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General Assembly Substitute Bill No. 1355
January Session, 2025
AN ACT CONCERNING PRESCRIPTION DRUGS, DEVICES AND
NONLEGEND DRUGS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective from passage) (a) As used in this section: 1
(1) "Component" means any active or nonactive ingredient of a drug 2
product; 3
(2) "Nonsterile compounded pharmaceutical product" means a drug 4
product produced by compounding one or more components; and 5
(3) "Nonsterile compounding pharmacy" means a pharmacy that is 6
licensed pursuant to section 20-594 of the general statutes and dispenses 7
nonsterile compounded pharmaceutical products. 8
(b) The Commissioner of Consumer Protection, in consultation with 9
the Commission of Pharmacy, shall adopt regulations, in accordance 10
with the provisions of chapter 54 of the general statutes, to: 11
(1) Ensure that nonsterile compounding pharmacies are able to 12
engage in nonsterile compounding (A) in accordance with (i) the laws 13
and regulations of this state, and (ii) all applicable provisions of United 14
States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – 15
Nonsterile Preparations, as amended from time to time, and (B) to 16 Substitute Bill No. 1355
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maintain patients' ability to readily access nonsterile compounded 17
pharmaceutical products that include (i) levonorgestrel, mifepristone or 18
misoprostol as an active ingredient, or (ii) an active ingredient that is 19
similar to levonorgestrel, mifepristone or misoprostol; and 20
(2) Provide for the Department of Consumer Protection, or one or 21
more public-private partnerships between the department and one or 22
more private entities, to import levonorgestrel, mifepristone and 23
misoprostol as a drug product and as a component, and to import drug 24
products and components that are similar to levonorgestrel, 25
mifepristone and misoprostol, to ensure that patients are able to readily 26
access drug products, including, but not limited to, nonsterile 27
compounded pharmaceutical products, that include (A) levonorgestrel, 28
mifepristone or misoprostol as an active ingredient, or (B) an active 29
ingredient that is similar to levonorgestrel, mifepristone or misoprostol. 30
(c) Notwithstanding the requirements of sections 4-168 to 4-172, 31
inclusive, of the general statutes, in order to effectuate this section, prior 32
to adopting regulations pursuant to subsection (b) of this section, the 33
Commissioner of Consumer Protection shall issue policies and 34
procedures to implement the provisions of this section that shall have 35
the force and effect of law. The commissioner shall post all policies and 36
procedures on the Department of Consumer Protection's Internet web 37
site and submit such policies and procedures to the Secretary of the State 38
for posting on the eRegulations System, at least fifteen days prior to the 39
effective date of any such policy or procedure. Any such policy or 40
procedure shall no longer be effective upon the earlier of either the 41
adoption of the policy or procedure as a final regulation under section 42
4-172 of the general statutes or forty-eight months after the effective date 43
of this section, if such regulation has not been submitted to the 44
legislative regulation review committee for consideration under section 45
4-170 of the general statutes. 46
Sec. 2. Section 21a-70i of the general statutes is repealed and the 47
following is substituted in lieu thereof (Effective from passage): 48 Substitute Bill No. 1355
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(a) On and after October 1, 2023, a pharmaceutical manufacturer that 49
employs a pharmaceutical representative shall register annually with 50
the department as a pharmaceutical marketing firm, in a form and 51
manner prescribed by the commissioner. No pharmaceutical 52
manufacturer shall authorize an individual to perform the duties of a 53
pharmaceutical representative on such manufacturer's behalf unless 54
such manufacturer has obtained a pharmaceutical marketing firm 55
registration from the department pursuant to this section. Registrations 56
issued pursuant to this section shall expire annually on June thirtieth. 57
(b) The nonrefundable fee for registration as a pharmaceutical 58
marketing firm and for annual renewal of such registration shall be one 59
hundred fifty dollars. Any pharmaceutical marketing firm that fails to 60
renew its registration on or before June thirtieth shall pay a late fee of 61
one hundred dollars for each year that such firm did not renew, in 62
addition to the annual renewal fee required under this section. 63
(c) On the date of its initial registration, and annually thereafter, each 64
pharmaceutical marketing firm shall provide to the department a list of 65
all pharmaceutical representatives employed or compensated by such 66
firm. Each pharmaceutical marketing firm shall notify the department, 67
in a form and manner prescribed by the commissioner, of each 68
individual who is no longer employed or compensated as a 69
pharmaceutical representative or who was hired or compensated as a 70
pharmaceutical representative after the date on which such firm 71
provided such annual list, not later than two weeks after such individual 72
leaves employment or was hired or otherwise compensated. 73
[(d) The department shall prominently post on its Internet web site 74
the most recent list provided by each pharmaceutical marketing firm 75
pursuant to subsection (c) of this section.] 76
[(e)] (d) Any person who is not identified to the department pursuant 77
to subsection (c) of this section shall not perform the duties of a 78
pharmaceutical representative on behalf of the pharmaceutical 79
marketing firm. 80 Substitute Bill No. 1355
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[(f)] (e) Not later than July 1, 2024, and annually thereafter, each 81
pharmaceutical marketing firm shall provide the commissioner with the 82
following information regarding the performance for the previous 83
calendar year of each of its pharmaceutical representatives identified to 84
the department pursuant to subsection (c) of this section at any time 85
during the previous calendar year, in a form and manner prescribed by 86
the commissioner: 87
(1) The aggregate number of contacts such pharmaceutical 88
representative had with prescribing practitioners and pharmacists; 89
(2) The specialty of such prescribing practitioner and each pharmacist 90
with whom such pharmaceutical representative made contact; 91
(3) Whether product samples, materials or gifts of any value were 92
provided to a prescribing practitioner or such practitioner's staff in a 93
prescribing practitioner's office or to a pharmacist; and 94
(4) An aggregate report of all free samples, by drug name and 95
strength, in a form and manner prescribed by the commissioner. 96
[(g)] (f) The department shall annually compile a report on the 97
activities of pharmaceutical marketing firms in the state. Not later than 98
December 31, 2024, and annually thereafter, the department shall post 99
such report on its Internet web site and submit such report to the 100
Secretary of the Office of Policy and Management. 101
Sec. 3. (NEW) (Effective from passage) (a) A veterinarian licensed in 102
accordance with the provisions of chapter 384 of the general statutes 103
may authorize a person to dispense a prescription veterinary drug, 104
provided: 105
(1) The prescription veterinary drug is dispensed (A) upon the lawful 106
written or oral order of the veterinarian acting in the course of the 107
veterinarian's professional practice, as required under Section 503(f) of 108
the Federal Food, Drug and Cosmetic Act, as amended from time to 109
time, (B) in accordance with all applicable state and federal laws and 110 Substitute Bill No. 1355
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regulations concerning the dispensing of prescription veterinary drugs, 111
and (C) for an animal for which the veterinarian, or another veterinarian 112
in the same practice who is licensed in accordance with the provisions 113
