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| 1 | + | ||
| 2 | + | ||
| 3 | + | LCO \\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 4 | + | SB.docx | |
| 5 | + | 1 of 29 | |
| 6 | + | ||
| 7 | + | General Assembly Substitute Bill No. 1102 | |
| 8 | + | January Session, 2023 | |
| 1 | 9 | ||
| 2 | 10 | ||
| 3 | 11 | ||
| 4 | - | Substitute Senate Bill No. 1102 | |
| 5 | - | ||
| 6 | - | Public Act No. 23-19 | |
| 7 | 12 | ||
| 8 | 13 | ||
| 9 | 14 | AN ACT CONCERNING PHARMACIES AND PHARMACISTS. | |
| 10 | 15 | Be it enacted by the Senate and House of Representatives in General | |
| 11 | 16 | Assembly convened: | |
| 12 | 17 | ||
| 13 | - | Section 1. Section 20-571 of the general statutes is repealed and the | |
| 14 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 15 | - | As used in this chapter and sections 2 to 4, inclusive, of this act, unless | |
| 16 | - | the context otherwise requires: | |
| 17 | - | (1) "Administer" or ["Administration"] "administration" means the | |
| 18 | - | direct application of a drug or device to the body of a patient or research | |
| 19 | - | subject by injection, inhalation, ingestion or any other means; | |
| 20 | - | (2) "Automated prescription dispensing machine" means a device | |
| 21 | - | and associated software operated by a pharmacy or a pharmacy that is | |
| 22 | - | registered as a nonresident pharmacy pursuant to section 20-627, in a | |
| 23 | - | nursing home or skilled nursing facility licensed pursuant to sections | |
| 24 | - | 19a-490 and 19a-491, that packages and labels patient-specific | |
| 25 | - | medication or multiple medications for the purposes of administration | |
| 26 | - | by a registered nurse or a licensed practical nurse based on a | |
| 27 | - | prescription that has completed final verification by a licensed | |
| 28 | - | pharmacist; | |
| 29 | - | (3) "Care-giving institution" means an institution that provides Substitute Senate Bill No. 1102 | |
| 18 | + | Section 1. Section 20-571 of the general statutes is repealed and the 1 | |
| 19 | + | following is substituted in lieu thereof (Effective July 1, 2023): 2 | |
| 20 | + | As used in this chapter and sections 2 to 4, inclusive, of this act, 3 | |
| 21 | + | unless the context otherwise requires: 4 | |
| 22 | + | (1) "Administer" or ["Administration"] "administration" means the 5 | |
| 23 | + | direct application of a drug or device to the body of a patient or 6 | |
| 24 | + | research subject by injection, inhalation, ingestion or any other means; 7 | |
| 25 | + | (2) "Automated prescription dispensing machine" means a device 8 | |
| 26 | + | and associated software operated by a pharmacy or a pharmacy that is 9 | |
| 27 | + | registered as a nonresident pharmacy pursuant to section 20-627, in a 10 | |
| 28 | + | nursing home or skilled nursing facility licensed pursuant to sections 11 | |
| 29 | + | 19a-490 and 19a-491, that packages and labels patient-specific 12 | |
| 30 | + | medication or multiple medications for the purposes of administration 13 | |
| 31 | + | by a registered nurse or a licensed practical nurse based on a 14 | |
| 32 | + | prescription that has completed final verification by a licensed 15 | |
| 33 | + | pharmacist; 16 | |
| 34 | + | (3) "Care-giving institution" means an institution that provides 17 | |
| 35 | + | medical services and is licensed, operated, certified or approved by the 18 Substitute Bill No. 1102 | |
| 30 | 36 | ||
| 31 | - | Public Act No. 23-19 2 of 35 | |
| 32 | 37 | ||
| 33 | - | medical services and is licensed, operated, certified or approved by the | |
| 34 | - | Commissioner of Public Health, the Commissioner of Developmental | |
| 35 | - | Services or the Commissioner of Mental Health and Addiction Services; | |
| 36 | - | (4) "Commission" means the Commission of Pharmacy appointed | |
| 37 | - | under the provisions of section 20-572; | |
| 38 | - | (5) "Commissioner" means the Commissioner of Consumer | |
| 39 | - | Protection; | |
| 40 | - | (6) "Compound" means to combine, mix or put together two or more | |
| 41 | - | ingredients pursuant to a prescription and includes the preparation of | |
| 42 | - | drugs or devices in anticipation of prescriptions based on routine, | |
| 43 | - | regularly-observed prescribing patterns; | |
| 44 | - | (7) "Correctional or juvenile training institution" means a facility for | |
| 45 | - | the detention or incarceration of persons convicted or accused of crimes | |
| 46 | - | or offenses or for training of delinquent juveniles, including those state | |
| 47 | - | facilities under the jurisdiction of the Commissioner of Correction, | |
| 48 | - | training schools for delinquent juveniles and any other facilities | |
| 49 | - | operated by the state or municipalities for such detention, incarceration | |
| 50 | - | or training; | |
| 51 | - | (8) "Device" means instruments, apparatuses and contrivances, | |
| 52 | - | including their components, parts and accessories, intended: (A) [for] | |
| 53 | - | For use in the diagnosis, cure, mitigation, treatment or prevention of | |
| 54 | - | disease in humans or other animals; [,] or (B) to affect the structure or | |
| 55 | - | any function of the body of humans or other animals, but does not mean | |
| 56 | - | contact lenses; | |
| 57 | - | (9) "Department" means the Department of Consumer Protection; | |
| 58 | - | (10) "Deprescribing" means the systematic process of identifying and | |
| 59 | - | discontinuing drugs in instances in which existing or potential harms | |
| 60 | - | outweigh existing or potential benefits within the context of an Substitute Senate Bill No. 1102 | |
| 38 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 39 | + | SB.docx } | |
| 40 | + | 2 of 29 | |
| 61 | 41 | ||
| 62 | - | Public Act No. 23-19 3 of 35 | |
| 42 | + | Commissioner of Public Health, the Commissioner of Developmental 19 | |
| 43 | + | Services or the Commissioner of Mental Health and Addiction 20 | |
| 44 | + | Services; 21 | |
| 45 | + | (4) "Commission" means the Commission of Pharmacy appointed 22 | |
| 46 | + | under the provisions of section 20-572; 23 | |
| 47 | + | (5) "Commissioner" means the Commissioner of Consumer 24 | |
| 48 | + | Protection; 25 | |
| 49 | + | (6) "Compound" means to combine, mix or put together two or 26 | |
| 50 | + | more ingredients pursuant to a prescription and includes the 27 | |
| 51 | + | preparation of drugs or devices in anticipation of prescriptions based 28 | |
| 52 | + | on routine, regularly-observed prescribing patterns; 29 | |
| 53 | + | (7) "Correctional or juvenile training institution" means a facility for 30 | |
| 54 | + | the detention or incarceration of persons convicted or accused of 31 | |
| 55 | + | crimes or offenses or for training of delinquent juveniles, including 32 | |
| 56 | + | those state facilities under the jurisdiction of the Commissioner of 33 | |
| 57 | + | Correction, training schools for delinquent juveniles and any other 34 | |
| 58 | + | facilities operated by the state or municipalities for such detention, 35 | |
| 59 | + | incarceration or training; 36 | |
| 60 | + | (8) "Device" means instruments, apparatuses and contrivances, 37 | |
| 61 | + | including their components, parts and accessories, intended: (A) [for] 38 | |
| 62 | + | For use in the diagnosis, cure, mitigation, treatment or prevention of 39 | |
| 63 | + | disease in humans or other animals; [,] or (B) to affect the structure or 40 | |
| 64 | + | any function of the body of humans or other animals, but does not 41 | |
| 65 | + | mean contact lenses; 42 | |
| 66 | + | (9) "Department" means the Department of Consumer Protection; 43 | |
| 67 | + | (10) "Deprescribing" means the systematic process of identifying 44 | |
| 68 | + | and discontinuing drugs in instances in which existing or potential 45 | |
| 69 | + | harms outweigh existing or potential benefits within the context of an 46 | |
| 70 | + | individual patient's care goals, current level of functioning, life 47 | |
| 71 | + | expectancy, values and preferences; 48 Substitute Bill No. 1102 | |
| 63 | 72 | ||
| 64 | - | individual patient's care goals, current level of functioning, life | |
| 65 | - | expectancy, values and preferences; | |
| 66 | - | (11) "Dispense" means those acts of processing a drug or device for | |
| 67 | - | delivery or for administration for a patient pursuant to a prescription | |
| 68 | - | consisting of: (A) Comparing the directions on the label with the | |
| 69 | - | directions on the prescription to determine accuracy; (B) the selection of | |
| 70 | - | the drug or device from stock to fill the prescription; (C) the counting, | |
| 71 | - | measuring, compounding or preparation of the drug or device; (D) the | |
| 72 | - | placing of the drug or device in the proper container; (E) the affixing of | |
| 73 | - | the label to the container; and (F) the addition to a written prescription | |
| 74 | - | of any required notations. "Dispense" does not include the acts of | |
| 75 | - | delivering a drug or device to a patient or of administering the drug or | |
| 76 | - | device to the patient; | |
| 77 | - | (12) "Dispensing outpatient facility" means a facility operated by a | |
| 78 | - | corporation or municipality which provides medical services to patients | |
