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General Assembly Raised Bill No. 1102
January Session, 2023
LCO No. 4736
Referred to Committee on GENERAL LAW
Introduced by:
(GL)
AN ACT CONCERNING PHARMACIES AND PHARMACISTS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. Section 20-571 of the general statutes is repealed and the 1
following is substituted in lieu thereof (Effective July 1, 2023): 2
As used in this chapter and sections 2 and 3 of this act, unless the 3
context otherwise requires: 4
(1) "Administer" or ["Administration"] "administration" means the 5
direct application of a drug or device to the body of a patient or research 6
subject by injection, inhalation, ingestion or any other means; 7
(2) "Automated prescription dispensing machine" means a device 8
and associated software operated by a pharmacy or a pharmacy that is 9
registered as a nonresident pharmacy pursuant to section 20-627, in a 10
nursing home or skilled nursing facility licensed pursuant to sections 11
19a-490 and 19a-491, that packages and labels patient-specific 12
medication or multiple medications for the purposes of administration 13
by a registered nurse or a licensed practical nurse based on a 14
prescription that has completed final verification by a licensed 15 Raised Bill No. 1102
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pharmacist; 16
(3) "Care-giving institution" means an institution that provides 17
medical services and is licensed, operated, certified or approved by the 18
Commissioner of Public Health, the Commissioner of Developmental 19
Services or the Commissioner of Mental Health and Addiction Services; 20
(4) "Commission" means the Commission of Pharmacy appointed 21
under the provisions of section 20-572; 22
(5) "Commissioner" means the Commissioner of Consumer 23
Protection; 24
(6) "Compound" means to combine, mix or put together two or more 25
ingredients pursuant to a prescription and includes the preparation of 26
drugs or devices in anticipation of prescriptions based on routine, 27
regularly-observed prescribing patterns; 28
(7) "Correctional or juvenile training institution" means a facility for 29
the detention or incarceration of persons convicted or accused of crimes 30
or offenses or for training of delinquent juveniles, including those state 31
facilities under the jurisdiction of the Commissioner of Correction, 32
training schools for delinquent juveniles and any other facilities 33
operated by the state or municipalities for such detention, incarceration 34
or training; 35
(8) "Device" means instruments, apparatuses and contrivances, 36
including their components, parts and accessories, intended: (A) [for] 37
For use in the diagnosis, cure, mitigation, treatment or prevention of 38
disease in humans or other animals; [,] or (B) to affect the structure or 39
any function of the body of humans or other animals, but does not mean 40
contact lenses; 41
(9) "Department" means the Department of Consumer Protection; 42
(10) "Deprescribing" means the systematic process of identifying and 43
discontinuing drugs in instances in which existing or potential harms 44
outweigh existing or potential benefits within the context of an 45 Raised Bill No. 1102
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individual patient's care goals, current level of functioning, life 46
expectancy, values and preferences; 47
(11) "Dispense" means those acts of processing a drug or device for 48
delivery or for administration for a patient pursuant to a prescription 49
consisting of: (A) Comparing the directions on the label with the 50
directions on the prescription to determine accuracy; (B) the selection of 51
the drug or device from stock to fill the prescription; (C) the counting, 52
measuring, compounding or preparation of the drug or device; (D) the 53
placing of the drug or device in the proper container; (E) the affixing of 54
the label to the container; and (F) the addition to a written prescription 55
of any required notations. "Dispense" does not include the acts of 56
delivering a drug or device to a patient or of administering the drug or 57
device to the patient; 58
(12) "Dispensing outpatient facility" means a facility operated by a 59
corporation or municipality which provides medical services to patients 60
on an outpatient basis and which maintains stocks of drugs for 61
dispensing of drugs on a regular basis to patients for use off the 62
premises; 63
(13) "Drug" means: (A) [an] An article recognized in the official 64
United States Pharmacopoeia, official Homeopathic Pharmacopoeia of 65
the United States or official National Formulary, or any supplement to 66
any of them; [,] (B) an article intended for use in the diagnosis, cure, 67
mitigation, treatment or prevention of disease in humans or other 68
animals; [,] (C) an article, other than food, intended to affect the 69
structure or any function of the body of humans or any other animal; [,] 70
and (D) an article intended for use as a component of any article 71
specified in this subdivision, but does not include a device; 72
(14) "Health care institution" means institution, as defined in section 73
19a-490; 74
(15) "Health care institutional pharmacy" means an institutional 75
pharmacy located within a health care institution; 76 Raised Bill No. 1102
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[(14)] (16) "Institutional pharmacy" means that area within a care-77
giving institution or within a correctional or juvenile training 78
institution, commonly known as the pharmacy, that is under the direct 79
charge of a pharmacist and in which drugs are stored and dispensed; 80
[(15)] (17) "Legend device" means a device that is required by 81
applicable federal or state law to be dispensed pursuant only to a 82
prescription or is restricted to use by prescribing practitioners only or 83
that, under federal law, is required to bear either of the following 84
legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES 85
ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC 86
ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE 87
FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN."; 88
[(16)] (18) "Legend drug" means a drug that is required by any 89
applicable federal or state law to be dispensed pursuant only to a 90
prescription or is restricted to use by prescribing practitioners only, or 91
means a drug that, under federal law, is required to bear either of the 92
following legends: (A) "RX ONLY" IN ACCORDAN CE WITH 93
GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND 94
COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS 95
DRUG FOR USE BY OR ON THE ORDER OF A LICENSED 96
VETERINARIAN."; 97
[(17)] (19) "Medical device and oxygen provider" means a person who 98
distributes devices or oxygen pursuant to a medical order or 99
prescription, except if such person already maintains an active 100
pharmacy license; 101
[(18)] (20) "Medication reconciliation" means a process of comparing 102
the medications a patient is taking and should be taking with newly 103
ordered medications: (A) [for] For the purpose of addressing 104
duplications, omissions and interactions and the need to continue 105
current medications; [,] and (B) by looking at information such as the 106
medication name, dose, frequency, route of administration and 107
purpose; 108 Raised Bill No. 1102
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[(19)] (21) "Nonlegend device" means a device that is not a legend 109
device; 110
[(20)] (22) "Nonlegend drug" means a drug that is not a legend drug; 111
(23) "Nonresident pharmacy" has the same meaning as provided in 112
section 20-627; 113
[(21)] (24) "Person" means an individual, corporation, business trust, 114
estate trust, partnership, association, joint venture or any other legal or 115
commercial entity; 116
[(22)] (25) "Pharmacist" means an individual who is licensed to 117
practice pharmacy under the provisions of section 20-590, 20-591, 20-592 118
or 20-593, and who is thereby recognized as a health care provider by 119
the state of Connecticut; 120
[(23)] (26) "Pharmacy" means a place of business where drugs and 121
devices may be sold at retail and for which a pharmacy license has been 122
issued to an applicant under the provisions of section 20-594, as 123
amended by this act; 124
[(24)] (27) "Pharmacy intern" means an individual registered under 125
the provisions of section 20-598; 126
[(25)] (28) "Pharmacy technician" means an individual who is 127
registered with the department and qualified in accordance with section 128
20-598a; 129
[(26)] (29) "Polypharmacy" means the use of multiple drugs by a 130
patient, including any medication that is inappropriate or not medically 131
necessary, such as those not indicated, not effective or constituting a 132
therapeutic duplication; 133
[(27)] (30) "Practice of pharmacy" or "to practice pharmacy" means the 134
sum total of knowledge, understanding, judgments, procedures, 135
securities, controls and ethics used by a pharmacist to assure optimal 136
safety and accuracy in the distributing, dispensing and use of drugs and 137 Raised Bill No. 1102
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devices; 138
[(28)] (31) "Prescribing practitioner" means an individual licensed by 139
the state of Connecticut, any other state of the United States, the District 140
of Columbia, the Commonwealth of Puerto Rico or any territory or 141
insular possession subject to the jurisdiction of the United States who is 142
authorized to issue a prescription within the scope of the individual's 143
practice; 144
[(29)] (32) "Prescription" means a lawful order of a prescribing 145
practitioner transmitted either orally, in writing or by electronic means 146
for a drug or device for a specific patient; 147
[(30)] (33) "Sale" includes barter, exchange or gift or offer and each 148
such transaction made by a person whether as principal proprietor, 149
agent, servant or employee; 150
[(31)] (34) "Substitute" means to dispense without the prescribing 151
practitioner's express authorization a different drug product than the 152
drug product prescribed; 153
[(32)] (35) "Third-party logistics provider" means a person who 154
distributes drugs, devices or cosmetics while taking possession of the 155
drugs, devices or cosmetics but who does not take title of the drugs, 156
devices or cosmetics; 157
[(33)] (36) "Virtual manufacturer" means a person who engages in the 158
manufacture of drugs, devices or cosmetics for which such person: (A) 159
Owns the new drug application or abbreviated new drug application 160
number, if a prescription drug; (B) owns the unique device identification 161
number, as available, for a prescription device; (C) contracts with a 162
contract manufacturing organization for the physical manufacture of 163
the drugs, devices or cosmetics; (D) is not involved in the physical 164
manufacture of the drugs, devices or cosmetics; and (E) at no time takes 165
physical possession of or stores the drugs, devices or cosmetics; and 166
[(34)] (37) "Virtual wholesale distributor" means a person who 167 Raised Bill No. 1102
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facilitates or brokers the transfer of drugs, devices or cosmetics without 168
taking physical possession of the drugs, devices or cosmetics. 169
Sec. 2. (NEW) (Effective July 1, 2023) (a) For the purposes of this 170
section: 171
(1) "COVID-19" means the respiratory disease designated by the 172
World Health Organization on February 11, 2020, as coronavirus 2019, 173
and any related mutation thereof recognized by said organization as a 174
communicable respiratory disease; 175
(2) "COVID-19-related test" means any laboratory test, or series of 176
laboratory tests, for any virus, antibody, antigen or etiologic agent 177
thought to cause, or indicate the presence of, COVID-19; 178
(3) "HIV-related prophylaxis" means any drug approved by the 179
federal Food and Drug Administration or any successor agency as a pre-180
exposure or post-exposure prophylaxis for the human 181
immunodeficiency virus; 182
(4) "HIV-related test" has the same meaning as provided in section 183
19a-7o of the general statutes; and 184
(5) "Influenza-related test" means any laboratory test, or series of 185
laboratory tests, for any virus, antibody, antigen or etiologic agent 186
thought to cause, or indicate the presence of, influenza disease. 187
(b) (1) Any person who is licensed as a pharmacist under part II of 188
chapter 400j of the general statutes and employed by a pharmacy that 189
has submitted to the Department of Public Health a complete clinical 190
laboratory improvement amendment application for certification for a 191
COVID-19-related test, HIV-related test or Influenza-related test may 192
order and administer the COVID-19-related test, HIV-related test or 193
Influenza-related test to any patient who is: (A) Eighteen years of age or 194
older; or (B) at least twelve years of age but younger than eighteen years 195