of chapter 384 of the general statutes and has access to the animal's 114
medical records, has established a veterinarian-client-patient 115
relationship; and 116
(2) The person is working under the direct supervision of the 117
veterinarian or another veterinarian described in subparagraph (C) of 118
subdivision (1) of this subsection. 119
(b) A veterinarian who authorizes a person to dispense a prescription 120
veterinary drug in accordance with the provisions of subsection (a) of 121
this section shall be responsible for ensuring that all applicable 122
requirements for dispensing such prescription veterinary drug are 123
satisfied. 124
(c) The Commissioner of Public Health, in consultation with the 125
Connecticut Board of Veterinary Medicine and the Commissioner of 126
Consumer Protection, may adopt regulations, in accordance with the 127
provisions of chapter 54 of the general statutes, to implement the 128
provisions of this section. 129
Sec. 4. Section 21a-70 of the general statutes is repealed and the 130
following is substituted in lieu thereof (Effective October 1, 2025): 131
(a) As used in this section: [(1) "Drugs", "devices" and "cosmetics" 132
have the same meanings as defined in section 21a-92, "wholesaler" or 133
"distributor" means a person, including, but not limited to, a medical 134
device and oxygen provider, a third-party logistics provider, a virtual 135
manufacturer or a virtual wholesale distributor, as such terms are 136
defined in section 20-571, whether within or without the boundaries of 137
the state of Connecticut, who supplies drugs, devices or cosmetics 138
prepared, produced or packaged by manufacturers, to other 139
wholesalers, manufacturers, distributors, hospitals, prescribing 140
practitioners, as defined in section 20-571, pharmacies, federal, state or 141
municipal agencies, clinics or any other person as permitted under 142 Substitute Bill No. 1355
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subsection (h) of this section, except that: (A) A retail pharmacy or a 143
pharmacy within a licensed hospital that supplies to another such 144
pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or 145
V controlled substance normally stocked by such pharmacies to provide 146
for the immediate needs of a patient pursuant to a prescription or 147
medication order of an authorized practitioner, (B) a pharmacy within a 148
licensed hospital that supplies drugs to another hospital or an 149
authorized practitioner for research purposes, (C) a retail pharmacy that 150
supplies a limited quantity of a noncontrolled drug or of a schedule II, 151
III, IV or V controlled substance for emergency stock to a practitioner 152
who is a medical director of a chronic and convalescent nursing home, 153
of a rest home with nursing supervision, of a hospice inpatient facility 154
licensed pursuant to section 19a-491 or of a state correctional institution, 155
and (D) a pharmacy within a licensed hospital that contains another 156
hospital wholly within such licensed hospital's physical structure that 157
supplies to such contained hospital a quantity of a noncontrolled drug 158
or a schedule II, III, IV, or V controlled substance normally stocked by 159
such hospitals to provide for the needs of a patient, pursuant to a 160
prescription or medication order of an authorized practitioner, receiving 161
inpatient care on a unit that is operated by the contained hospital, or 162
receiving outpatient care in a setting operated by the contained hospital 163
and such drug or substance is administered on-site by the contained 164
hospital, shall not be deemed a wholesaler under this section; (2) 165
"manufacturer" means (A) a person, whether within or without the 166
boundaries of the state of Connecticut, who produces, prepares, 167
cultivates, grows, propagates, compounds, converts or processes, 168
directly or indirectly, by extraction from substances of natural origin or 169
by means of chemical synthesis or by a combination of extraction and 170
chemical synthesis, or who packages, repackages, labels or relabels a 171
container under such manufacturer's own or any other trademark or 172
label any drug, device or cosmetic for the purpose of selling such items, 173
or (B) a sterile compounding pharmacy, as defined in section 20-633b, 174
that dispenses sterile pharmaceuticals without a prescription or a 175
patient-specific medical order; (3) "drug", "device" and "cosmetic" have 176
the same meanings as provided in section 21a -92; and (4) 177 Substitute Bill No. 1355
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"commissioner" means the Commissioner of Consumer Protection or 178
the commissioner's designee.] 179
(1) "Commissioner" means the Commissioner of Consumer 180
Protection; 181
(2) "Cosmetic" has the same meaning as provided in section 21a-92; 182
(3) "Device" has the same meaning as provided in section 21a-92; 183
(4) "Distributor" or "wholesaler" (A) means a person, including, but 184
not limited to, a medical device and oxygen provider, a third-party 185
logistics provider, a virtual manufacturer or a virtual wholesale 186
distributor, as such terms are defined in section 20-571, whether within 187
or without the boundaries of the state of Connecticut, who supplies 188
drugs, devices or cosmetics prepared, produced or packaged by 189
manufacturers to other wholesalers, manufacturers, distributors, 190
hospitals, prescribing practitioners, as defined in section 20-571, 191
pharmacies, federal, state or municipal agencies, clinics or any other 192
person as permitted under subsection (i) of this section, and (B) does not 193
include (i) a retail pharmacy or a pharmacy within a licensed hospital 194
that supplies to another such pharmacy a quantity of a noncontrolled 195
drug or a schedule II, III, IV or V controlled substance normally stocked 196
by such pharmacies to provide for the immediate needs of a patient 197
pursuant to a prescription or medication order of an authorized 198
practitioner, (ii) a pharmacy within a licensed hospital that supplies 199
drugs to another hospital or an authorized practitioner for research 200
purposes, (iii) a retail pharmacy that supplies a limited quantity of a 201
noncontrolled drug or of a schedule II, III, IV or V controlled substance 202
for emergency stock to a practitioner who is a medical director of (I) a 203
chronic and convalescent nursing home, (II) a rest home with nursing 204
supervision, (III) a hospice inpatient facility licensed pursuant to section 205
19a-491, or (IV) a correctional institution unless the correctional 206
institution has actual knowledge that the noncontrolled drug or 207
controlled substance will be used to execute a sentence of death, and (iv) 208
a pharmacy within a licensed hospital that contains another hospital 209 Substitute Bill No. 1355
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wholly within such licensed hospital's physical structure that supplies 210
to such contained hospital a quantity of a noncontrolled drug or a 211
schedule II, III, IV or V controlled substance normally stocked by such 212
hospitals to provide for the needs of a patient, pursuant to a prescription 213
or medication order of an authorized practitioner, receiving inpatient 214
care on a unit that is operated by the contained hospital, or receiving 215
outpatient care in a setting operated by the contained hospital and such 216
drug or substance is administered on-site by the contained hospital; 217
(5) "Drug" has the same meaning as provided in section 21a-92; 218
(6) "Manufacturer" means (A) a person, whether within or without 219
the boundaries of the state of Connecticut, who produces, prepares, 220
cultivates, grows, propagates, compounds, converts or processes, 221
directly or indirectly, by extraction from substances of natural origin or 222
by means of chemical synthesis or by a combination of extraction and 223
chemical synthesis, or who packages, repackages, labels or relabels a 224
container under such manufacturer's own or any other trademark or 225
label any drug, device or cosmetic for the purpose of selling such items, 226
or (B) a sterile compounding pharmacy, as defined in section 20-633b, 227
