Chapter 2925., 3715., 3719., or 4729. of the Revised Code, | 823 |
or any rule of the board, adequate safeguards are assured to | 824 |
prevent the recurrence of the violation. | 825 |
(F) In the case of an applicant who is a food processor or | 826 |
retail seller of food, the applicant will maintain supervision and | 827 |
control over the possession and custody of nitrous oxide. | 828 |
(G) In the case of an applicant who is a retail seller of | 829 |
oxygen in original packages labeled as required by the "Federal | 830 |
Food, Drug, and Cosmetic Act," the applicant will maintain | 831 |
supervision and control over the possession, custody, and retail | 832 |
sale of the oxygen. | 833 |
(H) If the application is made on behalf of an animal | 834 |
shelter, at least one of the agents or employees of the animal | 835 |
shelter is certified in compliance with section 4729.532 of the | 836 |
Revised Code. | 837 |
(I) In the case of an applicant who is a retail seller of | 838 |
peritoneal dialysis solutions in original packages labeled as | 839 |
required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat. | 840 |
1040 (1938), 21 U.S.C.A. 301, the applicant will maintain | 841 |
supervision and control over the possession, custody, and retail | 842 |
sale of the peritoneal dialysis solutions. | 843 |
(J) In the case of an applicant who is a pain management | 844 |
clinic, the applicant meets the requirements to receive a license | 845 |
with a pain management clinic classification issued under section | 846 |
4729.552 of the Revised Code. | 847 |
Sec. 4729.552. (A) To be eligible for a license as a category | 848 |
III terminal distributor of dangerous drugs with a pain management | 849 |
clinic classification, an applicant shall meet all of the | 850 |
following requirements: | 851 |
(1) Be in control of a facility that is owned and operated | 852 |
solely by either of the following: | 853 |
(a) One or more physicians authorized under Chapter 4731. of | 854 |
the Revised Code to practice medicine and surgery or osteopathic | 855 |
medicine and surgery; | 856 |
(b) An entity described in division (B)(1)(j) or (k) of | 857 |
section 4729.51 of the Revised Code. | 858 |
(2) Ensure that any person employed by the facility complies | 859 |
with the requirements for the operation of a pain management | 860 |
clinic established by the state medical board in rules adopted | 861 |
under section 4731.054 of the Revised Code; | 862 |
(3) Require any person with ownership of the facility to | 863 |
submit to a criminal records check in accordance with section | 864 |
4776.02 of the Revised Code and send the results of the criminal | 865 |
records check directly to the state board of pharmacy for review | 866 |
and decision under section 4729.071 of the Revised Code; | 867 |
(4) Require all employees of the facility to submit to a | 868 |
criminal records check in accordance with section 4776.02 of the | 869 |
Revised Code and ensure that no person is employed who has | 870 |
previously been convicted of, or pleaded guilty to, any felony in | 871 |
this state, another state, or the United States. | 872 |
(B) If the state board of pharmacy determines that an | 873 |
applicant meets the requirements of division (A) of this section | 874 |
and any other applicable requirements under this chapter or | 875 |
Chapter 3719. of the Revised Code, the board shall issue to the | 876 |
applicant a license as a category III terminal distributor of | 877 |
dangerous drugs and specify on the license that the terminal | 878 |
distributor is classified as a pain management clinic. | 879 |
(C) No person shall operate a facility that under this | 880 |
chapter is subject to licensure as a category III terminal | 881 |
distributor of dangerous drugs with a pain management clinic | 882 |
classification without obtaining and maintaining the license with | 883 |
the classification. | 884 |
No person who holds a category III license with a pain | 885 |
management clinic classification shall fail to remain in | 886 |
compliance with the requirements of division (A) of this section | 887 |
and any other applicable requirements under this chapter or | 888 |
Chapter 3719. of the Revised Code. | 889 |
(D) The board may impose a fine of not more than five | 890 |
thousand dollars on a terminal distributor of dangerous drugs | 891 |
license holder who violates division (C) of this section. A | 892 |
separate fine may be imposed for each day the violation continues. | 893 |
Sec. 4729.561. If the state board of pharmacy determines that | 894 |
there is clear and convincing evidence that the method used by a | 895 |
wholesale distributor of dangerous drugs to distribute controlled | 896 |
substances presents a danger of immediate and serious harm to | 897 |
others, the board may suspend the wholesale distributor's | 898 |
registration certificate without a hearing. The board shall follow | 899 |
the procedure for suspension without a prior hearing in section | 900 |
119.07 of the Revised Code. The suspension shall remain in effect, | 901 |
unless removed by the board, until the board's final adjudication | 902 |
order becomes effective, except that if the board does not issue | 903 |
its final adjudication order within ninety days after the hearing, | 904 |
the suspension shall be void on the ninety-first day after the | 905 |
suspension. | 906 |
Sec. 4729.571. If the state board of pharmacy determines that | 907 |
there is clear and convincing evidence that the method used by a | 908 |
terminal distributor of dangerous drugs to distribute controlled | 909 |
substances presents a danger of immediate and serious harm to | 910 |
others, the board may suspend the terminal distributor's license | 911 |
without a hearing. The board shall follow the procedure for | 912 |
suspension without a prior hearing in section 119.07 of the | 913 |
Revised Code. The suspension shall remain in effect, unless | 914 |
removed by the board, until the board's final adjudication order | 915 |
becomes effective, except that if the board does not issue its | 916 |
final adjudication order within ninety days after the hearing, the | 917 |
suspension shall be void on the ninety-first day after the | 918 |
suspension. | 919 |
If the terminal distributor holds a license with a pain | 920 |
management clinic classification issued under section 4729.552 of | 921 |
the Revised Code and the person holding the license also holds a | 922 |
certificate issued under Chapter 4731. of the Revised Code to | 923 |
practice medicine and surgery or osteopathic medicine and surgery, | 924 |
prior to suspending the license without a hearing, the board shall | 925 |
consult with the secretary of the state medical board or, if the | 926 |
secretary is unavailable, another member of the board. | 927 |
Sec. 4729.69. (A) The state board of pharmacy, in | 928 |
collaboration with the director of alcohol and drug addiction | 929 |
services and attorney general, shall establish and administer a | 930 |
drug take-back program under which drugs are collected from the | 931 |
community for the purpose of destruction or disposal of the drugs. | 932 |
(B) The program shall be established and administered in such | 933 |
a manner that it does both of the following: | 934 |
(1) Complies with any state or federal laws regarding the | 935 |
collection, destruction, or disposal of drugs; | 936 |
(2) Maintains the confidentiality of individuals who submit | 937 |
or otherwise provide drugs under the program. | 938 |
(C) In consultation with the director of alcohol and drug | 939 |
addiction services and attorney general, the board shall adopt | 940 |
rules governing the program. The rules shall be adopted in | 941 |
accordance with Chapter 119. of the Revised Code. In adopting the | 942 |
rules, the board shall specify all of the following: | 943 |
(1) The entities that may participate, including health care | 944 |
providers, law enforcement personnel, universities, or | 945 |
individuals; | 946 |
(2) The drugs that may be collected; | 947 |
(3) The schedule, duration, and frequency of collections of | 948 |
drugs, except that the first collection shall occur not later than | 949 |
December 31, 2011; | 950 |
(4) Procedures for maintaining the confidentiality of | 951 |
individuals who submit or otherwise provide drugs under the | 952 |
program; | 953 |
(5) Any other standards and procedures the board considers | 954 |
necessary for purposes of governing the program. | 955 |
(D) The board, director, and attorney general shall advertise | 956 |
the program and otherwise inform the public about the program. | 957 |
(E) Entities that participate in the program may compile data | 958 |
on the amount and type of drugs collected. In compiling the data, | 959 |
the entities shall protect the confidentiality of individuals who | 960 |
submit or otherwise provide drugs to the program. The entities | 961 |
shall not be reimbursed through the program for compiling the | 962 |
data. | 963 |
(F) Any costs of the program shall be divided equally between | 964 |
the board, attorney general, and department of alcohol and drug | 965 |
addiction services. | 966 |
Sec. 4729.75. The state board of pharmacy may establish and | 967 |
maintain a drug database. The board shall use the drug database to | 968 |
monitor the misuse and diversion of controlled substances, as | 969 |
defined in section 3719.01 of the Revised Code, and other | 970 |
dangerous drugs the board includes in the database pursuant to | 971 |
rules adopted under section | 972 |
In establishing and maintaining the database, the board shall | 973 |
electronically collect information pursuant to sections 4729.77 | 974 |
and | 975 |
information as authorized or required by sections | 976 |
and | 977 |
and dissemination of information shall be conducted in accordance | 978 |
with rules adopted under section | 979 |
Code. | 980 |
Sec. 4729.77. (A) If the state board of pharmacy establishes | 981 |
and maintains a drug database pursuant to section 4729.75 of the | 982 |
Revised Code, each pharmacy licensed as a terminal distributor of | 983 |
dangerous drugs that dispenses drugs to patients in this state and | 984 |
is included in the types of pharmacies specified in rules adopted | 985 |
under section | 986 |
the board the following prescription information: | 987 |
(1) Terminal distributor identification; | 988 |
(2) Patient identification; | 989 |
(3) Prescriber identification; | 990 |
(4) Date prescription was issued by prescriber; | 991 |
(5) Date prescription was dispensed; | 992 |
(6) Indication of whether prescription dispensed is new or a | 993 |
refill; | 994 |
(7) Name, strength, and national drug code of the drug | 995 |
dispensed; | 996 |
(8) Quantity of drug dispensed; | 997 |
(9) Number of days' supply of drug dispensed; | 998 |
(10) Serial or prescription number assigned by the terminal | 999 |
distributor; | 1000 |
(11) Source of payment for the prescription. | 1001 |
(B)(1) The information shall be transmitted as specified by | 1002 |
the board in rules adopted under section | 1003 |
Revised Code. | 1004 |
| 1005 |
the format specified by the board, except that the board may grant | 1006 |
a waiver allowing the distributor to submit the information in | 1007 |
another format. | 1008 |
| 1009 |
any time limits specified by the board, except that the board may | 1010 |
grant an extension if either of the following occurs: | 1011 |
(a) The distributor suffers a mechanical or electronic | 1012 |
failure, or cannot meet the deadline for other reasons beyond the | 1013 |
distributor's control. | 1014 |
(b) The board is unable to receive electronic submissions. | 1015 |
(C) This section does not apply to a prescriber personally | 1016 |
furnishing or administering dangerous drugs to the prescriber's | 1017 |
patient. | 1018 |
Sec. 4729.78. (A) If the state board of pharmacy establishes | 1019 |
and maintains a drug database pursuant to section 4729.75 of the | 1020 |
Revised Code, each wholesale distributor of dangerous drugs that | 1021 |
delivers drugs in this state to prescribers | 1022 |
terminal distributors of dangerous drugs shall submit to the board | 1023 |
the following purchase information: | 1024 |
(1) Purchaser identification; | 1025 |
(2) Identification of the drug sold; | 1026 |
(3) Quantity of the drug sold; | 1027 |
(4) Date of sale; | 1028 |
(5) The wholesale distributor's license number issued by the | 1029 |
board. | 1030 |
(B)(1) The information shall be transmitted as specified by | 1031 |
the board in rules adopted under section | 1032 |
Revised Code. | 1033 |
| 1034 |
the format specified by the board, except that the board may grant | 1035 |
a waiver allowing the distributor to submit the information in | 1036 |
another format. | 1037 |
| 1038 |
any time limits specified by the board, except that the board may | 1039 |
grant an extension if either of the following occurs: | 1040 |
(a) The distributor suffers a mechanical or electronic | 1041 |
failure, or cannot meet the deadline for other reasons beyond the | 1042 |
distributor's control. | 1043 |
(b) The board is unable to receive electronic submissions. | 1044 |
