LCO \\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx 1 of 29 General Assembly Substitute Bill No. 1102 January Session, 2023 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 Section 20-571 of the general statutes is repealed and the 1 following is substituted in lieu thereof (Effective July 1, 2023): 2 As used in this chapter and sections 2 to 4, inclusive, of this act, 3 unless the 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 6 research 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 pharmacist; 16 (3) "Care-giving institution" means an institution that provides 17 medical services and is licensed, operated, certified or approved by the 18 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 2 of 29 Commissioner of Public Health, the Commissioner of Developmental 19 Services or the Commissioner of Mental Health and Addiction 20 Services; 21 (4) "Commission" means the Commission of Pharmacy appointed 22 under the provisions of section 20-572; 23 (5) "Commissioner" means the Commissioner of Consumer 24 Protection; 25 (6) "Compound" means to combine, mix or put together two or 26 more ingredients pursuant to a prescription and includes the 27 preparation of drugs or devices in anticipation of prescriptions based 28 on routine, regularly-observed prescribing patterns; 29 (7) "Correctional or juvenile training institution" means a facility for 30 the detention or incarceration of persons convicted or accused of 31 crimes or offenses or for training of delinquent juveniles, including 32 those state facilities under the jurisdiction of the Commissioner of 33 Correction, training schools for delinquent juveniles and any other 34 facilities operated by the state or municipalities for such detention, 35 incarceration or training; 36 (8) "Device" means instruments, apparatuses and contrivances, 37 including their components, parts and accessories, intended: (A) [for] 38 For use in the diagnosis, cure, mitigation, treatment or prevention of 39 disease in humans or other animals; [,] or (B) to affect the structure or 40 any function of the body of humans or other animals, but does not 41 mean contact lenses; 42 (9) "Department" means the Department of Consumer Protection; 43 (10) "Deprescribing" means the systematic process of identifying 44 and discontinuing drugs in instances in which existing or potential 45 harms outweigh existing or potential benefits within the context of an 46 individual patient's care goals, current level of functioning, life 47 expectancy, values and preferences; 48 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 3 of 29 (11) "Dispense" means those acts of processing a drug or device for 49 delivery or for administration for a patient pursuant to a prescription 50 consisting of: (A) Comparing the directions on the label with the 51 directions on the prescription to determine accuracy; (B) the selection 52 of the drug or device from stock to fill the prescription; (C) the 53 counting, measuring, compounding or preparation of the drug or 54 device; (D) the placing of the drug or device in the proper container; 55 (E) the affixing of the label to the container; and (F) the addition to a 56 written prescription of any required notations. "Dispense" does not 57 include the acts of delivering a drug or device to a patient or of 58 administering the drug or device to the patient; 59 (12) "Dispensing outpatient facility" means a facility operated by a 60 corporation or municipality which provides medical services to 61 patients on an outpatient basis and which maintains stocks of drugs 62 for dispensing of drugs on a regular basis to patients for use off the 63 premises; 64 (13) "Drug" means: (A) [an] An article recognized in the official 65 United States Pharmacopoeia, official Homeopathic Pharmacopoeia of 66 the United States or official National Formulary, or any supplement to 67 any of them; [,] (B) an article intended for use in the diagnosis, cure, 68 mitigation, treatment or prevention of disease in humans or other 69 animals; [,] (C) an article, other than food, intended to affect the 70 structure or any function of the body of humans or any other animal; 71 [,] and (D) an article intended for use as a component of any article 72 specified in this subdivision, but does not include a device; 73 (14) "Health care institution" means institution, as defined in section 74 19a-490; 75 (15) "Health care institutional pharmacy" means an institutional 76 pharmacy located within a health care institution; 77 [(14)] (16) "Institutional pharmacy" means that area within a care-78 giving institution or within a correctional or juvenile training 79 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 4 of 29 institution, commonly known as the pharmacy, that is under the direct 80 charge of a pharmacist and in which drugs are stored and dispensed; 81 [(15)] (17) "Legend device" means a device that is required by 82 applicable federal or state law to be dispensed pursuant only to a 83 prescription or is restricted to use by prescribing practitioners only or 84 that, under federal law, is required to bear either of the following 85 legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES 86 ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC 87 ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE 88 FOR USE BY OR ON THE OR DER OF A LICENSED 89 VETERINARIAN."; 90 [(16)] (18) "Legend drug" means a drug that is required by any 91 applicable federal or state law to be dispensed pursuant only to a 92 prescription or is restricted to use by prescribing practitioners only, or 93 means a drug that, under federal law, is required to bear either of the 94 following legends: (A) "RX ONLY" IN ACCORDANCE WITH 95 GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND 96 COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS 97 THIS DRUG FOR USE BY OR ON THE ORDER OF A L ICENSED 98 VETERINARIAN."; 99 [(17)] (19) "Medical device and oxygen provider" means a person 100 who distributes devices or oxygen pursuant to a medical order or 101 prescription, except if such person already maintains an active 102 pharmacy license; 103 [(18)] (20) "Medication reconciliation" means a process of comparing 104 the medications a patient is taking and should be taking with newly 105 ordered medications: (A) [for] For the purpose of addressing 106 duplications, omissions and interactions and the need to continue 107 current medications; [,] and (B) by looking at information such as the 108 medication name, dose, frequency, route of administration and 109 purpose; 110 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 5 of 29 [(19)] (21) "Nonlegend device" means a device that is not a legend 111 device; 112 [(20)] (22) "Nonlegend drug" means a drug that is not a legend drug; 113 (23) "Nonresident pharmacy" has the same meaning as provided in 114 section 20-627; 115 [(21)] (24) "Person" means an individual, corporation, business trust, 116 estate trust, partnership, association, joint venture or any other legal or 117 commercial entity; 118 [(22)] (25) "Pharmacist" means an individual who is licensed to 119 practice pharmacy under the provisions of section 20-590, 20-591, 20-120 592 or 20-593, and who is thereby recognized as a health care provider 121 by the state of Connecticut; 122 [(23)] (26) "Pharmacy" means a place of business where drugs and 123 devices may be sold at retail and for