As Reported by the Senate Health, Human Services and Aging Committee

Corrected Version

127th General Assembly Regular Session 2007-2008

Sub. H. B. No. 283

Representative Webster 

Cosponsors: Representatives Setzer, Stebelton, Wagner, Williams, S., Schindel, McGregor, J., Fessler, Evans, Seitz, Latta, Yuko, Koziura, Coley, Combs, Collier, Fende, Peterson, Heard, Ujvagi, Hughes, Reinhard, Letson, Otterman, Williams, B., Uecker, Aslanides, Bacon, Batchelder, Brown, Budish, Chandler, Daniels, DeBose, Dodd, Domenick, Dyer, Flowers, Gibbs, Goodwin, Hagan, J., Huffman, Luckie, Patton, Schlichter, Schneider, Wachtmann, Wagoner, Yates, Zehringer 

Senators Schuring, Seitz, Wagoner, Miller, D., Morano 

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A BILL

To amend sections 2947.23, 3715.521, 3715.55,

1

3715.63, 4729.41, 4729.51, and 4729.54 and to

2

enact sections 2947.231, 3715.88, 3715.89,

3

3715.90, 3715.91, 3715.92, and 4729.541 of the

4

Revised Code to permit pharmacy schools to

5

accept for instructional purposes donations of

6

certain dangerous drugs, including expired

7

drugs, to eliminate the requirement that certain

8

professional business entities be licensed as a

9

terminal distributor of dangerous drugs, and to

10

permit the Board of Pharmacy to recover

11

investigation costs in certain cases.

12

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That sections 2947.23, 3715.521, 3715.55, 3715.63,	13
4729.41, 4729.51, and 4729.54 be amended and sections 2947.231,	14
3715.88, 3715.89, 3715.90, 3715.91, 3715.92, and 4729.541 of the	15
Revised Code be enacted to read as follows:	16

Sec. 2947.23.  (A)(1) In all criminal cases, including	17
violations of ordinances, the judge or magistrate shall include in	18
the sentence the costs of prosecution, including any costs under	19
section 2947.231 of the Revised Code, and render a judgment	20
against the defendant for such costs. At the time the judge or	21
magistrate imposes sentence, the judge or magistrate shall notify	22
the defendant of both of the following:	23

(a) If the defendant fails to pay that judgment or fails to	24
timely make payments towards that judgment under a payment	25
schedule approved by the court, the court may order the defendant	26
to perform community service in an amount of not more than forty	27
hours per month until the judgment is paid or until the court is	28
satisfied that the defendant is in compliance with the approved	29
payment schedule.	30

(b) If the court orders the defendant to perform the	31
community service, the defendant will receive credit upon the	32
judgment at the specified hourly credit rate per hour of community	33
service performed, and each hour of community service performed	34
will reduce the judgment by that amount.	35

(2) The following shall apply in all criminal cases:

36

(a) If a jury has been sworn at the trial of a case, the fees	37
of the jurors shall be included in the costs, which shall be paid	38
to the public treasury from which the jurors were paid.	39

(b) If a jury has not been sworn at the trial of a case	40
because of a defendant's failure to appear without good cause, the	41
costs incurred in summoning jurors for that particular trial may	42
be included in the costs of prosecution. If the costs incurred in	43
summoning jurors are assessed against the defendant, those costs	44
shall be paid to the public treasury from which the jurors were	45
paid.	46

(B) If a judge or magistrate has reason to believe that a	47
defendant has failed to pay the judgment described in division (A)	48
of this section or has failed to timely make payments towards that	49
judgment under a payment schedule approved by the judge or	50
magistrate, the judge or magistrate shall hold a hearing to	51
determine whether to order the offender to perform community	52
service for that failure. The judge or magistrate shall notify	53
both the defendant and the prosecuting attorney of the place,	54
time, and date of the hearing and shall give each an opportunity	55
to present evidence. If, after the hearing, the judge or	56
magistrate determines that the defendant has failed to pay the	57
judgment or to timely make payments under the payment schedule and	58
that imposition of community service for the failure is	59
appropriate, the judge or magistrate may order the offender to	60
perform community service in an amount of not more than forty	61
hours per month until the judgment is paid or until the judge or	62
magistrate is satisfied that the offender is in compliance with	63
the approved payment schedule. If the judge or magistrate orders	64
the defendant to perform community service under this division,	65
the defendant shall receive credit upon the judgment at the	66
specified hourly credit rate per hour of community service	67
performed, and each hour of community service performed shall	68
reduce the judgment by that amount. Except for the credit and	69
reduction provided in this division, ordering an offender to	70
perform community service under this division does not lessen the	71
amount of the judgment and does not preclude the state from taking	72
any other action to execute the judgment.	73

(C) As used in this section, "specified hourly credit rate"	74
means the wage rate that is specified in 26 U.S.C.A. 206(a)(1)	75
under the federal Fair Labor Standards Act of 1938, that then is	76
in effect, and that an employer subject to that provision must pay	77
per hour to each of the employer's employees who is subject to	78
that provision.	79

