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General Assembly Raised Bill No. 202
February Session, 2024
LCO No. 1642
Referred to Committee on GENERAL LAW
Introduced by:
(GL)
AN ACT CONCERNING THE DEPARTMENT OF CONSUMER
PROTECTION'S RECOMMENDATIONS REGARDING PRESCRIPTION
DRUG CONTROL.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. Subsection (a) of section 21a-65 of the 2024 supplement to 1
the general statutes is repealed and the following is substituted in lieu 2
thereof (Effective from passage): 3
(a) A licensed manufacturer or licensed wholesaler may sell 4
hypodermic needles and syringes only to the following: (1) To a licensed 5
manufacturer, licensed wholesaler or licensed pharmacy; (2) to [a] an 6
advanced practice registered nurse, dentist, embalmer, optometrist, 7
physician, [dentist,] physician assistant, podiatrist, scientific 8
investigator or veterinarian [, embalmer, podiatrist or scientific 9
investigator] licensed to practice in this state; (3) to a person in charge of 10
a care-giving institution, as defined in section 20-571, incorporated 11
college or scientific institution, but only for use by or in such care-giving 12
institution, college or institution for medical or scientific purposes; (4) 13
to a person in charge of a licensed or registered laboratory, but only for 14 Raised Bill No. 202
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use in that laboratory for scientific and medical purposes; (5) to a farmer 15
but only for use on the farmer's own animals or poultry; (6) to a business 16
authorized in accordance with the regulations adopted under section 17
21a-66 to purchase hypodermic needles and syringes but only for 18
legitimate industrial or medical use within that business; and (7) to a 19
syringe services program established pursuant to section 19a-124. 20
Sec. 2. Section 21a-70h of the 2024 supplement to the general statutes 21
is repealed and the following is substituted in lieu thereof (Effective from 22
passage): 23
For the purposes of this section and sections 21a-70i to 21a-70k, as 24
amended by this act: 25
(1) "Commissioner" means the Commissioner of Consumer 26
Protection or the commissioner's authorized representative; 27
(2) "Contact" means any communication transmitted in person or by 28
telephone, electronic mail, text message or other electronic means 29
between a pharmaceutical representative and a prescribing practitioner 30
or pharmacist, to promote or provide information relating to a legend 31
drug; 32
(3) "Department" means the Department of Consumer Protection; 33
(4) "Legend drug" has the same meaning as provided in section 20-34
571; 35
(5) "Pharmaceutical manufacturer" (A) means a [(A)] (i) person, 36
whether within or without the boundaries of the state of Connecticut, 37
that (I) produces, prepares, cultivates, grows, propagates, compounds, 38
converts or processes a drug, [device or cosmetic,] directly or indirectly, 39
by extraction from substances of natural origin, by means of chemical 40
synthesis or by a combination of extraction and chemical synthesis, or 41
(II) [that] packages, repackages, labels or relabels a drug container under 42
such manufacturer's own trademark or label, or any other trademark or 43
label, [or a drug, device or cosmetic] for the purpose of selling the drug, 44 Raised Bill No. 202
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[device or cosmetic,] or [(B)] (ii) sterile compounding pharmacy, as 45
defined in section 20-633b that dispenses sterile pharmaceuticals 46
without a prescription or a patient-specific medical order intended for 47
use in humans, and (B) includes, but is not limited to, a virtual 48
manufacturer, as defined in section 20-571; 49
[(6) "Pharmaceutical manufacturer" includes a virtual manufacturer, 50
as defined in section 20-571;] 51
[(7)] (6) "Pharmaceutical marketing firm" means a pharmaceutical 52
manufacturer that employs or compensates pharmaceutical 53
representatives; 54
[(8)] (7) "Pharmaceutical representative" means any person, 55
including, but not limited to, a sales representative, who markets, 56
promotes or provides information regarding a legend drug for human 57
use to a prescribing practitioner and is employed or compensated by a 58
pharmaceutical manufacturer; 59
[(9)] (8) "Pharmacist" has the same meaning as provided in section 20-60
571; and 61
[(10)] (9) "Prescribing practitioner" has the same meaning as provided 62
in section 20-571. 63
Sec. 3. Section 21a-70i of the 2024 supplement to the general statutes 64
is repealed and the following is substituted in lieu thereof (Effective from 65
passage): 66
(a) On and after October 1, 2023, a pharmaceutical manufacturer that 67
employs [an individual to perform the duties of] a pharmaceutical 68
[sales] representative shall register annually with the department as a 69
pharmaceutical marketing firm, in a form and manner prescribed by the 70
commissioner. No pharmaceutical manufacturer shall authorize an 71
individual to perform [such] the duties of a pharmaceutical 72