of age with (i) the consent of such patient's parent, legal guardian or 196
other person having legal custody of such patient, or (ii) proof that such 197 Raised Bill No. 1102
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patient is an emancipated minor. 198
(2) If a pharmacist orders and administers a COVID-19-related test, 199
HIV-related test or Influenza-related test to a patient under subdivision 200
(1) of this subsection, the pharmacist shall: (A) Provide to the patient, in 201
writing, the results of such test; (B) maintain a record of the results of 202
such test for a period of three years; and (C) provide to the 203
Commissioner of Consumer Protection or the commissioner's designee, 204
upon a request made by the commissioner or the commissioner's 205
designee, a copy of the results of such test. 206
(c) (1) If a pharmacist orders and administers any HIV-related test to 207
a patient under subdivision (1) of subsection (b) of this section and the 208
result of such test is negative, the pharmacist may prescribe and 209
dispense to the patient any HIV-related prophylaxis according to the 210
manufacturer's package insert, provided: (A) Such patient's 211
circumstances satisfy the criteria established in such package insert; and 212
(B) prescribing and dispensing such HIV-related prophylaxis satisfies 213
all applicable requirements established in chapter 400j of the general 214
statutes. 215
(2) If a pharmacist prescribes any HIV-related prophylaxis under 216
subdivision (1) of this subsection, the pharmacist shall provide to the 217
Commissioner of Consumer Protection or the commissioner's designee, 218
upon a request made by the commissioner or the commissioner's 219
designee: (A) A copy of the results of the HIV-related test; (B) 220
prescription information maintained pursuant to chapter 400j of the 221
general statutes; and (C) any other documentation the commissioner 222
requires in regulations adopted pursuant to subsection (d) of this 223
section. 224
(d) The Commissioner of Consumer Protection, in consultation with 225
the Commissioner of Public Health and the Commission of Pharmacy, 226
shall adopt regulations, in accordance with chapter 54 of the general 227
statutes, to implement the provisions of this section. Such regulations 228
shall, at a minimum: (1) Identify qualifying training programs, which 229 Raised Bill No. 1102
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are accredited by the National Centers for Disease Control and 230
Prevention, the Accreditation Council for Pharmacy Education or 231
another appropriate national accrediting body; and (2) establish a 232
system of control and reporting. 233
Sec. 3. (NEW) (Effective July 1, 2023) (a) (1) A pharmacy may apply to 234
the department, in a form and manner prescribed by the commissioner, 235
to operate a mobile pharmacy in a temporary location for the purpose 236
of: (A) Conducting (i) a temporary clinic, (ii) a vaccination event, or (iii) 237
an opioid antagonist training and prescribing event; or (B) serving a 238
community that may not have adequate access to such pharmacy's 239
services. 240
(2) No pharmacy may operate a mobile pharmacy without prior 241
approval from the department. Each mobile pharmacy shall be 242
supervised by a pharmacist. The department may inspect a mobile 243
pharmacy before pharmacy services are provided in the mobile 244
pharmacy, and at any time during usual business hours. The 245
department may issue an order closing a mobile pharmacy if the 246
department determines that: (A) The mobile pharmacy has failed to 247
comply with the provisions of this section; (B) conditions are unsafe to 248
store and dispense drugs; or (C) there is insufficient security at such 249
mobile pharmacy. 250
(b) A pharmacy that operates a mobile pharmacy under this section 251
shall: (1) Maintain a record of all drugs that are removed from the 252
pharmacy premises for the purpose of operating such mobile pharmacy; 253
(2) maintain a record of each drug that is dispensed at such mobile 254
pharmacy and include such record in such pharmacy's records not later 255
than twenty-four hours after such drug is dispensed; (3) except as 256
provided in subsection (c) of this section, inventory and return all 257
unused drugs to the pharmacy premises by the close of business each 258
day; (4) while operating such mobile pharmacy, store all drugs in such 259
mobile pharmacy in a manner that (A) prevents any drug diversion, and 260
(B) is consistent with the storage conditions specified by the 261
manufacturers of such drugs; (5) establish and maintain a plan to ensure 262 Raised Bill No. 1102
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that patients receive necessary treatments if such mobile pharmacy is 263
unavailable; and (6) if permitted by the federal Drug Enforcement 264
Administration or a successor agency, store controlled substances in the 265
mobile pharmacy in accordance with regulations adopted by the 266
commissioner pursuant to section 21a-262 of the general statutes. 267
(c) No pharmacy shall, without prior approval from the department: 268
(1) Operate a mobile pharmacy for more than (A) seven consecutive 269
days in a single location, or (B) fourteen days in any geographic area; or 270
(2) store drugs overnight in a mobile pharmacy or outside of the 271
pharmacy premises. 272
(d) The commissioner may, with the advice and consent of the 273
commission, adopt regulations in accordance with chapter 54 of the 274
general statutes to implement the provisions of this section. 275
Sec. 4. Section 20-633 of the general statutes is repealed and the 276
following is substituted in lieu thereof (Effective July 1, 2023): 277
(a) (1) Any person licensed as a pharmacist under part II of this 278
chapter may [(1)] administer: [, to an adult, any] 279
(A) Any vaccine, approved or authorized by the United States Food 280
and Drug Administration that is listed on the National Centers for 281
Disease Control and Prevention's Adult Immunization Schedule, [and 282
(2) on and after July 1, 2022, administer to any person between the ages 283
of twelve and seventeen, with the consent of such person's parent or 284
guardian, the influenza vaccine approved by the United States Food and 285
Drug Administration, provided the administration of any vaccine under 286
this subsection is conducted pursuant to the order of a licensed health 287
care provider and in accordance with the regulations established 288
pursuant to subsection (b) of this section.] to any patient who is: (i) 289