which a pharmacy license has 124 been issued to an applicant under the provisions of section 20-594, as 125 amended by this act; 126 [(24)] (27) "Pharmacy intern" means an individual registered under 127 the provisions of section 20-598; 128 [(25)] (28) "Pharmacy technician" means an individual who is 129 registered with the department and qualified in accordance with 130 section 20-598a; 131 [(26)] (29) "Polypharmacy" means the use of multiple drugs by a 132 patient, including any medication that is inappropriate or not 133 medically necessary, such as those not indicated, not effective or 134 constituting a therapeutic duplication; 135 [(27)] (30) "Practice of pharmacy" or "to practice pharmacy" means 136 the sum total of knowledge, understanding, judgments, procedures, 137 securities, controls and ethics used by a pharmacist to assure optimal 138 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 6 of 29 safety and accuracy in the distributing, dispensing and use of drugs 139 and devices; 140 [(28)] (31) "Prescribing practitioner" means an individual licensed by 141 the state of Connecticut, any other state of the United States, the 142 District of Columbia, the Commonwealth of Puerto Rico or any 143 territory or insular possession subject to the jurisdiction of the United 144 States who is authorized to issue a prescription within the scope of the 145 individual's practice; 146 [(29)] (32) "Prescription" means a lawful order of a prescribing 147 practitioner transmitted either orally, in writing or by electronic means 148 for a drug or device for a specific patient; 149 [(30)] (33) "Sale" includes barter, exchange or gift or offer and each 150 such transaction made by a person whether as principal proprietor, 151 agent, servant or employee; 152 [(31)] (34) "Substitute" means to dispense without the prescribing 153 practitioner's express authorization a different drug product than the 154 drug product prescribed; 155 [(32)] (35) "Third-party logistics provider" means a person who 156 distributes drugs, devices or cosmetics while taking possession of the 157 drugs, devices or cosmetics but who does not take title of the drugs, 158 devices or cosmetics; 159 [(33)] (36) "Virtual manufacturer" means a person who engages in 160 the manufacture of drugs, devices or cosmetics for which such person: 161 (A) Owns the new drug application or abbreviated new drug 162 application number, if a prescription drug; (B) owns the unique device 163 identification number, as available, for a prescription device; (C) 164 contracts with a contract manufacturing organization for the physical 165 manufacture of the drugs, devices or cosmetics; (D) is not involved in 166 the physical manufacture of the drugs, devices or cosmetics; and (E) at 167 no time takes physical possession of or stores the drugs, devices or 168 cosmetics; and 169 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 7 of 29 [(34)] (37) "Virtual wholesale distributor" means a person who 170 facilitates or brokers the transfer of drugs, devices or cosmetics 171 without taking physical possession of the drugs, devices or cosmetics. 172 Sec. 2. (NEW) (Effective July 1, 2023) (a) For the purposes of this 173 section: 174 (1) "COVID-19" means the respiratory disease designated by the 175 World Health Organization on February 11, 2020, as coronavirus 2019, 176 and any related mutation thereof recognized by said organization; 177 (2) "COVID-19-related test" means any laboratory test, or series of 178 laboratory tests, for any virus, antibody, antigen or etiologic agent 179 thought to cause, or indicate the presence of, COVID-19; 180 (3) "HIV-related prophylaxis" means any drug approved by the 181 federal Food and Drug Administration or any successor agency as a 182 pre-exposure or post-exposure prophylaxis for the human 183 immunodeficiency virus; 184 (4) "HIV-related test" has the same meaning as provided in section 185 19a-7o of the general statutes; and 186 (5) "Influenza-related test" means any laboratory test, or series of 187 laboratory tests, for any virus, antibody, antigen or etiologic agent 188 thought to cause, or indicate the presence of, influenza disease. 189 (b) (1) Any person who is licensed as a pharmacist under chapter 190 400j of the general statutes and employed by: (A) A pharmacy that has 191 submitted to the Department of Public Health a complete clinical 192 laboratory improvement amendment application for certification for a 193 COVID-19-related test, HIV-related test or influenza-related test may 194 order, and administer to a patient, the COVID-19-related test, HIV-195 related test or influenza-related test if the patient is (i) eighteen years 196 of age or older, or (ii) at least twelve years of age but younger than 197 eighteen years of age with (I) the consent of such patient's parent, legal 198 guardian or other person having legal custody of such patient, or (II) 199 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 8 of 29 proof that such patient is an emancipated minor; or (B) a hospital may 200 order, and administer to a patient, a COVID-19-related test, HIV-201 related test or influenza-related test if the patient is (i) eighteen years 202 of age or older, or (ii) at least twelve years of age but younger than 203 eighteen years of age with (I) the consent of such patient's parent, legal 204 guardian or other person having legal custody of such patient, or (II) 205 proof that such patient is an emancipated minor. 206 (2) If a pharmacist orders and administers a COVID-19-related test, 207 HIV-related test or influenza-related test under subdivision (1) of this 208 subsection, the pharmacist shall: (A) Provide to the patient, in writing, 209 the results of such test; (B) maintain a record of the results of such test 210 for a period of three years; and (C) provide to the Commissioner of 211 Consumer Protection or the commissioner's designee, upon a request 212 made by the commissioner or the commissioner's designee, a copy of 213 the results of such test. 214 (c) (1) If a pharmacist orders and administers any HIV-related test 215 under subdivision (1) of subsection (b) of this section and the result of 216 such test is negative, the pharmacist may prescribe and dispense to the 217 patient any HIV-related prophylaxis according to the manufacturer's 218 package insert, provided: (A) Such patient satisfies the criteria 219 established in such package insert; and (B) such HIV -related 220 prophylaxis is prescribed and dispensed in accordance with all 221 applicable requirements established in chapter 400j of the general 222 statutes. 223 (2) If a pharmacist prescribes any HIV-related prophylaxis under 224 subdivision (1) of this subsection, the pharmacist shall provide to the 225 Commissioner of Consumer Protection or the commissioner's 226 designee, upon a request made by the comm issioner or the 227 commissioner's designee: (A) A copy of the results of the HIV-related 228 test; (B) prescription information maintained pursuant to chapter 400j 229 of the general statutes; and (C) any other documentation the 230 commissioner requires in regulations adopted pursuant to subsection 231 (d) of this section. 