representative on such manufacturer's behalf unless such manufacturer 73
has obtained a pharmaceutical marketing firm registration from the 74 Raised Bill No. 202
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department pursuant to this section. Registrations issued pursuant to 75
this section shall expire annually on June thirtieth. 76
(b) The nonrefundable fee for registration as a pharmaceutical 77
marketing firm and for annual renewal of such registration shall be one 78
hundred fifty dollars. Any pharmaceutical marketing firm that fails to 79
renew its registration on or before June thirtieth shall pay a late fee of 80
one hundred dollars for each year that such firm did not renew, in 81
addition to the annual renewal fee required under this section. 82
(c) On the date of its initial registration, and annually thereafter, each 83
pharmaceutical marketing firm shall provide to the department a list of 84
all [individuals] pharmaceutical representatives employed or 85
compensated by such firm. [as a pharmaceutical sales representative.] 86
Each pharmaceutical marketing firm shall notify the department, in a 87
form and manner prescribed by the commissioner, of each individual 88
who is no longer employed or compensated as a pharmaceutical [sales] 89
representative or who was hired or compensated as a pharmaceutical 90
representative after the date on which such firm provided such annual 91
list, not later than two weeks after such individual leaves employment, 92
or was hired or otherwise compensated. 93
(d) The department shall prominently post on its Internet web site the 94
most recent list provided by each pharmaceutical marketing firm 95
pursuant to subsection (c) of this section. 96
(e) Any person who is not identified to the department pursuant to 97
subsection (c) of this section shall not perform the duties of a 98
pharmaceutical [sales] representative on behalf of the pharmaceutical 99
marketing firm. [for any prescribing practitioner in this state.] 100
(f) Not later than July 1, 2024, and annually thereafter, each 101
pharmaceutical marketing firm shall provide the commissioner with the 102
following information regarding the performance for the previous 103
calendar year of each of its pharmaceutical [sales] representatives 104
identified to the department pursuant to subsection (c) of this section at 105
any time during the previous calendar year, in a form and manner 106 Raised Bill No. 202
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prescribed by the commissioner: 107
(1) The aggregate number of contacts such pharmaceutical [sales] 108
representative had with prescribing practitioners and pharmacists; 109
(2) The specialty of [each] such prescribing practitioner and each 110
pharmacist with whom such pharmaceutical [sales] representative 111
made contact; 112
(3) Whether product samples, materials or gifts of any value were 113
provided to a prescribing practitioner or such practitioner's staff in a 114
prescribing practitioner's office or to a pharmacist; and 115
(4) An aggregate report of all free samples, by drug name and 116
strength, in a form and manner prescribed by the commissioner. 117
(g) The department shall annually [analyze the information 118
submitted pursuant to this section and] compile a report on the activities 119
of pharmaceutical [sales representatives] marketing firms in the state. 120
Not later than December [1] 31, 2024, and annually thereafter, the 121
department shall post such report on its Internet web site and submit 122
such report to the Secretary of the Office of Policy and Management. 123
Sec. 4. Section 21a-70j of the 2024 supplement to the general statutes 124
is repealed and the following is substituted in lieu thereof (Effective from 125
passage): 126
Each pharmaceutical marketing firm that employs or compensates a 127
pharmaceutical representative who is engaged in marketing a legend 128
drug [marketing] in this state shall [disclose] ensure that such 129
pharmaceutical representative discloses, in writing, to a prescribing 130
practitioner or pharmacist, [at the] each time [of each] such 131
pharmaceutical representative makes contact with [such] the 132
prescribing practitioner or pharmacist: [, the following information:] 133
(1) The list price of a legend drug when such pharmaceutical 134
representative provides information concerning [such] the legend drug 135
to [the] such prescribing practitioner or pharmacist based on the dose 136 Raised Bill No. 202
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and quantity of such legend drug as described in the medication 137
package insert; and 138
(2) Information on the variation efficacy of the legend drug marketed 139
to different racial and ethnic groups, if such information is available. 140
Sec. 5. Section 19a-17d of the 2024 supplement to the general statutes 141
is repealed and the following is substituted in lieu thereof (Effective from 142
passage): 143
If a [pharmacist or] health care professional who is currently licensed 144