Sec. 2947.231. If a business entity described in division	80
(B)(1)(j) or (k) of section 4729.51 of the Revised Code pleads	81
guilty or no contest to or is found guilty of any criminal	82
offense, the judge or magistrate shall include in the sentence any	83
costs incurred by the state board of pharmacy in an investigation	84
leading to the plea or conviction. Investigative costs include	85
staff salaries, administrative costs, travel expenses, attorney's	86
fees, and any other reasonable expense incurred by the board. The	87
board shall set forth the costs the entity is required to pay in	88
an itemized statement provided to the judge or magistrate.	89

Sec. 3715.521.  No person shall sell, offer for sale, or	90
deliver at retail or to the consumer, any of the following:	91

(A) Any drug after the expiration date required by 21 C.F.R.	92
211.137 except pursuant to sections 3715.88 to 3715.92 of the	93
Revised Code;	94

(B) Any infant formula after the "use by" date required by 21	95
C.F.R. 107.20;	96

(C) Any baby food after any expiration date, "use by" date,	97
or sale date required by state or federal law or marked on the	98
container by the manufacturer, processor, or packager.	99

Sec. 3715.55.  (A) As used in this section, "expired" means:

100

(1) In the case of a drug, that the expiration date required	101
by 21 C.F.R. 211.137 has passed;	102

(2) In the case of infant formula, the "use by" date required	103
by 21 C.F.R. 107.20 has passed;	104

(3) In the case of baby food, that any expiration date, "use	105
by" date, or sale date established by state or federal law or	106
marked on the container by the manufacturer, processor, or	107
packager has passed.	108

(B) WheneverExcept as otherwise provided in this division,	109
whenever the director of agriculture or the state board of	110
pharmacy finds or has cause to believe, that any food, drug,	111
device, or cosmetic is adulterated, or so misbranded as to be	112
dangerous or fraudulent, within the meaning of sections 3715.01	113
and 3715.52 to 3715.72 of the Revised Code, or that a drug, infant	114
formula, or baby food is expired, the director or board shall	115
affix to the article a tag or other appropriate marking, giving	116
notice that the article is, or is suspected of being, adulterated,	117
misbranded, or expired and has been detained or embargoed, and	118
warning all persons not to remove or dispose of the article by	119
sale or otherwise until permission for removal or disposal is	120
given by the director or the board or the court. No person may	121
remove or dispose of a detained or embargoed article by sale or	122
otherwise without such permission. This division does not apply to	123
expired drugs donated pursuant to sections 3715.88 to 3715.92 of	124
the Revised Code.	125

(C) When an article detained or embargoed has been found by	126
the director or board to be adulterated, misbranded, or expired,	127
the director or board shall petition the municipal or county court	128
in whose jurisdiction the article is detained or embargoed for an	129
order for condemnation of the article. When the director or the	130
board has not found within ten days that an article so detained or	131
embargoed is adulterated, misbranded, or expired, the director or	132
board shall remove the tag or other marking.	133

(D) If the court finds that a detained or embargoed article	134
is adulterated, misbranded, or expired, the article shall, after	135
entry of the decree, be destroyed at the expense of the claimant	136
thereof, under the supervision of the director or the board, and	137
all court costs, fees, storage, and other proper expenses shall be	138
taxed against the claimant of the article or the claimant's agent;	139
provided, that when the adulteration or misbranding can be	140
corrected by proper labeling or processing of the article, the	141
court, after entry of the decree and after such costs, fees, and	142
expenses have been paid and a good and sufficient bond,	143
conditioned that the article shall be so labeled or processed, has	144
been executed, may by order direct that the article be delivered	145
to the claimant thereof for labeling or processing under the	146
supervision of the director or the board. The expense of	147
supervision shall be paid by the claimant. The bond shall be	148
returned to the claimant of the article on representation to the	149
court by the director or the board that the article is no longer	150
in violation of sections 3715.01 and 3715.52 to 3715.72 of the	151
Revised Code, and that the expenses of supervision have been paid.	152

(E) Whenever the director finds in any room, building,	153
vehicle of transportation, or other structure, any meat, sea food	154
seafood, poultry, vegetable, fruit, or other perishable articles	155
that are unsound, or contain any filthy, decomposed, or putrid	156
substance, or that may be poisonous or deleterious to health or	157
otherwise unsafe, the articles are declared to be a nuisance, and	158
the director shall forthwith condemn or destroy the articles, or	159
in any other manner render the articles unsalable as human food.	160

Sec. 3715.63. (A) A drug or device is adulterated within the	161
meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised	162
Code, if any of the following apply:	163

(A)(1) It consists, in whole or in part, of any filthy,	164
putrid, or decomposed substance.	165