| 79 | - | on an outpatient basis and which maintains stocks of drugs for | |
| 80 | - | dispensing of drugs on a regular basis to patients for use off the | |
| 81 | - | premises; | |
| 82 | - | (13) "Drug" means: (A) [an] An article recognized in the official | |
| 83 | - | United States Pharmacopoeia, official Homeopathic Pharmacopoeia of | |
| 84 | - | the United States or official National Formulary, or any supplement to | |
| 85 | - | any of them; [,] (B) an article intended for use in the diagnosis, cure, | |
| 86 | - | mitigation, treatment or prevention of disease in humans or other | |
| 87 | - | animals; [,] (C) an article, other than food, intended to affect the | |
| 88 | - | structure or any function of the body of humans or any other animal; [,] | |
| 89 | - | and (D) an article intended for use as a component of any article | |
| 90 | - | specified in this subdivision, but does not include a device; | |
| 91 | - | (14) "Health care institution" means institution, as defined in section | |
| 92 | - | 19a-490; Substitute Senate Bill No. 1102 | |
| 93 | 73 | ||
| 94 | - | Public Act No. 23-19 4 of 35 | |
| 74 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 75 | + | SB.docx } | |
| 76 | + | 3 of 29 | |
| 95 | 77 | ||
| 96 | - | (15) "Health care institutional pharmacy" means an institutional | |
| 97 | - | pharmacy located within a health care institution; | |
| 98 | - | [(14)] (16) "Institutional pharmacy" means that area within a care- | |
| 99 | - | giving institution or within a correctional or juvenile training | |
| 100 | - | institution, commonly known as the pharmacy, that is under the direct | |
| 101 | - | charge of a pharmacist and in which drugs are stored and dispensed; | |
| 102 | - | [(15)] (17) "Legend device" means a device that is required by | |
| 103 | - | applicable federal or state law to be dispensed pursuant only to a | |
| 104 | - | prescription or is restricted to use by prescribing practitioners only or | |
| 105 | - | that, under federal law, is required to bear either of the following | |
| 106 | - | legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES | |
| 107 | - | ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC | |
| 108 | - | ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE | |
| 109 | - | FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN."; | |
| 110 | - | [(16)] (18) "Legend drug" means a drug that is required by any | |
| 111 | - | applicable federal or state law to be dispensed pursuant only to a | |
| 112 | - | prescription or is restricted to use by prescribing practitioners only, or | |
| 113 | - | means a drug that, under federal law, is required to bear either of the | |
| 114 | - | following legends: (A) "RX ONLY" IN ACCORDANCE WITH | |
| 115 | - | GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND | |
| 116 | - | COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS | |
| 117 | - | DRUG FOR USE BY OR ON THE ORDER OF A LICENSED | |
| 118 | - | VETERINARIAN."; | |
| 119 | - | [(17)] (19) "Medical device and oxygen provider" means a person who | |
| 120 | - | distributes devices or oxygen pursuant to a medical order or | |
| 121 | - | prescription, except if such person already maintains an active | |
| 122 | - | pharmacy license; | |
| 123 | - | [(18)] (20) "Medication reconciliation" means a process of comparing | |
| 124 | - | the medications a patient is taking and should be taking with newly Substitute Senate Bill No. 1102 | |
| 78 | + | (11) "Dispense" means those acts of processing a drug or device for 49 | |
| 79 | + | delivery or for administration for a patient pursuant to a prescription 50 | |
| 80 | + | consisting of: (A) Comparing the directions on the label with the 51 | |
| 81 | + | directions on the prescription to determine accuracy; (B) the selection 52 | |
| 82 | + | of the drug or device from stock to fill the prescription; (C) the 53 | |
| 83 | + | counting, measuring, compounding or preparation of the drug or 54 | |
| 84 | + | device; (D) the placing of the drug or device in the proper container; 55 | |
| 85 | + | (E) the affixing of the label to the container; and (F) the addition to a 56 | |
| 86 | + | written prescription of any required notations. "Dispense" does not 57 | |
| 87 | + | include the acts of delivering a drug or device to a patient or of 58 | |
| 88 | + | administering the drug or device to the patient; 59 | |
| 89 | + | (12) "Dispensing outpatient facility" means a facility operated by a 60 | |
| 90 | + | corporation or municipality which provides medical services to 61 | |
| 91 | + | patients on an outpatient basis and which maintains stocks of drugs 62 | |
| 92 | + | for dispensing of drugs on a regular basis to patients for use off the 63 | |
| 93 | + | premises; 64 | |
| 94 | + | (13) "Drug" means: (A) [an] An article recognized in the official 65 | |
| 95 | + | United States Pharmacopoeia, official Homeopathic Pharmacopoeia of 66 | |
| 96 | + | the United States or official National Formulary, or any supplement to 67 | |
| 97 | + | any of them; [,] (B) an article intended for use in the diagnosis, cure, 68 | |
| 98 | + | mitigation, treatment or prevention of disease in humans or other 69 | |
| 99 | + | animals; [,] (C) an article, other than food, intended to affect the 70 | |
| 100 | + | structure or any function of the body of humans or any other animal; 71 | |
| 101 | + | [,] and (D) an article intended for use as a component of any article 72 | |
| 102 | + | specified in this subdivision, but does not include a device; 73 | |
| 103 | + | (14) "Health care institution" means institution, as defined in section 74 | |
| 104 | + | 19a-490; 75 | |
| 105 | + | (15) "Health care institutional pharmacy" means an institutional 76 | |
| 106 | + | pharmacy located within a health care institution; 77 | |
| 107 | + | [(14)] (16) "Institutional pharmacy" means that area within a care-78 | |
| 108 | + | giving institution or within a correctional or juvenile training 79 Substitute Bill No. 1102 | |
| 125 | 109 | ||
| 126 | - | Public Act No. 23-19 5 of 35 | |
| 127 | 110 | ||
| 128 | - | ordered medications: (A) [for] For the purpose of addressing | |
| 129 | - | duplications, omissions and interactions and the need to continue | |
| 130 | - | current medications; [,] and (B) by looking at information such as the | |
| 131 | - | medication name, dose, frequency, route of administration and | |
| 132 | - | purpose; | |
| 133 | - | [(19)] (21) "Nonlegend device" means a device that is not a legend | |
| 134 | - | device; | |
| 135 | - | [(20)] (22) "Nonlegend drug" means a drug that is not a legend drug; | |
| 136 | - | (23) "Nonresident pharmacy" has the same meaning as provided in | |
| 137 | - | section 20-627; | |
| 138 | - | [(21)] (24) "Person" means an individual, corporation, business trust, | |
| 139 | - | estate trust, partnership, association, joint venture or any other legal or | |
| 140 | - | commercial entity; | |
| 141 | - | [(22)] (25) "Pharmacist" means an individual who is licensed to | |
| 142 | - | practice pharmacy under the provisions of section 20-590, 20-591, 20-592 | |
| 143 | - | or 20-593, and who is thereby recognized as a health care provider by | |
| 144 | - | the state of Connecticut; | |
| 145 | - | [(23)] (26) "Pharmacy" means a place of business where drugs and | |
| 146 | - | devices may be sold at retail and for which a pharmacy license has been | |
| 147 | - | issued to an applicant under the provisions of section 20-594, as | |
| 148 | - | amended by this act; | |
| 149 | - | [(24)] (27) "Pharmacy intern" means an individual registered under | |
| 150 | - | the provisions of section 20-598; | |
| 151 | - | [(25)] (28) "Pharmacy technician" means an individual who is | |
| 152 | - | registered with the department and qualified in accordance with section | |
| 153 | - | 20-598a; | |
| 154 | - | [(26)] (29) "Polypharmacy" means the use of multiple drugs by a Substitute Senate Bill No. 1102 | |
| 111 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 112 | + | SB.docx } | |
| 113 | + | 4 of 29 | |
| 155 | 114 | ||
| 156 | - | Public Act No. 23-19 6 of 35 | |
| 115 | + | institution, commonly known as the pharmacy, that is under the direct 80 | |
| 116 | + | charge of a pharmacist and in which drugs are stored and dispensed; 81 | |
| 117 | + | [(15)] (17) "Legend device" means a device that is required by 82 | |
| 118 | + | applicable federal or state law to be dispensed pursuant only to a 83 | |
| 119 | + | prescription or is restricted to use by prescribing practitioners only or 84 | |
| 120 | + | that, under federal law, is required to bear either of the following 85 | |
| 121 | + | legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES 86 | |
| 122 | + | ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC 87 | |
| 123 | + | ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE 88 | |
| 124 | + | FOR USE BY OR ON THE OR DER OF A LICENSED 89 | |
| 125 | + | VETERINARIAN."; 90 | |
| 126 | + | [(16)] (18) "Legend drug" means a drug that is required by any 91 | |
| 127 | + | applicable federal or state law to be dispensed pursuant only to a 92 | |
| 128 | + | prescription or is restricted to use by prescribing practitioners only, or 93 | |