as amended by this act, that dispenses sterile pharmaceuticals without 228
a prescription or a patient-specific medical order; and 229
(7) "Person" means any individual, partnership, corporation, limited 230
liability company, association or other legal entity. 231
(b) No [wholesaler or manufacturer] person shall operate as [such] a 232
manufacturer or wholesaler until [he] such person has received a 233
certificate of registration issued by the commissioner, which certificate 234
shall be renewed annually, provided no such certificate shall be 235
required of a manufacturer, except a sterile compounding pharmacy, as 236
defined in subsection (a) of section 20-633b, whose principal place of 237
business is located outside the state, who is registered with the federal 238
Food and Drug Administration or any successor agency and who files a 239
copy of such registration with the commissioner. A fee of one hundred 240
ninety dollars shall be charged for each wholesaler's certificate and 241 Substitute Bill No. 1355
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renewal thereof. A separate certificate and corresponding fee is required 242
for each location existing in this state and for each location existing 243
outside of this state that distributes products into this state. The fee for 244
a manufacturer's certificate and renewal thereof shall be two hundred 245
eighty-five dollars for manufacturers employing not more than five 246
licensed pharmacists or qualified chemists or both; three hundred 247
seventy-five dollars for manufacturers employing not more than ten 248
licensed pharmacists or qualified chemists or both; and nine hundred 249
forty dollars for manufacturers employing more than ten licensed 250
pharmacists or qualified chemists or both. No such certificate shall be 251
issued to a manufacturer unless such drugs, devices or cosmetics are 252
manufactured or compounded under the direct supervision of a 253
licensed pharmacist or a qualified chemist. No certificate of registration 254
shall be issued under this section until the applicant has furnished proof 255
satisfactory to the commissioner that the applicant is equipped as to 256
facilities and apparatus to properly carry on the business described in 257
his application and that the applicant conforms to chapter 418 and 258
regulations adopted thereunder. 259
(c) The commissioner shall have the right to deny a certificate of 260
registration if [he] the commissioner determines that the issuance of 261
such registration is inconsistent with the public interest. In determining 262
the public interest, the commissioner shall consider, at a minimum, the 263
following factors: 264
(1) Any convictions or regulatory actions involving the applicant 265
under any federal, state or local law relating to drug samples, wholesale 266
or retail drug distribution, or distribution or possession of drugs 267
including controlled substances; 268
(2) Any felony convictions of the applicant under federal, state or 269
local laws; 270
(3) The applicant's past experience in the manufacture or distribution 271
of drugs; 272
(4) The furnishing by the applicant of false or fraudulent material in 273 Substitute Bill No. 1355
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any application made in connection with drug manufacturing or 274
distribution; 275
(5) Suspension, revocation or other sanction by federal, state or local 276
government of any license or registration currently or previously held 277
by the applicant for the manufacture or distribution of any drugs; 278
(6) Compliance with licensing or registration requirements under 279
previously granted licenses or registrations; 280
(7) Compliance with requirements to maintain or make available to 281
the commissioner or to federal, state or local law enforcement officials 282
those records required by any federal or state statute or regulation; 283
(8) Failure to provide adequate control against the diversion, theft 284
and loss of drugs; 285
(9) Provision of required security for legend drugs and, in the case of 286
controlled substances, compliance with security requirements for 287
wholesalers set forth in regulations adopted under chapter 420b; [and] 288
(10) Manufacturing, selling or dispensing any drug or device with 289
actual knowledge that the person purchasing or receiving such drug or 290
device directly from the applicant intends to use such drug or device to 291
execute a sentence of death; and 292
[(10)] (11) Compliance with all regulations adopted to enforce the 293
provisions of this section. 294
(d) The commissioner may suspend, revoke or refuse to renew a 295
registration, or may issue a letter of reprimand or place a registrant on 296
probationary status, for sufficient cause. Any of the following shall be 297
sufficient cause for such action: 298
(1) The furnishing of false or fraudulent information in any 299
application or other document filed with the commissioner; 300
(2) Any criminal conviction of the registrant under any federal or 301 Substitute Bill No. 1355
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state statute concerning drugs; 302
(3) The suspension, revocation or other restriction or penalty issued 303
against a license or registration related to drugs; 304
(4) Failure to provide adequate control against the diversion, theft 305
and loss of drugs; [or] 306
(5) Manufacturing, selling or dispensing any drug or device with 307
actual knowledge that the person purchasing or receiving such drug or 308
device directly from the registrant intends to use such drug or device to 309
execute a sentence of death; or 310
[(5)] (6) A violation of any provision of any federal or state statute or 311
regulation concerning drugs. 312
(e) The commissioner shall not issue or renew a certificate of 313
registration unless the applicant or registrant seeking such certificate or 314
renewal submits to the commissioner, in a form and manner prescribed 315
by the commissioner, a signed, written statement attesting that such 316
applicant or registrant shall not manufacture, sell or dispense any drug 317
or device with actual knowledge that the person purchasing or receiving 318
such drug or device directly from such applicant or registrant intends 319
to use such drug or device to execute a sentence of death. 320
[(e)] (f) Wholesalers and manufacturers shall operate in compliance 321
with applicable federal, state and local statutes, regulations and 322
ordinances, including any applicable laws concerning controlled 323
substances, drug product salvaging or reprocessing. 324
[(f)] (g) Wholesalers and manufacturers shall permit the 325
commissioner, or his authorized representatives, to enter and inspect 326
their premises and delivery vehicles, and to audit their records and 327
written operating procedures, at reasonable times and in a reasonable 328
manner. 329
[(g)] (h) Before denying, suspending, revoking or refusing to renew a 330
registration, or before issuing a letter of reprimand or placing a 331 Substitute Bill No. 1355
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registrant on probationary status, the commissioner shall afford the 332
applicant or registrant an opportunity for a hearing in accordance with 333
the provisions of chapter 54. Notice of such hearing may be given by 334
certified mail. The commissioner may subpoena witnesses and require 335
the production of records, papers and documents pertinent to such 336
hearing. 337
[(h)] (i) No [wholesaler or] manufacturer or wholesaler shall sell any 338
drugs except to the state or any political subdivision thereof, to another 339
manufacturer or wholesaler, to any hospital recognized by the state as a 340
general or specialty hospital, to any institution having a full-time 341
pharmacist who is actively engaged in the practice of pharmacy in such 342
institution not less than thirty-five hours a week, to a chronic and 343
convalescent nursing home having a pharmacist actively engaged in the 344
practice of pharmacy based upon the ratio of one-tenth of one hour per 345
patient per week but not less than twelve hours per week, to a practicing 346
physician, podiatrist, dentist, optometrist or veterinarian, to a licensed 347
