Am. Sub. H. B. No. 378 CORRECTED VERSION

CORRECTED VERSION

As Passed by the House

130th General Assembly

Regular Session

2013-2014

Am. Sub. H. B. No. 378

Representatives Smith, Sprague

Cosponsors: Representatives Wachtmann, Brown, Sears, Adams, R., Anielski, Antonio, Baker, Bishoff, Blessing, Boose, Buchy, Budish, Burkley, Butler, Conditt, Derickson, Dovilla, Driehaus, Duffey, Fedor, Gerberry, Green, Grossman, Hackett, Hagan, C., Hall, Hayes, Hill, Kunze, Letson, Mallory, McClain, Milkovich, O'Brien, Patterson, Pelanda, Reece, Rogers, Ruhl, Sheehy, Stinziano, Terhar, Thompson, Winburn Speaker Batchelder

A BILL

To amend sections 4729.291, 4729.541, and 4729.99 and

to enact section 4731.056 of the Revised Code to

establish requirements regarding controlled

substances containing buprenorphine used for the

purpose of treating drug dependence or addiction.

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

Section 1. That sections 4729.291, 4729.541, and 4729.99 be	6
amended and section 4731.056 of the Revised Code be enacted to	7
read as follows:	8

Sec. 4729.291. (A) When a licensed health professional	9
authorized to prescribe drugs personally furnishes drugs to a	10
patient pursuant to division (B) of section 4729.29 of the Revised	11
Code, the prescriber shall ensure that the drugs are labeled and	12
packaged in accordance with state and federal drug laws and any	13
rules and regulations adopted pursuant to those laws. Records of	14
purchase and disposition of all drugs personally furnished to	15
patients shall be maintained by the prescriber in accordance with	16
state and federal drug statutes and any rules adopted pursuant to	17
those statutes.	18

(B) When personally furnishing to a patient RU-486	19
(mifepristone), a prescriber is subject to section 2919.123 of the	20
Revised Code. A prescription for RU-486 (mifepristone) shall be in	21
writing and in accordance with section 2919.123 of the Revised	22
Code.	23

(C)(1) Except as provided in division (D) of this section, a	24
no prescriber ~~may not~~shall do either of the following:	25

(a) In any thirty-day period, personally furnish to or for	26
patients, taken as a whole, controlled substances in an amount	27
that exceeds a total of two thousand five hundred dosage units;	28

(b) In any seventy-two-hour period, personally furnish to or	29
for a patient an amount of a controlled substance that exceeds the	30
amount necessary for the patient's use in a seventy-two-hour	31
period.	32

(2) The state board of pharmacy may impose a fine of not more	33
than five thousand dollars on a prescriber who fails to comply	34
with the limits established under division (C)(1) of this section.	35
A separate fine may be imposed for each instance of failing to	36
comply with the limits. In imposing the fine, the board's actions	37
shall be taken in accordance with Chapter 119. of the Revised	38
Code.	39

(D)(1) None of the following shall be counted in determining	40
whether the amounts specified in division (C)(1) of this section	41
have been exceeded:	42

(a) Methadone provided to patients for the purpose of	43
treating drug dependence or addiction, if the prescriber meets the	44
conditions specified in 21 C.F.R. 1306.07;	45

(b) Buprenorphine provided to patients for the purpose of	46
treating drug dependence or addiction~~, if the prescriber is exempt~~	47
~~from separate registration with the United States drug enforcement~~	48
~~administration~~as part of an opioid treatment program that is the	49
subject of a current, valid certification from the substance abuse	50
and mental health services administration of the United States	51
department of health and human services pursuant to 2142 C.F.R.	52
~~1301.28~~8.11 and distributes both buprenorphine and methadone;	53

(c) Controlled substances provided to research subjects by a	54
facility conducting clinical research in studies approved by a	55
hospital-based institutional review board or an institutional	56
review board accredited by the association for the accreditation	57
of human research protection programs.	58

(2) Division (C)(1) of this section does not apply to a	59
prescriber who is a veterinarian.	60

Sec. 4729.541. (A) Except as provided in divisions (B) and	61
(C) of this section, a business entity described in division	62
(B)(1)(j) or (k) of section 4729.51 of the Revised Code may	63
possess, have custody or control of, and distribute the dangerous	64
drugs in category I, category II, and category III, as defined in	65
section 4729.54 of the Revised Code, without holding a terminal	66
distributor of dangerous drugs license issued under that section.	67

(B) If a business entity described in division (B)(1)(j) or	68
(k) of section 4729.51 of the Revised Code is a pain management	69
clinic or is operating a pain management clinic, the entity shall	70
hold a license as a terminal distributor of dangerous drugs with a	71
pain management clinic classification issued under section	72
4729.552 of the Revised Code.	73