| 129 | + | means a drug that, under federal law, is required to bear either of the 94 | |
| 130 | + | following legends: (A) "RX ONLY" IN ACCORDANCE WITH 95 | |
| 131 | + | GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND 96 | |
| 132 | + | COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS 97 | |
| 133 | + | THIS DRUG FOR USE BY OR ON THE ORDER OF A L ICENSED 98 | |
| 134 | + | VETERINARIAN."; 99 | |
| 135 | + | [(17)] (19) "Medical device and oxygen provider" means a person 100 | |
| 136 | + | who distributes devices or oxygen pursuant to a medical order or 101 | |
| 137 | + | prescription, except if such person already maintains an active 102 | |
| 138 | + | pharmacy license; 103 | |
| 139 | + | [(18)] (20) "Medication reconciliation" means a process of comparing 104 | |
| 140 | + | the medications a patient is taking and should be taking with newly 105 | |
| 141 | + | ordered medications: (A) [for] For the purpose of addressing 106 | |
| 142 | + | duplications, omissions and interactions and the need to continue 107 | |
| 143 | + | current medications; [,] and (B) by looking at information such as the 108 | |
| 144 | + | medication name, dose, frequency, route of administration and 109 | |
| 145 | + | purpose; 110 Substitute Bill No. 1102 | |
| 157 | 146 | ||
| 158 | - | patient, including any medication that is inappropriate or not medically | |
| 159 | - | necessary, such as those not indicated, not effective or constituting a | |
| 160 | - | therapeutic duplication; | |
| 161 | - | [(27)] (30) "Practice of pharmacy" or "to practice pharmacy" means the | |
| 162 | - | sum total of knowledge, understanding, judgments, procedures, | |
| 163 | - | securities, controls and ethics used by a pharmacist to assure optimal | |
| 164 | - | safety and accuracy in the distributing, dispensing and use of drugs and | |
| 165 | - | devices; | |
| 166 | - | [(28)] (31) "Prescribing practitioner" means an individual licensed by | |
| 167 | - | the state of Connecticut, any other state of the United States, the District | |
| 168 | - | of Columbia, the Commonwealth of Puerto Rico or any territory or | |
| 169 | - | insular possession subject to the jurisdiction of the United States who is | |
| 170 | - | authorized to issue a prescription within the scope of the individual's | |
| 171 | - | practice; | |
| 172 | - | [(29)] (32) "Prescription" means a lawful order of a prescribing | |
| 173 | - | practitioner transmitted either orally, in writing or by electronic means | |
| 174 | - | for a drug or device for a specific patient; | |
| 175 | - | [(30)] (33) "Sale" includes barter, exchange or gift or offer and each | |
| 176 | - | such transaction made by a person whether as principal proprietor, | |
| 177 | - | agent, servant or employee; | |
| 178 | - | [(31)] (34) "Substitute" means to dispense without the prescribing | |
| 179 | - | practitioner's express authorization a different drug product than the | |
| 180 | - | drug product prescribed; | |
| 181 | - | [(32)] (35) "Third-party logistics provider" means a person who | |
| 182 | - | distributes drugs, devices or cosmetics while taking possession of the | |
| 183 | - | drugs, devices or cosmetics but who does not take title of the drugs, | |
| 184 | - | devices or cosmetics; | |
| 185 | - | [(33)] (36) "Virtual manufacturer" means a person who engages in the Substitute Senate Bill No. 1102 | |
| 186 | 147 | ||
| 187 | - | Public Act No. 23-19 7 of 35 | |
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| 188 | 151 | ||
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| 152 | + | [(19)] (21) "Nonlegend device" means a device that is not a legend 111 | |
| 153 | + | device; 112 | |
| 154 | + | [(20)] (22) "Nonlegend drug" means a drug that is not a legend drug; 113 | |
| 155 | + | (23) "Nonresident pharmacy" has the same meaning as provided in 114 | |
| 156 | + | section 20-627; 115 | |
| 157 | + | [(21)] (24) "Person" means an individual, corporation, business trust, 116 | |
| 158 | + | estate trust, partnership, association, joint venture or any other legal or 117 | |
| 159 | + | commercial entity; 118 | |
| 160 | + | [(22)] (25) "Pharmacist" means an individual who is licensed to 119 | |
| 161 | + | practice pharmacy under the provisions of section 20-590, 20-591, 20-120 | |
| 162 | + | 592 or 20-593, and who is thereby recognized as a health care provider 121 | |
| 163 | + | by the state of Connecticut; 122 | |
| 164 | + | [(23)] (26) "Pharmacy" means a place of business where drugs and 123 | |
| 165 | + | devices may be sold at retail and for which a pharmacy license has 124 | |
| 166 | + | been issued to an applicant under the provisions of section 20-594, as 125 | |
| 167 | + | amended by this act; 126 | |
| 168 | + | [(24)] (27) "Pharmacy intern" means an individual registered under 127 | |
| 169 | + | the provisions of section 20-598; 128 | |
| 170 | + | [(25)] (28) "Pharmacy technician" means an individual who is 129 | |
| 171 | + | registered with the department and qualified in accordance with 130 | |
| 172 | + | section 20-598a; 131 | |
| 173 | + | [(26)] (29) "Polypharmacy" means the use of multiple drugs by a 132 | |
| 174 | + | patient, including any medication that is inappropriate or not 133 | |
| 175 | + | medically necessary, such as those not indicated, not effective or 134 | |
| 176 | + | constituting a therapeutic duplication; 135 | |
| 177 | + | [(27)] (30) "Practice of pharmacy" or "to practice pharmacy" means 136 | |
| 178 | + | the sum total of knowledge, understanding, judgments, procedures, 137 | |
| 179 | + | securities, controls and ethics used by a pharmacist to assure optimal 138 Substitute Bill No. 1102 | |
| 217 | 180 | ||
| 218 | - | Public Act No. 23-19 8 of 35 | |
| 219 | 181 | ||
| 220 | - | (b) (1) Any pharmacist licensed under chapter 400j of the general | |
| 221 | - | statutes may order, and administer to a patient, a COVID-19-related test | |
| 222 | - | or influenza-related test if: (A) Such pharmacist (i) is employed by a | |
| 223 | - | pharmacy that has submitted to the Department of Public Health a | |
| 224 | - | complete clinical laboratory improvement amendment application for | |
| 225 | - | certification for the COVID-19-related test or influenza-related test and | |
| 226 | - | the Department of Public Health has approved such application, and (ii) | |
| 227 | - | has completed any training required by the Department of Consumer | |
| 228 | - | Protection; and (B) the patient is (i) eighteen years of age or older, or (ii) | |
| 229 | - | at least twelve years of age but younger than eighteen years of age with | |
| 230 | - | (I) the consent of such patient's parent, legal guardian or other person | |
| 231 | - | having legal custody of such patient, or (II) proof that such patient is an | |
| 232 | - | emancipated minor. | |
| 233 | - | (2) Any pharmacist licensed under chapter 400j of the general statutes | |
| 234 | - | may order, and administer to a patient, a COVID-19-related test or | |
| 235 | - | influenza-related test if: (A) Such pharmacist is employed by a hospital; | |
| 236 | - | and (B) the patient is (i) eighteen years of age or older, or (ii) at least | |
| 237 | - | twelve years of age but younger than eighteen years of age with (I) the | |
| 238 | - | consent of such patient's parent, legal guardian or other person having | |
| 239 | - | legal custody of such patient, or (II) proof that such patient is an | |
| 240 | - | emancipated minor. | |
| 241 | - | (c) (1) On or after the adoption of regulations pursuant to subsection | |
| 242 | - | (g) of this section, any pharmacist licensed under chapter 400j of the | |
| 243 | - | general statutes may order, and administer to a patient, an HIV-related | |
| 244 | - | test if: (A) Such pharmacist (i) is employed by a pharmacy that has | |
| 245 | - | submitted to the Department of Public Health a complete clinical | |
| 246 | - | laboratory improvement amendment application for certification for the | |
| 247 | - | HIV-related test and the Department of Public Health has approved | |
| 248 | - | such application, and (ii) has completed the training required under | |
| 249 | - | regulations adopted pursuant to subsection (g) of this section; and (B) | |
| 250 | - | the patient is (i) eighteen years of age or older, or (ii) at least twelve years Substitute Senate Bill No. 1102 | |
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| 186 | + | safety and accuracy in the distributing, dispensing and use of drugs 139 | |
| 187 | + | and devices; 140 | |
| 188 | + | [(28)] (31) "Prescribing practitioner" means an individual licensed by 141 | |
| 189 | + | the state of Connecticut, any other state of the United States, the 142 | |
| 190 | + | District of Columbia, the Commonwealth of Puerto Rico or any 143 | |
| 191 | + | territory or insular possession subject to the jurisdiction of the United 144 | |
| 192 | + | States who is authorized to issue a prescription within the scope of the 145 | |
| 193 | + | individual's practice; 146 | |
| 194 | + | [(29)] (32) "Prescription" means a lawful order of a prescribing 147 | |
| 195 | + | practitioner transmitted either orally, in writing or by electronic means 148 | |
| 196 | + | for a drug or device for a specific patient; 149 | |