232 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 9 of 29 (d) The Commissioner of Consumer Protection, in consultation with 233 the Commissioner of Public Health and the Commission of Pharmacy, 234 shall adopt regulations, in accordance with chapter 54 of the general 235 statutes, to implement the provisions of this section. Such regulations 236 shall, at a minimum: (1) Identify qualifying training programs, which 237 are accredited by the National Centers for Disease Control and 238 Prevention, the Accreditation Council for Pharmacy Education or 239 another appropriate national accrediting body; and (2) establish a 240 system of control and reporting. 241 Sec. 3. (NEW) (Effective July 1, 2023) (a) (1) A pharmacy may apply to 242 the department, in a form and manner prescribed by the 243 commissioner, to operate a mobile pharmacy in a temporary location 244 for the purpose of: (A) Conducting (i) a temporary clinic, (ii) a 245 vaccination event, or (iii) an opioid antagonist training and prescribing 246 event; or (B) serving a community that may not have adequate access 247 to pharmacy services. 248 (2) No pharmacy may operate a mobile pharmacy without prior 249 written approval from the department. Each mobile pharmacy shall be 250 supervised by a pharmacist. The department may inspect a mobile 251 pharmacy before pharmacy services are provided in the mobile 252 pharmacy, and at any time during usual business hours or while such 253 mobile pharmacy is in operation. The department may issue an order 254 closing a mobile pharmacy if the department determines that: (A) The 255 mobile pharmacy has failed to comply with the provisions of this 256 section; (B) conditions are unsafe to store or dispense drugs; or (C) 257 there is insufficient security at such mobile pharmacy. 258 (b) A pharmacy that operates a mobile pharmacy under this section 259 shall: (1) Maintain a record of all drugs that are removed from the 260 pharmacy premises for the purpose of operating such mobile 261 pharmacy; (2) maintain a record of each drug that is dispensed at such 262 mobile pharmacy and include such record in such pharmacy's records 263 not later than twenty-four hours after such drug is dispensed; (3) 264 except as provided in subsection (c) of this section, inventory and 265 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 10 of 29 return all unused drugs to the pharmacy premises by the close of 266 business each day; (4) while operating such mobile pharmacy, store all 267 drugs in such mobile pharmacy in a manner that (A) prevents any 268 drug diversion, and (B) is consistent with the storage conditions 269 specified by the manufacturers of such drugs; (5) establish and 270 maintain a patient communication plan to ensure that patients can 271 obtain prescription refills if such mobile pharmacy is unavailable; and 272 (6) if permitted by the federal Drug Enforcement Administration or a 273 successor agency, store controlled substances in the mobile pharmacy 274 in accordance with regulations adopted by the commissioner pursuant 275 to section 21a-262 of the general statutes. 276 (c) No pharmacy shall, without prior approval from the department: 277 (1) Operate a mobile pharmacy for more than (A) seven consecutive 278 days in a single location, or (B) fourteen days within a five-mile radius 279 of the prior mobile pharmacy location; or (2) store drugs overnight in a 280 mobile pharmacy or outside of the pharmacy premises. 281 (d) The commissioner may, with the advice and consent of the 282 commission, adopt regulations in accordance with chapter 54 of the 283 general statutes to implement the provisions of this section. 284 Sec. 4. (NEW) (Effective July 1, 2023) (a) For the purposes of this 285 section, "pharmacy district manager" means an individual who (1) 286 supervises at least three pharmacies within this state, and (2) is 287 responsible for the activities within such pharmacies, including, but 288 not limited to, staffing, payroll and hiring. 289 (b) Each pharmacy shall maintain a plan to manage unscheduled 290 closings. Such plan shall be reviewed and updated, if necessary, on an 291 annual basis, and be provided to, and reviewed with, all pharmacy 292 personnel on an annual basis. Such plan shall include: 293 (1) The name of the individual who is responsible for notifying the 294 Commission of Pharmacy of an unscheduled closing; 295 (2) The name of the individual who is responsible for updating the 296 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 11 of 29 hours of operation in the pharmacy's electronic record system to 297 prevent acceptance of electronically transmitted prescriptions during 298 an unscheduled closing; 299 (3) The name of the individual who is responsible for updating the 300 pharmacy's telephone system during an unscheduled closing to (A) 301 prevent the acceptance of orally transmitted prescriptions during the 302 unscheduled closing, and (B) provide a message that alerts patients 303 that such pharmacy will be closed and their prescriptions may be 304 obtained from a nearby pharmacy; 305 (4) A list of all pharmacies that are located within a two-mile radius 306 of the pharmacy that is experiencing an unscheduled closing, or the 307 next closest pharmacy if there is no pharmacy within such two-mile 308 radius; and 309 (5) The name of the individual who is responsible for posting, at the 310 entrance to such pharmacy and at each entrance of the structure if such 311 pharmacy is located within another structure, signage stating the 312 duration of an unscheduled closing. 313 (c) If a pharmacy experiences an unscheduled closing, the 314 pharmacist manager of the pharmacy or, if the pharmacy operates 315 more than five pharmacy locations in this state, the pharmacy district 316 manager shall: 317 (1) Modify such pharmacy's hours of operation in such pharmacy's 318 electronic record system to prevent the acceptance of electronically 319 transmitted prescriptions during the unscheduled closing; 320 (2) Adjust such pharmacy's telephone system to prevent the 321 acceptance of orally transmitted prescriptions during the unscheduled 322 closing; 323 (3) Provide a telephone system message alert to patients notifying 324 patients that (A) such pharmacy is not open, and (B) patients may 325 obtain medications from a nearby pharmacy; 326 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 12 of 29 (4) Post signage at the entrance to such pharmacy, and at each 327 entrance of the structure if such pharmacy is located within another 328 structure, (A) stating that such pharmacy is closed, (B) disclosing the 329 duration of the unscheduled closing, and (C) providing (i) a list of all 330 pharmacies that are located within a two-mile radius of such 331 pharmacy, or (ii) the next closest pharmacy if there is no pharmacy 332 within such two-mile radius; and 333 (5) Upon request by another pharmacy to transfer a prescription to 334 such other pharmacy, transfer any prescription dispensed by the 335 pharmacy experiencing the unscheduled closing and reverse any third-336 party payor claims associated with such prescription. 