(C) Beginning April 1, 2015, a business entity described in	74
division (B)(1)(j) or (k) of section 4729.51 of the Revised Code	75
shall hold a license as a terminal distributor of dangerous drugs	76
in order to possess, have custody or control of, and distribute	77
~~dangerous~~either of the following:	78

(1) Dangerous drugs that are compounded or used for the	79
purpose of compounding;	80

(2) Controlled substances containing buprenorphine that are	81
used for the purpose of treating drug dependence or addiction.	82

Sec. 4729.99. (A) Whoever violates section 4729.16, division	83
(A) or (B) of section 4729.38, or section 4729.57 of the Revised	84
Code is guilty of a minor misdemeanor. Each day's violation	85
constitutes a separate offense.	86

(B) Whoever violates section 4729.27, 4729.28, or 4729.36 of	87
the Revised Code is guilty of a misdemeanor of the third degree.	88
Each day's violation constitutes a separate offense. If the	89
offender previously has been convicted of or pleaded guilty to a	90
violation of this chapter, that person is guilty of a misdemeanor	91
of the second degree.	92

(C) Whoever violates section 4729.32, 4729.33, or 4729.34 of	93
the Revised Code is guilty of a misdemeanor.	94

(D) Whoever violates division (A), (B), (D), or (E) of	95
section 4729.51 of the Revised Code is guilty of a misdemeanor of	96
the first degree.	97

(E)(1) Whoever violates section 4729.37, division (C)(2) of	98
section 4729.51, division (J) of section 4729.54, or section	99
4729.61 of the Revised Code is guilty of a felony of the fifth	100
degree. If the offender previously has been convicted of or	101
pleaded guilty to a violation of this chapter or a violation of	102
Chapter 2925. or 3719. of the Revised Code, that person is guilty	103
of a felony of the fourth degree.	104

(2) If an offender is convicted of or pleads guilty to a	105
violation of section 4729.37, division (C) of section 4729.51,	106
division (J) of section 4729.54, or section 4729.61 of the Revised	107
Code, if the violation involves the sale, offer to sell, or	108
possession of a schedule I or II controlled substance, with the	109
exception of marihuana, and if the court imposing sentence upon	110
the offender finds that the offender as a result of the violation	111
is a major drug offender, as defined in section 2929.01 of the	112
Revised Code, and is guilty of a specification of the type	113
described in section 2941.1410 of the Revised Code, the court, in	114
lieu of the prison term authorized or required by division (E)(1)	115
of this section and sections 2929.13 and 2929.14 of the Revised	116
Code and in addition to any other sanction imposed for the offense	117
under sections 2929.11 to 2929.18 of the Revised Code, shall	118
impose upon the offender, in accordance with division (B)(3) of	119
section 2929.14 of the Revised Code, the mandatory prison term	120
specified in that division.	121

(3) Notwithstanding any contrary provision of section 3719.21	122
of the Revised Code, the clerk of court shall pay any fine imposed	123
for a violation of section 4729.37, division (C) of section	124
4729.51, division (J) of section 4729.54, or section 4729.61 of	125
the Revised Code pursuant to division (A) of section 2929.18 of	126
the Revised Code in accordance with and subject to the	127
requirements of division (F) of section 2925.03 of the Revised	128
Code. The agency that receives the fine shall use the fine as	129
specified in division (F) of section 2925.03 of the Revised Code.	130

(F) Whoever violates section 4729.531 of the Revised Code or	131
any rule adopted thereunder or section 4729.532 of the Revised	132
Code is guilty of a misdemeanor of the first degree.	133

(G) Whoever violates division (C)(1) of section 4729.51 of	134
the Revised Code is guilty of a felony of the fourth degree. If	135
the offender has previously been convicted of or pleaded guilty to	136
a violation of this chapter, or of a violation of Chapter 2925. or	137
3719. of the Revised Code, that person is guilty of a felony of	138
the third degree.	139

(H) Whoever violates division (C)(3) of section 4729.51 of	140
the Revised Code is guilty of a misdemeanor of the first degree.	141
If the offender has previously been convicted of or pleaded guilty	142
to a violation of this chapter, or of a violation of Chapter 2925.	143
or 3719. of the Revised Code, that person is guilty of a felony of	144
the fifth degree.	145