Eighteen years of age or older; or (ii) at least twelve years of age but 290
younger than eighteen years of age with (I) the consent of such patient's 291
parent, legal guardian or other person having legal custody of such 292
patient, or (II) proof that such patient is an emancipated minor. 293 Raised Bill No. 1102
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(B) Any vaccine not included on the National Centers for Disease 294
Control and Prevention's Adult Immunization Schedule, provided the 295
vaccine administration instructions for such vaccine are available on the 296
National Centers for Disease Control and Prevention's Internet web site; 297
and 298
(C) Any vaccine pursuant to a verbal or written prescription of a 299
prescribing practitioner for a specific patient. 300
(2) A pharmacist shall make a reasonable effort to review a patient's 301
vaccination history to prevent any inappropriate use of a requested 302
vaccine. 303
(3) All vaccines administered pursuant to this section shall be 304
administered in accordance with the: (A) Vaccine manufacturer's 305
package insert or upon the orders of a prescribing practitioner based on 306
the age of the patient being vaccinated; and (B) regulations adopted 307
pursuant to subsection (c) of this section. 308
(b) A pharmacist who has completed the training required in 309
regulations adopted pursuant to subsection (c) of this section may 310
administer an epinephrine cartridge injector, as defined in section 19a-311
909, to a patient whom the pharmacist reasonably believes, based on 312
such pharmacist's knowledge and training, is experiencing anaphylaxis, 313
regardless of whether such patient has a prescription for an epinephrine 314
cartridge injector. Such pharmacist, or such pharmacist's designee, shall 315
call the 9-1-1 emergency telephone number either before or immediately 316
after such pharmacist administers the epinephrine cartridge injector to 317
such patient. Such pharmacist shall document the date, time and 318
circumstances in which such pharmacist administered such epinephrine 319
cartridge injector, and maintain such documentation for at least three 320
years. 321
[(b)] (c) The Commissioner of Consumer Protection, in consultation 322
with the Commissioner of Public Health and the Commission of 323
Pharmacy, shall adopt regulations, in accordance with the provisions of 324
chapter 54, to implement the provisions of this section. Such regulations 325 Raised Bill No. 1102
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shall: (1) [require] Require any pharmacist who administers a vaccine 326
pursuant to this section to successfully complete an immunization 327
training program for pharmacists; (2) define the basic requirements of 328
such training program, which shall include training and instruction in 329
pre-administration education and screening, vaccine storage and 330
handling, subcutaneous and intramuscular injections, recordkeeping, 331
vaccine safety, cardiopulmonary resuscitation, basic cardiac life support 332
and adverse event reporting; (3) identify qualifying training programs, 333
which are accredited by the National Centers for Disease Control 334
Prevention, the Accreditation Council for Pharmacy Education or 335
[other] another appropriate national accrediting body; and (4) establish 336
a system of control and reporting. 337
[(c) For purposes of this section, "adult" means a person who has 338
attained the age of eighteen years.] 339
Sec. 5. Subsection (a) of section 20-576 of the general statutes is 340
repealed and the following is substituted in lieu thereof (Effective July 1, 341
2023): 342
(a) The commissioner may, with the advice and assistance of the 343
commission, adopt regulations, in accordance with chapter 54, to 344
govern the performance of the commission's duties, the practice of 345
pharmacy and the business of retailing drugs and devices. Such 346
regulations may include, but are not limited to, provisions (1) 347
concerning the licensing of any pharmacist or pharmacy, disciplinary 348
action that may be taken against a licensee, the conduct of a pharmacist 349
and the operation of a pharmacy, (2) specifying various classes of 350
pharmacy licenses issued under section 20-594, as amended by this act, 351
including, but not limited to, licenses for infusion therapy pharmacies, 352
[and] nuclear pharmacies and health care institutional pharmacies, and 353
specifying requirements for operation of pharmacies under the classes 354
of pharmacy licenses permitted under the regulations, (3) concerning 355
creation and maintenance of prescription records, and (4) concerning 356
registration and activities of pharmacy interns, registered pharmacy 357
technicians and certified pharmacy technicians. 358 Raised Bill No. 1102
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Sec. 6. Section 20-594 of the general statutes is repealed and the 359
following is substituted in lieu thereof (Effective July 1, 2023): 360
(a) Except as limited by section 20-596, a pharmacist, health care 361
institution or any other person may apply to the commission for a 362
pharmacy license or for renewal of a pharmacy license. 363
(b) The applicant shall disclose on the application the name and 364
address of the applicant and the owner of the pharmacy, the name and 365
street and mailing address of the pharmacy and the name, address and 366
license number of the pharmacist who manages the pharmacy. The 367
commissioner may, by regulation adopted with the advice and 368
assistance of the commission, in accordance with chapter 54, require 369
such other information on the application as is necessary for the 370
department to carry out [its] the department's duties under sections 20-371
570 to 20-630, inclusive. 372
(c) The department shall, after receipt of an application under this 373
section, (1) issue, on authorization of the commission, a pharmacy 374
license to an applicant for a new pharmacy on payment of the fee 375
required in section 20-601 and on satisfactory evidence to the 376
commission that the pharmacy will be managed by a pharmacist and 377
will be operated in accordance with the general statutes and the 378
regulations adopted by the commissioner in accordance with chapter 54, 379
and (2) issue a renewal of a pharmacy license to an applicant on 380
payment of the fee required in section 20-601. 381
(d) Pharmacy licenses shall expire annually. Pharmacy licenses may 382
be renewed on application and payment of the fee required in section 383