Sec. 4729.79. (A) If the state board of pharmacy establishes | 1045 |
and maintains a drug database pursuant to section 4729.75 of the | 1046 |
Revised Code, each physician authorized under Chapter 4731. of the | 1047 |
Revised Code to practice medicine and surgery or osteopathic | 1048 |
medicine and surgery who personally furnishes a drug to a patient | 1049 |
in this state shall submit to the board the following information: | 1050 |
(1) Physician name; | 1051 |
(2) Patient identification; | 1052 |
(3) Date drug was furnished by the physician; | 1053 |
(4) Indication of whether the drug furnished is new or a | 1054 |
refill; | 1055 |
(5) Name and strength of drug furnished; | 1056 |
(6) Quantity of drug furnished; | 1057 |
(7) Number of days' supply of drug furnished. | 1058 |
(B)(1) The information shall be transmitted as specified by | 1059 |
the board in rules adopted under section 4729.84 of the Revised | 1060 |
Code. | 1061 |
(2) The information shall be submitted electronically in the | 1062 |
format specified by the board, except that the board may grant a | 1063 |
waiver allowing the physician to submit the information in another | 1064 |
format. | 1065 |
(3) The information shall be submitted in accordance with any | 1066 |
time limits specified by the board, except that the board may | 1067 |
grant an extension if either of the following occurs: | 1068 |
(a) The physician's transmission system suffers a mechanical | 1069 |
or electronic failure, or the physician cannot meet the deadline | 1070 |
for other reasons beyond the physician's control. | 1071 |
(b) The board is unable to receive electronic submissions. | 1072 |
(C) If the board becomes aware of a physician's failure to | 1073 |
comply with this section, the board shall notify the state medical | 1074 |
board. | 1075 |
| 1076 |
establishes and maintains a drug database pursuant to section | 1077 |
4729.75 of the Revised Code, the board may provide information | 1078 |
from the database in accordance with the following: | 1079 |
(1) On receipt of a request from a designated representative | 1080 |
of a government entity responsible for the licensure, regulation, | 1081 |
or discipline of | 1082 |
with authority to prescribe, administer, or dispense drugs, the | 1083 |
board may provide to the representative information from the | 1084 |
database relating to the professional who is the subject of an | 1085 |
active investigation being conducted by the government entity. | 1086 |
(2) On receipt of a request from a federal officer, or a | 1087 |
state or local officer of this or any other state, whose duties | 1088 |
include enforcing laws relating to drugs, the board may provide to | 1089 |
the officer information from the database relating to the person | 1090 |
who is the subject of an active investigation of a drug abuse | 1091 |
offense, as defined in section 2925.01 of the Revised Code, being | 1092 |
conducted by the officer's employing government entity. | 1093 |
(3) Pursuant to a subpoena issued by a grand jury, the board | 1094 |
may provide to the grand jury information from the database | 1095 |
relating to the person who is the subject of an investigation of | 1096 |
any offense being conducted by the grand jury. | 1097 |
(4) On receipt of a request from a | 1098 |
or the prescriber's agent registered with the board, the board may | 1099 |
provide to the | 1100 |
relating to a current patient of the | 1101 |
1102 | |
that it is for the purpose of providing medical | 1103 |
treatment to the patient who is the subject of the request. | 1104 |
(5) On receipt of a request from a pharmacist, the board may | 1105 |
provide to the pharmacist information from the database relating | 1106 |
to a current patient of the pharmacist, if the pharmacist | 1107 |
certifies in a form specified by the board that it is for the | 1108 |
purpose of the pharmacist's practice of pharmacy involving the | 1109 |
patient who is the subject of the request. | 1110 |
(6) On receipt of a request from an individual seeking the | 1111 |
individual's own database information in accordance with the | 1112 |
procedure established in rules adopted under section | 1113 |
4729.84 of the Revised Code, the board may provide to the | 1114 |
individual the individual's own database information. | 1115 |
(7) On receipt of a request from a physician in compliance | 1116 |
with section 4731.055 of the Revised Code, the board may provide | 1117 |
information relating to a current patient of the physician. | 1118 |
(8) On receipt of a request from the medical director of a | 1119 |
managed care organization that has entered into a data security | 1120 |
agreement with the board required by section 5111.1710 of the | 1121 |
Revised Code, the board may provide to the medical director | 1122 |
information from the database relating to a medicaid recipient | 1123 |
enrolled in the managed care organization. | 1124 |
(9) On receipt of a request from the director of job and | 1125 |
family services, the board may provide to the director information | 1126 |
from the database relating to a recipient of a program | 1127 |
administered by the department of job and family services. | 1128 |
(10) On receipt of a request from a requestor described in | 1129 |
division (A)(1), (2), (4), or (5) of this section who is from or | 1130 |
participating with another state's prescription monitoring | 1131 |
program, the board may provide to the requestor information from | 1132 |
the database, but only if there is a written agreement with that | 1133 |
state under which the information is to be used and disseminated | 1134 |
according to the laws of this state. | 1135 |
(B) The state board of pharmacy shall maintain a record of | 1136 |
each individual or entity that requests information from the | 1137 |
database pursuant to this section. In accordance with rules | 1138 |
adopted under section | 1139 |
board may use the records to document and report statistics and | 1140 |
law enforcement outcomes. | 1141 |
The board may provide records of an individual's requests for | 1142 |
database information to the following: | 1143 |
(1) A designated representative of a government entity that | 1144 |
is responsible for the licensure, regulation, or discipline of | 1145 |
1146 | |
prescribe, administer, or dispense drugs who is involved in an | 1147 |
active investigation being conducted by the government entity of | 1148 |
the individual who submitted the requests for database | 1149 |
information; | 1150 |
(2) A federal officer, or a state or local officer of this or | 1151 |
any other state, whose duties include enforcing laws relating to | 1152 |
drugs and who is involved in an active investigation being | 1153 |
conducted by the officer's employing government entity of the | 1154 |
individual who submitted the requests for database information. | 1155 |
(C) Information contained in the database and any information | 1156 |
obtained from it is not a public record. Information contained in | 1157 |
the records of requests for information from the database is not a | 1158 |
public record. Information that does not identify a person may be | 1159 |
released in summary, statistical, or aggregate form. | 1160 |
(D) | 1161 |
1162 | |
1163 | |
damages to any person in any civil action for injury, death, or | 1164 |
loss to person or property on the basis that the pharmacist or | 1165 |
prescriber did or did not seek or obtain information from the | 1166 |
database. | 1167 |
| 1168 |
establishes and maintains a drug database pursuant to section | 1169 |
4729.75 of the Revised Code, the board shall review the | 1170 |
information in the drug database. If the board determines from the | 1171 |
review that a violation of law may have occurred, it shall notify | 1172 |
the appropriate law enforcement agency or a government entity | 1173 |
responsible for the licensure, regulation, or discipline of | 1174 |
licensed health | 1175 |
and supply information required by the agency or entity for an | 1176 |
investigation of the violation of law that may have occurred. | 1177 |
| 1178 |
establishes a drug database pursuant to section 4729.75 of the | 1179 |
Revised Code, the information collected for the database shall be | 1180 |
retained in the database for at least two years.
| 1181 |
information that identifies a patient shall | 1182 |
after it has been retained for two years unless a law enforcement | 1183 |
agency or a government entity responsible for the licensure, | 1184 |
regulation, or discipline of licensed health | 1185 |
authorized to prescribe drugs has submitted a written request to | 1186 |
the board for retention of
| 1187 |
with rules adopted by the board under section | 1188 |
the Revised Code. | 1189 |
| 1190 |
establishes and maintains a drug database pursuant to section | 1191 |
4729.75 of the Revised Code, the board shall not impose any charge | 1192 |
on a terminal distributor of dangerous drugs, pharmacist, or | 1193 |
prescriber for the establishment or maintenance of the database. | 1194 |
The board shall not charge any fees for the transmission of data | 1195 |
to the database or for the receipt of information from the | 1196 |
database, except that the board may charge a fee in accordance | 1197 |
with rules adopted under section | 1198 |
Code to an individual who requests the individual's own database | 1199 |
information under section | 1200 |
(B) The board may accept grants, gifts, or donations to | 1201 |
operate the drug database. Such grants, gifts, or donations shall | 1202 |
be deposited in the drug database fund, which is hereby created in | 1203 |
the state treasury. Money in the fund shall be used solely for the | 1204 |
operation of the drug database. | 1205 |
| 1206 |
maintaining a drug database pursuant to section 4729.75 of the | 1207 |
Revised Code, the state board of pharmacy shall adopt rules in | 1208 |
accordance with Chapter 119. of the Revised Code to carry out and | 1209 |
enforce sections 4729.75 to | 1210 |
The rules shall specify all of the following: | 1211 |
(A) A means of identifying each patient, terminal distributor | 1212 |
of dangerous drugs, and each purchase at wholesale of dangerous | 1213 |
drugs about which information is entered into the drug database; | 1214 |
(B) Requirements for the transmission of information from | 1215 |
terminal distributors | 1216 |
distributors of dangerous drugs, and physicians for purposes of | 1217 |
the database; | 1218 |
(C) An electronic format for the submission of information | 1219 |
from terminal distributors | 1220 |
1221 |
(D) A procedure whereby a terminal distributor | 1222 |
wholesale distributor | 1223 |
submit information electronically may obtain a waiver to submit | 1224 |
information in another format; | 1225 |
(E) A procedure whereby the board may grant a request from a | 1226 |
law enforcement agency or a government entity responsible for the | 1227 |
licensure, regulation, or discipline of licensed health | 1228 |
professionals authorized to prescribe drugs that information that | 1229 |
has been stored for two years be retained when the information | 1230 |
pertains to an open investigation being conducted by the agency or | 1231 |
entity; | 1232 |
(F) A procedure whereby a terminal | 1233 |
distributor, or physician may apply for an extension to the time | 1234 |
by which information must be transmitted to the board; | 1235 |
(G) A procedure whereby a person or government entity to | 1236 |
which the board is authorized to provide information may submit a | 1237 |
request to the board for the information and the board may verify | 1238 |
the identity of the requestor; | 1239 |
(H) A procedure whereby the board can use the database | 1240 |
request records required by division (B) of section
| 1241 |
4729.80 of the Revised Code to document and report statistics and | 1242 |
law enforcement outcomes; | 1243 |
(I) A procedure whereby an individual may request the | 1244 |
individual's own database information and the board may verify the | 1245 |
identity of the requestor; | 1246 |
(J) A reasonable fee that the board may charge under section | 1247 |
1248 | |
with the individual's own database information pursuant to section | 1249 |
1250 |
(K) The specific dangerous drugs other than controlled | 1251 |
substances that must be included in the database; | 1252 |
(L) The types of pharmacies licensed as terminal distributors | 1253 |
of dangerous drugs that are required to submit prescription | 1254 |
information to the board pursuant to section 4729.77 of the | 1255 |
Revised Code. | 1256 |
| 1257 |
establishes and maintains a drug database pursuant to section | 1258 |
4729.75 of the Revised Code, the board shall present a biennial | 1259 |
report to the standing committees of the house of representatives | 1260 |
and the senate that are primarily responsible for considering | 1261 |
health and human services issues. The initial report shall be | 1262 |
presented not later than two years after the database is | 1263 |
established. | 1264 |
(B) Each report presented under this section shall include | 1265 |
all of the following: | 1266 |
(1) The cost to the state of establishing and maintaining the | 1267 |
database; | 1268 |