| 197 | + | [(30)] (33) "Sale" includes barter, exchange or gift or offer and each 150 | |
| 198 | + | such transaction made by a person whether as principal proprietor, 151 | |
| 199 | + | agent, servant or employee; 152 | |
| 200 | + | [(31)] (34) "Substitute" means to dispense without the prescribing 153 | |
| 201 | + | practitioner's express authorization a different drug product than the 154 | |
| 202 | + | drug product prescribed; 155 | |
| 203 | + | [(32)] (35) "Third-party logistics provider" means a person who 156 | |
| 204 | + | distributes drugs, devices or cosmetics while taking possession of the 157 | |
| 205 | + | drugs, devices or cosmetics but who does not take title of the drugs, 158 | |
| 206 | + | devices or cosmetics; 159 | |
| 207 | + | [(33)] (36) "Virtual manufacturer" means a person who engages in 160 | |
| 208 | + | the manufacture of drugs, devices or cosmetics for which such person: 161 | |
| 209 | + | (A) Owns the new drug application or abbreviated new drug 162 | |
| 210 | + | application number, if a prescription drug; (B) owns the unique device 163 | |
| 211 | + | identification number, as available, for a prescription device; (C) 164 | |
| 212 | + | contracts with a contract manufacturing organization for the physical 165 | |
| 213 | + | manufacture of the drugs, devices or cosmetics; (D) is not involved in 166 | |
| 214 | + | the physical manufacture of the drugs, devices or cosmetics; and (E) at 167 | |
| 215 | + | no time takes physical possession of or stores the drugs, devices or 168 | |
| 216 | + | cosmetics; and 169 Substitute Bill No. 1102 | |
| 253 | 217 | ||
| 254 | - | of age but younger than eighteen years of age with (I) the consent of | |
| 255 | - | such patient's parent, legal guardian or other person having legal | |
| 256 | - | custody of such patient, or (II) proof that such patient is an emancipated | |
| 257 | - | minor. | |
| 258 | - | (2) On or after the adoption of regulations pursuant to subsection (g) | |
| 259 | - | of this section, any pharmacist licensed under chapter 400j of the general | |
| 260 | - | statutes may order, and administer to a patient, an HIV-related test if: | |
| 261 | - | (A) Such pharmacist is employed by a hospital; and (B) the patient is (i) | |
| 262 | - | eighteen years of age or older, or (ii) at least twelve years of age but | |
| 263 | - | younger than eighteen years of age and such pharmacist has obtained | |
| 264 | - | (I) the consent of such patient's parent, legal guardian or other person | |
| 265 | - | having legal custody of such patient, or (II) proof that such patient is an | |
| 266 | - | emancipated minor. | |
| 267 | - | (d) If a pharmacist orders and administers a COVID-19-related test or | |
| 268 | - | influenza-related test under subsection (b) of this section, or an HIV- | |
| 269 | - | related test under subsection (c) of this section, the pharmacist shall: (1) | |
| 270 | - | Provide the results of such test to (A) the patient, in writing, (B) the | |
| 271 | - | patient's primary care provider, if the patient identifies any such | |
| 272 | - | primary care provider, and (C) the Commissioner of Consumer | |
| 273 | - | Protection or said commissioner's designee, upon request by said | |
| 274 | - | commissioner or such designee; (2) report the results of such test to the | |
| 275 | - | director of health of the town, city or borough in which such case resides | |
| 276 | - | and to the Department of Public Health in the manner set forth in section | |
| 277 | - | 19a-215 of the general statutes and applicable regulations; and (3) | |
| 278 | - | maintain a record of the results of such test for three years. | |
| 279 | - | (e) (1) If a pharmacist orders and administers an HIV-related test | |
| 280 | - | under subsection (c) of this section and the result of such test is negative, | |
| 281 | - | the pharmacist may prescribe and dispense to the patient any HIV- | |
| 282 | - | related prophylaxis according to the manufacturer's package insert, | |
| 283 | - | provided: (A) Such pharmacist has completed the training required | |
| 284 | - | under the regulations adopted pursuant to subsection (g) of this section; Substitute Senate Bill No. 1102 | |
| 285 | 218 | ||
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| 288 | - | (B) such patient satisfies the criteria established in such package insert; | |
| 289 | - | and (C) such HIV-related prophylaxis is prescribed and dispensed in | |
| 290 | - | accordance with all applicable requirements established in (i) this | |
| 291 | - | section, (ii) chapter 400j of the general statutes, or (iii) any regulations | |
| 292 | - | adopted pursuant to subsection (g) of this section or chapter 400j of the | |
| 293 | - | general statutes. | |
| 294 | - | (2) If a pharmacist prescribes any HIV-related prophylaxis under | |
| 295 | - | subdivision (1) of this subsection, the pharmacist shall provide to the | |
| 296 | - | Commissioner of Consumer Protection or the commissioner's designee, | |
| 297 | - | upon request by said commissioner or such designee: (A) A copy of the | |
| 298 | - | results of the HIV-related test described in subdivision (1) of this | |
| 299 | - | subsection; (B) prescription information maintained pursuant to chapter | |
| 300 | - | 400j of the general statutes; and (C) any other documentation the | |
| 301 | - | commissioner may require in regulations adopted pursuant to | |
| 302 | - | subsection (g) of this section. | |
| 303 | - | (f) Notwithstanding the provisions of section 1-210 of the general | |
| 304 | - | statutes, all information a pharmacist submits to the Department of | |
| 305 | - | Consumer Protection pursuant to this section, or any regulation | |
| 306 | - | adopted pursuant to subsection (g) of this section, shall be confidential. | |
| 307 | - | The department shall use such information to perform the department's | |
| 308 | - | duties concerning pharmacy, to ensure compliance with and enforce | |
| 309 | - | provisions of the general statutes and regulations of Connecticut state | |
| 310 | - | agencies concerning pharmacy and for no other purpose. If the | |
| 311 | - | department brings an enforcement action and uses any such | |
| 312 | - | information as part of such action, the department may disclose such | |
| 313 | - | information to the parties to such action only if such disclosure is | |
| 314 | - | required by applicable law. No such party shall further disclose such | |
| 315 | - | information except to a tribunal, the Commission of Pharmacy, an | |
| 316 | - | administrative agency or a court with jurisdiction over such action. Such | |
| 317 | - | tribunal, commission, agency or court shall ensure that such | |
| 318 | - | information is subject to a qualified protective order, as defined in 45 Substitute Senate Bill No. 1102 | |
| 223 | + | [(34)] (37) "Virtual wholesale distributor" means a person who 170 | |
| 224 | + | facilitates or brokers the transfer of drugs, devices or cosmetics 171 | |
| 225 | + | without taking physical possession of the drugs, devices or cosmetics. 172 | |
| 226 | + | Sec. 2. (NEW) (Effective July 1, 2023) (a) For the purposes of this 173 | |
| 227 | + | section: 174 | |
| 228 | + | (1) "COVID-19" means the respiratory disease designated by the 175 | |
| 229 | + | World Health Organization on February 11, 2020, as coronavirus 2019, 176 | |
| 230 | + | and any related mutation thereof recognized by said organization; 177 | |
| 231 | + | (2) "COVID-19-related test" means any laboratory test, or series of 178 | |
| 232 | + | laboratory tests, for any virus, antibody, antigen or etiologic agent 179 | |
| 233 | + | thought to cause, or indicate the presence of, COVID-19; 180 | |
| 234 | + | (3) "HIV-related prophylaxis" means any drug approved by the 181 | |
| 235 | + | federal Food and Drug Administration or any successor agency as a 182 | |
| 236 | + | pre-exposure or post-exposure prophylaxis for the human 183 | |
| 237 | + | immunodeficiency virus; 184 | |
| 238 | + | (4) "HIV-related test" has the same meaning as provided in section 185 | |
| 239 | + | 19a-7o of the general statutes; and 186 | |
| 240 | + | (5) "Influenza-related test" means any laboratory test, or series of 187 | |
| 241 | + | laboratory tests, for any virus, antibody, antigen or etiologic agent 188 | |
| 242 | + | thought to cause, or indicate the presence of, influenza disease. 189 | |
| 243 | + | (b) (1) Any person who is licensed as a pharmacist under chapter 190 | |
| 244 | + | 400j of the general statutes and employed by: (A) A pharmacy that has 191 | |
| 245 | + | submitted to the Department of Public Health a complete clinical 192 | |
| 246 | + | laboratory improvement amendment application for certification for a 193 | |
| 247 | + | COVID-19-related test, HIV-related test or influenza-related test may 194 | |
| 248 | + | order, and administer to a patient, the COVID-19-related test, HIV-195 | |
| 249 | + | related test or influenza-related test if the patient is (i) eighteen years 196 | |
| 250 | + | of age or older, or (ii) at least twelve years of age but younger than 197 | |
| 251 | + | eighteen years of age with (I) the consent of such patient's parent, legal 198 | |
| 252 | + | guardian or other person having legal custody of such patient, or (II) 199 Substitute Bill No. 1102 | |