or was previously licensed in another state or jurisdiction is subject to 145
automatic reciprocal discipline for a disciplinary action in such state or 146
jurisdiction, such automatic reciprocal discipline shall be automatically 147
rescinded and shall not be entered into the licensing record of the 148
[pharmacist or] health care professional if the discipline was based 149
solely on the termination of pregnancy under conditions that would not 150
violate the general statutes or the regulations of Connecticut state 151
agencies. The provisions of this section shall not preclude or affect the 152
ability of an agency or board of the state to seek or impose any discipline 153
pursuant to the general statutes against a [pharmacist or other] health 154
care professional licensed by the state. 155
Sec. 6. Subsection (a) of section 21a-70k of the 2024 supplement to the 156
general statutes is repealed and the following is substituted in lieu 157
thereof (Effective from passage): 158
(a) The commissioner may (1) refuse to authorize the issuance or 159
renewal of a registration to operate as a pharmaceutical marketing firm, 160
(2) revoke, suspend or place conditions on a registration to operate as a 161
pharmaceutical marketing firm, and (3) assess a penalty of up to one 162
thousand dollars for each violation of any provision of section 21a-70i, 163
as amended by this act, or 21a-70j, as amended by this act, or take other 164
action permitted by [subdivision (7) of subsection (a) of section 21a-7] 165
section 21a-11, if the applicant or holder of the registration fails to 166
comply with the requirements set forth in section 21a-70i, as amended 167
by this act, or 21a-70j, as amended by this act. 168 Raised Bill No. 202
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Sec. 7. Section 21a-322 of the general statutes is repealed and the 169
following is substituted in lieu thereof (Effective from passage): 170
(a) The [commissioner] Commissioner of Consumer Protection may 171
suspend, revoke or refuse to renew a registration, place a registration on 172
probation, place conditions on a registration and assess a civil penalty 173
of not more than one thousand dollars per violation of this chapter, for 174
sufficient cause. Any of the following shall be sufficient cause for such 175
action by the commissioner: (1) The furnishing of false or fraudulent 176
information in any application filed under this chapter; (2) conviction of 177
a crime under any state or federal law relating to the registrant's 178
profession, controlled substances or drugs or fraudulent practices, 179
including, but not limited to, fraudulent billing practices; (3) failure to 180
maintain effective controls against diversion of controlled substances 181
into other than duly authorized legitimate medical, scientific, or 182
commercial channels; (4) the suspension, revocation, expiration or 183
surrender of the practitioner's federal controlled substance registration; 184
(5) prescribing, distributing, administering or dispensing a controlled 185
substance in schedules other than those specified in the practitioner's 186
state or federal registration or in violation of any condition placed on 187
the practitioner's registration; (6) suspension, revocation, expiration, 188
surrender or other disciplinary action taken against any professional 189
license or registration held by the practitioner; (7) abuse or excessive use 190
of drugs; (8) possession, use, prescription for use or distribution of 191
controlled substances or legend drugs, except for therapeutic or other 192
proper medical or scientific purpose; (9) a practitioner's failure to 193
account for disposition of controlled substances as determined by an 194
audit of the receipt and disposition records of said practitioner; (10) 195
failure to keep records of medical evaluations of patients and all 196
controlled substances dispensed, administered or prescribed to patients 197
by a practitioner; (11) failure to establish and implement administrative 198
safeguards for the protection of electronic protected health information 199
pursuant to 45 CFR 164.308, as amended from time to time; and (12) 200
breach of any such safeguards by a prescribing practitioner's authorized 201
agent. 202 Raised Bill No. 202
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(b) If a practitioner dispenses, administers or prescribes any 203
controlled substance to a patient, the practitioner shall make available 204
to the Department of Consumer Protection, for inspection by the 205
department, records of medical evaluations associated with dispensing, 206
administering or prescribing such controlled substance. Such records 207
shall be confidential and not be subject to disclosure under the Freedom 208
of Information Act, as defined in section 1-200. The department may 209
inspect such records solely for the purpose of investigating any violation 210
or suspected violation, or enforcing any provision, of this chapter or any 211
regulation promulgated under this chapter. Nothing in this subsection 212