(2) Information from terminal distributors of dangerous | 1269 |
drugs, prescribers, and the board regarding the board's | 1270 |
effectiveness in providing information from the database; | 1271 |
(3) The board's timeliness in transmitting information from | 1272 |
the database. | 1273 |
Sec. 4729.86. (A)(1) No person identified in divisions (A)(1) | 1274 |
to (9) or (B) of section 4729.80 of the Revised Code shall | 1275 |
disseminate any written or electronic document received from the | 1276 |
drug database to any person not authorized to receive a document | 1277 |
from the drug database. | 1278 |
(2) No person shall provide false information to the state | 1279 |
board of pharmacy with the intent to obtain information contained | 1280 |
in the drug database. | 1281 |
(3) No person shall obtain drug database information by any | 1282 |
means except as provided under divisions (A) and (B) of section | 1283 |
4729.80 of the Revised Code. | 1284 |
(B)(1) A person shall not use a document obtained pursuant to | 1285 |
division (A) of section 4729.80 of the Revised Code as evidence in | 1286 |
any civil, criminal, or administrative proceeding. | 1287 |
(2) If a person does not comply with division (B)(1) of this | 1288 |
section, the state board of pharmacy may restrict the person from | 1289 |
obtaining further information from the drug database. The extent | 1290 |
to which the person is restricted shall be determined by the | 1291 |
board. | 1292 |
Sec. 4729.99. (A) Whoever violates section 4729.16, division | 1293 |
(A) or (B) of section 4729.38, or section 4729.57 of the Revised | 1294 |
Code is guilty of a minor misdemeanor. Each day's violation | 1295 |
constitutes a separate offense. | 1296 |
(B) Whoever violates section 4729.27, 4729.28, or 4729.36 of | 1297 |
the Revised Code is guilty of a misdemeanor of the third degree. | 1298 |
Each day's violation constitutes a separate offense. If the | 1299 |
offender previously has been convicted of or pleaded guilty to a | 1300 |
violation of this chapter, that person is guilty of a misdemeanor | 1301 |
of the second degree. | 1302 |
(C) Whoever violates section 4729.32, 4729.33, or 4729.34 of | 1303 |
the Revised Code is guilty of a misdemeanor. | 1304 |
(D) Whoever violates division (A), (B), (D), or (E) of | 1305 |
section 4729.51 of the Revised Code is guilty of a misdemeanor of | 1306 |
the first degree. | 1307 |
(E)(1) Whoever violates section 4729.37, division (C)(2) of | 1308 |
section 4729.51, division (J) of section 4729.54, or section | 1309 |
4729.61 of the Revised Code is guilty of a felony of the fifth | 1310 |
degree. If the offender previously has been convicted of or | 1311 |
pleaded guilty to a violation of this chapter or a violation of | 1312 |
Chapter 2925. or 3719. of the Revised Code, that person is guilty | 1313 |
of a felony of the fourth degree. | 1314 |
(2) If an offender is convicted of or pleads guilty to a | 1315 |
violation of section 4729.37, division (C) of section 4729.51, | 1316 |
division (J) of section 4729.54, or section 4729.61 of the Revised | 1317 |
Code, if the violation involves the sale, offer to sell, or | 1318 |
possession of a schedule I or II controlled substance, with the | 1319 |
exception of marihuana, and if the court imposing sentence upon | 1320 |
the offender finds that the offender as a result of the violation | 1321 |
is a major drug offender, as defined in section 2929.01 of the | 1322 |
Revised Code, and is guilty of a specification of the type | 1323 |
described in section 2941.1410 of the Revised Code, the court, in | 1324 |
lieu of the prison term authorized or required by division (E)(1) | 1325 |
of this section and sections 2929.13 and 2929.14 of the Revised | 1326 |
Code and in addition to any other sanction imposed for the offense | 1327 |
under sections 2929.11 to 2929.18 of the Revised Code, shall | 1328 |
impose upon the offender, in accordance with division (D)(3)(a) of | 1329 |
section 2929.14 of the Revised Code, the mandatory prison term | 1330 |
specified in that division and may impose an additional prison | 1331 |
term under division (D)(3)(b) of that section. | 1332 |
(3) Notwithstanding any contrary provision of section 3719.21 | 1333 |
of the Revised Code, the clerk of court shall pay any fine imposed | 1334 |
for a violation of section 4729.37, division (C) of section | 1335 |
4729.51, division (J) of section 4729.54, or section 4729.61 of | 1336 |
the Revised Code pursuant to division (A) of section 2929.18 of | 1337 |
the Revised Code in accordance with and subject to the | 1338 |
requirements of division (F) of section 2925.03 of the Revised | 1339 |
Code. The agency that receives the fine shall use the fine as | 1340 |
specified in division (F) of section 2925.03 of the Revised Code. | 1341 |
(F) Whoever violates section 4729.531 of the Revised Code or | 1342 |
any rule adopted thereunder or section 4729.532 of the Revised | 1343 |
Code is guilty of a misdemeanor of the first degree. | 1344 |
(G) Whoever violates division (C)(1) of section 4729.51 of | 1345 |
the Revised Code is guilty of a felony of the fourth degree. If | 1346 |
the offender has previously been convicted of or pleaded guilty to | 1347 |
a violation of this chapter, or of a violation of Chapter 2925. or | 1348 |
3719. of the Revised Code, that person is guilty of a felony of | 1349 |
the third degree. | 1350 |
(H) Whoever violates division (C)(3) of section 4729.51 of | 1351 |
the Revised Code is guilty of a misdemeanor of the first degree. | 1352 |
If the offender has previously been convicted of or pleaded guilty | 1353 |
to a violation of this chapter, or of a violation of Chapter 2925. | 1354 |
or 3719. of the Revised Code, that person is guilty of a felony of | 1355 |
the fifth degree. | 1356 |
(I)(1) Whoever violates division (B) of section 4729.42 of | 1357 |
the Revised Code is guilty of unauthorized pharmacy-related drug | 1358 |
conduct. Except as otherwise provided in this section, | 1359 |
unauthorized pharmacy-related drug conduct is a misdemeanor of the | 1360 |
second degree. If the offender previously has been convicted of or | 1361 |
pleaded guilty to a violation of division (B), (C), (D), or (E) of | 1362 |
that section, unauthorized pharmacy-related drug conduct is a | 1363 |
misdemeanor of the first degree on a second offense and a felony | 1364 |
of the fifth degree on a third or subsequent offense. | 1365 |
(2) Whoever violates division (C) or (D) of section 4729.42 | 1366 |
of the Revised Code is guilty of permitting unauthorized | 1367 |
pharmacy-related drug conduct. Except as otherwise provided in | 1368 |
this section, permitting unauthorized pharmacy-related drug | 1369 |
conduct is a misdemeanor of the second degree. If the offender | 1370 |
previously has been convicted of or pleaded guilty to a violation | 1371 |
of division (B), (C), (D), or (E) of that section, permitting | 1372 |
unauthorized pharmacy-related drug conduct is a misdemeanor of the | 1373 |
first degree on a second offense and a felony of the fifth degree | 1374 |
on a third or subsequent offense. | 1375 |
(3) Whoever violates division (E) of section 4729.42 of the | 1376 |
Revised Code is guilty of the offense of falsification under | 1377 |
section 2921.13 of the Revised Code. In addition to any other | 1378 |
sanction imposed for the violation, the offender is forever | 1379 |
disqualified from engaging in any activity specified in division | 1380 |
(B)(1), (2), or (3) of section 4729.42 of the Revised Code and | 1381 |
from performing any function as a health care professional or | 1382 |
health care worker. As used in this division, "health care | 1383 |
professional" and "health care worker" have the same meanings as | 1384 |
in section 2305.234 of the Revised Code. | 1385 |
(4) Notwithstanding any contrary provision of section 3719.21 | 1386 |
of the Revised Code or any other provision of law that governs the | 1387 |
distribution of fines, the clerk of the court shall pay any fine | 1388 |
imposed pursuant to division (I)(1), (2), or (3) of this section | 1389 |
to the state board of pharmacy if the board has adopted a written | 1390 |
internal control policy under division (F)(2) of section 2925.03 | 1391 |
of the Revised Code that addresses fine moneys that it receives | 1392 |
under Chapter 2925. of the Revised Code and if the policy also | 1393 |
addresses fine moneys paid under this division. The state board of | 1394 |
pharmacy shall use the fines so paid in accordance with the | 1395 |
written internal control policy to subsidize the board's law | 1396 |
enforcement efforts that pertain to drug offenses. | 1397 |
(J)(1) Whoever violates division (A)(1) of section 4729.86 of | 1398 |
the Revised Code is guilty of a misdemeanor of the third degree. | 1399 |
If the offender has previously been convicted of or pleaded guilty | 1400 |
to a violation of section 4729.86 of the Revised Code, that person | 1401 |
is guilty of a misdemeanor of the first degree. | 1402 |
(2) Whoever violates division (A)(2) of section 4729.86 of | 1403 |
the Revised Code is guilty of a misdemeanor of the first degree. | 1404 |
If the offender has previously been convicted of or pleaded guilty | 1405 |
to a violation of section 4729.86 of the Revised Code, that person | 1406 |
is guilty of a felony of the fifth degree. | 1407 |
(3) Whoever violates division (A)(3) of section 4729.86 of | 1408 |
the Revised Code is guilty of a felony of the fifth degree. If the | 1409 |
offender has previously been convicted of or pleaded guilty to a | 1410 |
violation of section 4729.86 of the Revised Code, that person is | 1411 |
guilty of a felony of the fourth degree. | 1412 |
(K) A person who violates division (C) of section 4729.552 of | 1413 |
the Revised Code is guilty of a misdemeanor of the first degree. | 1414 |
If the person previously has been convicted of or pleaded guilty | 1415 |
to a violation of section 4729.552 of the Revised Code, that | 1416 |
person is guilty of a felony of the fifth degree. | 1417 |
(L) Whoever violates division (C) of section 4729.291 of the | 1418 |
Revised Code shall be fined five thousand dollars. Each instance | 1419 |
of a violation is subject to a fine. This penalty is in addition | 1420 |
to any action taken by the state board of pharmacy under section | 1421 |
4729.57 of the Revised Code. | 1422 |
Sec. 4731.052. (A) As used in this section: | 1423 |
(1) "Dangerous drug" has the same meaning as in section | 1424 |
4729.01 of the Revised Code. | 1425 |
(2) " | 1426 |
1427 | |
1428 | |
1429 | |
Chronic pain" means pain that has persisted after reasonable | 1430 |
medical efforts have been made to relieve the pain or cure its | 1431 |
cause and that has continued, either continuously or episodically, | 1432 |
for longer than three continuous months. "Chronic pain" does not | 1433 |
include pain associated with a terminal condition or with a | 1434 |
progressive disease that, in the normal course of progression, may | 1435 |
reasonably be expected to result in a terminal condition. | 1436 |
(3) "Physician" means an individual authorized under this | 1437 |
chapter to practice medicine and surgery or osteopathic medicine | 1438 |
and surgery. | 1439 |
(B) The state medical board shall adopt rules in accordance | 1440 |
with Chapter 119. of the Revised Code that establish standards and | 1441 |
procedures to be followed by physicians in the diagnosis and | 1442 |
treatment of
| 1443 |
managing | 1444 |
furnishing, or administering dangerous drugs in amounts or | 1445 |
combinations that may not be appropriate when treating other | 1446 |
medical conditions. In developing the rules, the board shall | 1447 |
consult with and permit review by physicians who are experienced | 1448 |
in the diagnosis and treatment of | 1449 |
(C) When a physician diagnoses an individual as having | 1450 |
1451 | |
managing it with dangerous drugs in amounts or combinations that | 1452 |
may not be appropriate when treating other medical conditions. The | 1453 |
physician's diagnosis shall be made after having the individual | 1454 |
evaluated by one or more other physicians who specialize in the | 1455 |
treatment of the area, system, or organ of the body perceived as | 1456 |
the source of the pain. The physician's diagnosis and treatment | 1457 |
decisions shall be made according to accepted and prevailing | 1458 |
standards for medical care. The physician shall maintain a record | 1459 |
of all of the following: | 1460 |
(1) Medical history and physical examination of the | 1461 |
individual; | 1462 |
(2) The diagnosis of | 1463 |
signs, symptoms, and causes; | 1464 |
(3) The plan of treatment proposed, the patient's response to | 1465 |
treatment, and any modification to the plan of treatment; | 1466 |
(4) The dates on which dangerous drugs were prescribed, | 1467 |
furnished, or administered, the name and address of the individual | 1468 |
to or for whom the dangerous drugs were prescribed, dispensed, or | 1469 |
administered, and the amounts and dosage forms for the dangerous | 1470 |
drugs prescribed, furnished, or administered; | 1471 |
(5) A copy of the report made by the physician or the | 1472 |