| 319 | 253 | ||
| 320 | - | Public Act No. 23-19 11 of 35 | |
| 321 | 254 | ||
| 322 | - | CFR 164.512(e), as amended from time to time. | |
| 323 | - | (g) The Commissioner of Consumer Protection, in consultation with | |
| 324 | - | the Commissioner of Public Health, the Commission of Pharmacy, a | |
| 325 | - | state-wide professional society representing the interests of physicians | |
| 326 | - | practicing medicine in this state and a state-wide organization | |
| 327 | - | representing the interests of health care professionals and scientists | |
| 328 | - | specializing in the control and prevention of infectious diseases, shall | |
| 329 | - | adopt regulations, in accordance with chapter 54 of the general statutes, | |
| 330 | - | to implement the provisions of this section. Such regulations shall, at a | |
| 331 | - | minimum: (1) Ensure compliance with all applicable guidance issued by | |
| 332 | - | the federal Centers for Disease Control and Prevention; (2) ensure that | |
| 333 | - | each HIV-related prophylaxis prescribed and dispensed under | |
| 334 | - | subsection (e) of this section is prescribed and dispensed in accordance | |
| 335 | - | with the approval the federal Food and Drug Administration has | |
| 336 | - | granted for such HIV-related prophylaxis; (3) establish permissible | |
| 337 | - | routes of administration; (4) establish prescription duration limits not to | |
| 338 | - | exceed (A) sixty days for any pre-exposure HIV-related prophylaxis, or | |
| 339 | - | (B) thirty days for any post-exposure HIV-related prophylaxis; (5) | |
| 340 | - | specify (A) how frequently a pharmacist shall provide treatment to a | |
| 341 | - | patient under this section, (B) when a pharmacist providing treatment | |
| 342 | - | to a patient under this section shall refer such patient to such patient's | |
| 343 | - | primary care provider or any other health care provider identified by | |
| 344 | - | such patient, and (C) the circumstances in which a pharmacist shall | |
| 345 | - | recommend that a patient undergo screenings for sexually transmitted | |
| 346 | - | infections other than the human immunodeficiency virus; (6) establish | |
| 347 | - | requirements concerning private areas for consultations between | |
| 348 | - | pharmacists and patients; (7) establish training requirements | |
| 349 | - | concerning (A) methods to obtain a patient's complete sexual history, | |
| 350 | - | (B) delivering a positive HIV-related test result to a patient, (C) referring | |
| 351 | - | a patient who has tested positive for the human immunodeficiency | |
| 352 | - | virus to the services that are available to such patient, and (D) using | |
| 353 | - | HIV-related prophylaxes for patients who have tested negative for the Substitute Senate Bill No. 1102 | |
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| 259 | + | proof that such patient is an emancipated minor; or (B) a hospital may 200 | |
| 260 | + | order, and administer to a patient, a COVID-19-related test, HIV-201 | |
| 261 | + | related test or influenza-related test if the patient is (i) eighteen years 202 | |
| 262 | + | of age or older, or (ii) at least twelve years of age but younger than 203 | |
| 263 | + | eighteen years of age with (I) the consent of such patient's parent, legal 204 | |
| 264 | + | guardian or other person having legal custody of such patient, or (II) 205 | |
| 265 | + | proof that such patient is an emancipated minor. 206 | |
| 266 | + | (2) If a pharmacist orders and administers a COVID-19-related test, 207 | |
| 267 | + | HIV-related test or influenza-related test under subdivision (1) of this 208 | |
| 268 | + | subsection, the pharmacist shall: (A) Provide to the patient, in writing, 209 | |
| 269 | + | the results of such test; (B) maintain a record of the results of such test 210 | |
| 270 | + | for a period of three years; and (C) provide to the Commissioner of 211 | |
| 271 | + | Consumer Protection or the commissioner's designee, upon a request 212 | |
| 272 | + | made by the commissioner or the commissioner's designee, a copy of 213 | |
| 273 | + | the results of such test. 214 | |
| 274 | + | (c) (1) If a pharmacist orders and administers any HIV-related test 215 | |
| 275 | + | under subdivision (1) of subsection (b) of this section and the result of 216 | |
| 276 | + | such test is negative, the pharmacist may prescribe and dispense to the 217 | |
| 277 | + | patient any HIV-related prophylaxis according to the manufacturer's 218 | |
| 278 | + | package insert, provided: (A) Such patient satisfies the criteria 219 | |
| 279 | + | established in such package insert; and (B) such HIV -related 220 | |
| 280 | + | prophylaxis is prescribed and dispensed in accordance with all 221 | |
| 281 | + | applicable requirements established in chapter 400j of the general 222 | |
| 282 | + | statutes. 223 | |
| 283 | + | (2) If a pharmacist prescribes any HIV-related prophylaxis under 224 | |
| 284 | + | subdivision (1) of this subsection, the pharmacist shall provide to the 225 | |
| 285 | + | Commissioner of Consumer Protection or the commissioner's 226 | |
| 286 | + | designee, upon a request made by the comm issioner or the 227 | |
| 287 | + | commissioner's designee: (A) A copy of the results of the HIV-related 228 | |
| 288 | + | test; (B) prescription information maintained pursuant to chapter 400j 229 | |
| 289 | + | of the general statutes; and (C) any other documentation the 230 | |
| 290 | + | commissioner requires in regulations adopted pursuant to subsection 231 | |
| 291 | + | (d) of this section. 232 Substitute Bill No. 1102 | |
| 356 | 292 | ||
| 357 | - | human immunodeficiency virus; (8) identify qualifying training | |
| 358 | - | programs, which are accredited by the National Centers for Disease | |
| 359 | - | Control and Prevention, the Accreditation Council for Pharmacy | |
| 360 | - | Education or another appropriate national accrediting body; and (9) | |
| 361 | - | establish a system of control and reporting. | |
| 362 | - | Sec. 3. (NEW) (Effective July 1, 2023) (a) (1) A pharmacy may apply to | |
| 363 | - | the department, in a form and manner prescribed by the commissioner, | |
| 364 | - | to operate a mobile pharmacy in a temporary location for the purpose | |
| 365 | - | of: (A) Conducting (i) a temporary pharmacy operation, (ii) a | |
| 366 | - | vaccination event, or (iii) an opioid antagonist training and prescribing | |
| 367 | - | event; or (B) serving a community that may not have adequate access to | |
| 368 | - | pharmacy services. | |
| 369 | - | (2) No pharmacy may operate a mobile pharmacy without prior | |
| 370 | - | written approval from the department. Each mobile pharmacy shall be | |
| 371 | - | supervised by a pharmacist. The department may inspect a mobile | |
| 372 | - | pharmacy before pharmacy services are provided in the mobile | |
| 373 | - | pharmacy, and at any time during usual business hours or while such | |
| 374 | - | mobile pharmacy is in operation. The department may issue an order | |
| 375 | - | closing a mobile pharmacy if the department determines that: (A) The | |
| 376 | - | mobile pharmacy has failed to comply with (i) any provision of this | |
| 377 | - | section or chapter 400j of the general statutes, (ii) any regulation adopted | |
| 378 | - | pursuant to subsection (d) of this section or chapter 400j of the general | |
| 379 | - | statutes, or (iii) any applicable law or regulation of any jurisdiction | |
| 380 | - | concerning drugs, devices or the practice of pharmacy; (B) conditions | |
| 381 | - | are unsafe to store or dispense drugs; or (C) there is insufficient security | |
| 382 | - | at such mobile pharmacy. | |
| 383 | - | (b) A pharmacy that operates a mobile pharmacy under this section | |
| 384 | - | shall: (1) Maintain a record of all drugs that are removed from the | |
| 385 | - | pharmacy premises for the purpose of operating such mobile pharmacy; | |
| 386 | - | (2) maintain a record of each drug that is dispensed at such mobile | |
| 387 | - | pharmacy and include such record in such pharmacy's records not later Substitute Senate Bill No. 1102 | |
| 388 | 293 | ||
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| 391 | - | than twenty-four hours after such drug is dispensed; (3) except as | |
| 392 | - | provided in subsection (c) of this section, inventory and return all | |
| 393 | - | unused drugs to the pharmacy premises by the close of business each | |
| 394 | - | day; (4) while operating such mobile pharmacy, store all drugs in such | |
| 395 | - | mobile pharmacy in a manner that (A) prevents any drug diversion, and | |
| 396 | - | (B) is consistent with the storage conditions specified by the | |
| 397 | - | manufacturers of such drugs; (5) establish and maintain a patient | |
| 398 | - | communication plan to ensure that patients can obtain prescription | |
| 399 | - | refills if such mobile pharmacy is unavailable; and (6) if permitted by | |
| 400 | - | the federal Drug Enforcement Administration or a successor agency, | |
| 401 | - | store controlled substances in the mobile pharmacy in accordance with | |
| 402 | - | regulations adopted by the commissioner pursuant to section 21a-262 of | |
| 403 | - | the general statutes. | |