(B)(2) It has been produced, processed, prepared, packed, or	166
held under unsanitary conditions whereby it may have been	167
contaminated with filth, or whereby it may have been rendered	168
injurious to health.	169

(C)(3) It is a drug and its container is composed, in whole	170
or in part, of any poisonous or deleterious substance that may	171
render the contents injurious to health.	172

(D)(4) It is a drug and it bears or contains, for purposes of	173
coloring only, a coal-tar color other than one from a batch	174
certified under authority of the "Federal Food, Drug, and Cosmetic	175
Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.	176

(E)(5) It purports to be or is represented as a drug the name	177
of which is recognized in the United States pharmacopoeia and	178
national formulary, or any supplement to them, and its strength	179
differs from or its quality or purity falls below the standard set	180
forth in those compendiums. A determination as to strength,	181
quality, or purity shall be made in accordance with the tests or	182
methods of assay set forth in the compendiums, or in the absence	183
or inadequacy of such tests or methods of assay, those prescribed	184
under the authority of the "Federal Food, Drug, and Cosmetic Act."	185
A drug recognized in the compendiums is not adulterated under this	186
division because it differs from the standard of strength,	187
quality, or purity set forth for that drug in the compendiums, if	188
the difference in strength, quality, or purity is plainly stated	189
on its label. Whenever a drug is recognized in both the	190
homoeopathic pharmacopoeia of the United States and in the United	191
States pharmacopoeia and national formulary, including their	192
supplements, it shall be subject to the requirements of the United	193
States pharmacopoeia and national formulary unless it is labeled	194
and offered for sale as a homoeopathic drug, in which case it	195
shall be subject to the provisions of the homoeopathic	196
pharmacopoeia of the United States and not to those of the United	197
States pharmacopoeia and national formulary.	198

(F)(6) It is not subject to the provisions of division	199
(E)(A)(5) of this section, and its strength differs from or its	200
purity or quality falls below that which it purports or is	201
represented to possess.	202

(G)(7) It is a drug and any substance has been:

203

(1)(a) Mixed or packed with the drug so as to reduce the	204
drug's quality or strength;	205

(2)(b) Substituted wholly or in part for the drug.

206

(B) An expired drug is not adulterated within the meaning of	207
sections 3715.01 and 3715.52 to 3715.72 of the Revised Code if the	208
drug is donated pursuant to sections 3715.88 to 3715.92 of the	209
Revised Code.	210

Sec. 3715.88. As used in this section and in sections 3715.89	211
to 3715.92 of the Revised Code:	212

(A) "Expired" has the same meaning as in section 3715.55 of	213
the Revised Code.	214

(B) "National drug code number" means the number registered	215
for a drug pursuant to the listing system established by the	216
United States food and drug administration under the "Drug Listing	217
Act of 1972," 86 Stat. 559, 21 U.S.C. 360, as amended.	218

(C) "Pharmacy school" means a school, college, university, or	219
other educational institution that operates a pharmacy program	220
recognized and approved by the state board of pharmacy.	221

(D) "Controlled substance" has the same meaning as in section	222
3719.01 of the Revised Code.	223

(E) "Manufacturer of dangerous drugs," "terminal distributor	224
of dangerous drugs," and "wholesale distributor of dangerous	225
drugs" have the same meanings as in section 4729.01 of the Revised	226
Code.	227

Sec. 3715.89. (A) Subject to divisions (B) and (C) of this	228
section, any manufacturer of dangerous drugs, terminal distributor	229
of dangerous drugs, or wholesale distributor of dangerous drugs	230
may donate a dangerous drug, including a dangerous drug that has	231
expired, to a pharmacy school.	232

(B) A dangerous drug donation to a pharmacy school shall meet	233
all of the following requirements:	234

(1) The dangerous drug is not a controlled substance.

235

(2) Each container in which a dangerous drug is donated	236
contains a single national drug code number of that drug and no	237
other drugs.	238

(3) If the dangerous drug is of a type that deteriorates with	239
time, the container in which the drug is contained is plainly	240
marked with the drug's expiration date.	241

(C) A dangerous drug donation to a pharmacy school shall be	242
accompanied by a form signed by a representative of the	243
manufacturer, terminal distributor, or wholesale distributor	244
donating the drug. On delivery, a representative of the pharmacy	245
school accepting the drug donation shall also sign the form. The	246
form shall do both of the following:	247

(1) Confirm the acceptance of the dangerous drug donation by	248
the pharmacy school;	249

(2) Confirm that both the manufacturer, terminal distributor,	250
or wholesale distributor donating the dangerous drug and the	251
pharmacy school accepting the donation understand the immunity	252
provisions of section 3719.92 of the Revised Code.	253

Sec. 3715.90. (A) A pharmacy school may accept a donation of	254
a dangerous drug if the donation is made in accordance with	255
section 3715.89 of the Revised Code.	256

(B) All of the following apply to a dangerous drug donated to	257
a pharmacy school:	258