physician to whom referral for evaluation was made under this | 1473 |
division. | 1474 |
(D) A physician who treats | 1475 |
managing it with dangerous drugs is not subject to disciplinary | 1476 |
action by the board under section 4731.22 of the Revised Code | 1477 |
solely because the physician treated the | 1478 |
with dangerous drugs. The physician is subject to disciplinary | 1479 |
action only if the dangerous drugs are not prescribed, furnished, | 1480 |
or administered in accordance with this section and the rules | 1481 |
adopted under it. | 1482 |
Sec. 4731.054. (A) As used in this section: | 1483 |
(1) "Chronic pain" has the same meaning as in section | 1484 |
4731.052 of the Revised Code. | 1485 |
(2) "Controlled substance" has the same meaning as in section | 1486 |
3719.01 of the Revised Code. | 1487 |
(3) "Narcotic drug" has the same meaning as in section | 1488 |
3719.01 of the Revised Code. | 1489 |
(4)(a) "Pain management clinic" means a facility to which | 1490 |
both of the following apply: | 1491 |
(i) The facility, as the primary component of its practice, | 1492 |
provides treatment for pain; | 1493 |
(ii) The majority of patients at the facility are provided | 1494 |
treatment for chronic pain with the use of controlled substances | 1495 |
that are narcotic drugs or with the use of tramadol. | 1496 |
(b) "Pain management clinic" does not include any of the | 1497 |
following: | 1498 |
(i) A hospital registered with the department of health under | 1499 |
section 3701.07 of the Revised Code, a facility owned by such a | 1500 |
hospital, or a facility located inside or on property owned by | 1501 |
such a hospital; | 1502 |
(ii) A medical or dental school that is part of or affiliated | 1503 |
with a state institution of higher education or an institution | 1504 |
that holds a certificate of authorization issued by the Ohio board | 1505 |
of regents under section 1713.02 of the Revised Code or a facility | 1506 |
affiliated with such a medical or dental school; | 1507 |
(iii) A hospice program licensed under Chapter 3712. of the | 1508 |
Revised Code. | 1509 |
(5) "Physician" means an individual authorized under this | 1510 |
chapter to practice medicine and surgery or osteopathic medicine | 1511 |
and surgery. | 1512 |
(B) The state medical board shall adopt rules in accordance | 1513 |
with Chapter 119. of the Revised Code that establish both of the | 1514 |
following: | 1515 |
(1) Standards and procedures for the operation of a pain | 1516 |
management clinic by a physician; | 1517 |
(2) Standards and procedures to be followed by physicians who | 1518 |
provide care at pain management clinics. | 1519 |
(C) The board may impose a penalty of not more than twenty | 1520 |
thousand dollars on a physician who fails to comply with rules | 1521 |
adopted under division (B) of this section. The penalty may be in | 1522 |
addition to or in lieu of any other action that may be taken by | 1523 |
the board under section 4731.22 of the Revised Code. The board | 1524 |
shall deposit any amounts received under this division in | 1525 |
accordance with section 4731.24 of the Revised Code. | 1526 |
Sec. 4731.055. (A) As used in this section: | 1527 |
(1) "Drug database" means the database established and | 1528 |
maintained by the state board of pharmacy pursuant to section | 1529 |
4729.75 of the Revised Code. | 1530 |
(2) "Physician" means an individual authorized under this | 1531 |
chapter to practice medicine and surgery or osteopathic medicine | 1532 |
and surgery. | 1533 |
(B) The state medical board shall adopt rules in accordance | 1534 |
with Chapter 119. of the Revised Code that establish standards and | 1535 |
procedures to be followed by physicians regarding the review of | 1536 |
patient information available through the drug database. | 1537 |
(C) This section and the rules adopted under it do not apply | 1538 |
if the state board of pharmacy no longer maintains the drug | 1539 |
database. | 1540 |
Sec. 4731.22. (A) The state medical board, by an affirmative | 1541 |
vote of not fewer than six of its members, may revoke or may | 1542 |
refuse to grant a certificate to a person found by the board to | 1543 |
have committed fraud during the administration of the examination | 1544 |
for a certificate to practice or to have committed fraud, | 1545 |
misrepresentation, or deception in applying for or securing any | 1546 |
certificate to practice or certificate of registration issued by | 1547 |
the board. | 1548 |
(B) The board, by an affirmative vote of not fewer than six | 1549 |
members, shall, to the extent permitted by law, limit, revoke, or | 1550 |
suspend an individual's certificate to practice, refuse to | 1551 |
register an individual, refuse to reinstate a certificate, or | 1552 |
reprimand or place on probation the holder of a certificate for | 1553 |
one or more of the following reasons: | 1554 |
(1) Permitting one's name or one's certificate to practice or | 1555 |
certificate of registration to be used by a person, group, or | 1556 |
corporation when the individual concerned is not actually | 1557 |
directing the treatment given; | 1558 |
(2) Failure to maintain minimal standards applicable to the | 1559 |
selection or administration of drugs, or failure to employ | 1560 |
acceptable scientific methods in the selection of drugs or other | 1561 |
modalities for treatment of disease; | 1562 |
(3) Selling, giving away, personally furnishing, prescribing, | 1563 |
or administering drugs for other than legal and legitimate | 1564 |
therapeutic purposes or a plea of guilty to, a judicial finding of | 1565 |
guilt of, or a judicial finding of eligibility for intervention in | 1566 |
lieu of conviction of, a violation of any federal or state law | 1567 |
regulating the possession, distribution, or use of any drug; | 1568 |
(4) Willfully betraying a professional confidence. | 1569 |
For purposes of this division, "willfully betraying a | 1570 |
professional confidence" does not include providing any | 1571 |
information, documents, or reports to a child fatality review | 1572 |
board under sections 307.621 to 307.629 of the Revised Code and | 1573 |
does not include the making of a report of an employee's use of a | 1574 |
drug of abuse, or a report of a condition of an employee other | 1575 |
than one involving the use of a drug of abuse, to the employer of | 1576 |
the employee as described in division (B) of section 2305.33 of | 1577 |
the Revised Code. Nothing in this division affects the immunity | 1578 |
from civil liability conferred by that section upon a physician | 1579 |
who makes either type of report in accordance with division (B) of | 1580 |
that section. As used in this division, "employee," "employer," | 1581 |
and "physician" have the same meanings as in section 2305.33 of | 1582 |
the Revised Code. | 1583 |
(5) Making a false, fraudulent, deceptive, or misleading | 1584 |
statement in the solicitation of or advertising for patients; in | 1585 |
relation to the practice of medicine and surgery, osteopathic | 1586 |
medicine and surgery, podiatric medicine and surgery, or a limited | 1587 |
branch of medicine; or in securing or attempting to secure any | 1588 |
certificate to practice or certificate of registration issued by | 1589 |
the board. | 1590 |
As used in this division, "false, fraudulent, deceptive, or | 1591 |
misleading statement" means a statement that includes a | 1592 |
misrepresentation of fact, is likely to mislead or deceive because | 1593 |
of a failure to disclose material facts, is intended or is likely | 1594 |
to create false or unjustified expectations of favorable results, | 1595 |
or includes representations or implications that in reasonable | 1596 |
probability will cause an ordinarily prudent person to | 1597 |
misunderstand or be deceived. | 1598 |
(6) A departure from, or the failure to conform to, minimal | 1599 |
standards of care of similar practitioners under the same or | 1600 |
similar circumstances, whether or not actual injury to a patient | 1601 |
is established; | 1602 |
(7) Representing, with the purpose of obtaining compensation | 1603 |
or other advantage as personal gain or for any other person, that | 1604 |
an incurable disease or injury, or other incurable condition, can | 1605 |
be permanently cured; | 1606 |
(8) The obtaining of, or attempting to obtain, money or | 1607 |
anything of value by fraudulent misrepresentations in the course | 1608 |
of practice; | 1609 |
(9) A plea of guilty to, a judicial finding of guilt of, or a | 1610 |
judicial finding of eligibility for intervention in lieu of | 1611 |
conviction for, a felony; | 1612 |
(10) Commission of an act that constitutes a felony in this | 1613 |
state, regardless of the jurisdiction in which the act was | 1614 |
committed; | 1615 |
(11) A plea of guilty to, a judicial finding of guilt of, or | 1616 |
a judicial finding of eligibility for intervention in lieu of | 1617 |
conviction for, a misdemeanor committed in the course of practice; | 1618 |
(12) Commission of an act in the course of practice that | 1619 |
constitutes a misdemeanor in this state, regardless of the | 1620 |
jurisdiction in which the act was committed; | 1621 |
(13) A plea of guilty to, a judicial finding of guilt of, or | 1622 |
a judicial finding of eligibility for intervention in lieu of | 1623 |
conviction for, a misdemeanor involving moral turpitude; | 1624 |
(14) Commission of an act involving moral turpitude that | 1625 |
constitutes a misdemeanor in this state, regardless of the | 1626 |
jurisdiction in which the act was committed; | 1627 |
(15) Violation of the conditions of limitation placed by the | 1628 |
board upon a certificate to practice; | 1629 |
(16) Failure to pay license renewal fees specified in this | 1630 |
chapter; | 1631 |
(17) Except as authorized in section 4731.31 of the Revised | 1632 |
Code, engaging in the division of fees for referral of patients, | 1633 |
or the receiving of a thing of value in return for a specific | 1634 |
referral of a patient to utilize a particular service or business; | 1635 |
(18) Subject to section 4731.226 of the Revised Code, | 1636 |
violation of any provision of a code of ethics of the American | 1637 |
medical association, the American osteopathic association, the | 1638 |
American podiatric medical association, or any other national | 1639 |
professional organizations that the board specifies by rule. The | 1640 |
state medical board shall obtain and keep on file current copies | 1641 |
of the codes of ethics of the various national professional | 1642 |
organizations. The individual whose certificate is being suspended | 1643 |
or revoked shall not be found to have violated any provision of a | 1644 |
code of ethics of an organization not appropriate to the | 1645 |
individual's profession. | 1646 |
For purposes of this division, a "provision of a code of | 1647 |
ethics of a national professional organization" does not include | 1648 |
any provision that would preclude the making of a report by a | 1649 |
physician of an employee's use of a drug of abuse, or of a | 1650 |
condition of an employee other than one involving the use of a | 1651 |
drug of abuse, to the employer of the employee as described in | 1652 |
division (B) of section 2305.33 of the Revised Code. Nothing in | 1653 |
this division affects the immunity from civil liability conferred | 1654 |
by that section upon a physician who makes either type of report | 1655 |
in accordance with division (B) of that section. As used in this | 1656 |
division, "employee," "employer," and "physician" have the same | 1657 |
meanings as in section 2305.33 of the Revised Code. | 1658 |
(19) Inability to practice according to acceptable and | 1659 |
prevailing standards of care by reason of mental illness or | 1660 |
physical illness, including, but not limited to, physical | 1661 |
deterioration that adversely affects cognitive, motor, or | 1662 |
perceptive skills. | 1663 |
In enforcing this division, the board, upon a showing of a | 1664 |
possible violation, may compel any individual authorized to | 1665 |
practice by this chapter or who has submitted an application | 1666 |
pursuant to this chapter to submit to a mental examination, | 1667 |
physical examination, including an HIV test, or both a mental and | 1668 |
a physical examination. The expense of the examination is the | 1669 |
responsibility of the individual compelled to be examined. Failure | 1670 |
to submit to a mental or physical examination or consent to an HIV | 1671 |
test ordered by the board constitutes an admission of the | 1672 |
allegations against the individual unless the failure is due to | 1673 |
circumstances beyond the individual's control, and a default and | 1674 |
final order may be entered without the taking of testimony or | 1675 |
presentation of evidence. If the board finds an individual unable | 1676 |
to practice because of the reasons set forth in this division, the | 1677 |
board shall require the individual to submit to care, counseling, | 1678 |
or treatment by physicians approved or designated by the board, as | 1679 |
a condition for initial, continued, reinstated, or renewed | 1680 |