20-601 for a period not to exceed one year. 384
(e) When a pharmacy is transferred to a new location the pharmacy 385
license for such pharmacy shall terminate. A pharmacy license that has 386
been terminated under this subsection may be renewed under the 387
provisions of subsection (d) of this section and on satisfactory evidence 388
to the commission that the pharmacy will be managed by a pharmacist 389
and will be operated in accordance with the general statutes and the 390 Raised Bill No. 1102
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regulations adopted by the commissioner in accordance with chapter 54. 391
(f) Each pharmacy licensed pursuant to this section shall report to the 392
department any administrative or legal action commenced against [it] 393
such pharmacy by any state or federal regulatory agency or 394
accreditation entity not later than ten business days after receiving 395
notice of the commencement of such action. 396
Sec. 7. Section 20-633b of the general statutes is repealed and the 397
following is substituted in lieu thereof (Effective July 1, 2023): 398
(a) As used in this section: 399
(1) "Medical order" means a written, oral or electronic order by a 400
prescribing practitioner [, as defined in section 20-14c,] for a drug to be 401
dispensed by a pharmacy for administration to a patient; 402
(2) "Prescribing practitioner" has the same meaning as provided in 403
section 20-14c; 404
[(2)] (3) "Sterile compounding pharmacy" means a pharmacy [, as 405
defined in section 20-571, a] or nonresident pharmacy [registered 406
pursuant to section 20-627,] that dispenses or compounds sterile 407
pharmaceuticals; 408
[(3)] (4) "Sterile pharmaceutical" means any dosage form of a drug, 409
including, but not limited to, parenterals, injectables, surgical irrigants 410
and ophthalmics devoid of viable microorganisms; and 411
[(4)] (5) "USP chapters" means chapters 797, 800 and 825 of the United 412
States Pharmacopeia that pertain to comp ounding sterile 413
pharmaceuticals and their referenced companion documents, as 414
amended from time to time. 415
(b) (1) (A) If an applicant for a new pharmacy license pursuant to 416
section 20-594, as amended by this act, intends to compound sterile 417
pharmaceuticals, the applicant shall file an addendum to [its] the 418
pharmacy license application such applicant files pursuant to section 20-419 Raised Bill No. 1102
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594, as amended by this act, to include sterile pharmaceutical 420
compounding. The [Department of Consumer Protection] department 421
shall inspect the proposed pharmacy premises of [the] such applicant 422
and [the] such applicant shall not compound sterile pharmaceuticals 423
until [it] such applicant receives notice that the addendum to such 424
applicant's application has been approved by the department and the 425
[Commission of Pharmacy] commission. 426
[(2)] (B) If an existing pharmacy licensed pursuant to section 20-594, 427
as amended by this act, intends to compound sterile pharmaceuticals for 428
the first time on or after July 1, 2014, such pharmacy shall [file an] apply 429
for an addendum [application to its] to such pharmacy's application on 430
file with the department to include sterile pharmaceutical 431
compounding. The [Department of Consumer Protection] department 432
shall inspect the pharmacy premises of such pharmacy and [the] such 433
pharmacy shall not compound sterile pharmaceuticals until [it] such 434
pharmacy receives notice that such addendum application has been 435
approved by the department and the [Commission of Pharmacy] 436
commission. 437
(C) If an existing health care institutional pharmacy licensed 438
pursuant to section 20-594, as amended by this act, intends to compound 439
sterile pharmaceuticals for the first time on or after July 1, 2023, such 440
health care institutional pharmacy shall apply for an addendum to such 441
health care institutional pharmacy's application on file with the 442
department to include sterile pharmaceutical compounding. The 443
department shall inspect the pharmacy premises of such health care 444
institutional pharmacy and such health care institutional pharmacy 445
shall not compound sterile pharmaceuticals until such health care 446
institutional pharmacy receives notice that such health care institutional 447
pharmacy's application has been approved by the department and the 448
commission. 449
[(3)] (2) (A) If an applicant for a new nonresident pharmacy 450
registration intends to compound sterile pharmaceuticals for sale or 451
delivery in this state, the applicant shall file an addendum to [its] the 452 Raised Bill No. 1102
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registration application such applicant files pursuant to section 20-627 453
to include sterile pharmaceutical compounding. [The] Such applicant 454
shall provide to the department [with] written proof [it] that such 455
applicant has passed inspection by the appropriate state agency in the 456
state where such [nonresident pharmacy] applicant is located. Such 457
[pharmacy] applicant shall not compound sterile pharmaceuticals for 458
sale or delivery in this state until [it] such applicant receives notice that 459
[the] such addendum [application] has been approved by the 460
department and the [Commission of Pharmacy] commission. 461
[(4)] (B) If [a] an existing nonresident pharmacy [registered pursuant 462
to section 20-627] intends to compound sterile pharmaceuticals for sale 463
or delivery in this state for the first time on or after July 1, 2014, [the] 464
such nonresident pharmacy shall [file] apply for an addendum to [its] 465
such nonresident pharmacy's application on file with the department to 466
include sterile pharmaceutical compounding. [The] Such nonresident 467
pharmacy shall provide to the department [with] written proof [it] that 468
such nonresident pharmacy has passed inspection by the appropriate 469
state agency in the state where such nonresident pharmacy is located. 470
Such nonresident pharmacy shall not compound sterile 471
pharmaceuticals until [it] such nonresident pharmacy receives notice 472
that [the] such addendum application has been approved by the 473
department and the [Commission of Pharmacy] commission. 474
(c) A sterile compounding pharmacy shall comply with the USP 475
chapters. A sterile compounding pharmacy shall also comply with all 476
applicable federal and state statutes and regulations. 477