337 (d) Any pharmacy that verifies that another pharmacy is 338 experiencing an unscheduled closing may, upon a patient's request, 339 dispense a prescription that is dispensed and waiting at the pharmacy 340 experiencing the unscheduled closing by using information obtained 341 from the closed pharmacy, the electronic prescription drug monitoring 342 program or another source that the pharmacist dispensing such 343 prescription believes provides a reasonable assurance of accurate 344 information necessary to dispense such prescription. In the event that a 345 pharmacy dispenses a prescription during an unscheduled closing of 346 another pharmacy: 347 (1) The pharmacy dispensing such prescription shall contact the 348 pharmacy experiencing the unscheduled closing not later than twenty-349 four hours after such closed pharmacy reopens to transfer such 350 prescription, in accordance with section 20-616 of the general statutes; 351 (2) The pharmacy that experienced the unscheduled closing shall 352 provide to the pharmacy that dispensed such prescription during such 353 unscheduled closing all information necessary for the transfer of such 354 prescription; and 355 (3) The pharmacy that experienced the unscheduled closing shall 356 reverse any third-party payor claims associated with such transferred 357 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 13 of 29 prescription not later than twenty-four hours after such pharmacy 358 reopens. 359 (e) The Department of Consumer Protection shall adopt regulations, 360 in accordance with chapter 54 of the general statutes, to implement the 361 provisions of this section. Such regulations shall include, but need not 362 be limited to, provisions for the placement of a secured container at a 363 pharmacy that allows patients to, during the hours in which the 364 pharmacy may be open or closed, obtain prescriptions that were 365 dispensed by such pharmacy. Prior to the effective date of such 366 regulations, the department may temporarily permit the use and 367 placement of a secured container at a pharmacy, provided the 368 pharmacy submits to the department, for the department's approval, 369 written protocols prior to placing, providing access to or using the 370 secured container and such pharmacy receives written approval from 371 the department for such placement, access or use. To obtain temporary 372 approval under this subsection, a secure container shall: 373 (1) Weigh more than seven hundred fifty pounds or be affixed to the 374 physical structure of the building where the pharmacy is located, and 375 be located immediately adjacent to the portion of such building where 376 such pharmacy is located; 377 (2) Only permit access to authorized pharmacy personnel or 378 individuals retrieving the prescriptions with a unique identification 379 system; 380 (3) Be under video surveillance at all times; 381 (4) Be capable of maintaining a record of all products that are placed 382 inside of the secure container, and the date and time each individual 383 prescription is accessed; and 384 (5) Comply with any other protocol required by the department to 385 ensure patient confidentiality, ensure public health and safety and 386 prevent diversion. 387 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 14 of 29 Sec. 5. Section 20-633 of the general statutes is repealed and the 388 following is substituted in lieu thereof (Effective July 1, 2023): 389 (a) (1) Any person licensed as a pharmacist under part II of this 390 chapter may [(1)] administer: [, to an adult, any] 391 (A) Any vaccine, approved or authorized by the United States Food 392 and Drug Administration that is listed on the National Centers for 393 Disease Control and Prevention's Adult Immunization Schedule, [and 394 (2) on and after July 1, 2022, administer to any person between the ages 395 of twelve and seventeen, with the consent of such person's parent or 396 guardian, the influenza vaccine approved by the United States Food 397 and Drug Administration, provided the administration of any vaccine 398 under this subsection is conducted pursuant to the order of a licensed 399 health care provider and in accordance with the regulations 400 established pursuant to subsection (b) of this section.] to any patient 401 who is: (i) Eighteen years of age or older; or (ii) at least twelve years of 402 age but younger than eighteen years of age with (I) the consent of such 403 patient's parent, legal guardian or other person having legal custody of 404 such patient, or (II) proof that such patient is an emancipated minor. 405 (B) Any vaccine not included on the National Centers for Disease 406 Control and Prevention's Adult Immunization Schedule, provided the 407 vaccine administration instructions for such vaccine are available on 408 the National Centers for Disease Control and Prevention's Internet web 409 site; and 410 (C) Any vaccine pursuant to a verbal or written prescription of a 411 prescribing practitioner for a specific patient. 412 (2) A pharmacist shall make a reasonable effort to review a patient's 413 vaccination history to prevent any inappropriate use of a requested 414 vaccine. 415 (3) All vaccines administered pursuant to this section shall be 416 administered in accordance with the: (A) Vaccine manufacturer's 417 package insert or the orders of a prescribing practitioner; and (B) 418 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 15 of 29 regulations adopted pursuant to subsection (c) of this section. 419 (b) A pharmacist who has completed the training required in 420 regulations adopted pursuant to subsection (c) of this section may 421 administer an epinephrine cartridge injector, as defined in section 19a-422 909, to a patient whom the pharmacist reasonably believes, based on 423 such pharmacist's knowledge and training, is experiencing 424 anaphylaxis, regardless of whether such patient has a prescription for 425 an epinephrine cartridge injector. Such pharmacist, or such 426 pharmacist's designee, shall call the 9-1-1 emergency telephone 427 number either before or immediately after suc h pharmacist 428 administers the epinephrine cartridge injector to such patient. Such 429 pharmacist shall document the date, time and circumstances in which 430 such pharmacist administered such epinephrine cartridge injector, and 431 maintain such documentation for at least three years. 432 [(b)] (c) The Commissioner of Consumer Protection, in consultation 433 with the Commissioner of Public Health and the Commission of 434 Pharmacy, shall adopt regulations, in accordance with the provisions 435 of chapter 54, to implement the provisions of this section. Such 436 regulations shall: (1) [require] Require any pharmacist who 437 administers a vaccine pursuant to this section to successfully complete 438 an immunization training program for pharmacists; (2) define the basic 439 requirements of such training program, which shall include training 440 and instruction in pre-administration education and screening, vaccine 441 storage and handling, subcutaneous and intramuscular injections, 442 recordkeeping, vaccine safety, cardiopulmonary resuscitation, basic 443 cardiac life support and adverse event reporting; (3) identify 444 qualifying training programs, which are accredited by the National 445 Centers for Disease Control Prevention, the Accreditation Council for 446 Pharmacy Education or [other] another appropriate national 447 accrediting body; and (4) establish a system of control and reporting. 448 [(c) For purposes of this section, "adult" means a person who has 449 attained the age of eighteen years.] 