pharmacy or a store to which a permit to sell nonlegend drugs has been 348
issued as provided in section 20-624, as amended by this act, or to an 349
authorized entity that has established a medical protocol with a 350
prescribing practitioner pursuant to section 19a-909, as amended by this 351
act, provided drugs sold to an authorized entity shall be limited to 352
epinephrine cartridge injectors. [The commissioner may adopt such 353
regulations as are necessary to administer and enforce the provisions of 354
this section.] 355
[(i)] (j) (1) Each registered manufacturer or wholesaler of drugs shall 356
operate a system to identify suspicious orders of controlled substances 357
and shall immediately inform the Director of the Drug Control Division 358
of suspicious orders. Suspicious orders include, but are not limited to, 359
orders of unusual size, orders deviating substantially from a normal 360
pattern and orders of unusual frequency. Each registered manufacturer 361
or wholesaler of drugs shall also send the Drug Control Division a copy 362
of any suspicious orders submitted to the federal Drug Enforcement 363
Administration pursuant to 21 CFR 1301.74. 364 Substitute Bill No. 1355
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(2) Each registered manufacturer or wholesaler of drugs that, based 365
on concerns of potential diversion, ceases or declines distribution of any 366
schedule II, III, IV or V controlled substance to a pharmacy, as defined 367
in section 20-594, or to a practitioner, as defined in section 21a-316, in 368
the state of Connecticut shall report the name of the pharmacy or 369
practitioner, location of the pharmacy or practitioner and the reasons for 370
ceasing or declining distribution of such controlled substance in writing 371
to the Director of the Drug Control Division, or to an electronic system 372
designated by the Drug Control Division, not later than five business 373
days after ceasing or declining distribution of such controlled substance. 374
(k) The commissioner may adopt regulations, in accordance with the 375
provisions of chapter 54, to administer and enforce the provisions of this 376
section. 377
[(j)] (l) Any person who violates any provision of this section shall be 378
fined not more than five hundred dollars or imprisoned not more than 379
six months, or both. 380
Sec. 5. Subdivision (4) of subsection (a) of section 19a-909 of the 381
general statutes is repealed and the following is substituted in lieu 382
thereof (Effective October 1, 2025): 383
(4) "Authorized entity" means any for-profit or nonprofit entity or 384
organization that employs at least one person with training. 385
"Authorized entity" does not include the state or any political 386
subdivision thereof authorized to purchase epinephrine pursuant to 387
subsection [(h)] (i) of section 21a-70, as amended by this act, a local or 388
regional board of education required to maintain epinephrine cartridge 389
injectors pursuant to subdivision (2) of subsection (d) of section 10-212a 390
or a licensed or a certified ambulance service required to be equipped 391
with epinephrine cartridge injectors pursuant to subsection (b) of 392
section 19a-197a. 393
Sec. 6. Section 21a-248 of the general statutes is repealed and the 394
following is substituted in lieu thereof (Effective October 1, 2025): 395 Substitute Bill No. 1355
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(a) (1) A licensed manufacturer or wholesaler may sell and dispense 396
controlled drugs to any of the following-named persons, but in the case 397
of schedule II drugs only on an official written order or electronically 398
through the Drug Enforcement Agency's Controlled Substance 399
Ordering System: [(1)] (A) To a manufacturer, wholesaler or pharmacist; 400
[(2)] (B) to a physician, dentist or veterinarian; [(3)] (C) to a person in 401
charge of a hospital, incorporated college or scientific institution, but 402
only for use by or in that hospital, incorporated college or scientific 403
institution for medical or scientific purposes; [(4)] (D) to a person in 404
charge of a laboratory, but only for use in that laboratory for scientific 405
and medical purposes; and [(5)] (E) to any registrant as defined in 406
section 21a-240. 407
[(b)] (2) A licensed manufacturer or wholesaler may sell controlled 408
drugs only to registrants when permitted under federal and state laws 409
and regulations. 410
(3) Notwithstanding the provisions of subdivisions (1) and (2) of this 411
subsection, no licensed manufacturer or wholesaler shall sell or 412
dispense a controlled drug directly to another person with actual 413
knowledge that such other person intends to use the controlled drug to 414
execute a sentence of death. 415
[(c)] (b) An official order for any schedule I or II drug shall be signed 416
by the person giving such order or by such person's authorized agent 417
and such order shall be presented to the person who sells or dispenses 418
the drug or drugs named therein as provided by federal law. If such 419
order is accepted by such person, each party to the transaction shall 420
preserve such party's copy of such order for a period of three years in 421
such a way so as to be readily accessible for inspection by any public 422
officer or employee engaged in the enforcement of this chapter. 423
[(d)] (c) The manufacturer or wholesaler shall keep records of all sales 424
and dispensing of controlled drugs and shall comply fully with 425
applicable provisions of the federal controlled drug laws and the federal 426
food and drug laws, and the state food, drug and cosmetic laws in such 427 Substitute Bill No. 1355
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sale or dispensing of controlled drugs. 428
[(e)] (d) Possession or control of controlled drugs obtained as 429
authorized by this section shall be lawful only if obtained in the regular 430
course of the business, occupation, profession, employment or duty of 431
the possessor. 432
[(f)] (e) (1) A person in charge of a hospital, incorporated college or 433
scientific institution, or of a laboratory, or in the employ of this state or 434
of any other state, or of any political subdivision thereof, and a master 435
or other proper officer of a ship or aircraft, who obtains controlled drugs 436
under the provisions of this section or otherwise, shall not administer, 437
or dispense, or otherwise use such drugs within this state, except within 438
the scope of such person's, master's or officer's employment or official 439
duty, and then only for scientific or medicinal purposes or for the 440
purposes of research or analysis and subject to the provisions of this 441
chapter. 442
(2) The provisions of subdivision (1) of this subsection shall not be 443
construed to authorize any person to obtain, administer, dispense or 444
otherwise use a controlled drug to execute a sentence of death. 445
Sec. 7. Subsection (a) of section 20-579 of the general statutes is 446
repealed and the following is substituted in lieu thereof (Effective October 447
1, 2025): 448
(a) The commission may refuse to authorize the issuance of a 449
temporary permit to practice pharmacy, may refuse to authorize the 450
issuance or renewal of a license to practice pharmacy, a license to 451
operate a pharmacy or a registration of a pharmacy intern or pharmacy 452
technician, and may revoke, suspend or place conditions on a license or 453
temporary permit to practice pharmacy, a license to operate a pharmacy, 454
or a registration of a pharmacy intern or a pharmacy technician, and 455
may assess a civil penalty of up to one thousand dollars per violation of 456
any provision of this chapter or take other action permitted in 457
subdivision (7) of section 21a-7 if the applicant or holder of the license, 458
temporary permit or registration: (1) Has violated a statute or regulation 459 Substitute Bill No. 1355
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relating to drugs, devices or the practice of pharmacy of this state, any 460
state of the United States, the United States, the District of Columbia, the 461
Commonwealth of Puerto Rico, any territory or insular possession 462