(1) The dangerous drug shall be used solely for instructional	259
purposes.	260

(2) The dangerous drug shall not be sold or transferred for	261
consideration of any kind.	262

(3) In accordance with 21 C.F.R. 201.125, the dangerous drug	263
shall not be used for a clinical use. "Clinical use" includes the	264
drug being furnished to a human or animal with the intent or	265
understanding that the human or animal will ingest or otherwise	266
absorb the drug into the human's or animal's body.	267

Sec. 3715.91. The state board of pharmacy shall, in	268
accordance with Chapter 119. of the Revised Code, adopt rules as	269
necessary to give effect to sections 3715.89 and 3715.90 of the	270
Revised Code.	271

Sec. 3715.92. The state board of pharmacy, any manufacturer	272
of dangerous drugs, terminal distributor of dangerous drugs, or	273
wholesale distributor of dangerous drugs that in good faith	274
donates a dangerous drug under section 3715.89 of the Revised	275
Code, and any pharmacy school that accepts a dangerous drug	276
donation under section 3715.90 of the Revised Code, shall not, in	277
the absence of bad faith, be subject to any of the following for	278
matters related to the donation or acceptance of the drug:	279
criminal prosecution; liability in tort or other civil action for	280
injury, death, or loss to person or property; or professional	281
liability.	282

Sec. 4729.41. (A)(1) A pharmacist licensed under this	283
chapter who meets the requirements of division (B) of this section	284
may do either or bothany of the following:	285

(a) Administer immunizations for influenza to individuals	286
fourteen years of age or older;	287

(b) Administer immunizations to individuals eighteen years of	288
age or older for any of the following:	289

(i) Pneumonia;

290

(ii) Tetanus;

291

(iii) Hepatitis A;

292

(iv) Hepatitis B;

293

(v) Meningitis;

294

(vi) Diphtheria;

295

(vii) Pertussis.

296

(c) Administer to individuals eighteen years of age or older	297
any other immunization listed in the rule adopted under division	298
(E)(1)(d) of this section.	299

(2) A pharmacy intern licensed under this chapter who meets	300
the requirements of division (B) of this section and is working	301
under the direct supervision of a pharmacist who meets the	302
requirements of that division may administer immunizations for	303
influenza to individuals eighteen years of age or older.	304

(3) As part of engaging in the administration of	305
immunizations or supervising a pharmacy intern's administration of	306
immunizations, a pharmacist may administer epinephrine or	307
diphenhydramine, or both, to individuals in emergency situations	308
resulting from adverse reactions to the immunizations administered	309
by the pharmacist or pharmacy intern.	310

(B) For a pharmacist or pharmacy intern to be authorized to	311
engage in the administration of immunizations as specified in	312
division (A) of this section, the pharmacist or pharmacy intern	313
shall do all of the following:	314

(1) Successfully complete a course in the administration of	315
immunizations that has been approved by the state board of	316
pharmacy as meeting the standards established for such courses by	317
the centers for disease control and prevention in the public	318
health service of the United States department of health and human	319
services;	320

(2) Receive and maintain certification to perform basic	321
life-support procedures by successfully completing a basic	322
life-support training course certified by the American red cross	323
or American heart association;	324

(3) Practice in accordance with a definitive set of treatment	325
guidelines specified in a protocol established by a physician and	326
approved by the state board of pharmacy.	327

(C) The protocol required by division (B)(3) of this section	328
shall include provisions for implementation of the following	329
requirements:	330

(1) The pharmacist or pharmacy intern who administers an	331
immunization shall observe the individual who receives the	332
immunization to determine whether the individual has an adverse	333
reaction to the immunization. The length of time and location of	334
the observation shall comply with the standards specified in rules	335
adopted by the state board of pharmacy under division (E) of this	336
section for the approval of protocols. The protocol shall specify	337
procedures to be followed by a pharmacist when administering	338
epinephrine, diphenhydramine, or both, to an individual who has an	339
adverse reaction to an immunization administered by the pharmacist	340
or a pharmacy intern.	341

(2) For each immunization administered to an individual by a	342
pharmacist, other than an immunization for influenza administered	343
to an individual eighteen years of age or older, the pharmacist	344
shall notify the individual's family physician or, if the	345
individual has no family physician, the board of health of the	346
health district in which the individual resides or the authority	347
having the duties of a board of health for that district under	348
section 3709.05 of the Revised Code. The notice shall be given not	349
later than thirty days after the immunization is administered.	350

(3) For each immunization for influenza administered by a	351
pharmacist to an individual who is fourteen years of age or older	352
but younger than eighteen years of age, the pharmacist or a	353
pharmacy intern shall obtain permission from the individual's	354
parent or legal guardian in accordance with the procedures	355
specified in rules adopted under division (E) of this section.	356

(D)(1) No pharmacist shall do either of the following:

357

(a) Engage in the administration of immunizations unless the	358
requirements of division (B) of this section have been met;	359

(b) Delegate to any person the pharmacist's authority to	360
engage in or supervise the administration of immunizations.	361