450 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 16 of 29 Sec. 6. Subsection (a) of section 20-576 of the general statutes is 451 repealed and the following is substituted in lieu thereof (Effective July 452 1, 2023): 453 (a) The commissioner may, with the advice and assistance of the 454 commission, adopt regulations, in accordance with chapter 54, to 455 govern the performance of the commission's duties, the practice of 456 pharmacy and the business of retailing drugs and devices. Such 457 regulations may include, but are not limited to, provisions (1) 458 concerning the licensing of any pharmacist or pharmacy, disciplinary 459 action that may be taken against a licensee, the conduct of a 460 pharmacist and the operation of a pharmacy, (2) specifying various 461 classes of pharmacy licenses issued under section 20-594, as amended 462 by this act, including, but not limited to, licenses for infusion therapy 463 pharmacies, [and] nuclear pharmacies and health care institutional 464 pharmacies, and specifying requirements for operation of pharmacies 465 under the classes of pharmacy licenses permitted under the 466 regulations, (3) concerning creation and maintenance of prescription 467 records, and (4) concerning registration and activities of pharmacy 468 interns, registered pharmacy technicians and certified pharmacy 469 technicians. 470 Sec. 7. Section 20-594 of the general statutes is repealed and the 471 following is substituted in lieu thereof (Effective July 1, 2023): 472 (a) Except as limited by section 20-596, a pharmacist, health care 473 institution or any other person may apply to the commission for a 474 pharmacy license or for renewal of a pharmacy license. 475 (b) The applicant shall disclose on the application the name and 476 address of the applicant and the owner of the pharmacy, the name and 477 street and mailing address of the pharmacy and the name, address and 478 license number of the pharmacist who manages the pharmacy. The 479 commissioner may, by regulation adopted with the advice and 480 assistance of the commission, in accordance with chapter 54, require 481 such other information on the application as is necessary for the 482 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 17 of 29 department to carry out [its] the department's duties under sections 20-483 570 to 20-630, inclusive. 484 (c) The department shall, after receipt of an application under this 485 section, (1) issue, on authorization of the commission, a pharmacy 486 license to an applicant for a new pharmacy on payment of the fee 487 required in section 20-601 and on satisfactory evidence to the 488 commission that the pharmacy will be managed by a pharmacist and 489 will be operated in accordance with the general statutes and the 490 regulations adopted by the commissioner in accordance with chapter 491 54, and (2) issue a renewal of a pharmacy license to an applicant on 492 payment of the fee required in section 20-601. 493 (d) Pharmacy licenses shall expire annually. Pharmacy licenses may 494 be renewed on application and payment of the fee required in section 495 20-601 for a period not to exceed one year. 496 (e) When a pharmacy is transferred to a new location the pharmacy 497 license for such pharmacy shall terminate. A pharmacy license that has 498 been terminated under this subsection may be renewed under the 499 provisions of subsection (d) of this section and on satisfactory evidence 500 to the commission that the pharmacy will be managed by a pharmacist 501 and will be operated in accordance with the general statutes and the 502 regulations adopted by the commissioner in accordance with chapter 503 54. 504 (f) Each pharmacy licensed pursuant to this section shall report to 505 the department any administrative or legal action commenced against 506 [it] such pharmacy by any state or federal regulatory agency or 507 accreditation entity not later than ten business days after receiving 508 notice of the commencement of such action. 509 Sec. 8. Section 20-633b of the general statutes is repealed and the 510 following is substituted in lieu thereof (Effective July 1, 2023): 511 (a) As used in this section: 512 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 18 of 29 (1) "Medical order" means a written, oral or electronic order by a 513 prescribing practitioner [, as defined in section 20-14c,] for a drug to be 514 dispensed by a pharmacy for administration to a patient; 515 (2) "Prescribing practitioner" has the same meaning as provided in 516 section 20-14c; 517 [(2)] (3) "Sterile compounding pharmacy" means a pharmacy [, as 518 defined in section 20-571, a] or nonresident pharmacy [registered 519 pursuant to section 20-627,] that dispenses or compounds sterile 520 pharmaceuticals; 521 [(3)] (4) "Sterile pharmaceutical" means any dosage form of a drug, 522 including, but not limited to, parenterals, injectables, surgical irrigants 523 and ophthalmics devoid of viable microorganisms; and 524 [(4)] (5) "USP chapters" means chapters 797, 800 and 825 of the 525 United States Pharmacopeia that pertain to compounding sterile 526 pharmaceuticals and their referenced companion documents, as 527 amended from time to time. 528 (b) (1) (A) If an applicant for a new pharmacy license [pursuant to] 529 under section 20-594, as amended by this act, intends to compound 530 sterile pharmaceuticals, the applicant shall file an addendum to [its] 531 the pharmacy license application such applicant files pursuant to 532 section 20-594, as amended by this act, to include sterile 533 pharmaceutical compounding. The [Department of Consumer 534 Protection] department shall inspect the proposed pharmacy premises 535 of [the] such applicant and [the] such applicant shall not compound 536 sterile pharmaceuticals until [it] such applicant receives notice that the 537 addendum to such applicant's application has been approved by the 538 department and the [Commission of Pharmacy] commission. Nothing 539 in this section shall be construed to affect a licensed hospital's ability to 540 compound sterile pharmaceuticals for such hospital's patients 541 consistent with federal law. 542 [(2)] (B) If an existing pharmacy licensed pursuant to section 20-594, 543 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 19 of 29 as amended by this act, intends to compound sterile pharmaceuticals 544 for the first time on or after July 1, 2014, such pharmacy shall [file an] 545 apply for an addendum [application to its] to such pharmacy's 546 application on file with the department to include sterile 547 pharmaceutical compounding. The [Department of Consumer 548 Protection] department shall inspect the pharmacy premises of such 549 pharmacy and [the] such pharmacy shall not compound sterile 550 pharmaceuticals until [it] such pharmacy receives written notice that 551 such addendum application has been approved by the department and 552 the [Commission of Pharmacy] commission. 553 (C) If an existing health care institutional pharmacy licensed 554 pursuant to section 20-594, as amended by this act, intends to 555 compound sterile pharmaceuticals for the first time on or after July 1, 556 2023, such health care institutional pharmacy shall apply for an 557 addendum to such health care institutional pharmacy's application on 558 file with the department to include sterile pharmaceutical 559 compounding. The department shall inspect the pharmacy premises of 560 such health care institutional pharmacy, and such health care 561 institutional pharmacy shall not compound sterile pharmaceuticals 562 until such health care institutional pharmacy receives written notice 563 that such health care institutional pharmacy's addendum application 564 has been approved by the department and the commission. 