| 404 | - | (c) No pharmacy shall, without prior approval from the department: | |
| 405 | - | (1) Operate a mobile pharmacy for more than (A) seven consecutive | |
| 406 | - | days in a single location, or (B) fourteen days within a five-mile radius | |
| 407 | - | of the prior mobile pharmacy location; or (2) store drugs overnight in a | |
| 408 | - | mobile pharmacy or outside of the pharmacy premises. | |
| 409 | - | (d) The commissioner may, with the advice and consent of the | |
| 410 | - | commission, adopt regulations in accordance with chapter 54 of the | |
| 411 | - | general statutes to implement the provisions of this section. | |
| 412 | - | Sec. 4. (NEW) (Effective July 1, 2023) (a) For the purposes of this | |
| 413 | - | section, "pharmacy district manager" means an individual who (1) | |
| 414 | - | supervises at least three pharmacies within this state, and (2) is | |
| 415 | - | responsible for the activities within such pharmacies, including, but not | |
| 416 | - | limited to, staffing, payroll and hiring. | |
| 417 | - | (b) Each pharmacy shall maintain a plan to manage unscheduled | |
| 418 | - | closings. Such plan shall be reviewed and updated, if necessary, on an | |
| 419 | - | annual basis, and be provided to, and reviewed with, all pharmacy | |
| 420 | - | personnel on an annual basis. Such plan shall include: Substitute Senate Bill No. 1102 | |
| 298 | + | (d) The Commissioner of Consumer Protection, in consultation with 233 | |
| 299 | + | the Commissioner of Public Health and the Commission of Pharmacy, 234 | |
| 300 | + | shall adopt regulations, in accordance with chapter 54 of the general 235 | |
| 301 | + | statutes, to implement the provisions of this section. Such regulations 236 | |
| 302 | + | shall, at a minimum: (1) Identify qualifying training programs, which 237 | |
| 303 | + | are accredited by the National Centers for Disease Control and 238 | |
| 304 | + | Prevention, the Accreditation Council for Pharmacy Education or 239 | |
| 305 | + | another appropriate national accrediting body; and (2) establish a 240 | |
| 306 | + | system of control and reporting. 241 | |
| 307 | + | Sec. 3. (NEW) (Effective July 1, 2023) (a) (1) A pharmacy may apply to 242 | |
| 308 | + | the department, in a form and manner prescribed by the 243 | |
| 309 | + | commissioner, to operate a mobile pharmacy in a temporary location 244 | |
| 310 | + | for the purpose of: (A) Conducting (i) a temporary clinic, (ii) a 245 | |
| 311 | + | vaccination event, or (iii) an opioid antagonist training and prescribing 246 | |
| 312 | + | event; or (B) serving a community that may not have adequate access 247 | |
| 313 | + | to pharmacy services. 248 | |
| 314 | + | (2) No pharmacy may operate a mobile pharmacy without prior 249 | |
| 315 | + | written approval from the department. Each mobile pharmacy shall be 250 | |
| 316 | + | supervised by a pharmacist. The department may inspect a mobile 251 | |
| 317 | + | pharmacy before pharmacy services are provided in the mobile 252 | |
| 318 | + | pharmacy, and at any time during usual business hours or while such 253 | |
| 319 | + | mobile pharmacy is in operation. The department may issue an order 254 | |
| 320 | + | closing a mobile pharmacy if the department determines that: (A) The 255 | |
| 321 | + | mobile pharmacy has failed to comply with the provisions of this 256 | |
| 322 | + | section; (B) conditions are unsafe to store or dispense drugs; or (C) 257 | |
| 323 | + | there is insufficient security at such mobile pharmacy. 258 | |
| 324 | + | (b) A pharmacy that operates a mobile pharmacy under this section 259 | |
| 325 | + | shall: (1) Maintain a record of all drugs that are removed from the 260 | |
| 326 | + | pharmacy premises for the purpose of operating such mobile 261 | |
| 327 | + | pharmacy; (2) maintain a record of each drug that is dispensed at such 262 | |
| 328 | + | mobile pharmacy and include such record in such pharmacy's records 263 | |
| 329 | + | not later than twenty-four hours after such drug is dispensed; (3) 264 | |
| 330 | + | except as provided in subsection (c) of this section, inventory and 265 Substitute Bill No. 1102 | |
| 421 | 331 | ||
| 422 | - | Public Act No. 23-19 14 of 35 | |
| 423 | 332 | ||
| 424 | - | (1) The name of the individual who is responsible for notifying the | |
| 425 | - | Commission of Pharmacy of an unscheduled closing; | |
| 426 | - | (2) The name of the individual who is responsible for updating the | |
| 427 | - | hours of operation in the pharmacy's electronic record system to prevent | |
| 428 | - | acceptance of electronically transmitted prescriptions during an | |
| 429 | - | unscheduled closing; | |
| 430 | - | (3) The name of the individual who is responsible for updating the | |
| 431 | - | pharmacy's telephone system during an unscheduled closing to (A) | |
| 432 | - | prevent the acceptance of orally transmitted prescriptions during the | |
| 433 | - | unscheduled closing, and (B) provide a message that alerts patients that | |
| 434 | - | such pharmacy will be closed and their prescriptions may be obtained | |
| 435 | - | from a nearby pharmacy; | |
| 436 | - | (4) A list of all pharmacies that are located within a two-mile radius | |
| 437 | - | of the pharmacy that is experiencing an unscheduled closing, or the next | |
| 438 | - | closest pharmacy if there is no pharmacy within such two-mile radius; | |
| 439 | - | and | |
| 440 | - | (5) The name of the individual who is responsible for posting, at the | |
| 441 | - | entrance to such pharmacy and at each entrance of the structure if such | |
| 442 | - | pharmacy is located within another structure, signage stating the | |
| 443 | - | duration of an unscheduled closing. | |
| 444 | - | (c) If a pharmacy experiences an unscheduled closing, the pharmacist | |
| 445 | - | manager of the pharmacy or, if the pharmacy operates more than five | |
| 446 | - | pharmacy locations in this state, the pharmacy district manager shall: | |
| 447 | - | (1) Modify such pharmacy's hours of operation in such pharmacy's | |
| 448 | - | electronic record system to prevent the acceptance of electronically | |
| 449 | - | transmitted prescriptions during the unscheduled closing; | |
| 450 | - | (2) Adjust such pharmacy's telephone system to prevent the | |
| 451 | - | acceptance of orally transmitted prescriptions during the unscheduled Substitute Senate Bill No. 1102 | |
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| 337 | + | return all unused drugs to the pharmacy premises by the close of 266 | |
| 338 | + | business each day; (4) while operating such mobile pharmacy, store all 267 | |
| 339 | + | drugs in such mobile pharmacy in a manner that (A) prevents any 268 | |
| 340 | + | drug diversion, and (B) is consistent with the storage conditions 269 | |
| 341 | + | specified by the manufacturers of such drugs; (5) establish and 270 | |
| 342 | + | maintain a patient communication plan to ensure that patients can 271 | |
| 343 | + | obtain prescription refills if such mobile pharmacy is unavailable; and 272 | |
| 344 | + | (6) if permitted by the federal Drug Enforcement Administration or a 273 | |
| 345 | + | successor agency, store controlled substances in the mobile pharmacy 274 | |
| 346 | + | in accordance with regulations adopted by the commissioner pursuant 275 | |
| 347 | + | to section 21a-262 of the general statutes. 276 | |
| 348 | + | (c) No pharmacy shall, without prior approval from the department: 277 | |
| 349 | + | (1) Operate a mobile pharmacy for more than (A) seven consecutive 278 | |
| 350 | + | days in a single location, or (B) fourteen days within a five-mile radius 279 | |
| 351 | + | of the prior mobile pharmacy location; or (2) store drugs overnight in a 280 | |
| 352 | + | mobile pharmacy or outside of the pharmacy premises. 281 | |
| 353 | + | (d) The commissioner may, with the advice and consent of the 282 | |
| 354 | + | commission, adopt regulations in accordance with chapter 54 of the 283 | |
| 355 | + | general statutes to implement the provisions of this section. 284 | |
| 356 | + | Sec. 4. (NEW) (Effective July 1, 2023) (a) For the purposes of this 285 | |
| 357 | + | section, "pharmacy district manager" means an individual who (1) 286 | |
| 358 | + | supervises at least three pharmacies within this state, and (2) is 287 | |
| 359 | + | responsible for the activities within such pharmacies, including, but 288 | |
| 360 | + | not limited to, staffing, payroll and hiring. 289 | |
| 361 | + | (b) Each pharmacy shall maintain a plan to manage unscheduled 290 | |
| 362 | + | closings. Such plan shall be reviewed and updated, if necessary, on an 291 | |
| 363 | + | annual basis, and be provided to, and reviewed with, all pharmacy 292 | |
| 364 | + | personnel on an annual basis. Such plan shall include: 293 | |
| 365 | + | (1) The name of the individual who is responsible for notifying the 294 | |
| 366 | + | Commission of Pharmacy of an unscheduled closing; 295 | |
| 367 | + | (2) The name of the individual who is responsible for updating the 296 Substitute Bill No. 1102 | |
| 454 | 368 | ||
| 455 | - | closing; | |
| 456 | - | (3) Provide a telephone system message alert to patients notifying | |
| 457 | - | patients that (A) such pharmacy is not open, and (B) patients may obtain | |