(2) No pharmacy intern shall engage in the administration of	362
immunizations for influenza unless the requirements of division	363
(B) of this section have been met.	364

(E)(1) The state board of pharmacy shall adopt rules to	365
implement this section. The rules shall be adopted in accordance	366
with Chapter 119. of the Revised Code and shall include provisions	367
for the following:	368

(a) ApprovalProvisions for approval of courses in	369
administration of immunizations;	370

(b) ApprovalProvisions for approval of protocols to be	371
followed by pharmacists and pharmacy interns in engaging in the	372
administration of immunizations, including protocols that contain	373
provisions specifying the locations at which a pharmacist or	374
pharmacy intern may engage in the administration of immunizations;	375

(c) Procedures to be followed by pharmacists and pharmacy	376
interns in obtaining from the individual's parent or legal	377
guardian permission to administer influenza immunizations to an	378
individual younger than eighteen years of age pursuant to division	379
(A)(1)(a) of this section;	380

(d) A list of immunizations that may be administered under	381
division (A)(1)(c) of this section.	382

(2) Prior to adopting rules regarding approval of protocols	383
to be followed by pharmacists and pharmacy interns in engaging in	384
the administration of immunizations, the state board of pharmacy	385
shall consult with the state medical board and the board of	386
nursing.	387

(3) Prior to adopting a rule listing immunizations that may	388
be administered under division (A)(1)(c) of this section, the	389
state board of pharmacy shall consult with the state medical	390
board.	391

Sec. 4729.51.  (A) No person other than a registered	392
wholesale distributor of dangerous drugs shall possess for sale,	393
sell, distribute, or deliver, at wholesale, dangerous drugs,	394
except as follows:	395

(1) A pharmacist who is a licensed terminal distributor of	396
dangerous drugs or who is employed by a licensed terminal	397
distributor of dangerous drugs may make occasional sales of	398
dangerous drugs at wholesale;	399

(2) A licensed terminal distributor of dangerous drugs	400
having more than one establishment or place may transfer or	401
deliver dangerous drugs from one establishment or place for which	402
a license has been issued to the terminal distributor to another	403
establishment or place for which a license has been issued to the	404
terminal distributor if the license issued for each establishment	405
or place is in effect at the time of the transfer or delivery.	406

(B)(1) No registered wholesale distributor of dangerous drugs	407
shall possess for sale, or sell, at wholesale, dangerous drugs to	408
any person other than the following:	409

(a) A licensed health professional authorized to prescribe	410
drugs;	411

(b) An optometrist licensed under Chapter 4725. of the	412
Revised Code who holds a topical ocular pharmaceutical agents	413
certificate;	414

(c) A registered wholesale distributor of dangerous drugs;

415

(d) A manufacturer of dangerous drugs;

416

(e) A licensed terminal distributor of dangerous drugs,	417
subject to division (B)(2) of this section;	418

(f) Carriers or warehousers for the purpose of carriage or	419
storage;	420

(g) Terminal or wholesale distributors of dangerous drugs who	421
are not engaged in the sale of dangerous drugs within this state;	422

(h) An individual who holds a current license, certificate,	423
or registration issued under Title 47 of the Revised Code and has	424
been certified to conduct diabetes education by a national	425
certifying body specified in rules adopted by the state board of	426
pharmacy under section 4729.68 of the Revised Code, but only with	427
respect to insulin that will be used for the purpose of diabetes	428
education and only if diabetes education is within the	429
individual's scope of practice under statutes and rules regulating	430
the individual's profession;	431

(i) An individual who holds a valid certificate issued by a	432
nationally recognized S.C.U.B.A. diving certifying organization	433
approved by the pharmacy board in rule, but only with respect to	434
medical oxygen that will be used for the purpose of emergency care	435
or treatment at the scene of a diving emergency;	436

(j) A business entity that is a corporation formed under	437
division (B) of section 1701.03 of the Revised Code, a limited	438
liability company formed under Chapter 1705. of the Revised Code,	439
or a professional association formed under Chapter 1785. of the	440
Revised Code if the entity has a sole shareholder who is a	441
licensed health professional authorized to prescribe drugs and is	442
authorized to provide the professional services being offered by	443
the entity;	444

(k) A business entity that is a corporation formed under	445
division (B) of section 1701.03 of the Revised Code, a limited	446
liability company formed under Chapter 1705. of the Revised Code,	447
a partnership or a limited liability partnership formed under	448
Chapter 1775. of the Revised Code, or a professional association	449
formed under Chapter 1785. of the Revised Code, if, to be a	450
shareholder, member, or partner, an individual is required to be	451
licensed, certified, or otherwise legally authorized under Title	452
XLVII of the Revised Code to perform the professional service	453
provided by the entity and each such individual is a licensed	454
health professional authorized to prescribe drugs.	455