subject to the jurisdiction of the United States or a foreign jurisdiction; 463
(2) has been convicted of violating any criminal statute relating to drugs, 464
devices or the practice of pharmacy of this state, any state of the United 465
States, the United States, the District of Columbia, the Commonwealth 466
of Puerto Rico, any territory or insular possession subject to the 467
jurisdiction of the United States or a foreign jurisdiction; (3) has been 468
disciplined by, or is the subject of pending disciplinary action or an 469
unresolved complaint before, the duly authorized pharmacy 470
disciplinary agency of any state of the United States, the United States, 471
the District of Columbia, the Commonwealth of Puerto Rico, any 472
territory or insular possession subject to the jurisdiction of the United 473
States or a foreign jurisdiction; (4) has been refused a license or 474
registration or renewal of a license or registration by any state of the 475
United States, the United States, the District of Columbia, the 476
Commonwealth of Puerto Rico, any territory or insular possession 477
subject to the jurisdiction of the United States or a foreign jurisdiction 478
based on grounds that are similar to grounds on which Connecticut 479
could refuse to issue or renew such a license or registration; (5) has 480
illegally possessed, diverted, sold or dispensed drugs or devices; (6) 481
abuses or excessively uses drugs, including alcohol; (7) has made false, 482
misleading or deceptive representations to the public or the 483
commission; (8) has maintained exclusive telephone lines to, has 484
maintained exclusive electronic communication with, or has exclusive 485
access to computers located in offices of prescribing practitioners, 486
nursing homes, clinics, hospitals or other health care facilities; (9) has 487
substituted drugs or devices except as permitted in section 20-619; (10) 488
has accepted, for return to regular stock, any drug already dispensed in 489
good faith or delivered from a pharmacy, and exposed to possible and 490
uncontrolled contamination or substitution; (11) has accepted, for return 491
to general inventory or regular stock, any drug sold or delivered to a 492
patient, unless accepting such drug for return to general inventory or 493
regular stock is otherwise permitted or required by law; (12) has split 494 Substitute Bill No. 1355
LCO 17 of 31
fees for professional services, including a discount or rebate, with a 495
prescribing practitioner or an administrator or owner of a nursing home, 496
hospital or other health care facility; (13) has entered into an agreement 497
with a prescribing practitioner or an administrator or owner of a nursing 498
home, hospital or other health care facility for the compounding or 499
dispensing of secret formula or coded prescriptions; (14) has performed 500
or been a party to a fraudulent or deceitful practice or transaction; (15) 501
has presented to the commission a diploma, license or certificate 502
illegally or fraudulently obtained, or obtained from a college or school 503
of pharmacy not approved by the commission; (16) has performed 504
incompetent or negligent work; (17) while holding such license, 505
temporary permit or registration, has dispensed or distributed a drug or 506
device directly to another person with actual knowledge that such other 507
person intended to use such drug or device to execute a sentence of 508
death; (18) has falsified a continuing education document submitted to 509
the commission or department or a certificate retained in accordance 510
with the provisions of subsection (d) of section 20-600; [(18)] (19) has 511
permitted a person not licensed to practice pharmacy in this state to 512
practice pharmacy in violation of section 20-605, to use a pharmacist 513
license or pharmacy display document in violation of section 20-608, or 514
to use words, displays or symbols in violation of section 20-609; [(19)] 515
(20) has failed to maintain the entire pharmacy premises, its components 516
and contents in a clean, orderly and sanitary condition; [(20)] (21) has 517
failed to demonstrate adherence to applicable provisions of United 518
States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - 519
Sterile Preparations, as amended from time to time; or [(21)] (22) has 520
failed to demonstrate adherence to applicable provisions of United 521
States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – 522
Nonsterile Preparations, as amended from time to time. 523
Sec. 8. Subsection (c) of section 20-593 of the general statutes, as 524
amended by section 258 of public act 23-204, is repealed and the 525
following is substituted in lieu thereof (Effective October 1, 2025): 526
(c) The commission shall not grant a renewal license to an applicant 527
who (1) has not held a license authorized by the commission within five 528 Substitute Bill No. 1355
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years of the date of application unless the applicant has passed an 529
examination satisfactory to the commission and has paid the fee 530
required in section 20-601, or (2) within the calendar year preceding the 531
date of application, dispensed or distributed a drug or device directly to 532
another person with actual knowledge that such other person intended 533
to use the drug or device to execute a sentence of death. 534
Sec. 9. Subsection (d) of section 20-613 of the general statutes is 535
repealed and the following is substituted in lieu thereof (Effective October 536
1, 2025): 537
(d) Nothing in sections 20-570 to 20-630, inclusive, shall (1) prevent a 538
prescribing practitioner from dispensing the prescribing practitioner's 539
own prescriptions to the prescribing practitioner's own patients when 540
authorized within the scope of the prescribing practitioner's own 541
practice and when done in compliance with sections 20-14c to 20-14g, 542
inclusive, or (2) authorize a person to dispense or transfer a drug or 543
device directly to another person with actual knowledge that such other 544
person intends to use the drug or device to execute a sentence of death. 545
Sec. 10. Section 20-613a of the general statutes is repealed and the 546
following is substituted in lieu thereof (Effective October 1, 2025): 547
(a) For the purposes of this section, "electronic questionnaire" means 548
any form in an electronic format that may require personal, financial or 549
medical information from a consumer or patient. 550
(b) In the absence of a documented patient evaluation that includes a 551
physical examination, any request for a controlled substance issued 552
solely on the results of answers to an electronic questionnaire shall be 553
considered to be issued outside the context of a valid practitioner-554
patient relationship and not be a valid prescription. 555
(c) Any request for a controlled substance to execute a sentence of 556
death shall be considered to be issued outside the context of a valid 557
practitioner-patient relationship and not be a valid prescription. 558 Substitute Bill No. 1355
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(d) The Commissioner of Consumer Protection may adopt 559
regulations, in accordance with chapter 54, concerning [such] requests 560
for controlled substances. [For the purposes of this section, "electronic 561
questionnaire" means any form in an electronic format that may require 562
personal, financial or medical information from a consumer or patient.] 563
Sec. 11. Subsection (a) of section 20-629 of the general statutes is 564
repealed and the following is substituted in lieu thereof (Effective October 565
1, 2025): 566
(a) The commission may deny, revoke or suspend any certificate of 567
registration as a nonresident pharmacy for: 568
(1) Failure to comply with any requirement of this chapter or chapter 569
420b; 570
(2) Failure to comply with any federal or state statute or regulation 571
concerning drugs or the practice of pharmacy; 572
(3) Delivering in any manner into this state legend drugs or legend 573
devices that are adulterated or misbranded in violation of chapter 418; 574
[or] 575