| 458 | - | medications from a nearby pharmacy; | |
| 459 | - | (4) Post signage at the entrance to such pharmacy, and at each | |
| 460 | - | entrance of the structure if such pharmacy is located within another | |
| 461 | - | structure, (A) stating that such pharmacy is closed, (B) disclosing the | |
| 462 | - | duration of the unscheduled closing, and (C) providing (i) a list of all | |
| 463 | - | pharmacies that are located within a two-mile radius of such pharmacy, | |
| 464 | - | or (ii) the next closest pharmacy if there is no pharmacy within such | |
| 465 | - | two-mile radius; and | |
| 466 | - | (5) Upon request by another pharmacy to transfer a prescription to | |
| 467 | - | such other pharmacy, transfer any prescription dispensed by the | |
| 468 | - | pharmacy experiencing the unscheduled closing and reverse any third- | |
| 469 | - | party payor claims associated with such prescription. | |
| 470 | - | (d) Any pharmacy that verifies that another phar macy is | |
| 471 | - | experiencing an unscheduled closing may, upon a patient's request, | |
| 472 | - | dispense a prescription that is dispensed and waiting at the pharmacy | |
| 473 | - | experiencing the unscheduled closing by using information obtained | |
| 474 | - | from the closed pharmacy, the electronic prescription drug monitoring | |
| 475 | - | program or another source that the pharmacist dispensing such | |
| 476 | - | prescription believes provides a reasonable assurance of accurate | |
| 477 | - | information necessary to dispense such prescription. In the event that a | |
| 478 | - | pharmacy dispenses a prescription during an unscheduled closing of | |
| 479 | - | another pharmacy: | |
| 480 | - | (1) The pharmacy dispensing such prescription shall contact the | |
| 481 | - | pharmacy experiencing the unscheduled closing not later than twenty- | |
| 482 | - | four hours after such closed pharmacy reopens to transfer such | |
| 483 | - | prescription, in accordance with section 20-616 of the general statutes; Substitute Senate Bill No. 1102 | |
| 484 | 369 | ||
| 485 | - | Public Act No. 23-19 16 of 35 | |
| 370 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 371 | + | SB.docx } | |
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| 486 | 373 | ||
| 487 | - | (2) The pharmacy that experienced the unscheduled closing shall | |
| 488 | - | provide to the pharmacy that dispensed such prescription during such | |
| 489 | - | unscheduled closing all information necessary for the transfer of such | |
| 490 | - | prescription; and | |
| 491 | - | (3) The pharmacy that experienced the unscheduled closing shall | |
| 492 | - | reverse any third-party payor claims associated with such transferred | |
| 493 | - | prescription not later than twenty-four hours after such pharmacy | |
| 494 | - | reopens. | |
| 495 | - | (e) The Department of Consumer Protection shall adopt regulations, | |
| 496 | - | in accordance with chapter 54 of the general statutes, to implement the | |
| 497 | - | provisions of this section. Such regulations shall include, but need not | |
| 498 | - | be limited to, provisions for the placement of a secured container at a | |
| 499 | - | pharmacy that allows patients to, during the hours in which the | |
| 500 | - | pharmacy may be open or closed, obtain prescriptions that were | |
| 501 | - | dispensed by such pharmacy. Prior to the effective date of such | |
| 502 | - | regulations, the department may temporarily permit the use and | |
| 503 | - | placement of a secured container at a pharmacy, provided the pharmacy | |
| 504 | - | submits to the department, for the department's approval, written | |
| 505 | - | protocols prior to placing, providing access to or using the secured | |
| 506 | - | container and such pharmacy receives written approval from the | |
| 507 | - | department for such placement, access or use. To obtain temporary | |
| 508 | - | approval under this subsection, a secure container shall: | |
| 509 | - | (1) Weigh more than seven hundred fifty pounds or be affixed to the | |
| 510 | - | physical structure of the building where the pharmacy is located, and | |
| 511 | - | be located immediately adjacent to the portion of such building where | |
| 512 | - | such pharmacy is located; | |
| 513 | - | (2) Only permit access to authorized pharmacy personnel or | |
| 514 | - | individuals retrieving the prescriptions with a unique identification | |
| 515 | - | system; Substitute Senate Bill No. 1102 | |
| 374 | + | hours of operation in the pharmacy's electronic record system to 297 | |
| 375 | + | prevent acceptance of electronically transmitted prescriptions during 298 | |
| 376 | + | an unscheduled closing; 299 | |
| 377 | + | (3) The name of the individual who is responsible for updating the 300 | |
| 378 | + | pharmacy's telephone system during an unscheduled closing to (A) 301 | |
| 379 | + | prevent the acceptance of orally transmitted prescriptions during the 302 | |
| 380 | + | unscheduled closing, and (B) provide a message that alerts patients 303 | |
| 381 | + | that such pharmacy will be closed and their prescriptions may be 304 | |
| 382 | + | obtained from a nearby pharmacy; 305 | |
| 383 | + | (4) A list of all pharmacies that are located within a two-mile radius 306 | |
| 384 | + | of the pharmacy that is experiencing an unscheduled closing, or the 307 | |
| 385 | + | next closest pharmacy if there is no pharmacy within such two-mile 308 | |
| 386 | + | radius; and 309 | |
| 387 | + | (5) The name of the individual who is responsible for posting, at the 310 | |
| 388 | + | entrance to such pharmacy and at each entrance of the structure if such 311 | |
| 389 | + | pharmacy is located within another structure, signage stating the 312 | |
| 390 | + | duration of an unscheduled closing. 313 | |
| 391 | + | (c) If a pharmacy experiences an unscheduled closing, the 314 | |
| 392 | + | pharmacist manager of the pharmacy or, if the pharmacy operates 315 | |
| 393 | + | more than five pharmacy locations in this state, the pharmacy district 316 | |
| 394 | + | manager shall: 317 | |
| 395 | + | (1) Modify such pharmacy's hours of operation in such pharmacy's 318 | |
| 396 | + | electronic record system to prevent the acceptance of electronically 319 | |
| 397 | + | transmitted prescriptions during the unscheduled closing; 320 | |
| 398 | + | (2) Adjust such pharmacy's telephone system to prevent the 321 | |
| 399 | + | acceptance of orally transmitted prescriptions during the unscheduled 322 | |
| 400 | + | closing; 323 | |
| 401 | + | (3) Provide a telephone system message alert to patients notifying 324 | |
| 402 | + | patients that (A) such pharmacy is not open, and (B) patients may 325 | |
| 403 | + | obtain medications from a nearby pharmacy; 326 Substitute Bill No. 1102 | |
| 516 | 404 | ||
| 517 | - | Public Act No. 23-19 17 of 35 | |
| 518 | 405 | ||
| 519 | - | (3) Be under video surveillance at all times; | |
| 520 | - | (4) Be capable of maintaining a record of all products that are placed | |
| 521 | - | inside of the secure container, and the date and time each individual | |
| 522 | - | prescription is accessed; and | |
| 523 | - | (5) Comply with any other protocol required by the department to | |
| 524 | - | ensure patient confidentiality, ensure public health and safety and | |
| 525 | - | prevent diversion. | |
| 526 | - | Sec. 5. Section 20-633 of the general statutes is repealed and the | |
| 527 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 528 | - | (a) (1) Any person licensed as a pharmacist under part II of this | |
| 529 | - | chapter may [(1)] administer: [, to an adult, any] | |
| 530 | - | (A) Any vaccine, approved or authorized by the United States Food | |
| 531 | - | and Drug Administration that is listed on the National Centers for | |
| 532 | - | Disease Control and Prevention's Adult Immunization Schedule, [and | |
| 533 | - | (2) on and after July 1, 2022, administer to any person between the ages | |
| 534 | - | of twelve and seventeen, with the consent of such person's parent or | |
| 535 | - | guardian, the influenza vaccine approved by the United States Food and | |
| 536 | - | Drug Administration, provided the administration of any vaccine under | |
| 537 | - | this subsection is conducted pursuant to the order of a licensed health | |
| 538 | - | care provider and in accordance with the regulations established | |
| 539 | - | pursuant to subsection (b) of this section.] to any patient who is: (i) | |
| 540 | - | Eighteen years of age or older; or (ii) at least twelve years of age but | |
| 541 | - | younger than eighteen years of age with (I) the consent of such patient's | |
| 542 | - | parent, legal guardian or other person having legal custody of such | |
| 543 | - | patient, or (II) proof that such patient is an emancipated minor. | |
| 544 | - | (B) Any vaccine not included on the National Centers for Disease | |
| 545 | - | Control and Prevention's Adult Immunization Schedule, provided the | |
| 546 | - | vaccine administration instructions for such vaccine are available on the | |
| 547 | - | National Centers for Disease Control and Prevention's Internet web site; Substitute Senate Bill No. 1102 | |