(2) No registered wholesale distributor of dangerous drugs	456
shall possess dangerous drugs for sale at wholesale, or sell such	457
drugs at wholesale, to a licensed terminal distributor of	458
dangerous drugs, except to:	459

(a) A terminal distributor who has a category I license, only	460
dangerous drugs described in category I, as defined in division	461
(A)(1) of section 4729.54 of the Revised Code;	462

(b) A terminal distributor who has a category II license,	463
only dangerous drugs described in category I and category II, as	464
defined in divisions (A)(1) and (2) of section 4729.54 of the	465
Revised Code;	466

(c) A terminal distributor who has a category III license,	467
dangerous drugs described in category I, category II, and category	468
III, as defined in divisions (A)(1), (2), and (3) of section	469
4729.54 of the Revised Code;	470

(d) A terminal distributor who has a limited category I, II,	471
or III license, only the dangerous drugs specified in the	472
certificate furnished by the terminal distributor in accordance	473
with section 4729.60 of the Revised Code.	474

(C)(1) Except as provided in division (C)(4) of this section,	475
no person shall sell, at retail, dangerous drugs.	476

(2) Except as provided in division (C)(4) of this section, no	477
person shall possess for sale, at retail, dangerous drugs.	478

(3) Except as provided in division (C)(4) of this section, no	479
person shall possess dangerous drugs.	480

(4) Divisions (C)(1), (2), and (3) of this section do not	481
apply to a registered wholesale distributor of dangerous drugs, a	482
licensed terminal distributor of dangerous drugs, or a person who	483
possesses, or possesses for sale or sells, at retail, a dangerous	484
drug in accordance with Chapters 3719., 4715., 4723., 4725.,	485
4729., 4730., 4731., and 4741. of the Revised Code.	486

Divisions (C)(1), (2), and (3) of this section do not apply	487
to an individual who holds a current license, certificate, or	488
registration issued under Title XLVII of the Revised Code and has	489
been certified to conduct diabetes education by a national	490
certifying body specified in rules adopted by the state board of	491
pharmacy under section 4729.68 of the Revised Code, but only to	492
the extent that the individual possesses insulin or personally	493
supplies insulin solely for the purpose of diabetes education and	494
only if diabetes education is within the individual's scope of	495
practice under statutes and rules regulating the individual's	496
profession.	497

Divisions (C)(1), (2), and (3) of this section do not apply	498
to an individual who holds a valid certificate issued by a	499
nationally recognized S.C.U.B.A. diving certifying organization	500
approved by the pharmacy board in rule, but only to the extent	501
that the individual possesses medical oxygen or personally	502
supplies medical oxygen for the purpose of emergency care or	503
treatment at the scene of a diving emergency.	504

(D) No licensed terminal distributor of dangerous drugs shall	505
purchase for the purpose of resale dangerous drugs from any person	506
other than a registered wholesale distributor of dangerous drugs,	507
except as follows:	508

(1) A licensed terminal distributor of dangerous drugs may	509
make occasional purchases of dangerous drugs for resale from a	510
pharmacist who is a licensed terminal distributor of dangerous	511
drugs or who is employed by a licensed terminal distributor of	512
dangerous drugs;	513

(2) A licensed terminal distributor of dangerous drugs having	514
more than one establishment or place may transfer or receive	515
dangerous drugs from one establishment or place for which a	516
license has been issued to the terminal distributor to another	517
establishment or place for which a license has been issued to the	518
terminal distributor if the license issued for each establishment	519
or place is in effect at the time of the transfer or receipt.	520

(E) No licensed terminal distributor of dangerous drugs shall	521
engage in the sale or other distribution of dangerous drugs at	522
retail or maintain possession, custody, or control of dangerous	523
drugs for any purpose other than the distributor's personal use or	524
consumption, at any establishment or place other than that or	525
those described in the license issued by the board of pharmacy to	526
such terminal distributor.	527

(F) Nothing in this section shall be construed to interfere	528
with the performance of official duties by any law enforcement	529
official authorized by municipal, county, state, or federal law to	530
collect samples of any drug, regardless of its nature or in whose	531
possession it may be.	532

Sec. 4729.54.  (A) As used in this section and section	533
4729.541 of the Revised Code:	534

(1) "Category I" means single-dose injections of intravenous	535
fluids, including saline, Ringer's lactate, five per cent dextrose	536
and distilled water, and other intravenous fluids or parenteral	537
solutions included in this category by rule of the board of	538
pharmacy, that have a volume of one hundred milliliters or more	539
and that contain no added substances, or single-dose injections of	540
epinephrine to be administered pursuant to sections 4765.38 and	541
4765.39 of the Revised Code.	542

(2) "Category II" means any dangerous drug that is not	543
included in category I or III.	544

(3) "Category III" means any controlled substance that is	545
contained in schedule I, II, III, IV, or V.	546

(4) "Emergency medical service organization" has the same	547
meaning as in section 4765.01 of the Revised Code.	548