(4) Delivering a legend drug or legend device directly to another 576
person with actual knowledge that such other person intends to use the 577
legend drug or legend device to execute a sentence of death; or 578
[(4)] (5) Any disciplinary action taken against the nonresident 579
pharmacy by any state or federal agency. 580
Sec. 12. Subsections (d) to (n), inclusive, of section 20-633b of the 581
general statutes are repealed and the following is substituted in lieu 582
thereof (Effective October 1, 2025): 583
(d) (1) A sterile compounding pharmacy may only provide patient-584
specific sterile pharmaceuticals to patients, to practitioners of medicine, 585
osteopathy, podiatry, dentistry or veterinary medicine, or to an acute 586
care or long-term care hospital or health care facility licensed by the 587 Substitute Bill No. 1355
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Department of Public Health. 588
(2) If a sterile compounding pharmacy provides sterile 589
pharmaceuticals without a patient-specific prescription or medical 590
order, the sterile compounding pharmacy shall also obtain a certificate 591
of registration from the Department of Consumer Protection pursuant 592
to section 21a-70, as amended by this act, and any required federal 593
license or registration. A sterile compounding pharmacy may prepare 594
and maintain on-site inventory of sterile pharmaceuticals no greater 595
than a thirty-day supply, calculated from the completion of 596
compounding, which thirty-day period shall include the period 597
required for third-party analytical testing, to be performed in 598
accordance with the USP chapters. 599
(3) Nothing in subdivision (1) or (2) of this subsection shall be 600
construed to authorize a sterile compounding pharmacy to provide a 601
sterile pharmaceutical directly to another person with actual knowledge 602
that such other person intends to use the sterile pharmaceutical to 603
execute a sentence of death. 604
(e) (1) If a sterile compounding pharmacy plans to remodel any area 605
utilized for the compounding of sterile pharmaceuticals or adjacent 606
space, relocate any space utilized for the compounding of sterile 607
pharmaceuticals or upgrade or conduct a nonemergency repair to the 608
heating, ventilation, air conditioning or primary or secondary 609
engineering controls for any space utilized for the compounding of 610
sterile pharmaceuticals, the sterile compounding pharmacy shall notify 611
the Department of Consumer Protection, in writing, not later than forty-612
five days prior to commencing such remodel, relocation, upgrade or 613
repair. Such written notification shall include a plan for such remodel, 614
relocation, upgrade or repair and such plan shall be subject to 615
department review and approval. If a sterile compounding pharmacy 616
makes an emergency repair, the sterile compounding pharmacy shall 617
notify the department of such emergency repair, in writing, not later 618
than twenty-four hours after such repair is commenced. 619 Substitute Bill No. 1355
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(2) If the USP chapters require sterile recertification after such 620
remodel, relocation, upgrade or repair, the sterile compounding 621
pharmacy shall provide a copy of such sterile compounding pharmacy's 622
sterile recertification to the Department of Consumer Protection not 623
later than five days after the sterile recertification approval. The 624
recertification shall only be performed by an independent licensed 625
environmental monitoring entity. 626
(f) A sterile compounding pharmacy shall report, in writing, to the 627
Department of Consumer Protection any known violation or 628
noncompliance with viable and nonviable environmental sampling 629
testing, as defined in the USP chapters, not later than the end of the next 630
business day after discovering such violation or noncompliance. 631
(g) (1) If a sterile compounding pharmacy initiates a recall of sterile 632
pharmaceuticals that were dispensed pursuant to a patient-specific 633
prescription or medical order, the sterile compounding pharmacy shall 634
notify each patient or patient care giver, the prescribing practitioner and 635
the Department of Consumer Protection of such recall not later than 636
twenty-four hours after such recall was initiated. 637
(2) If a sterile compounding pharmacy initiates a recall of sterile 638
pharmaceuticals that were not dispensed pursuant to a patient-specific 639
prescription or a medical order, the sterile compounding pharmacy 640
shall notify (A) each purchaser of such sterile pharmaceuticals, to the 641
extent such sterile compounding pharmacy possesses contact 642
information for each such purchaser, (B) the Department of Consumer 643
Protection, and (C) the federal Food and Drug Administration of such 644
recall not later than the end of the next business day after such recall 645
was initiated. 646
(h) Each sterile compounding pharmacy shall prepare and maintain 647
a policy and procedure manual. The policy and procedure manual shall 648
comply with the USP chapters. 649
(i) Each sterile compounding pharmacy shall report to the 650
Department of Consumer Protection any administrative or legal action 651 Substitute Bill No. 1355
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commenced against such sterile compounding pharmacy by any state 652
or federal regulatory agency or accreditation entity not later than five 653
business days after receiving notice of the commencement of such 654
action. 655
(j) Notwithstanding the provisions of subdivision (2) of subsection (b) 656
of this section, a sterile compounding pharmacy that is a nonresident 657
pharmacy shall provide to the Department of Consumer Protection 658
proof that such nonresident pharmacy has passed an inspection in such 659
nonresident pharmacy's home state, based on the USP chapters. Such 660
nonresident pharmacy shall submit to the Department of Consumer 661
Protection a copy of the most recent inspection report with such 662
nonresident pharmacy's initial nonresident pharmacy application and 663
shall submit to the department a copy of such nonresident pharmacy's 664
most recent inspection report every two years thereafter. If the state in 665
which such nonresident pharmacy is located does not conduct 666
inspections based on standards required in the USP chapters, such 667
nonresident pharmacy shall provide satisfactory proof to the 668
department that such nonresident pharmacy is in compliance with the 669
standards required in the USP chapters. 670
(k) A practitioner, as specified in subdivision (1) of subsection (d) of 671
this section, a hospital or a health care facility that receives sterile 672
pharmaceuticals shall report any errors related to such dispensing or 673
any suspected adulterated sterile pharmaceuticals to the Department of 674
Consumer Protection. 675
(l) (1) For purposes of this subsection, a "designated pharmacist" 676
means a pharmacist responsible for overseeing the compounding of 677
sterile pharmaceuticals and the application of the USP chapters, as said 678
chapters pertain to sterile compounding. 679
(2) Any pharmacy licensed pursuant to section 20-594 that provides 680
sterile pharmaceuticals shall notify the department of such pharmacy's 681
designated pharmacist. 682
(3) The designated pharmacist shall be responsible for providing 683 Substitute Bill No. 1355
LCO 23 of 31
proof such designated pharmacist has completed a program approved 684
by the commissioner that demonstrates the competence necessary for 685
the compounding of sterile pharmaceuticals, in compliance with all 686
applicable federal and state statutes and regulations. 687
(4) The designated pharmacist shall immediately notify the 688
department whenever such designated pharmacist ceases such 689
designation. 690
(5) Nothing in this section shall prevent a designated pharmacist 691
from being the pharmacy manager. 692
(m) Notwithstanding the provisions of this section, (1) the addition 693
of a flavoring agent in accordance with subsections (a) and (b) of section 694
20-617a shall be exempt from the requirements of United States 695
Pharmacopeia, Chapter 795, Pharmaceutical Compounding – 696