authority to practice. An individual affected under this division | 1681 |
shall be afforded an opportunity to demonstrate to the board the | 1682 |
ability to resume practice in compliance with acceptable and | 1683 |
prevailing standards under the provisions of the individual's | 1684 |
certificate. For the purpose of this division, any individual who | 1685 |
applies for or receives a certificate to practice under this | 1686 |
chapter accepts the privilege of practicing in this state and, by | 1687 |
so doing, shall be deemed to have given consent to submit to a | 1688 |
mental or physical examination when directed to do so in writing | 1689 |
by the board, and to have waived all objections to the | 1690 |
admissibility of testimony or examination reports that constitute | 1691 |
a privileged communication. | 1692 |
(20) Except when civil penalties are imposed under section | 1693 |
4731.225 or 4731.281 of the Revised Code, and subject to section | 1694 |
4731.226 of the Revised Code, violating or attempting to violate, | 1695 |
directly or indirectly, or assisting in or abetting the violation | 1696 |
of, or conspiring to violate, any provisions of this chapter or | 1697 |
any rule promulgated by the board. | 1698 |
This division does not apply to a violation or attempted | 1699 |
violation of, assisting in or abetting the violation of, or a | 1700 |
conspiracy to violate, any provision of this chapter or any rule | 1701 |
adopted by the board that would preclude the making of a report by | 1702 |
a physician of an employee's use of a drug of abuse, or of a | 1703 |
condition of an employee other than one involving the use of a | 1704 |
drug of abuse, to the employer of the employee as described in | 1705 |
division (B) of section 2305.33 of the Revised Code. Nothing in | 1706 |
this division affects the immunity from civil liability conferred | 1707 |
by that section upon a physician who makes either type of report | 1708 |
in accordance with division (B) of that section. As used in this | 1709 |
division, "employee," "employer," and "physician" have the same | 1710 |
meanings as in section 2305.33 of the Revised Code. | 1711 |
(21) The violation of section 3701.79 of the Revised Code or | 1712 |
of any abortion rule adopted by the public health council pursuant | 1713 |
to section 3701.341 of the Revised Code; | 1714 |
(22) Any of the following actions taken by the agency | 1715 |
responsible for regulating the practice of medicine and surgery, | 1716 |
osteopathic medicine and surgery, podiatric medicine and surgery, | 1717 |
or the limited branches of medicine in another jurisdiction, for | 1718 |
any reason other than the nonpayment of fees: the limitation, | 1719 |
revocation, or suspension of an individual's license to practice; | 1720 |
acceptance of an individual's license surrender; denial of a | 1721 |
license; refusal to renew or reinstate a license; imposition of | 1722 |
probation; or issuance of an order of censure or other reprimand; | 1723 |
(23) The violation of section 2919.12 of the Revised Code or | 1724 |
the performance or inducement of an abortion upon a pregnant woman | 1725 |
with actual knowledge that the conditions specified in division | 1726 |
(B) of section 2317.56 of the Revised Code have not been satisfied | 1727 |
or with a heedless indifference as to whether those conditions | 1728 |
have been satisfied, unless an affirmative defense as specified in | 1729 |
division (H)(2) of that section would apply in a civil action | 1730 |
authorized by division (H)(1) of that section; | 1731 |
(24) The revocation, suspension, restriction, reduction, or | 1732 |
termination of clinical privileges by the United States department | 1733 |
of defense or department of veterans affairs or the termination or | 1734 |
suspension of a certificate of registration to prescribe drugs by | 1735 |
the drug enforcement administration of the United States | 1736 |
department of justice; | 1737 |
(25) Termination or suspension from participation in the | 1738 |
medicare or medicaid programs by the department of health and | 1739 |
human services or other responsible agency for any act or acts | 1740 |
that also would constitute a violation of division (B)(2), (3), | 1741 |
(6), (8), or (19) of this section; | 1742 |
(26) Impairment of ability to practice according to | 1743 |
acceptable and prevailing standards of care because of habitual or | 1744 |
excessive use or abuse of drugs, alcohol, or other substances that | 1745 |
impair ability to practice. | 1746 |
For the purposes of this division, any individual authorized | 1747 |
to practice by this chapter accepts the privilege of practicing in | 1748 |
this state subject to supervision by the board. By filing an | 1749 |
application for or holding a certificate to practice under this | 1750 |
chapter, an individual shall be deemed to have given consent to | 1751 |
submit to a mental or physical examination when ordered to do so | 1752 |
by the board in writing, and to have waived all objections to the | 1753 |
admissibility of testimony or examination reports that constitute | 1754 |
privileged communications. | 1755 |
If it has reason to believe that any individual authorized to | 1756 |
practice by this chapter or any applicant for certification to | 1757 |
practice suffers such impairment, the board may compel the | 1758 |
individual to submit to a mental or physical examination, or both. | 1759 |
The expense of the examination is the responsibility of the | 1760 |
individual compelled to be examined. Any mental or physical | 1761 |
examination required under this division shall be undertaken by a | 1762 |
treatment provider or physician who is qualified to conduct the | 1763 |
examination and who is chosen by the board. | 1764 |
Failure to submit to a mental or physical examination ordered | 1765 |
by the board constitutes an admission of the allegations against | 1766 |
the individual unless the failure is due to circumstances beyond | 1767 |
the individual's control, and a default and final order may be | 1768 |
entered without the taking of testimony or presentation of | 1769 |
evidence. If the board determines that the individual's ability to | 1770 |
practice is impaired, the board shall suspend the individual's | 1771 |
certificate or deny the individual's application and shall require | 1772 |
the individual, as a condition for initial, continued, reinstated, | 1773 |
or renewed certification to practice, to submit to treatment. | 1774 |
Before being eligible to apply for reinstatement of a | 1775 |
certificate suspended under this division, the impaired | 1776 |
practitioner shall demonstrate to the board the ability to resume | 1777 |
practice in compliance with acceptable and prevailing standards of | 1778 |
care under the provisions of the practitioner's certificate. The | 1779 |
demonstration shall include, but shall not be limited to, the | 1780 |
following: | 1781 |
(a) Certification from a treatment provider approved under | 1782 |
section 4731.25 of the Revised Code that the individual has | 1783 |
successfully completed any required inpatient treatment; | 1784 |
(b) Evidence of continuing full compliance with an aftercare | 1785 |
contract or consent agreement; | 1786 |
(c) Two written reports indicating that the individual's | 1787 |
ability to practice has been assessed and that the individual has | 1788 |
been found capable of practicing according to acceptable and | 1789 |
prevailing standards of care. The reports shall be made by | 1790 |
individuals or providers approved by the board for making the | 1791 |
assessments and shall describe the basis for their determination. | 1792 |
The board may reinstate a certificate suspended under this | 1793 |
division after that demonstration and after the individual has | 1794 |
entered into a written consent agreement. | 1795 |
When the impaired practitioner resumes practice, the board | 1796 |
shall require continued monitoring of the individual. The | 1797 |
monitoring shall include, but not be limited to, compliance with | 1798 |
the written consent agreement entered into before reinstatement or | 1799 |
with conditions imposed by board order after a hearing, and, upon | 1800 |
termination of the consent agreement, submission to the board for | 1801 |
at least two years of annual written progress reports made under | 1802 |
penalty of perjury stating whether the individual has maintained | 1803 |
sobriety. | 1804 |
(27) A second or subsequent violation of section 4731.66 or | 1805 |
4731.69 of the Revised Code; | 1806 |
(28) Except as provided in division (N) of this section: | 1807 |
(a) Waiving the payment of all or any part of a deductible or | 1808 |
copayment that a patient, pursuant to a health insurance or health | 1809 |
care policy, contract, or plan that covers the individual's | 1810 |
services, otherwise would be required to pay if the waiver is used | 1811 |
as an enticement to a patient or group of patients to receive | 1812 |
health care services from that individual; | 1813 |
(b) Advertising that the individual will waive the payment of | 1814 |
all or any part of a deductible or copayment that a patient, | 1815 |
pursuant to a health insurance or health care policy, contract, or | 1816 |
plan that covers the individual's services, otherwise would be | 1817 |
required to pay. | 1818 |
(29) Failure to use universal blood and body fluid | 1819 |
precautions established by rules adopted under section 4731.051 of | 1820 |
the Revised Code; | 1821 |
(30) Failure to provide notice to, and receive acknowledgment | 1822 |
of the notice from, a patient when required by section 4731.143 of | 1823 |
the Revised Code prior to providing nonemergency professional | 1824 |
services, or failure to maintain that notice in the patient's | 1825 |
file; | 1826 |
(31) Failure of a physician supervising a physician assistant | 1827 |
to maintain supervision in accordance with the requirements of | 1828 |
Chapter 4730. of the Revised Code and the rules adopted under that | 1829 |
chapter; | 1830 |
(32) Failure of a physician or podiatrist to enter into a | 1831 |
standard care arrangement with a clinical nurse specialist, | 1832 |
certified nurse-midwife, or certified nurse practitioner with whom | 1833 |
the physician or podiatrist is in collaboration pursuant to | 1834 |
section 4731.27 of the Revised Code or failure to fulfill the | 1835 |
responsibilities of collaboration after entering into a standard | 1836 |
care arrangement; | 1837 |
(33) Failure to comply with the terms of a consult agreement | 1838 |
entered into with a pharmacist pursuant to section 4729.39 of the | 1839 |
Revised Code; | 1840 |
(34) Failure to cooperate in an investigation conducted by | 1841 |
the board under division (F) of this section, including failure to | 1842 |
comply with a subpoena or order issued by the board or failure to | 1843 |
answer truthfully a question presented by the board at a | 1844 |
deposition or in written interrogatories, except that failure to | 1845 |
cooperate with an investigation shall not constitute grounds for | 1846 |
discipline under this section if a court of competent jurisdiction | 1847 |
has issued an order that either quashes a subpoena or permits the | 1848 |
individual to withhold the testimony or evidence in issue; | 1849 |
(35) Failure to supervise an acupuncturist in accordance with | 1850 |
Chapter 4762. of the Revised Code and the board's rules for | 1851 |
supervision of an acupuncturist; | 1852 |
(36) Failure to supervise an anesthesiologist assistant in | 1853 |
accordance with Chapter 4760. of the Revised Code and the board's | 1854 |
rules for supervision of an anesthesiologist assistant; | 1855 |
(37) Assisting suicide as defined in section 3795.01 of the | 1856 |
Revised Code; | 1857 |
(38) Failure to comply with the requirements of section | 1858 |
2317.561 of the Revised Code; | 1859 |
(39) Failure to supervise a radiologist assistant in | 1860 |
accordance with Chapter 4774. of the Revised Code and the board's | 1861 |
rules for supervision of radiologist assistants; | 1862 |
(40) Performing or inducing an abortion at an office or | 1863 |
facility with knowledge that the office or facility fails to post | 1864 |
the notice required under section 3701.791 of the Revised Code; | 1865 |
(41) Being the holder of a terminal distributor of dangerous | 1866 |
drugs license with a pain management clinic classification issued | 1867 |
under section 4729.552 of the Revised Code, if any person employed | 1868 |
by the clinic has violated Chapter 2925. of the Revised Code or is | 1869 |
subject to disciplinary action under this section or section | 1870 |
4723.28 or 4730.25 of the Revised Code; | 1871 |
(42) Failure to comply with the requirements of section | 1872 |
4729.79 of the Revised Code, as long as the state board of | 1873 |
pharmacy establishes and maintains a drug database pursuant to | 1874 |
section 4729.75 of the Revised Code. | 1875 |
(C) Disciplinary actions taken by the board under divisions | 1876 |
(A) and (B) of this section shall be taken pursuant to an | 1877 |
adjudication under Chapter 119. of the Revised Code, except that | 1878 |
in lieu of an adjudication, the board may enter into a consent | 1879 |