[(d) An institutional pharmacy within a facility licensed pursuant to 478
section 19a-490 that compounds sterile pharmaceuticals shall comply 479
with the USP chapters, and shall also comply with all applicable federal 480
and state statutes and regulations. Such institutional pharmacy may 481
request from the Commissioner of Consumer Protection an extension of 482
time, not to exceed six months, to comply, for state enforcement 483
purposes, with any amendments to USP chapters, for good cause 484
shown. The commissioner may grant an extension for a length of time 485 Raised Bill No. 1102
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not to exceed six months. Nothing in this section shall prevent such 486
institutional pharmacy from requesting a subsequent extension of time 487
or shall prevent the commissioner from granting such extension.] 488
[(e)] (d) (1) A sterile compounding pharmacy may only provide 489
patient-specific sterile pharmaceuticals to patients, practitioners of 490
medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to 491
an acute care or long-term care hospital or health care facility licensed 492
by the Department of Public Health. 493
(2) If a sterile compounding pharmacy provides sterile 494
pharmaceuticals without a patient-specific prescription or medical 495
order, the sterile compounding pharmacy shall also obtain a certificate 496
of registration from the Department of Consumer Protection pursuant 497
to section 21a-70, as amended by this act, and any required federal 498
license or registration. A sterile compounding pharmacy may prepare 499
and maintain on-site inventory of sterile pharmaceuticals no greater 500
than a thirty-day supply, calculated from the completion of 501
compounding, which thirty-day period shall include the period 502
required for third-party analytical testing, to be performed in 503
accordance with the USP chapters. 504
[(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any 505
area utilized for the compounding of sterile pharmaceuticals or adjacent 506
space, relocate any space utilized for the compounding of sterile 507
pharmaceuticals or upgrade or conduct a nonemergency repair to the 508
heating, ventilation, air conditioning or primary or secondary 509
engineering controls for any space utilized for the compounding of 510
sterile pharmaceuticals, the sterile compounding pharmacy shall notify 511
the Department of Consumer Protection, in writing, not later than forty-512
five days prior to commencing such remodel, relocation, upgrade or 513
repair. Such written notification shall include a plan for such remodel, 514
relocation, upgrade or repair and such plan shall be subject to 515
department review and approval. If a sterile compounding pharmacy 516
makes an emergency repair, the sterile compounding pharmacy shall 517
notify the department of such emergency repair, in writing, not later 518 Raised Bill No. 1102
LCO No. 4736 18 of 25
than twenty-four hours after such repair is commenced. 519
(2) If the USP chapters require sterile recertification after such 520
remodel, relocation, upgrade or repair, the sterile compounding 521
pharmacy shall provide a copy of [its] such sterile compounding 522
pharmacy's sterile recertification to the Department of Consumer 523
Protection not later than five days after the sterile recertification 524
approval. The recertification shall only be performed by an independent 525
licensed environmental monitoring entity. 526
[(g)] (f) A sterile compounding pharmacy shall report, in writing, to 527
the Department of Consumer Protection any known violation or 528
noncompliance with viable and nonviable environmental sampling 529
testing, as defined in the USP chapters, not later than the end of the next 530
business day after discovering such violation or noncompliance. 531
[(h)] (g) (1) If a sterile compounding pharmacy initiates a recall of 532
sterile pharmaceuticals that were dispensed pursuant to a patient-533
specific prescription or medical order, the sterile compounding 534
pharmacy shall notify each patient or patient care giver, the prescribing 535
practitioner and the Department of Consumer Protection of such recall 536
not later than twenty-four hours after such recall was initiated. 537
(2) If a sterile compounding pharmacy initiates a recall of sterile 538
pharmaceuticals that were not dispensed pursuant to a patient-specific 539
prescription or a medical order, the sterile compounding pharmacy 540
shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the 541
extent such sterile compounding pharmacy possesses contact 542
information for each such purchaser, (B) the Department of Consumer 543
Protection, and (C) the federal Food and Drug Administration of such 544
recall not later than the end of the next business day after such recall 545
was initiated. 546
[(i)] (h) Each sterile compounding pharmacy [and each institutional 547
pharmacy within a facility licensed pursuant to section 19a-490] shall 548
prepare and maintain a policy and procedure manual. The policy and 549
procedure manual shall comply with the USP chapters. 550 Raised Bill No. 1102
LCO No. 4736 19 of 25
[(j)] (i) Each sterile compounding pharmacy shall report to the 551
Department of Consumer Protection any administrative or legal action 552
commenced against [it] such sterile compounding pharmacy by any 553
state or federal regulatory agency or accreditation entity not later than 554
five business days after receiving notice of the commencement of such 555
action. 556
[(k)] (j) Notwithstanding the provisions of [subdivisions (3) and (4)] 557
subdivision (2) of subsection (b) of this section, a sterile compounding 558
pharmacy that is a nonresident pharmacy shall provide the Department 559
of Consumer Protection proof that [it] such nonresident pharmacy has 560
passed an inspection in such nonresident pharmacy's home state, based 561
on the USP chapters. Such nonresident pharmacy shall submit to the 562
Department of Consumer Protection a copy of the most recent 563
inspection report with [its] such nonresident pharmacy's initial 564
nonresident pharmacy application and shall submit to the department 565
a copy of [its] such nonresident pharmacy's most recent inspection 566
report every two years thereafter. If the state in which [the] such 567
nonresident pharmacy is located does not conduct inspections based on 568
standards required in the USP chapters, such nonresident pharmacy 569
shall provide satisfactory proof to the department that [it] such 570