565 [(3)] (2) (A) If an applicant for a new nonresident pharmacy 566 registration intends to compound sterile pharmaceuticals for sale or 567 delivery in this state, the applicant shall file an addendum to [its] the 568 registration application such applicant files pursuant to section 20-627 569 to include sterile pharmaceutical compounding. [The] Such applicant 570 shall provide to the department [with] written proof [it] that such 571 applicant has passed inspection by the appropriate state agency in the 572 state where such [nonresident pharmacy] applicant is located. Such 573 [pharmacy] applicant shall not compound sterile pharmaceuticals for 574 sale or delivery in this state until [it] such applicant receives written 575 notice that [the] such addendum [application] has been approved by 576 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 20 of 29 the department and the [Commission of Pharmacy] commission. 577 [(4)] (B) If [a] an existing nonresident pharmacy [registered 578 pursuant to section 20-627] intends to compound sterile 579 pharmaceuticals for sale or delivery in this state for the first time on or 580 after July 1, 2014, [the] such nonresident pharmacy shall [file] apply for 581 an addendum to [its] such nonresident pharmacy's application on file 582 with the department to include sterile pharmaceutical compounding. 583 [The] Such nonresident pharmacy shall provide to the department 584 [with] written proof [it] that such nonresident pharmacy has passed 585 inspection by the appropriate state agency in the state where such 586 nonresident pharmacy is located. Such nonresident pharmacy shall not 587 compound sterile pharmaceuticals until [it] such nonresident 588 pharmacy receives written notice that [the] such addendum 589 application has been approved by the department and the 590 [Commission of Pharmacy] commission. 591 (c) A sterile compounding pharmacy shall comply with the USP 592 chapters. A sterile compounding pharmacy shall also comply with all 593 applicable federal and state statutes and regulations. 594 [(d) An institutional pharmacy within a facility licensed pursuant to 595 section 19a-490 that compounds sterile pharmaceuticals shall comply 596 with the USP chapters, and shall also comply with all applicable 597 federal and state statutes and regulations. Such institutional pharmacy 598 may request from the Commissioner of Consumer Protection an 599 extension of time, not to exceed six months, to comply, for state 600 enforcement purposes, with any amendments to USP chapters, for 601 good cause shown. The commissioner may grant an extension for a 602 length of time not to exceed six months. Nothing in this section shall 603 prevent such institutional pharmacy from requesting a subsequent 604 extension of time or shall prevent the commissioner from granting 605 such extension.] 606 [(e)] (d) (1) A sterile compounding pharmacy may only provide 607 patient-specific sterile pharmaceuticals to patients, to practitioners of 608 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 21 of 29 medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to 609 an acute care or long-term care hospital or health care facility licensed 610 by the Department of Public Health. 611 (2) If a sterile compounding pharmacy provides sterile 612 pharmaceuticals without a patient-specific prescription or medical 613 order, the sterile compounding pharmacy shall also obtain a certificate 614 of registration from the Department of Consumer Protection pursuant 615 to section 21a-70, as amended by this act, and any required federal 616 license or registration. A sterile compounding pharmacy may prepare 617 and maintain on-site inventory of sterile pharmaceuticals no greater 618 than a thirty-day supply, calculated from the completion of 619 compounding, which thirty-day period shall include the period 620 required for third-party analytical testing, to be performed in 621 accordance with the USP chapters. 622 [(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any 623 area utilized for the compounding of sterile pharmaceuticals or 624 adjacent space, relocate any space utilized for the compounding of 625 sterile pharmaceuticals or upgrade or conduct a nonemergency repair 626 to the heating, ventilation, air conditioning or primary or secondary 627 engineering controls for any space utilized for the compounding of 628 sterile pharmaceuticals, the sterile compounding pharmacy shall notify 629 the Department of Consumer Protection, in writing, not later than 630 forty-five days prior to commencing such remodel, relocation, upgrade 631 or repair. Such written notification shall include a plan for such 632 remodel, relocation, upgrade or repair and such plan shall be subject to 633 department review and approval. If a sterile compounding pharmacy 634 makes an emergency repair, the sterile compounding pharmacy shall 635 notify the department of such emergency repair, in writing, not later 636 than twenty-four hours after such repair is commenced. 637 (2) If the USP chapters require sterile recertification after such 638 remodel, relocation, upgrade or repair, the sterile compounding 639 pharmacy shall provide a copy of [its] such sterile compounding 640 pharmacy's sterile recertification to the Department of Consumer 641 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 22 of 29 Protection not later than five days after the sterile recertification 642 approval. The recertification shall only be performed by an 643 independent licensed environmental monitoring entity. 644 [(g)] (f) A sterile compounding pharmacy shall report, in writing, to 645 the Department of Consumer Protection any known violation or 646 noncompliance with viable and nonviable environmental sampling 647 testing, as defined in the USP chapters, not later than the end of the 648 next business day after discovering such violation or noncompliance. 649 [(h)] (g) (1) If a sterile compounding pharmacy initiates a recall of 650 sterile pharmaceuticals that were dispensed pursuant to a patient-651 specific prescription or medical order, the sterile compounding 652 pharmacy shall notify each patient or patient care giver, the 653 prescribing practitioner and the Department of Consumer Protection 654 of such recall not later than twenty-four hours after such recall was 655 initiated. 656 (2) If a sterile compounding pharmacy initiates a recall of sterile 657 pharmaceuticals that were not dispensed pursuant to a patient-specific 658 prescription or a medical order, the sterile compounding pharmacy 659 shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the 660 extent such sterile compounding pharmacy possesses contact 661 information for each such purchaser, (B) the Department of Consumer 662 Protection, and (C) the federal Food and Drug Administration of such 663 recall not later than the end of the next business day after such recall 664 was initiated. 665 [(i)] (h) Each sterile compounding pharmacy [and each institutional 666 pharmacy within a facility licensed pursuant to section 19a-490] shall 667 prepare and maintain a policy and procedure manual. The policy and 668 procedure manual shall comply with the USP chapters. 