agreement with an individual to resolve an allegation of a | 1880 |
violation of this chapter or any rule adopted under it. A consent | 1881 |
agreement, when ratified by an affirmative vote of not fewer than | 1882 |
six members of the board, shall constitute the findings and order | 1883 |
of the board with respect to the matter addressed in the | 1884 |
agreement. If the board refuses to ratify a consent agreement, the | 1885 |
admissions and findings contained in the consent agreement shall | 1886 |
be of no force or effect. | 1887 |
If the board takes disciplinary action against an individual | 1888 |
under division (B) of this section for a second or subsequent plea | 1889 |
of guilty to, or judicial finding of guilt of, a violation of | 1890 |
section 2919.123 of the Revised Code, the disciplinary action | 1891 |
shall consist of a suspension of the individual's certificate to | 1892 |
practice for a period of at least one year or, if determined | 1893 |
appropriate by the board, a more serious sanction involving the | 1894 |
individual's certificate to practice. Any consent agreement | 1895 |
entered into under this division with an individual that pertains | 1896 |
to a second or subsequent plea of guilty to, or judicial finding | 1897 |
of guilt of, a violation of that section shall provide for a | 1898 |
suspension of the individual's certificate to practice for a | 1899 |
period of at least one year or, if determined appropriate by the | 1900 |
board, a more serious sanction involving the individual's | 1901 |
certificate to practice. | 1902 |
(D) For purposes of divisions (B)(10), (12), and (14) of this | 1903 |
section, the commission of the act may be established by a finding | 1904 |
by the board, pursuant to an adjudication under Chapter 119. of | 1905 |
the Revised Code, that the individual committed the act. The board | 1906 |
does not have jurisdiction under those divisions if the trial | 1907 |
court renders a final judgment in the individual's favor and that | 1908 |
judgment is based upon an adjudication on the merits. The board | 1909 |
has jurisdiction under those divisions if the trial court issues | 1910 |
an order of dismissal upon technical or procedural grounds. | 1911 |
(E) The sealing of conviction records by any court shall have | 1912 |
no effect upon a prior board order entered under this section or | 1913 |
upon the board's jurisdiction to take action under this section | 1914 |
if, based upon a plea of guilty, a judicial finding of guilt, or a | 1915 |
judicial finding of eligibility for intervention in lieu of | 1916 |
conviction, the board issued a notice of opportunity for a hearing | 1917 |
prior to the court's order to seal the records. The board shall | 1918 |
not be required to seal, destroy, redact, or otherwise modify its | 1919 |
records to reflect the court's sealing of conviction records. | 1920 |
(F)(1) The board shall investigate evidence that appears to | 1921 |
show that a person has violated any provision of this chapter or | 1922 |
any rule adopted under it. Any person may report to the board in a | 1923 |
signed writing any information that the person may have that | 1924 |
appears to show a violation of any provision of this chapter or | 1925 |
any rule adopted under it. In the absence of bad faith, any person | 1926 |
who reports information of that nature or who testifies before the | 1927 |
board in any adjudication conducted under Chapter 119. of the | 1928 |
Revised Code shall not be liable in damages in a civil action as a | 1929 |
result of the report or testimony. Each complaint or allegation of | 1930 |
a violation received by the board shall be assigned a case number | 1931 |
and shall be recorded by the board. | 1932 |
(2) Investigations of alleged violations of this chapter or | 1933 |
any rule adopted under it shall be supervised by the supervising | 1934 |
member elected by the board in accordance with section 4731.02 of | 1935 |
the Revised Code and by the secretary as provided in section | 1936 |
4731.39 of the Revised Code. The president may designate another | 1937 |
member of the board to supervise the investigation in place of the | 1938 |
supervising member. No member of the board who supervises the | 1939 |
investigation of a case shall participate in further adjudication | 1940 |
of the case. | 1941 |
(3) In investigating a possible violation of this chapter or | 1942 |
any rule adopted under this chapter, the board may administer | 1943 |
oaths, order the taking of depositions, issue subpoenas, and | 1944 |
compel the attendance of witnesses and production of books, | 1945 |
accounts, papers, records, documents, and testimony, except that a | 1946 |
subpoena for patient record information shall not be issued | 1947 |
without consultation with the attorney general's office and | 1948 |
approval of the secretary and supervising member of the board. | 1949 |
Before issuance of a subpoena for patient record information, the | 1950 |
secretary and supervising member shall determine whether there is | 1951 |
probable cause to believe that the complaint filed alleges a | 1952 |
violation of this chapter or any rule adopted under it and that | 1953 |
the records sought are relevant to the alleged violation and | 1954 |
material to the investigation. The subpoena may apply only to | 1955 |
records that cover a reasonable period of time surrounding the | 1956 |
alleged violation. | 1957 |
On failure to comply with any subpoena issued by the board | 1958 |
and after reasonable notice to the person being subpoenaed, the | 1959 |
board may move for an order compelling the production of persons | 1960 |
or records pursuant to the Rules of Civil Procedure. | 1961 |
A subpoena issued by the board may be served by a sheriff, | 1962 |
the sheriff's deputy, or a board employee designated by the board. | 1963 |
Service of a subpoena issued by the board may be made by | 1964 |
delivering a copy of the subpoena to the person named therein, | 1965 |
reading it to the person, or leaving it at the person's usual | 1966 |
place of residence. When the person being served is a person whose | 1967 |
practice is authorized by this chapter, service of the subpoena | 1968 |
may be made by certified mail, restricted delivery, return receipt | 1969 |
requested, and the subpoena shall be deemed served on the date | 1970 |
delivery is made or the date the person refuses to accept | 1971 |
delivery. | 1972 |
A sheriff's deputy who serves a subpoena shall receive the | 1973 |
same fees as a sheriff. Each witness who appears before the board | 1974 |
in obedience to a subpoena shall receive the fees and mileage | 1975 |
provided for under section 119.094 of the Revised Code. | 1976 |
(4) All hearings and investigations of the board shall be | 1977 |
considered civil actions for the purposes of section 2305.252 of | 1978 |
the Revised Code. | 1979 |
(5) Information received by the board pursuant to an | 1980 |
investigation is confidential and not subject to discovery in any | 1981 |
civil action. | 1982 |
The board shall conduct all investigations and proceedings in | 1983 |
a manner that protects the confidentiality of patients and persons | 1984 |
who file complaints with the board. The board shall not make | 1985 |
public the names or any other identifying information about | 1986 |
patients or complainants unless proper consent is given or, in the | 1987 |
case of a patient, a waiver of the patient privilege exists under | 1988 |
division (B) of section 2317.02 of the Revised Code, except that | 1989 |
consent or a waiver of that nature is not required if the board | 1990 |
possesses reliable and substantial evidence that no bona fide | 1991 |
physician-patient relationship exists. | 1992 |
The board may share any information it receives pursuant to | 1993 |
an investigation, including patient records and patient record | 1994 |
information, with law enforcement agencies, other licensing | 1995 |
boards, and other governmental agencies that are prosecuting, | 1996 |
adjudicating, or investigating alleged violations of statutes or | 1997 |
administrative rules. An agency or board that receives the | 1998 |
information shall comply with the same requirements regarding | 1999 |
confidentiality as those with which the state medical board must | 2000 |
comply, notwithstanding any conflicting provision of the Revised | 2001 |
Code or procedure of the agency or board that applies when it is | 2002 |
dealing with other information in its possession. In a judicial | 2003 |
proceeding, the information may be admitted into evidence only in | 2004 |
accordance with the Rules of Evidence, but the court shall require | 2005 |
that appropriate measures are taken to ensure that confidentiality | 2006 |
is maintained with respect to any part of the information that | 2007 |
contains names or other identifying information about patients or | 2008 |
complainants whose confidentiality was protected by the state | 2009 |
medical board when the information was in the board's possession. | 2010 |
Measures to ensure confidentiality that may be taken by the court | 2011 |
include sealing its records or deleting specific information from | 2012 |
its records. | 2013 |
(6) On a quarterly basis, the board shall prepare a report | 2014 |
that documents the disposition of all cases during the preceding | 2015 |
three months. The report shall contain the following information | 2016 |
for each case with which the board has completed its activities: | 2017 |
(a) The case number assigned to the complaint or alleged | 2018 |
violation; | 2019 |
(b) The type of certificate to practice, if any, held by the | 2020 |
individual against whom the complaint is directed; | 2021 |
(c) A description of the allegations contained in the | 2022 |
complaint; | 2023 |
(d) The disposition of the case. | 2024 |
The report shall state how many cases are still pending and | 2025 |
shall be prepared in a manner that protects the identity of each | 2026 |
person involved in each case. The report shall be a public record | 2027 |
under section 149.43 of the Revised Code. | 2028 |
(G) If the secretary and supervising member determine that | 2029 |
there is clear and convincing evidence that an individual has | 2030 |
violated division (B) of this section and that the individual's | 2031 |
continued practice presents a danger of immediate and serious harm | 2032 |
to the public, they may recommend that the board suspend the | 2033 |
individual's certificate to practice without a prior hearing. | 2034 |
Written allegations shall be prepared for consideration by the | 2035 |
board. | 2036 |
The board, upon review of those allegations and by an | 2037 |
affirmative vote of not fewer than six of its members, excluding | 2038 |
the secretary and supervising member, may suspend a certificate | 2039 |
without a prior hearing. A telephone conference call may be | 2040 |
utilized for reviewing the allegations and taking the vote on the | 2041 |
summary suspension. | 2042 |
The board shall issue a written order of suspension by | 2043 |
certified mail or in person in accordance with section 119.07 of | 2044 |
the Revised Code. The order shall not be subject to suspension by | 2045 |
the court during pendency of any appeal filed under section 119.12 | 2046 |
of the Revised Code. If the individual subject to the summary | 2047 |
suspension requests an adjudicatory hearing by the board, the date | 2048 |
set for the hearing shall be within fifteen days, but not earlier | 2049 |
than seven days, after the individual requests the hearing, unless | 2050 |
otherwise agreed to by both the board and the individual. | 2051 |
Any summary suspension imposed under this division shall | 2052 |
remain in effect, unless reversed on appeal, until a final | 2053 |
adjudicative order issued by the board pursuant to this section | 2054 |
and Chapter 119. of the Revised Code becomes effective. The board | 2055 |
shall issue its final adjudicative order within seventy-five days | 2056 |
after completion of its hearing. A failure to issue the order | 2057 |
within seventy-five days shall result in dissolution of the | 2058 |
summary suspension order but shall not invalidate any subsequent, | 2059 |
final adjudicative order. | 2060 |
(H) If the board takes action under division (B)(9), (11), or | 2061 |
(13) of this section and the judicial finding of guilt, guilty | 2062 |
plea, or judicial finding of eligibility for intervention in lieu | 2063 |
of conviction is overturned on appeal, upon exhaustion of the | 2064 |
criminal appeal, a petition for reconsideration of the order may | 2065 |
be filed with the board along with appropriate court documents. | 2066 |
Upon receipt of a petition of that nature and supporting court | 2067 |
documents, the board shall reinstate the individual's certificate | 2068 |
to practice. The board may then hold an adjudication under Chapter | 2069 |
119. of the Revised Code to determine whether the individual | 2070 |
committed the act in question. Notice of an opportunity for a | 2071 |
hearing shall be given in accordance with Chapter 119. of the | 2072 |