(5) "Person" includes an emergency medical service	549
organization.	550

(6) "Schedule I, schedule II, schedule III, schedule IV, and	551
schedule V" mean controlled substance schedules I, II, III, IV,	552
and V, respectively, as established pursuant to section 3719.41 of	553
the Revised Code and as amended.	554

(B) A person who desires to be licensed as a terminal	555
distributor of dangerous drugs shall file with the executive	556
director of the board of pharmacy a verified application that	557
contains the following:	558

(1) Information that the board requires relative to the	559
qualifications of a terminal distributor of dangerous drugs set	560
forth in section 4729.55 of the Revised Code;	561

(2) A statement that the person wishes to be licensed as a	562
category I, category II, category III, limited category I, limited	563
category II, or limited category III terminal distributor of	564
dangerous drugs;	565

(3) If the person wishes to be licensed as a limited category	566
I, limited category II, or limited category III terminal	567
distributor of dangerous drugs, a notarized list of the dangerous	568
drugs that the person wishes to possess, have custody or control	569
of, and distribute, which list shall also specify the purpose for	570
which those drugs will be used and their source;	571

(4) If the person is an emergency medical service	572
organization, the information that is specified in division (C)(1)	573
of this section;	574

(5) Except for an emergency medical service organization, the	575
identity of the one establishment or place at which the person	576
intends to engage in the sale or other distribution of dangerous	577
drugs at retail, and maintain possession, custody, or control of	578
dangerous drugs for purposes other than the person's own use or	579
consumption.	580

(C)(1) An emergency medical service organization that wishes	581
to be licensed as a terminal distributor of dangerous drugs shall	582
list in its application for licensure the following additional	583
information:	584

(a) The units under its control that the organization	585
determines will possess dangerous drugs for the purpose of	586
administering emergency medical services in accordance with	587
Chapter 4765. of the Revised Code;	588

(b) With respect to each such unit, whether the dangerous	589
drugs that the organization determines the unit will possess are	590
in category I, II, or III.	591

(2) An emergency medical service organization that is	592
licensed as a terminal distributor of dangerous drugs shall file a	593
new application for such licensure if there is any change in the	594
number, or location of, any of its units or any change in the	595
category of the dangerous drugs that any unit will possess.	596

(3) A unit listed in an application for licensure pursuant to	597
division (C)(1) of this section may obtain the dangerous drugs it	598
is authorized to possess from its emergency medical service	599
organization or, on a replacement basis, from a hospital pharmacy.	600
If units will obtain dangerous drugs from a hospital pharmacy, the	601
organization shall file, and maintain in current form, the	602
following items with the pharmacist who is responsible for the	603
hospital's terminal distributor of dangerous drugs license:	604

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

605

(b) A list of the personnel employed or used by the	606
organization to provide emergency medical services in accordance	607
with Chapter 4765. of the Revised Code, who are authorized to	608
possess the drugs, which list also shall indicate the personnel	609
who are authorized to administer the drugs.	610

(D) Each emergency medical service organization that applies	611
for a terminal distributor of dangerous drugs license shall submit	612
with its application the following:	613

(1) A notarized copy of its standing orders or protocol,	614
which orders or protocol shall be signed by a physician and	615
specify the dangerous drugs that its units may carry, expressed in	616
standard dose units;	617

(2) A list of the personnel employed or used by the	618
organization to provide emergency medical services in accordance	619
with Chapter 4765. of the Revised Code.	620

An emergency medical service organization that is licensed as	621
a terminal distributor shall notify the board immediately of any	622
changes in its standing orders or protocol.	623

(E) There shall be six categories of terminal distributor of	624
dangerous drugs licenses, which categories shall be as follows:	625

(1) Category I license. A person who obtains this license may	626
possess, have custody or control of, and distribute only the	627
dangerous drugs described in category I.	628

(2) Limited category I license. A person who obtains this	629
license may possess, have custody or control of, and distribute	630
only the dangerous drugs described in category I that were listed	631
in the application for licensure.	632

(3) Category II license. A person who obtains this license	633
may possess, have custody or control of, and distribute only the	634
dangerous drugs described in category I and category II.	635

(4) Limited category II license. A person who obtains this	636
license may possess, have custody or control of, and distribute	637
only the dangerous drugs described in category I or category II	638
that were listed in the application for licensure.	639

(5) Category III license. A person who obtains this license	640
may possess, have custody or control of, and distribute the	641
dangerous drugs described in category I, category II, and category	642
III.	643

(6) Limited category III license. A person who obtains this	644
license may possess, have custody or control of, and distribute	645
only the dangerous drugs described in category I, category II, or	646
category III that were listed in the application for licensure.	647