Nonsterile Preparations, and Chapter 800, Hazardous Drugs, as both 697
may be amended from time to time, and (2) no sterile compounding 698
pharmacy shall sell or transfer a sterile pharmaceutical directly to 699
another person with actual knowledge that such other person intends to 700
use the sterile pharmaceutical to execute a sentence of death. 701
(n) The Commissioner of Consumer Protection may adopt 702
regulations, in accordance with chapter 54, to implement the provisions 703
of subsections (a) to (m), inclusive, of this section. 704
Sec. 13. Section 20-623 of the general statutes is repealed and the 705
following is substituted in lieu thereof (Effective from passage): 706
(a) No nonlegend drug may be sold at retail except at a pharmacy, at 707
a store or in a vending machine that is owned and operated by a 708
business that has obtained from the [commission or the] department a 709
permit to sell nonlegend drugs pursuant to section 20-624, as amended 710
by this act. Nonlegend drugs may be sold in a vending machine, which 711
vending machine shall be owned and operated by a business that has 712
obtained from the department a permit for each vending machine in 713
which such business offers nonlegend drugs for sale. If an applicant 714 Substitute Bill No. 1355
LCO 24 of 31
seeks to locate two or more vending machines selling nonlegend drugs 715
at a single premises, only one permit to sell nonlegend drugs shall be 716
required. Any person who is not licensed as a pharmacy and wishes to 717
sell nonlegend drugs in a vending machine shall apply to the 718
department, in a form and manner prescribed by the commissioner, in 719
order to obtain a permit to sell nonlegend drugs. Nonlegend drugs shall 720
be labeled and packaged in accordance with state and federal law. 721
(b) (1) A vending machine offering nonlegend drugs may also offer 722
nonlegend devices or test strips intended for use by an individual to test 723
for a particular substance prior to injection, inhalation or ingestion of 724
the substance to prevent accidental overdose by injection, inhalation or 725
ingestion of such substance. Each vending machine offering nonlegend 726
drugs or nonlegend devices shall be individually registered with the 727
department, and each application to register a vending machine offering 728
nonlegend drugs or nonlegend devices shall designate an individual 729
who shall be responsible for properly maintaining such vending 730
machine. 731
(2) Each person who registers a vending machine pursuant to 732
subdivision (1) of this subsection, and the individual designated as the 733
individual responsible for properly maintaining the registered vending 734
machine, shall ensure that such vending machine (A) maintains the 735
proper temperature and humidity for each nonlegend drug offered in 736
such vending machine as required by the original manufacturer of such 737
nonlegend drug, (B) only contains nonlegend drugs and nonlegend 738
devices that remain in the original containers provided by the 739
manufacturers of such nonlegend drugs or nonlegend devices, (C) only 740
offers nonlegend drugs and nonlegend devices that are unexpired and 741
unadulterated, (D) only offers nonlegend drugs and nonlegend devices 742
that are not subject to a recall, provided any nonlegend drug or 743
nonlegend device that is the subject of a recall shall be promptly 744
removed from such vending machine, (E) only contains nonlegend 745
drugs and nonlegend devices, sundries and other nonperishable items, 746
(F) has a clear and conspicuous written statement attached to such 747
vending machine disclosing the name, address and toll-free telephone 748 Substitute Bill No. 1355
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number of the owner and operator of such vending machine, (G) has a 749
clear and conspicuous written statement attached to such vending 750
machine advising a consumer to check the expiration date of a 751
nonlegend drug or nonlegend device contained in such vending 752
machine before the consumer uses such nonlegend drug or nonlegend 753
device, (H) has attached to such vending machine, in a size and 754
prominent location visible to consumers, a written notice stating "Drug 755
tampering or expired product? Notify the Department of Consumer 756
Protection, Drug Control Division, by calling (telephone number of the 757
toll-free telephone line established by the department pursuant to 758
section 21a-2)", (I) does not offer any nonlegend drug or nonlegend 759
device that requires age verification, is subject to any quantity limit or is 760
subject to any sales restriction under state or federal law, and (J) does 761
not contain any package of a nonlegend drug that contains more than a 762
five-day supply of the nonlegend drug as determined according to the 763
usage directions provided by the manufacturer of such nonlegend drug. 764
(c) Notwithstanding the provisions of this section, no person who 765
solely distributes nonlegend naloxone to the public through a secure 766
box, without compensation or consideration, shall be required to obtain 767
a permit to sell nonlegend drugs pursuant to section 20-624, as amended 768
by this act, provided the secure box satisfies the requirements 769
established in section 21a-286, as amended by this act. As used in this 770
subsection, "secure box" has the same meaning as provided in section 771
21a-286, as amended by this act. 772
[(c)] (d) Any person who violates any provision of this section shall 773
be fined not more than one thousand dollars per violation. 774
Sec. 14. Section 20-624 of the general statutes is repealed and the 775
following is substituted in lieu thereof (Effective from passage): 776
(a) Any person may apply to the [commission] department, in a form 777
and manner prescribed by the commissioner, for a permit to sell 778
nonlegend drugs. 779
(b) (1) The [commission] department may, in accordance with 780 Substitute Bill No. 1355
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regulations adopted under sections 20-570 to 20-630, inclusive, in 781
accordance with chapter 54, and on payment of the fee required in 782
section 20-601, issue to an applicant a permit to sell nonlegend drugs for 783
one year. 784
(2) Notwithstanding subdivision (1) of this subsection, an applicant 785
for a permit to sell nonlegend drugs shall not be required to pay any 786
permit application or renewal fee required in section 20-601 if, as part of 787
the applicant's application, the applicant attests that the applicant shall 788
utilize such permit solely to distribute nonlegend drugs without 789
compensation or consideration. 790
(c) A permit that has expired under this section may be renewed, on 791
application and payment of the renewal fee and any late fee required in 792
section 20-601 or 21a-4. 793
(d) The holder of a permit to sell nonlegend drugs shall [notify the 794
commission] electronically submit to the department, in a form and 795
manner prescribed by the commissioner, notification of a change of 796
ownership, name or location of the [permit premises] permanent 797
physical location. Any holder who fails to notify the [commission] 798
department of such change within five days of the change shall pay the 799
late fee required in section 20-601. 800
[(e) Any nonlegend drug permit issued by the commission pursuant 801
to this section is nontransferable.] 802
Sec. 15. Section 21a-286 of the general statutes is repealed and the 803
following is substituted in lieu thereof (Effective from passage): 804
(a) For the purposes of this section: 805
(1) "Commissioner" means the Commissioner of Consumer 806
Protection; 807
(2) "Department" means the Department of Consumer Protection; 808
(3) "Host agency" means a community health organization, 809 Substitute Bill No. 1355
LCO 27 of 31
emergency medical service provider, government agency, law 810
enforcement agency or local or regional board of education; 811
(4) "Opioid antagonist" has the same meaning set forth in section 17a-812
714a; 813
(5) "Prescribing practitioner" has the same meaning set forth in 814
section 20-14c; 815
(6) "Pharmacist" has the same meaning set forth in section 20-609a; 816