Revised Code. If the board finds, pursuant to an adjudication held | 2073 |
under this division, that the individual committed the act or if | 2074 |
no hearing is requested, the board may order any of the sanctions | 2075 |
identified under division (B) of this section. | 2076 |
(I) The certificate to practice issued to an individual under | 2077 |
this chapter and the individual's practice in this state are | 2078 |
automatically suspended as of the date of the individual's second | 2079 |
or subsequent plea of guilty to, or judicial finding of guilt of, | 2080 |
a violation of section 2919.123 of the Revised Code, or the date | 2081 |
the individual pleads guilty to, is found by a judge or jury to be | 2082 |
guilty of, or is subject to a judicial finding of eligibility for | 2083 |
intervention in lieu of conviction in this state or treatment or | 2084 |
intervention in lieu of conviction in another jurisdiction for any | 2085 |
of the following criminal offenses in this state or a | 2086 |
substantially equivalent criminal offense in another jurisdiction: | 2087 |
aggravated murder, murder, voluntary manslaughter, felonious | 2088 |
assault, kidnapping, rape, sexual battery, gross sexual | 2089 |
imposition, aggravated arson, aggravated robbery, or aggravated | 2090 |
burglary. Continued practice after suspension shall be considered | 2091 |
practicing without a certificate. | 2092 |
The board shall notify the individual subject to the | 2093 |
suspension by certified mail or in person in accordance with | 2094 |
section 119.07 of the Revised Code. If an individual whose | 2095 |
certificate is automatically suspended under this division fails | 2096 |
to make a timely request for an adjudication under Chapter 119. of | 2097 |
the Revised Code, the board shall do whichever of the following is | 2098 |
applicable: | 2099 |
(1) If the automatic suspension under this division is for a | 2100 |
second or subsequent plea of guilty to, or judicial finding of | 2101 |
guilt of, a violation of section 2919.123 of the Revised Code, the | 2102 |
board shall enter an order suspending the individual's certificate | 2103 |
to practice for a period of at least one year or, if determined | 2104 |
appropriate by the board, imposing a more serious sanction | 2105 |
involving the individual's certificate to practice. | 2106 |
(2) In all circumstances in which division (I)(1) of this | 2107 |
section does not apply, enter a final order permanently revoking | 2108 |
the individual's certificate to practice. | 2109 |
(J) If the board is required by Chapter 119. of the Revised | 2110 |
Code to give notice of an opportunity for a hearing and if the | 2111 |
individual subject to the notice does not timely request a hearing | 2112 |
in accordance with section 119.07 of the Revised Code, the board | 2113 |
is not required to hold a hearing, but may adopt, by an | 2114 |
affirmative vote of not fewer than six of its members, a final | 2115 |
order that contains the board's findings. In that final order, the | 2116 |
board may order any of the sanctions identified under division (A) | 2117 |
or (B) of this section. | 2118 |
(K) Any action taken by the board under division (B) of this | 2119 |
section resulting in a suspension from practice shall be | 2120 |
accompanied by a written statement of the conditions under which | 2121 |
the individual's certificate to practice may be reinstated. The | 2122 |
board shall adopt rules governing conditions to be imposed for | 2123 |
reinstatement. Reinstatement of a certificate suspended pursuant | 2124 |
to division (B) of this section requires an affirmative vote of | 2125 |
not fewer than six members of the board. | 2126 |
(L) When the board refuses to grant a certificate to an | 2127 |
applicant, revokes an individual's certificate to practice, | 2128 |
refuses to register an applicant, or refuses to reinstate an | 2129 |
individual's certificate to practice, the board may specify that | 2130 |
its action is permanent. An individual subject to a permanent | 2131 |
action taken by the board is forever thereafter ineligible to hold | 2132 |
a certificate to practice and the board shall not accept an | 2133 |
application for reinstatement of the certificate or for issuance | 2134 |
of a new certificate. | 2135 |
(M) Notwithstanding any other provision of the Revised Code, | 2136 |
all of the following apply: | 2137 |
(1) The surrender of a certificate issued under this chapter | 2138 |
shall not be effective unless or until accepted by the board. | 2139 |
Reinstatement of a certificate surrendered to the board requires | 2140 |
an affirmative vote of not fewer than six members of the board. | 2141 |
(2) An application for a certificate made under the | 2142 |
provisions of this chapter may not be withdrawn without approval | 2143 |
of the board. | 2144 |
(3) Failure by an individual to renew a certificate of | 2145 |
registration in accordance with this chapter shall not remove or | 2146 |
limit the board's jurisdiction to take any disciplinary action | 2147 |
under this section against the individual. | 2148 |
(N) Sanctions shall not be imposed under division (B)(28) of | 2149 |
this section against any person who waives deductibles and | 2150 |
copayments as follows: | 2151 |
(1) In compliance with the health benefit plan that expressly | 2152 |
allows such a practice. Waiver of the deductibles or copayments | 2153 |
shall be made only with the full knowledge and consent of the plan | 2154 |
purchaser, payer, and third-party administrator. Documentation of | 2155 |
the consent shall be made available to the board upon request. | 2156 |
(2) For professional services rendered to any other person | 2157 |
authorized to practice pursuant to this chapter, to the extent | 2158 |
allowed by this chapter and rules adopted by the board. | 2159 |
(O) Under the board's investigative duties described in this | 2160 |
section and subject to division (F) of this section, the board | 2161 |
shall develop and implement a quality intervention program | 2162 |
designed to improve through remedial education the clinical and | 2163 |
communication skills of individuals authorized under this chapter | 2164 |
to practice medicine and surgery, osteopathic medicine and | 2165 |
surgery, and podiatric medicine and surgery. In developing and | 2166 |
implementing the quality intervention program, the board may do | 2167 |
all of the following: | 2168 |
(1) Offer in appropriate cases as determined by the board an | 2169 |
educational and assessment program pursuant to an investigation | 2170 |
the board conducts under this section; | 2171 |
(2) Select providers of educational and assessment services, | 2172 |
including a quality intervention program panel of case reviewers; | 2173 |
(3) Make referrals to educational and assessment service | 2174 |
providers and approve individual educational programs recommended | 2175 |
by those providers. The board shall monitor the progress of each | 2176 |
individual undertaking a recommended individual educational | 2177 |
program. | 2178 |
(4) Determine what constitutes successful completion of an | 2179 |
individual educational program and require further monitoring of | 2180 |
the individual who completed the program or other action that the | 2181 |
board determines to be appropriate; | 2182 |
(5) Adopt rules in accordance with Chapter 119. of the | 2183 |
Revised Code to further implement the quality intervention | 2184 |
program. | 2185 |
An individual who participates in an individual educational | 2186 |
program pursuant to this division shall pay the financial | 2187 |
obligations arising from that educational program. | 2188 |
Sec. 4731.228. (A) In accordance with division (B) of this | 2189 |
section, the state medical board may suspend without a prior | 2190 |
hearing a certificate to practice issued under this chapter to an | 2191 |
individual who also holds a license as a terminal distributor of | 2192 |
dangerous drugs with a pain management clinic classification | 2193 |
issued under section 4729.552 of the Revised Code if the secretary | 2194 |
and supervising member of the board determine that both of the | 2195 |
following apply: | 2196 |
(1) There is clear and convincing evidence that an employee | 2197 |
of the pain management clinic has violated any provision of | 2198 |
division (B) of section 4731.22 of the Revised Code. | 2199 |
(2) The continued operation of the pain management clinic | 2200 |
presents a danger of immediate and serious harm to others. | 2201 |
(B) The secretary and supervising member shall provide | 2202 |
written allegations to the board. The board, upon review of the | 2203 |
allegations and by an affirmative vote of not less than six | 2204 |
members, excluding the secretary and supervising member, may | 2205 |
suspend the individual's certificate to practice without a prior | 2206 |
hearing. A telephone conference call may be utilized for reviewing | 2207 |
the allegations and taking a vote on the suspension. | 2208 |
The board shall issue a written order of suspension under | 2209 |
this section by certified mail or in person in accordance with the | 2210 |
procedure for suspension without a prior hearing in section 119.07 | 2211 |
of the Revised Code. The order shall not be subject to suspension | 2212 |
by the court during pendency of any appeal filed under section | 2213 |
119.12 of the Revised Code. | 2214 |
(C) An individual subject to an order under division (B) of | 2215 |
this section may request an adjudicatory hearing. If the | 2216 |
individual requests a hearing, the date set for the hearing shall | 2217 |
be not less than fifteen days but not earlier than seven days | 2218 |
after the individual first requests the hearing, unless otherwise | 2219 |
agreed to by both the board and individual subject to the | 2220 |
suspension. | 2221 |
(D) Any summary suspension imposed under this section shall | 2222 |
remain in effect, unless reversed on appeal, until a final | 2223 |
adjudicative order issued by the board pursuant to Chapter 119. of | 2224 |
the Revised Code becomes effective. The board shall issue its | 2225 |
final adjudicative order within seventy-five days after completion | 2226 |
of its hearing. A failure to issue the order within seventy-five | 2227 |
days shall result in dissolution of the summary suspension but | 2228 |
shall not invalidate any subsequent, final adjudicative order. | 2229 |
Sec. 4731.241. The state medical board may solicit and accept | 2230 |
grants and services from public and private sources for the | 2231 |
purpose of developing and maintaining programs that address | 2232 |
patient safety and education, supply and demand of health care | 2233 |
professionals, and information sharing with the public and the | 2234 |
individuals regulated by the board. The board shall not solicit or | 2235 |
accept a grant or service that would interfere with the board's | 2236 |
independence or objectivity, as determined by the board. | 2237 |
All money received by the board under this section shall be | 2238 |
deposited into the medical board education and patient safety | 2239 |
fund, which is hereby created in the state treasury. The money | 2240 |
deposited in the fund shall be used solely in accordance with this | 2241 |
section. | 2242 |
Sec. 4731.283. | 2243 |
2244 | |
approve one or more continuing medical education courses of study | 2245 |
included within the programs certified by the Ohio state medical | 2246 |
association and the Ohio osteopathic association pursuant to | 2247 |
section 4731.281 of the Revised Code that assist doctors of | 2248 |
medicine and doctors of osteopathic medicine in diagnosing and | 2249 |
treating | 2250 |
of the Revised Code. | 2251 |
Sec. 4776.02. (A) An applicant for an initial license or | 2252 |
restored license from a licensing agency, | 2253 |
satisfy the criteria for being a qualified pharmacy technician | 2254 |
that are specified in section 4729.42 of the Revised Code, or a | 2255 |
person seeking to satisfy the requirements to be an employee of a | 2256 |
pain management clinic as specified in section 4729.552 of the | 2257 |
Revised Code shall submit a request to the bureau of criminal | 2258 |
identification and investigation for a criminal records check of | 2259 |
the applicant or person. The request shall be accompanied by a | 2260 |
completed copy of the form prescribed under division (C)(1) of | 2261 |
section 109.572 of the Revised Code, a set of fingerprint | 2262 |
impressions obtained as described in division (C)(2) of that | 2263 |
section, and the fee prescribed under division (C)(3) of that | 2264 |
section. The applicant or person shall ask the superintendent of | 2265 |
the bureau of criminal identification and investigation in the | 2266 |
request to obtain from the federal bureau of investigation any | 2267 |
information it has pertaining to the applicant or person. | 2268 |
An applicant or person requesting a criminal records check | 2269 |
shall provide the bureau of criminal identification and | 2270 |
investigation with the applicant's or person's name and address | 2271 |
and, regarding an applicant, with the licensing agency's name and | 2272 |
address. | 2273 |