shall be construed to require disclosure of any substance abuse 213
treatment record that is protected from disclosure under 42 USC 290dd-214
2 or other applicable federal law. 215
Sec. 8. Subparagraphs (A) and (B) of subdivision (10) of subsection (j) 216
of section 21a-254 of the general statutes are repealed and the following 217
is substituted in lieu thereof (Effective from passage): 218
(10) (A) A prescribing practitioner may designate an authorized 219
agent to review the electronic prescription drug monitoring program 220
and patient controlled substance prescription information on behalf of 221
the prescribing practitioner. The prescribing practitioner shall ensure 222
that any authorized agent's access to such program and patient 223
controlled substance prescription information is limited to the purposes 224
described in this section and occurs in a manner that protects the 225
confidentiality of information that is accessed through such program. 226
The prescribing practitioner and any authorized agent shall be subject 227
to the provisions of 45 CFR 164.308, as amended from time to time, 228
concerning administrative safeguards for the protection of electronic 229
protected health information. A prescribing practitioner may be subject 230
to disciplinary action for acts of the authorized agent as provided in 231
subsection (a) of section 21a-322, as amended by this act. 232
(B) Notwithstanding the provisions of subparagraph (A) of this 233
subdivision, a prescribing practitioner who is employed by or provides 234
professional services to a hospital shall, prior to designating an 235 Raised Bill No. 202
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authorized agent to review the electronic prescription drug monitoring 236
program and patient controlled substance prescription information on 237
behalf of the prescribing practitioner, (i) submit a request to designate 238
one or more authorized agents for such purposes and a written protocol 239
for oversight of the authorized agent or agents to the commissioner, in 240
the form and manner prescribed by the commissioner, and (ii) receive 241
the commissioner's approval to designate such authorized agent or 242
agents and of such written protocol. Such written protocol shall 243
designate either the hospital's medical director, a hospital department 244
head, who is a prescribing practitioner, or another prescribing 245
practitioner as the person responsible for ensuring that the authorized 246
agent's or agents' access to such program and patient controlled 247
substance prescription information is limited to the purposes described 248
in this section and occurs in a manner that protects the confidentiality 249
of information that is accessed through such program. A hospital 250
medical director, a hospital department head, who is a prescribing 251
practitioner, or another prescribing practitioner designated as the 252
person responsible for overseeing an authorized agent's or agents' 253
access to such program and information in the written protocol 254
approved by the commissioner may be subject to disciplinary action for 255
acts of the authorized agent or agents as provided in subsection (a) of 256
section 21a-322, as amended by this act. The commissioner may inspect 257
hospital records to determine compliance with written protocols 258
approved in accordance with this section. 259
This act shall take effect as follows and shall amend the following
sections:
Section 1 from passage 21a-65(a)
Sec. 2 from passage 21a-70h
Sec. 3 from passage 21a-70i
Sec. 4 from passage 21a-70j
Sec. 5 from passage 19a-17d
Sec. 6 from passage 21a-70k(a)
Sec. 7 from passage 21a-322
Sec. 8 from passage 21a-254(j)(10)(A) and (B)
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Statement of Purpose:
To: (1) Allow a licensed manufacturer or wholesaler to sell a
hypodermic needle or syringe to an advanced practice registered nurse,
optometrist or physician assistant; (2) redefine "commissioner",
"pharmaceutical manufacturer" and "pharmaceutical marketing firm"
for the purposes of various statutes concerning pharmaceutical
marketing; (3) eliminate a requirement that the Department of
Consumer Protection annually analyze certain information submitted to
the department concerning pharmaceutical marketing; (4) extend the
date by which the department is required to submit an annual report
concerning pharmaceutical marketing; (5) eliminate an overlapping
prohibition concerning automatic reciprocal discipline of pharmacists;
(6) modify the actions the Commissioner of Consumer Protection may
take following a violation of certain statutes concerning pharmaceutical
marketing; (7) require certain practitioners that dispense, administer or
prescribe controlled substances to make certain records available to the
department; and (8) make minor, technical and conforming changes to
various statutes concerning prescription drug control.
[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
underlined.]