(F) Except for an application made on behalf of an animal	648
shelter, if an applicant for licensure as a limited category I,	649
II, or III terminal distributor of dangerous drugs intends to	650
administer dangerous drugs to a person or animal, the applicant	651
shall submit, with the application, a notarized copy of its	652
protocol or standing orders, which protocol or orders shall be	653
signed by a licensed health professional authorized to prescribe	654
drugs, specify the dangerous drugs to be administered, and list	655
personnel who are authorized to administer the dangerous drugs in	656
accordance with federal law or the law of this state. An	657
application made on behalf of an animal shelter shall include a	658
notarized list of the dangerous drugs to be administered to	659
animals and the personnel who are authorized to administer the	660
drugs to animals in accordance with section 4729.532 of the	661
Revised Code. After obtaining a terminal distributor license, a	662
licensee shall notify the board immediately of any changes in its	663
protocol or standing orders, or in such personnel.	664

(G)(1) Except as provided in division (G)(2) of this section,	665
each applicant for licensure as a terminal distributor of	666
dangerous drugs shall submit, with the application, a license fee	667
determined as follows:	668

(a) For a category I or limited category I license,	669
forty-five dollars;	670

(b) For a category II or limited category II license, one	671
hundred twelve dollars and fifty cents;	672

(c) For a category III or limited category III license, one	673
hundred fifty dollars.	674

(2) For a professional association, corporation, partnership,	675
or limited liability company organized for the purpose of	676
practicing veterinary medicine, the fee shall be forty dollars.	677

Fees assessed under divisions (G)(1) and (2) of this section	678
shall not be returned if the applicant fails to qualify for	679
registration.	680

(H)(1) The board shall issue a terminal distributor of	681
dangerous drugs license to each person who submits an application	682
for such licensure in accordance with this section, pays the	683
required license fee, is determined by the board to meet the	684
requirements set forth in section 4729.55 of the Revised Code, and	685
satisfies any other applicable requirements of this section.	686

(2) The license of a person other than an emergency medical	687
service organization shall describe the one establishment or place	688
at which the licensee may engage in the sale or other distribution	689
of dangerous drugs at retail and maintain possession, custody, or	690
control of dangerous drugs for purposes other than the licensee's	691
own use or consumption. The one establishment or place shall be	692
that which is described in the application for licensure.	693

No such license shall authorize or permit the terminal	694
distributor of dangerous drugs named in it to engage in the sale	695
or other distribution of dangerous drugs at retail or to maintain	696
possession, custody, or control of dangerous drugs for any purpose	697
other than the distributor's own use or consumption, at any	698
establishment or place other than that described in the license,	699
except that an agent or employee of an animal shelter may possess	700
and use dangerous drugs in the course of business as provided in	701
division (D) of section 4729.532 of the Revised Code.	702

(3) The license of an emergency medical service organization	703
shall cover and describe all the units of the organization listed	704
in its application for licensure.	705

(4) The license of every terminal distributor of dangerous	706
drugs shall indicate, on its face, the category of licensure. If	707
the license is a limited category I, II, or III license, it shall	708
specify, and shall authorize the licensee to possess, have custody	709
or control of, and distribute only, the dangerous drugs that were	710
listed in the application for licensure.	711

(I) All licenses issued pursuant to this section shall be	712
effective for a period of twelve months from the first day of	713
January of each year. A license shall be renewed by the board for	714
a like period, annually, according to the provisions of this	715
section, and the standard renewal procedure of Chapter 4745. of	716
the Revised Code. A person who desires to renew a license shall	717
submit an application for renewal and pay the required fee on or	718
before the thirty-first day of December each year. The fee	719
required for the renewal of a license shall be the same as the fee	720
paid for the license being renewed, and shall accompany the	721
application for renewal.	722

A license that has not been renewed during December in any	723
year and by the first day of February of the following year may be	724
reinstated only upon payment of the required renewal fee and a	725
penalty fee of fifty-five dollars.	726

(J)(1) No emergency medical service organization that is	727
licensed as a terminal distributor of dangerous drugs shall fail	728
to comply with division (C)(2) or (3) of this section.	729

(2) No emergency medical service organization that is	730
licensed as a terminal distributor of dangerous drugs shall fail	731
to comply with division (D) of this section.	732

(3) No licensed terminal distributor of dangerous drugs shall	733
possess, have custody or control of, or distribute dangerous drugs	734
that the terminal distributor is not entitled to possess, have	735
custody or control of, or distribute by virtue of its category of	736
licensure.	737

(4) No licensee that is required by division (F) of this	738
section to notify the board of changes in its protocol or standing	739
orders, or in personnel, shall fail to comply with that division.	740

Sec. 4729.541.  A person described in division (B)(1)(j) or	741
(k) of section 4729.51 of the Revised Code may possess, have	742
custody or control of, and distribute the dangerous drugs in	743
category I, category II, and category III of section 4729.54 of	744
the Revised Code without holding a terminal distributor of	745
dangerous drugs license issued under that section.	746

Section 2. That existing sections 2947.23, 3715.521, 3715.55,	747
3715.63, 4729.41, 4729.51, and 4729.54 of the Revised Code are	748
hereby repealed.	749