(I)(1) Whoever violates division (B) of section 4729.42 of	146
the Revised Code is guilty of unauthorized pharmacy-related drug	147
conduct. Except as otherwise provided in this section,	148
unauthorized pharmacy-related drug conduct is a misdemeanor of the	149
second degree. If the offender previously has been convicted of or	150
pleaded guilty to a violation of division (B), (C), (D), or (E) of	151
that section, unauthorized pharmacy-related drug conduct is a	152
misdemeanor of the first degree on a second offense and a felony	153
of the fifth degree on a third or subsequent offense.	154

(2) Whoever violates division (C) or (D) of section 4729.42	155
of the Revised Code is guilty of permitting unauthorized	156
pharmacy-related drug conduct. Except as otherwise provided in	157
this section, permitting unauthorized pharmacy-related drug	158
conduct is a misdemeanor of the second degree. If the offender	159
previously has been convicted of or pleaded guilty to a violation	160
of division (B), (C), (D), or (E) of that section, permitting	161
unauthorized pharmacy-related drug conduct is a misdemeanor of the	162
first degree on a second offense and a felony of the fifth degree	163
on a third or subsequent offense.	164

(3) Whoever violates division (E) of section 4729.42 of the	165
Revised Code is guilty of the offense of falsification under	166
section 2921.13 of the Revised Code. In addition to any other	167
sanction imposed for the violation, the offender is forever	168
disqualified from engaging in any activity specified in division	169
(B)(1), (2), or (3) of section 4729.42 of the Revised Code and	170
from performing any function as a health care professional or	171
health care worker. As used in this division, "health care	172
professional" and "health care worker" have the same meanings as	173
in section 2305.234 of the Revised Code.	174

(4) Notwithstanding any contrary provision of section 3719.21	175
of the Revised Code or any other provision of law that governs the	176
distribution of fines, the clerk of the court shall pay any fine	177
imposed pursuant to division (I)(1), (2), or (3) of this section	178
to the state board of pharmacy if the board has adopted a written	179
internal control policy under division (F)(2) of section 2925.03	180
of the Revised Code that addresses fine moneys that it receives	181
under Chapter 2925. of the Revised Code and if the policy also	182
addresses fine moneys paid under this division. The state board of	183
pharmacy shall use the fines so paid in accordance with the	184
written internal control policy to subsidize the board's law	185
enforcement efforts that pertain to drug offenses.	186

(J)(1) Whoever violates division (A)(1) of section 4729.86 of	187
the Revised Code is guilty of a misdemeanor of the third degree.	188
If the offender has previously been convicted of or pleaded guilty	189
to a violation of division (A)(1), (2), or (3) of section 4729.86	190
of the Revised Code, that person is guilty of a misdemeanor of the	191
first degree.	192

(2) Whoever violates division (A)(2) of section 4729.86 of	193
the Revised Code is guilty of a misdemeanor of the first degree.	194
If the offender has previously been convicted of or pleaded guilty	195
to a violation of division (A)(1), (2), or (3) of section 4729.86	196
of the Revised Code, that person is guilty of a felony of the	197
fifth degree.	198

(3) Whoever violates division (A)(3) of section 4729.86 of	199
the Revised Code is guilty of a felony of the fifth degree. If the	200
offender has previously been convicted of or pleaded guilty to a	201
violation of division (A)(1), (2), or (3) of section 4729.86 of	202
the Revised Code, that person is guilty of a felony of the fourth	203
degree.	204

(K) A person who violates division (C) of section 4729.552 of	205
the Revised Code is guilty of a misdemeanor of the first degree.	206
If the person previously has been convicted of or pleaded guilty	207
to a violation of division (C) of section 4729.552 of the Revised	208
Code, that person is guilty of a felony of the fifth degree.	209

(L) A person who violates division (C) of section 4729.291 of	210
the Revised Code is guilty of a misdemeanor of the first degree.	211
If the person previously has been convicted of or pleaded guilty	212
to a violation of division (C) of section 4729.291 of the Revised	213
Code, that person is guilty of a felony of the fifth degree.	214

Sec. 4731.056. (A) As used in this section:

215

(1) "Controlled substance," "schedule III," "schedule IV,"	216
and "schedule V" have the same meanings as in section 3719.01 of	217
the Revised Code.	218

(2) "Physician" means an individual authorized by this	219
chapter to practice medicine and surgery or osteopathic medicine	220
and surgery.	221

(B) The state medical board shall adopt rules in accordance	222
with Chapter 119. of the Revised Code that establish standards and	223
procedures to be followed by physicians in the use of controlled	224
substances in schedule III, IV, or V to treat opioid dependence or	225
addiction. The board may limit the application of the rules to	226
treatment provided through an office-based practice or other	227
practice type or location specified by the board.	228

Section 2. That existing sections 4729.291, 4729.541, and	229
4729.99 of the Revised Code are hereby repealed.	230