669 [(j)] (i) Each sterile compounding pharmacy shall report to the 670 Department of Consumer Protection any administrative or legal action 671 commenced against [it] such sterile compounding pharmacy by any 672 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 23 of 29 state or federal regulatory agency or accreditation entity not later than 673 five business days after receiving notice of the commencement of such 674 action. 675 [(k)] (j) Notwithstanding the provisions of [subdivisions (3) and (4)] 676 subdivision (2) of subsection (b) of this section, a sterile compounding 677 pharmacy that is a nonresident pharmacy shall provide to the 678 Department of Consumer Protection proof that [it] such nonresident 679 pharmacy has passed an inspection in such nonresident pharmacy's 680 home state, based on the USP chapters. Such nonresident pharmacy 681 shall submit to the Department of Consumer Protection a copy of the 682 most recent inspection report with [its] such nonresident pharmacy's 683 initial nonresident pharmacy application and shall submit to the 684 department a copy of [its] such nonresident pharmacy's most recent 685 inspection report every two years thereafter. If the state in which [the] 686 such nonresident pharmacy is located does not conduct inspections 687 based on standards required in the USP chapters, such nonresident 688 pharmacy shall provide satisfactory proof to the department that [it] 689 such nonresident pharmacy is in compliance with the standards 690 required in the USP chapters. 691 [(l)] (k) A practitioner, as specified in subdivision (1) of subsection 692 [(e)] (d) of this section, a hospital or a health care facility that receives 693 sterile pharmaceuticals shall report any errors related to such 694 dispensing or any suspected adulterated sterile pharmaceuticals to the 695 Department of Consumer Protection. 696 [(m)] (l) (1) For purposes of this subsection, a "designated 697 pharmacist" means a pharmacist responsible for overseeing the 698 compounding of sterile pharmaceuticals and the application of the 699 USP chapters, as said chapters pertain to sterile compounding. 700 (2) Any pharmacy licensed pursuant to section 20-594, as amended 701 by this act, [or institutional pharmacy licensed pursuant to section 19a-702 490] that provides sterile pharmaceuticals shall notify the department 703 of [its] such pharmacy's designated pharmacist. 704 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 24 of 29 (3) The designated pharmacist shall be responsible for providing 705 proof [he or she] such designated pharmacist has completed a program 706 approved by the commissioner that demonstrates the competence 707 necessary for the compounding of sterile pharmaceuticals, in 708 compliance with all applicable federal and state statutes and 709 regulations. 710 (4) The designated pharmacist shall immediately notify the 711 department whenever [he or she] such designated pharmacist ceases 712 such designation. 713 (5) Nothing in this section shall prevent a designated pharmacist 714 from being the pharmacy manager. 715 [(n)] (m) The Commissioner of Consumer Protection may adopt 716 regulations, in accordance with chapter 54, to implement the 717 provisions of this section. 718 Sec. 9. Subsections (a) and (b) of section 21a-65 of the general 719 statutes are repealed and the following is substituted in lieu thereof 720 (Effective July 1, 2023): 721 (a) A licensed manufacturer or licensed wholesaler may sell 722 hypodermic needles and syringes only to the following: (1) To a 723 licensed manufacturer, licensed wholesaler or licensed pharmacy; (2) 724 to a physician, dentist, veterinarian, embalmer, podiatrist or scientific 725 investigator licensed to practice in this state; (3) to a person in charge 726 of a care-giving institution, as defined in [subdivision (3) of] section 20-727 571, as amended by this act, incorporated college or scientific 728 institution, but only for use by or in such care-giving institution, 729 college or institution for medical or scientific purposes; (4) to a person 730 in charge of a licensed or registered laboratory, but only for use in that 731 laboratory for scientific and medical purposes; (5) to a farmer but only 732 for use on the farmer's own animals or poultry; (6) to a business 733 authorized in accordance with the regulations adopted under section 734 21a-66 to purchase hypodermic needles and syringes but only for 735 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 25 of 29 legitimate industrial or medical use within that business; and (7) to a 736 syringe services program established pursuant to section 19a-124. 737 (b) Except as provided in subsection (a) of this section, no licensed 738 manufacturer, licensed wholesaler or licensed pharmacist shall sell and 739 no person shall buy a hypodermic needle or syringe except upon a 740 prescription of a prescribing practitioner, as defined in [subdivision 741 (28) of] section 20-571, as amended by this act, in a quantity greater 742 than ten. Any such prescription shall be retained on file by the seller 743 for a period of not less than three years and shall be accessible to any 744 public officer engaged in the enforcement of this section. Such a 745 prescription shall be valid for one year from the date thereof and 746 purchases and sales may be made thereunder during such period, 747 provided the seller shall confirm the continued need for such sales 748 with such practitioner at least every six months if sales continue to be 749 made thereunder. Hypodermic needles and syringes in a quantity of 750 ten or less without a prescription may be provided or sold at retail 751 only by the following: (1) By a pharmacy licensed in accordance with 752 section 20-594, as amended by this act, and in such pharmacy only by a 753 licensed pharmacist or under the pharmacist's direct supervision; (2) 754 by a syringe service program established pursuant to section 19a-124; 755 and (3) by a health care facility or a licensed health care practitioner for 756 use by their own patients. 757 Sec. 10. Subsection (a) of section 21a-70 of the general statutes is 758 repealed and the following is substituted in lieu thereof (Effective July 759 1, 2023): 760 (a) As used in this section: (1) "Drugs", "devices" and "cosmetics" 761 have the same meanings as defined in section 21a-92, "wholesaler" or 762 "distributor" means a person, including, but not limited to, a medical 763 device and oxygen provider, a third-party logistics provider, a virtual 764 manufacturer or a virtual wholesale distributor, as such terms are 765 defined in section 20-571, as amended by this act, whether within or 766 without the boundaries of the state of Connecticut, who supplies 767 drugs, devices or cosmetics prepared, produced or packaged by 768 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 26 of 29 manufacturers, to other wholesalers, manufacturers, distributors, 769 hospitals, prescribing practitioners, as defined in [subdivision (28) of] 770 section 20-571, as amended by this act, pharmacies, federal, state or 771 municipal agencies, clinics or any other person as permitted under 772 subsection (h) of this section, except that: (A) A retail pharmacy or a 773 pharmacy within a licensed hospital that supplies to another such 774 pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or 775 V controlled substance normally stocked by such pharmacies to 776 provide for the immediate needs of a patient pursuant to a prescription 777 or medication order of