nonresident pharmacy is in compliance with the standards required in 571
the USP chapters. 572
[(l)] (k) A practitioner, as specified in subdivision (1) of subsection 573
[(e)] (d) of this section, a hospital or a health care facility that receives 574
sterile pharmaceuticals shall report any errors related to such 575
dispensing or any suspected adulterated sterile pharmaceuticals to the 576
Department of Consumer Protection. 577
[(m)] (l) (1) For purposes of this subsection, a "designated pharmacist" 578
means a pharmacist responsible for overseeing the compounding of 579
sterile pharmaceuticals and the application of the USP chapters, as said 580
chapters pertain to sterile compounding. 581
(2) Any pharmacy licensed pursuant to section 20-594, as amended 582 Raised Bill No. 1102
LCO No. 4736 20 of 25
by this act, [or institutional pharmacy licensed pursuant to section 19a-583
490] that provides sterile pharmaceuticals shall notify the department of 584
[its] such pharmacy's designated pharmacist. 585
(3) The designated pharmacist shall be responsible for providing 586
proof [he or she] such designated pharmacist has completed a program 587
approved by the commissioner that demonstrates the competence 588
necessary for the compounding of sterile pharmaceuticals, in 589
compliance with all applicable federal and state statutes and 590
regulations. 591
(4) The designated pharmacist shall immediately notify the 592
department whenever [he or she] such designated pharmacist ceases 593
such designation. 594
(5) Nothing in this section shall prevent a designated pharmacist 595
from being the pharmacy manager. 596
[(n)] (m) The Commissioner of Consumer Protection may adopt 597
regulations, in accordance with chapter 54, to implement the provisions 598
of this section. 599
Sec. 8. Subsections (a) and (b) of section 21a-65 of the general statutes 600
are repealed and the following is substituted in lieu thereof (Effective July 601
1, 2023): 602
(a) A licensed manufacturer or licensed wholesaler may sell 603
hypodermic needles and syringes only to the following: (1) To a licensed 604
manufacturer, licensed wholesaler or licensed pharmacy; (2) to a 605
physician, dentist, veterinarian, embalmer, podiatrist or scientific 606
investigator licensed to practice in this state; (3) to a person in charge of 607
a care-giving institution, as defined in [subdivision (3) of] section 20-571, 608
as amended by this act, incorporated college or scientific institution, but 609
only for use by or in such care-giving institution, college or institution 610
for medical or scientific purposes; (4) to a person in charge of a licensed 611
or registered laboratory, but only for use in that laboratory for scientific 612
and medical purposes; (5) to a farmer but only for use on the farmer's 613 Raised Bill No. 1102
LCO No. 4736 21 of 25
own animals or poultry; (6) to a business authorized in accordance with 614
the regulations adopted under section 21a-66 to purchase hypodermic 615
needles and syringes but only for legitimate industrial or medical use 616
within that business; and (7) to a syringe services program established 617
pursuant to section 19a-124. 618
(b) Except as provided in subsection (a) of this section, no licensed 619
manufacturer, licensed wholesaler or licensed pharmacist shall sell and 620
no person shall buy a hypodermic needle or syringe except upon a 621
prescription of a prescribing practitioner, as defined in [subdivision (28) 622
of] section 20-571, as amended by this act, in a quantity greater than ten. 623
Any such prescription shall be retained on file by the seller for a period 624
of not less than three years and shall be accessible to any public officer 625
engaged in the enforcement of this section. Such a prescription shall be 626
valid for one year from the date thereof and purchases and sales may be 627
made thereunder during such period, provided the seller shall confirm 628
the continued need for such sales with such practitioner at least every 629
six months if sales continue to be made thereunder. Hypodermic 630
needles and syringes in a quantity of ten or less without a prescription 631
may be provided or sold at retail only by the following: (1) By a 632
pharmacy licensed in accordance with section 20-594, as amended by 633
this act, and in such pharmacy only by a licensed pharmacist or under 634
the pharmacist's direct supervision; (2) by a syringe service program 635
established pursuant to section 19a-124; and (3) by a health care facility 636
or a licensed health care practitioner for use by their own patients. 637
Sec. 9. Subsection (a) of section 21a-70 of the general statutes is 638
repealed and the following is substituted in lieu thereof (Effective July 1, 639
2023): 640
(a) As used in this section: (1) "Drugs", "devices" and "cosmetics" have 641
the same meanings as defined in section 21a-92, "wholesaler" or 642
"distributor" means a person, including, but not limited to, a medical 643
device and oxygen provider, a third-party logistics provider, a virtual 644
manufacturer or a virtual wholesale distributor, as such terms are 645
defined in section 20-571, as amended by this act, whether within or 646 Raised Bill No. 1102
LCO No. 4736 22 of 25
without the boundaries of the state of Connecticut, who supplies drugs, 647
devices or cosmetics prepared, produced or packaged by 648
manufacturers, to other wholesalers, manufacturers, distributors, 649
hospitals, prescribing practitioners, as defined in [subdivision (28) of] 650
section 20-571, as amended by this act, pharmacies, federal, state or 651
municipal agencies, clinics or any other person as permitted under 652
subsection (h) of this section, except that: (A) A retail pharmacy or a 653
pharmacy within a licensed hospital that supplies to another such 654
pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or 655
V controlled substance normally stocked by such pharmacies to provide 656
for the immediate needs of a patient pursuant to a prescription or 657
medication order of an authorized practitioner, (B) a pharmacy within a 658
licensed hospital that supplies drugs to another hospital or an 659
authorized practitioner for research purposes, (C) a retail pharmacy that 660
supplies a limited quantity of a noncontrolled drug or of a schedule II, 661
III, IV or V controlled substance for emergency stock to a practitioner 662
who is a medical director of a chronic and convalescent nursing home, 663
of a rest home with nursing supervision, of a hospice inpatient facility 664