(7) "Secure box" means a container that (A) is securely affixed in a 817
public location, (B) can be accessed by individuals for public use, [(C) is 818
temperature controlled or stored in an environment with temperature 819
controls, (D) is tamper-resistant, (E) is equipped with an alarm capable 820
of detecting and transmitting a signal when accessed by individuals, 821
and (F) is equipped with an alarm capable of alerting first responders 822
when accessed by individuals, unless equipping the container with such 823
an alarm is commercially impracticable] and (C) displays any signage 824
required by the department pursuant to subsection (g) of this section; 825
(8) "Secured machine" means a device that (A) restricts access to 826
individuals participating in a syringe services program by utilizing a 827
designated access number, personalized magnetic strip card or any 828
other technology to identify such individuals for the purpose of 829
providing access, and (B) is registered with the department in a form 830
and manner prescribed by the commissioner; and 831
(9) "Syringe services program" means a program that is (A) 832
established or authorized pursuant to section 19a-124, and (B) approved 833
by the department under section 21a-65. 834
(b) A prescribing practitioner, or a pharmacist who is certified to 835
prescribe an opioid antagonist pursuant to section 20-633c, may enter 836
into an agreement with a host agency related to the distribution and 837
administration of an opioid antagonist for the reversal of an opioid 838
overdose. The prescribing practitioner or pharmacist shall provide 839 Substitute Bill No. 1355
LCO 28 of 31
training to persons who will distribute or administer the opioid 840
antagonist pursuant to the terms of the agreement. Persons other than 841
the prescribing practitioner or pharmacist shall receive training in the 842
distribution or administration of opioid antagonists prior to distributing 843
or administering an opioid antagonist. The agreement shall address the 844
storage, handling, labeling, recalls and recordkeeping of opioid 845
antagonists by the host agency that is party to the agreement. 846
(c) (1) A prescribing practitioner, or a pharmacist who is certified to 847
prescribe an opioid antagonist pursuant to section 20-633c, may enter 848
into an agreement with a host agency to provide an intranasally or orally 849
administered opioid antagonist, or permit a host agency to install on the 850
host agency's premises a secure box containing an intranasally or orally 851
administered opioid antagonist. The agreement shall address the 852
environmental controls necessary to store such opioid antagonist, 853
establish procedures for replenishment of such opioid antagonist, 854
establish a process for monitoring the expiration dates of such opioid 855
antagonist and disposing of any expired opioid antagonist, and require 856
that signs be posted disclosing the presence of such opioid antagonist, 857
and usage directions for such opioid antagonist, in the language or 858
languages spoken in the community in which the secure box is installed. 859
The secure box shall not contain an amount of the opioid antagonist that 860
is greater than the amount necessary to serve the community in which 861
such secure box is installed. If the host agency is unable to maintain the 862
secure box, or the supplies necessary to maintain the secure box are 863
unavailable, such host agency shall remove such secure box, and all 864
signs required under this subdivision concerning such secure box, as 865
soon as practicable but in no event later than five days after such host 866
agency discovers that such host agency is unable to maintain such 867
secure box or the supplies necessary to maintain such secure box. 868
(2) A prescribing practitioner, or a pharmacist who is certified to 869
prescribe an opioid antagonist pursuant to section 20-633c, may enter 870
into an agreement with a host agency to operate a vending machine for 871
the purpose of distributing an opioid antagonist for nasal 872
administration. The vending machine shall be in a location that 873 Substitute Bill No. 1355
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maintains a temperature that is at all times consistent with the 874
manufacturer's package insert for the opioid antagonist, or have the 875
ability to maintain an environment, independent of the external 876
environment, that is appropriate for the opioid antagonist based on such 877
package insert. The following shall be clearly and conspicuously 878
displayed on the outside of the vending machine, adjacent to the 879
vending machine or upon distribution of an opioid antagonist contained 880
in such vending machine: (A) Information concerning the signs and 881
symptoms of an overdose; (B) instructions for the use of the opioid 882
antagonist; (C) information about the services that are offered in this 883
state to treat opioid use disorder; and (D) an Internet web site address 884
that contains, or a quick response code that directs an individual to an 885
Internet web site that contains, information concerning the signs and 886
symptoms of an overdose, overdose response and instructions for the 887
use of the opioid antagonist. 888
(3) Nothing in subdivision (1) or (2) of this subsection shall be 889
construed to prohibit placement of an opioid antagonist in a container 890
that also includes an automated external defibrillator or any other 891
product used to treat a medical emergency. 892
(d) A prescribing practitioner, or a pharmacist who is certified to 893
prescribe an opioid antagonist pursuant to section 20-633c, may enter 894
into an agreement with a syringe services program to permit the syringe 895
services program to include an opioid antagonist in such syringe 896
services program's secured machine. The agreement shall address the 897
environmental controls necessary to store such opioid antagonist, 898
establish procedures for replenishment of such opioid antagonist, 899
establish a process for monitoring the expiration dates of such opioid 900
antagonist and disposing of any expired opioid antagonist, and require 901
that signs be posted disclosing the presence of such opioid antagonist, 902
and usage directions for such opioid antagonist, in the language or 903
languages spoken in the community in which such secured machine is 904
installed. 905
(e) Nothing in this section shall be construed to prevent a secured 906 Substitute Bill No. 1355
LCO 30 of 31
machine from distributing a test strip intended for use by an individual 907
prior to injection, inhalation or ingestion of a particular substance to 908
prevent accidental overdose by injection, inhalation or ingestion of such 909
substance. 910
(f) A prescribing practitioner or pharmacist who enters into an 911
agreement pursuant to subsection (b), (c) or (d) of this section shall not 912
be liable for damages in a civil action or subject to administrative or 913
criminal prosecution for the administration or dispensing of an opioid 914
antagonist by the host agency who is a party to such agreement. 915
(g) Each secure box shall display such signage as the department, in 916
the department's discretion, deems necessary or appropriate for the 917
purposes of this section and posts on the department's Internet web site. 918
[(g)] (h) The Commissioner of Consumer Protection may adopt 919
regulations, in accordance with the provisions of chapter 54, to 920
implement the provisions of this section. 921
This act shall take effect as follows and shall amend the following
sections:
Section 1 from passage New section
Sec. 2 from passage 21a-70i
Sec. 3 from passage New section
Sec. 4 October 1, 2025 21a-70
Sec. 5 October 1, 2025 19a-909(a)(4)
Sec. 6 October 1, 2025 21a-248
Sec. 7 October 1, 2025 20-579(a)
Sec. 8 October 1, 2025 20-593(c)
Sec. 9 October 1, 2025 20-613(d)
Sec. 10 October 1, 2025 20-613a
Sec. 11 October 1, 2025 20-629(a)
Sec. 12 October 1, 2025 20-633b(d) to (n)
Sec. 13 from passage 20-623
Sec. 14 from passage 20-624
Sec. 15 from passage 21a-286
Substitute Bill No. 1355
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GL Joint Favorable Subst.