an authorized practitioner, (B) a pharmacy 778 within a licensed hospital that supplies drugs to another hospital or an 779 authorized practitioner for research purposes, (C) a retail pharmacy 780 that supplies a limited quantity of a noncontrolled drug or of a 781 schedule II, III, IV or V controlled substance for emergency stock to a 782 practitioner who is a medical director of a chronic and convalescent 783 nursing home, of a rest home with nursing supervision, of a hospice 784 inpatient facility licensed pursuant to section 19a-491 or of a state 785 correctional institution, and (D) a pharmacy within a licensed hospital 786 that contains another hospital wholly within [its] such licensed 787 hospital's physical structure that supplies to such contained hospital a 788 quantity of a noncontrolled drug or a schedule II, III, IV, or V 789 controlled substance normally stocked by such hospitals to provide for 790 the needs of a patient, pursuant to a prescription or medication order 791 of an authorized practitioner, receiving inpatient care on a unit that is 792 operated by the contained hospital, or receiving outpatient care in a 793 setting operated by the contained hospital and such drug or substance 794 is administered on-site by the contained hospital, shall not be deemed 795 a wholesaler under this section; (2) "manufacturer" means (A) a person, 796 whether within or without the boundaries of the state of Connecticut, 797 who produces, prepares, cultivates, grows, propagates, compounds, 798 converts or processes, directly or indirectly, by extraction from 799 substances of natural origin or by means of chemical synthesis or by a 800 combination of extraction and chemical synthesis, or who packages, 801 repackages, labels or relabels a container under such manufacturer's 802 own or any other trademark or label any drug, device or cosmetic for 803 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 27 of 29 the purpose of selling such items, or (B) a sterile compounding 804 pharmacy, as defined in section 20-633b, as amended by this act, that 805 dispenses sterile pharmaceuticals without a prescription or a patient-806 specific medical order; (3) "drug", "device" and "cosmetic" have the 807 same meanings as provided in section 21a-92; and (4) "commissioner" 808 means the Commissioner of Consumer Protection or [his or her] the 809 commissioner's designee. 810 Sec. 11. Subsection (k) of section 21a-106 of the general statutes is 811 repealed and the following is substituted in lieu thereof (Effective July 812 1, 2023): 813 (k) If it is a legend drug, as defined in [subdivision (16) of] section 814 20-571, as amended by this act, that is not administered, dispensed, 815 prescribed or otherwise possessed or distributed in accordance with 816 federal and state laws and regulations; 817 Sec. 12. Subsection (e) of section 21a-115 of the general statutes is 818 repealed and the following is substituted in lieu thereof (Effective July 819 1, 2023): 820 (e) In the promulgation of regulations under the provisions of this 821 section applicable to prescribing practitioners, care-giving institutions, 822 and correctional and juvenile training institutions, as defined in 823 [subdivision (7) of] section 20-571, as amended by this act, the 824 Commissioner of Consumer Protection shall act in place of the 825 director. Existing regulations shall continue in effect unless superseded 826 by action of said commissioner pursuant to this subsection. 827 Sec. 13. Subsection (j) of section 21a-249 of the general statutes is 828 repealed and the following is substituted in lieu thereof (Effective July 829 1, 2023): 830 (j) A pharmacy may sell and dispense controlled substances upon 831 the prescription of a prescribing practitioner, as defined in 832 [subdivision (28) of] section 20-571, as amended by this act. 833 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 28 of 29 Sec. 14. Section 38a-492a of the general statutes is repealed and the 834 following is substituted in lieu thereof (Effective July 1, 2023): 835 Each individual health insurance policy providing coverage of the 836 type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of 837 section 38a-469, delivered, issued for delivery, renewed, amended or 838 continued in this state shall provide coverage for hypodermic needles 839 or syringes prescribed by a prescribing practitioner, as defined in 840 [subdivision (28) of] section 20-571, as amended by this act, for the 841 purpose of administering medications for medical conditions, 842 provided such medications are covered under the policy. Such benefits 843 shall be subject to any policy provisions that apply to other services 844 covered by such policy. 845 Sec. 15. Section 38a-518a of the general statutes is repealed and the 846 following is substituted in lieu thereof (Effective July 1, 2023): 847 Each group health insurance policy providing coverage of the type 848 specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 849 38a-469, delivered, issued for delivery, renewed, amended or 850 continued in this state shall provide coverage for hypodermic needles 851 or syringes prescribed by a prescribing practitioner, as defined in 852 [subdivision (28) of] section 20-571, as amended by this act, for the 853 purpose of administering medications for medical conditions, 854 provided such medications are covered under the policy. Such benefits 855 shall be subject to any policy provisions that apply to other services 856 covered by such policy. 857 Sec. 16. Subdivision (1) of subsection (b) of section 53a-13 of the 858 general statutes is repealed and the following is substituted in lieu 859 thereof (Effective July 1, 2023): 860 (b) (1) It shall not be a defense under this section if such mental 861 disease or defect was proximately caused by the voluntary ingestion, 862 inhalation or injection of intoxicating liquor or any drug or substance, 863 or any combination thereof, unless such drug was prescribed for the 864 Substitute Bill No. 1102 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- SB.docx } 29 of 29 defendant by a prescribing practitioner, as defined in [subdivision (28) 865 of] section 20-571, as amended by this act, and was used in accordance 866 with the directions of such prescription. 867 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 New section Sec. 5 July 1, 2023 20-633 Sec. 6 July 1, 2023 20-576(a) Sec. 7 July 1, 2023 20-594 Sec. 8 July 1, 2023 20-633b Sec. 9 July 1, 2023 21a-65(a) and (b) Sec. 10 July 1, 2023 21a-70(a) Sec. 11 July 1, 2023 21a-106(k) Sec. 12 July 1, 2023 21a-115(e) Sec. 13 July 1, 2023 21a-249(j) Sec. 14 July 1, 2023 38a-492a Sec. 15 July 1, 2023 38a-518a Sec. 16 July 1, 2023 53a-13(b)(1) Statement of Legislative Commissioners: In Section 2(b)(1), Subparas. (A) and (B) were rewritten for clarity; in Section 2(b)(2) and (c)(1), "to a patient" was deleted for conciseness; in Section 4(e), "provisions" was substituted for "regulations providing" for consistency with standard drafting conventions; in Section 4(e)(5), "ensure" was added before "public" for clarity; in Section 5(a)(3), "upon" was deleted for clarity; in Section 8(b)(1)(C), "addendum" was added before "application" for consistency; in Section 8(d)(1), "to" was added before "practitioners" for consistency; and in Section 8(j), "to" was added after "provide" for consistency. GL Joint Favorable Subst.