(B) Upon receipt of the completed form, the set of | 2274 |
fingerprint impressions, and the fee provided for in division (A) | 2275 |
of this section, the superintendent of the bureau of criminal | 2276 |
identification and investigation shall conduct a criminal records | 2277 |
check of the applicant or person under division (B) of section | 2278 |
109.572 of the Revised Code. Upon completion of the criminal | 2279 |
records check, the superintendent shall do whichever of the | 2280 |
following is applicable: | 2281 |
(1) If the request was submitted by an applicant for an | 2282 |
initial license or restored license, report the results of the | 2283 |
criminal records check and any information the federal bureau of | 2284 |
investigation provides to the licensing agency identified in the | 2285 |
request for a criminal records check; | 2286 |
(2) If the request was submitted by a person seeking to | 2287 |
satisfy the criteria for being a qualified pharmacy technician | 2288 |
that are specified in section 4729.42 of the Revised Code or a | 2289 |
person seeking to satisfy the requirements to be an employee of a | 2290 |
pain management clinic as specified in section 4729.552 of the | 2291 |
Revised Code, do both of the following: | 2292 |
(a) Report the results of the criminal records check and any | 2293 |
information the federal bureau of investigation provides to the | 2294 |
person who submitted the request; | 2295 |
(b) Report the results of the portion of the criminal records | 2296 |
check performed by the bureau of criminal identification and | 2297 |
investigation under division (B)(1) of section 109.572 of the | 2298 |
Revised Code to the employer or potential employer specified in | 2299 |
the request of the person who submitted the request and send a | 2300 |
letter to that employer or potential employer regarding the | 2301 |
information provided by the federal bureau of investigation that | 2302 |
states either that based on that information there is no record of | 2303 |
any conviction or that based on that information the person who | 2304 |
submitted the request may not meet the criteria that are specified | 2305 |
in section 4729.42 of the Revised Code, whichever is applicable. | 2306 |
Sec. 4776.04. The results of any criminal records check | 2307 |
conducted pursuant to a request made under this chapter and any | 2308 |
report containing those results, including any information the | 2309 |
federal bureau of investigation provides, are not public records | 2310 |
for purposes of section 149.43 of the Revised Code and shall not | 2311 |
be made available to any person or for any purpose other than as | 2312 |
follows: | 2313 |
(A) If the request for the criminal records check was | 2314 |
submitted by an applicant for an initial license or restored | 2315 |
license, as follows: | 2316 |
(1) The superintendent of the bureau of criminal | 2317 |
identification and investigation shall make the results available | 2318 |
to the licensing agency for use in determining, under the agency's | 2319 |
authorizing chapter of the Revised Code, whether the applicant who | 2320 |
is the subject of the criminal records check should be granted a | 2321 |
license under that chapter. | 2322 |
(2) The licensing agency shall make the results available to | 2323 |
the applicant who is the subject of the criminal records check. | 2324 |
(B) If the request for the criminal records check was | 2325 |
submitted by a person seeking to satisfy the criteria for being a | 2326 |
qualified pharmacy technician that are specified in section | 2327 |
4729.42 of the Revised Code or a person seeking to satisfy the | 2328 |
requirements to be an employee of a pain management clinic as | 2329 |
specified in section 4729.552 of the Revised Code, the | 2330 |
superintendent of the bureau of criminal identification and | 2331 |
investigation shall make the results available in accordance with | 2332 |
the following: | 2333 |
(1) The superintendent shall make the results of the criminal | 2334 |
records check, including any information the federal bureau of | 2335 |
investigation provides, available to the person who submitted the | 2336 |
request and is the subject of the criminal records check. | 2337 |
(2) The superintendent shall make the results of the portion | 2338 |
of the criminal records check performed by the bureau of criminal | 2339 |
identification and investigation under division (B)(1) of section | 2340 |
109.572 of the Revised Code available to the employer or potential | 2341 |
employer specified in the request of the person who submitted the | 2342 |
request and shall send a letter of the type described in division | 2343 |
(B)(2) of section 4776.02 of the Revised Code to that employer or | 2344 |
potential employer regarding the information provided by the | 2345 |
federal bureau of investigation that contains one of the types of | 2346 |
statements described in that division. | 2347 |
Sec. 5111.172. (A) | 2348 |
department of job and family services enters into with a health | 2349 |
insuring corporation under section 5111.17 of the Revised Code | 2350 |
2351 | |
2352 | |
require the health insuring corporation to provide coverage of | 2353 |
prescription drugs for medicaid recipients enrolled in the health | 2354 |
insuring corporation. | 2355 |
cover all prescription drugs that the fee-for-service component of | 2356 |
the medicaid program covers, including drugs that are prescribed | 2357 |
for the purpose of treating mental illness. | 2358 |
(B) In providing the required coverage of prescription drugs, | 2359 |
2360 | |
2361 |
| 2362 |
2363 |
| 2364 |
2365 | |
2366 | |
2367 | |
for drugs other than drugs prescribed for the purpose of treating | 2368 |
mental illness. These strategies may include requiring medicaid | 2369 |
recipients enrolled in the health insuring corporation to obtain | 2370 |
prior authorization
| 2371 |
2372 | |
controlled substance | 2373 |
2374 | |
2375 | |
2376 | |
2377 | |
2378 | |
use of strategies for the management of drug utilization is | 2379 |
subject to the department's approval. | 2380 |
Sec. 5111.179. Each contract the department of job and family | 2381 |
services enters into with a managed care organization under | 2382 |
section 5111.17 of the Revised Code shall require the managed care | 2383 |
organization to implement a program consistent with section | 2384 |
1915(a)(2) of the "Social Security Act," 95 Stat. 810 (1981), 42 | 2385 |
U.S.C. 1396n(a)(2), as amended, and 42 C.F.R. 431.54(e) for | 2386 |
medicaid recipients enrolled in the organization who are found to | 2387 |
have obtained prescription drugs under the medicaid program at a | 2388 |
frequency or amount that is not medically necessary. The program | 2389 |
shall be known as a coordinated services program. | 2390 |
Under a coordinated services program, a managed care | 2391 |
organization shall require a medicaid recipient who is included in | 2392 |
the program to have prescriptions for drugs filled at a single | 2393 |
pharmacy, except in an emergency when it is necessary to obtain | 2394 |
the drugs from another pharmacy. The managed care organization | 2395 |
shall permit the medicaid recipient to designate the single | 2396 |
pharmacy from which prescriptions will be filled under the | 2397 |
medicaid program. | 2398 |
The director of job and family services shall adopt rules | 2399 |
specifying what constitutes an emergency for purposes of a managed | 2400 |
care organization's coordinated services program. The rules may | 2401 |
include as an emergency any period in which a medicaid recipient | 2402 |
is a hospital inpatient or a nursing facility resident. The rules | 2403 |
shall be adopted in accordance with Chapter 119. of the Revised | 2404 |
Code. | 2405 |
Sec. 5111.1710. Each contract the department of job and | 2406 |
family services enters into with a managed care organization under | 2407 |
section 5111.17 of the Revised Code shall require the managed care | 2408 |
organization to enter into a data security agreement with the | 2409 |
state board of pharmacy governing the managed care organization's | 2410 |
use of the board's drug database established and maintained under | 2411 |
section 4729.75 of the Revised Code. | 2412 |
This section does not apply if the board no longer maintains | 2413 |
the drug database. | 2414 |
Section 2. That existing sections 3719.08, 4723.481, | 2415 |
4729.01, 4729.071, 4729.29, 4729.51, 4729.54, 4729.541, 4729.55, | 2416 |
4729.75, 4729.77, 4729.78, 4729.79, 4729.80, 4729.81, 4729.82, | 2417 |
4729.83, 4729.84, 4729.99, 4731.052, 4731.22, 4731.283, 4776.02, | 2418 |
4776.04, and 5111.172 of the Revised Code are hereby repealed. | 2419 |
Section 3. (A) Section 5111.172 of the Revised Code, as | 2420 |
amended by this act, applies to contracts under section 5111.17 of | 2421 |
the Revised Code as follows: | 2422 |
(1) To each contract the Department of Job and Family | 2423 |
Services enters into with a health insuring corporation on or | 2424 |
after the effective date of this section; | 2425 |
(2) To each contract between the Department and a health | 2426 |
insuring corporation that is in effect on the effective date of | 2427 |
this section if on or after that date the contract is renewed or | 2428 |
is amended or otherwise modified. | 2429 |
(B) Section 5111.179 of the Revised Code, as enacted by this | 2430 |
act, shall be implemented not later than one year after the | 2431 |
effective date of this section. On and after the Department's | 2432 |
implementation date, that section applies to contracts under | 2433 |
section 5111.17 of the Revised Code as follows: | 2434 |
(1) To each contract the Department enters into with a | 2435 |
managed care organization on or after the Department's | 2436 |
implementation date; | 2437 |
(2) To each contract between the Department and a managed | 2438 |
care organization that is in effect on the Department's | 2439 |
implementation date if on or after that date the contract is | 2440 |
renewed or is amended or otherwise modified. | 2441 |
(C) Section 5111.1710 of the Revised Code, as enacted by this | 2442 |
act, shall be implemented not later than one year after the | 2443 |
effective date of this section. On and after the Department's | 2444 |
implementation date, that section applies to contracts under | 2445 |
section 5111.17 of the Revised Code as follows: | 2446 |
(1) To each contract the Department enters into with a | 2447 |
managed care organization on or after the Department's | 2448 |
implementation date; | 2449 |
(2) To each contract between the Department and a managed | 2450 |
care organization that is in effect on the Department's | 2451 |
implementation date if on or after that date the contract is | 2452 |
renewed or is amended or otherwise modified. | 2453 |
Section 4. (A) The State Board of Pharmacy shall consider | 2454 |
improvements to the state's methods of monitoring, through the | 2455 |
drug database established and maintained under section 4729.75 of | 2456 |
the Revised Code, the misuse and diversion of controlled | 2457 |
substances. Not later than six months after the effective date of | 2458 |
this section, the Board shall submit a report of its findings and | 2459 |
recommendations to the Speaker of the House of Representatives, | 2460 |
President of the Senate, and Governor. | 2461 |
(B) The report shall include all of the following: | 2462 |
(1) Recommendations on the establishment of a "real time" | 2463 |
drug database that permits information to be immediately submitted | 2464 |
to the database and immediately accessible to those individuals | 2465 |
authorized to access information in the database; | 2466 |
(2) Recommendations on potential improvements to the Board's | 2467 |
existing drug database, including both of the following: | 2468 |
(a) Improvements that are necessary to facilitate information | 2469 |
exchange between the database and database users; | 2470 |
(b) Improvements that allow a drug utilization review to | 2471 |
occur whereby patient use of controlled substances is monitored. | 2472 |
(3) The potential cost of upgrading the Board's existing drug | 2473 |
database or establishing a new database to monitor the misuse or | 2474 |
diversion of controlled substances in this state. | 2475 |
(4) Information on the availability of, and methods to | 2476 |
secure, federal grants necessary to implement the Board's | 2477 |
recommendations. | 2478 |
(5) A description of any other matters the Board considers | 2479 |
relevant to its findings and recommendations. | 2480 |
Section 5. Section 4731.22 of the Revised Code is presented | 2481 |
in this act as a composite of the section as amended by Am. Sub. | 2482 |
H.B. 280, Sub. H.B. 525, and Sub. S.B. 229 of the 127th General | 2483 |
Assembly. The General Assembly, applying the principle stated in | 2484 |
division (B) of section 1.52 of the Revised Code that amendments | 2485 |
are to be harmonized if reasonably capable of simultaneous | 2486 |
operation, finds that the composite is the resulting version of | 2487 |
the section in effect prior to the effective date of the section | 2488 |
as presented in this act. | 2489 |