licensed pursuant to section 19a-491 or of a state correctional institution, 665
and (D) a pharmacy within a licensed hospital that contains another 666
hospital wholly within [its] such licensed hospital's physical structure 667
that supplies to such contained hospital a quantity of a noncontrolled 668
drug or a schedule II, III, IV, or V controlled substance normally stocked 669
by such hospitals to provide for the needs of a patient, pursuant to a 670
prescription or medication order of an authorized practitioner, receiving 671
inpatient care on a unit that is operated by the contained hospital, or 672
receiving outpatient care in a setting operated by the contained hospital 673
and such drug or substance is administered on-site by the contained 674
hospital, shall not be deemed a wholesaler under this section; (2) 675
"manufacturer" means (A) a person, whether within or without the 676
boundaries of the state of Connecticut, who produces, prepares, 677
cultivates, grows, propagates, compounds, converts or processes, 678
directly or indirectly, by extraction from substances of natural origin or 679
by means of chemical synthesis or by a combination of extraction and 680
chemical synthesis, or who packages, repackages, labels or relabels a 681 Raised Bill No. 1102
LCO No. 4736 23 of 25
container under such manufacturer's own or any other trademark or 682
label any drug, device or cosmetic for the purpose of selling such items, 683
or (B) a sterile compounding pharmacy, as defined in section 20-633b, 684
as amended by this act, that dispenses sterile pharmaceuticals without 685
a prescription or a patient-specific medical order; (3) "drug", "device" 686
and "cosmetic" have the same meanings as provided in section 21a-92; 687
and (4) "commissioner" means the Commissioner of Consumer 688
Protection or [his or her] the commissioner's designee. 689
Sec. 10. Subsection (k) of section 21a-106 of the general statutes is 690
repealed and the following is substituted in lieu thereof (Effective July 1, 691
2023): 692
(k) If it is a legend drug, as defined in [subdivision (16) of] section 20-693
571, as amended by this act, that is not administered, dispensed, 694
prescribed or otherwise possessed or distributed in accordance with 695
federal and state laws and regulations; 696
Sec. 11. Subsection (e) of section 21a-115 of the general statutes is 697
repealed and the following is substituted in lieu thereof (Effective July 1, 698
2023): 699
(e) In the promulgation of regulations under the provisions of this 700
section applicable to prescribing practitioners, care-giving institutions, 701
and correctional and juvenile training institutions, as defined in 702
[subdivision (7) of] section 20-571, as amended by this act, the 703
Commissioner of Consumer Protection shall act in place of the director. 704
Existing regulations shall continue in effect unless superseded by action 705
of said commissioner pursuant to this subsection. 706
Sec. 12. Subsection (j) of section 21a-249 of the general statutes is 707
repealed and the following is substituted in lieu thereof (Effective July 1, 708
2023): 709
(j) A pharmacy may sell and dispense controlled substances upon the 710
prescription of a prescribing practitioner, as defined in [subdivision (28) 711
of] section 20-571, as amended by this act. 712 Raised Bill No. 1102
LCO No. 4736 24 of 25
Sec. 13. Section 38a-492a of the general statutes is repealed and the 713
following is substituted in lieu thereof (Effective July 1, 2023): 714
Each individual health insurance policy providing coverage of the 715
type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 716
38a-469, delivered, issued for delivery, renewed, amended or continued 717
in this state shall provide coverage for hypodermic needles or syringes 718
prescribed by a prescribing practitioner, as defined in [subdivision (28) 719
of] section 20-571, as amended by this act, for the purpose of 720
administering medications for medical conditions, provided such 721
medications are covered under the policy. Such benefits shall be subject 722
to any policy provisions that apply to other services covered by such 723
policy. 724
Sec. 14. Section 38a-518a of the general statutes is repealed and the 725
following is substituted in lieu thereof (Effective July 1, 2023): 726
Each group health insurance policy providing coverage of the type 727
specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 38a-728
469, delivered, issued for delivery, renewed, amended or continued in 729
this state shall provide coverage for hypodermic needles or syringes 730
prescribed by a prescribing practitioner, as defined in [subdivision (28) 731
of] section 20-571, as amended by this act, for the purpose of 732
administering medications for medical conditions, provided such 733
medications are covered under the policy. Such benefits shall be subject 734
to any policy provisions that apply to other services covered by such 735
policy. 736
Sec. 15. Subdivision (1) of subsection (b) of section 53a-13 of the 737
general statutes is repealed and the following is substituted in lieu 738
thereof (Effective July 1, 2023): 739
(b) (1) It shall not be a defense under this section if such mental 740
disease or defect was proximately caused by the voluntary ingestion, 741
inhalation or injection of intoxicating liquor or any drug or substance, 742
or any combination thereof, unless such drug was prescribed for the 743
defendant by a prescribing practitioner, as defined in [subdivision (28) 744 Raised Bill No. 1102
LCO No. 4736 25 of 25
of] section 20-571, as amended by this act, and was used in accordance 745
with the directions of such prescription. 746
This act shall take effect as follows and shall amend the following
sections:
Section 1 July 1, 2023 20-571
Sec. 2 July 1, 2023 New section
Sec. 3 July 1, 2023 New section
Sec. 4 July 1, 2023 20-633
Sec. 5 July 1, 2023 20-576(a)
Sec. 6 July 1, 2023 20-594
Sec. 7 July 1, 2023 20-633b
Sec. 8 July 1, 2023 21a-65(a) and (b)
Sec. 9 July 1, 2023 21a-70(a)
Sec. 10 July 1, 2023 21a-106(k)
Sec. 11 July 1, 2023 21a-115(e)
Sec. 12 July 1, 2023 21a-249(j)
Sec. 13 July 1, 2023 38a-492a
Sec. 14 July 1, 2023 38a-518a
Sec. 15 July 1, 2023 53a-13(b)(1)
Statement of Purpose:
To: (1) Authorize (A) pharmacists to administer additional vaccines,
tests and drugs, and (B) pharmacies to operate mobile pharmacies; and
(2) provide that an institutional pharmacy located in a licensed health
care facility may compound sterile pharmaceuticals.
[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.]