| 406 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 407 | + | SB.docx } | |
| 408 | + | 12 of 29 | |
| 548 | 409 | ||
| 549 | - | Public Act No. 23-19 18 of 35 | |
| 410 | + | (4) Post signage at the entrance to such pharmacy, and at each 327 | |
| 411 | + | entrance of the structure if such pharmacy is located within another 328 | |
| 412 | + | structure, (A) stating that such pharmacy is closed, (B) disclosing the 329 | |
| 413 | + | duration of the unscheduled closing, and (C) providing (i) a list of all 330 | |
| 414 | + | pharmacies that are located within a two-mile radius of such 331 | |
| 415 | + | pharmacy, or (ii) the next closest pharmacy if there is no pharmacy 332 | |
| 416 | + | within such two-mile radius; and 333 | |
| 417 | + | (5) Upon request by another pharmacy to transfer a prescription to 334 | |
| 418 | + | such other pharmacy, transfer any prescription dispensed by the 335 | |
| 419 | + | pharmacy experiencing the unscheduled closing and reverse any third-336 | |
| 420 | + | party payor claims associated with such prescription. 337 | |
| 421 | + | (d) Any pharmacy that verifies that another pharmacy is 338 | |
| 422 | + | experiencing an unscheduled closing may, upon a patient's request, 339 | |
| 423 | + | dispense a prescription that is dispensed and waiting at the pharmacy 340 | |
| 424 | + | experiencing the unscheduled closing by using information obtained 341 | |
| 425 | + | from the closed pharmacy, the electronic prescription drug monitoring 342 | |
| 426 | + | program or another source that the pharmacist dispensing such 343 | |
| 427 | + | prescription believes provides a reasonable assurance of accurate 344 | |
| 428 | + | information necessary to dispense such prescription. In the event that a 345 | |
| 429 | + | pharmacy dispenses a prescription during an unscheduled closing of 346 | |
| 430 | + | another pharmacy: 347 | |
| 431 | + | (1) The pharmacy dispensing such prescription shall contact the 348 | |
| 432 | + | pharmacy experiencing the unscheduled closing not later than twenty-349 | |
| 433 | + | four hours after such closed pharmacy reopens to transfer such 350 | |
| 434 | + | prescription, in accordance with section 20-616 of the general statutes; 351 | |
| 435 | + | (2) The pharmacy that experienced the unscheduled closing shall 352 | |
| 436 | + | provide to the pharmacy that dispensed such prescription during such 353 | |
| 437 | + | unscheduled closing all information necessary for the transfer of such 354 | |
| 438 | + | prescription; and 355 | |
| 439 | + | (3) The pharmacy that experienced the unscheduled closing shall 356 | |
| 440 | + | reverse any third-party payor claims associated with such transferred 357 Substitute Bill No. 1102 | |
| 550 | 441 | ||
| 551 | - | and | |
| 552 | - | (C) Any vaccine pursuant to a verbal or written prescription of a | |
| 553 | - | prescribing practitioner for a specific patient. | |
| 554 | - | (2) A pharmacist shall make a reasonable effort to review a patient's | |
| 555 | - | vaccination history to prevent any inappropriate use of a requested | |
| 556 | - | vaccine. | |
| 557 | - | (3) All vaccines administered pursuant to this section shall be | |
| 558 | - | administered in accordance with the: (A) Vaccine manufacturer's | |
| 559 | - | package insert or the orders of a prescribing practitioner; and (B) | |
| 560 | - | regulations adopted pursuant to subsection (d) of this section. | |
| 561 | - | (b) A pharmacist who has completed the training required in | |
| 562 | - | regulations adopted pursuant to subsection (d) of this section may | |
| 563 | - | administer an epinephrine cartridge injector, as defined in section 19a- | |
| 564 | - | 909, to a patient whom the pharmacist reasonably believes, based on | |
| 565 | - | such pharmacist's knowledge and training, is experiencing anaphylaxis, | |
| 566 | - | regardless of whether such patient has a prescription for an epinephrine | |
| 567 | - | cartridge injector. Such pharmacist, or such pharmacist's designee, shall | |
| 568 | - | call the 9-1-1 emergency telephone number either before or immediately | |
| 569 | - | after such pharmacist administers the epinephrine cartridge injector to | |
| 570 | - | such patient. Such pharmacist shall document the date, time and | |
| 571 | - | circumstances in which such pharmacist administered such epinephrine | |
| 572 | - | cartridge injector, and maintain such documentation for at least three | |
| 573 | - | years. | |
| 574 | - | (c) (1) A certified and registered pharmacy technician may administer | |
| 575 | - | a vaccine to a patient at a pharmacy if: (A) The managing pharmacist of | |
| 576 | - | such pharmacy is authorized to administer vaccines under this section; | |
| 577 | - | and (B) such pharmacy technician (i) has successfully completed a | |
| 578 | - | course of hands-on training, certified by the American Council for | |
| 579 | - | Pharmacy Education, concerning the administration of vaccines, (ii) has Substitute Senate Bill No. 1102 | |
| 580 | 442 | ||
| 581 | - | Public Act No. 23-19 19 of 35 | |
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| 444 | + | SB.docx } | |
| 445 | + | 13 of 29 | |
| 582 | 446 | ||
| 583 | - | been trained at such pharmacy regarding the process for administering | |
| 584 | - | vaccines to patients at such pharmacy, (iii) successfully completes at | |
| 585 | - | least one hour of annual continuing education concerning | |
| 586 | - | immunization, (iv) has been evaluated by the managing pharmacist of | |
| 587 | - | such pharmacy, and (v) administers such vaccine at the direction of the | |
| 588 | - | pharmacist on duty at such pharmacy. | |
| 589 | - | (2) During the period beginning on September first and ending on | |
| 590 | - | March thirty-first of the succeeding calendar year, a certified and | |
| 591 | - | registered pharmacy technician shall not count toward the pharmacist- | |
| 592 | - | to-technician ratio set forth in section 20-576-33 of the regulations of | |
| 593 | - | Connecticut state agencies if such pharmacy technician: (A) Is | |
| 594 | - | authorized to administer vaccines under this section; and (B) exclusively | |
| 595 | - | performs duties related to the administration of vaccines during such | |
| 596 | - | period. | |
| 597 | - | [(b)] (d) The Commissioner of Consumer Protection, in consultation | |
| 598 | - | with the Commissioner of Public Health and the Commission of | |
| 599 | - | Pharmacy, shall adopt regulations, in accordance with the provisions of | |
| 600 | - | chapter 54, to implement the provisions of this section. Such regulations | |
| 601 | - | shall: (1) [require] Require any pharmacist who administers a vaccine | |
| 602 | - | pursuant to this section to successfully complete an immunization | |
| 603 | - | training program for pharmacists; (2) define the basic requirements of | |
| 604 | - | such training program, which shall include training and instruction in | |
| 605 | - | pre-administration education and screening, vaccine storage and | |
| 606 | - | handling, subcutaneous and intramuscular injections, recordkeeping, | |
| 607 | - | vaccine safety, cardiopulmonary resuscitation, basic cardiac life support | |
| 608 | - | and adverse event reporting; (3) identify qualifying training programs, | |
| 609 | - | which are accredited by the National Centers for Disease Control | |
| 610 | - | Prevention, the Accreditation Council for Pharmacy Education or | |
| 611 | - | [other] another appropriate national accrediting body; and (4) establish | |
| 612 | - | a system of control and reporting. | |
| 613 | - | [(c) For purposes of this section, "adult" means a person who has Substitute Senate Bill No. 1102 | |
| 447 | + | prescription not later than twenty-four hours after such pharmacy 358 | |
| 448 | + | reopens. 359 | |
| 449 | + | (e) The Department of Consumer Protection shall adopt regulations, 360 | |
| 450 | + | in accordance with chapter 54 of the general statutes, to implement the 361 | |
| 451 | + | provisions of this section. Such regulations shall include, but need not 362 | |
| 452 | + | be limited to, provisions for the placement of a secured container at a 363 | |
| 453 | + | pharmacy that allows patients to, during the hours in which the 364 | |
| 454 | + | pharmacy may be open or closed, obtain prescriptions that were 365 | |
| 455 | + | dispensed by such pharmacy. Prior to the effective date of such 366 | |
| 456 | + | regulations, the department may temporarily permit the use and 367 | |
| 457 | + | placement of a secured container at a pharmacy, provided the 368 | |
| 458 | + | pharmacy submits to the department, for the department's approval, 369 | |
| 459 | + | written protocols prior to placing, providing access to or using the 370 | |
| 460 | + | secured container and such pharmacy receives written approval from 371 | |
| 461 | + | the department for such placement, access or use. To obtain temporary 372 | |
| 462 | + | approval under this subsection, a secure container shall: 373 | |
| 463 | + | (1) Weigh more than seven hundred fifty pounds or be affixed to the 374 | |
| 464 | + | physical structure of the building where the pharmacy is located, and 375 | |
| 465 | + | be located immediately adjacent to the portion of such building where 376 | |
| 466 | + | such pharmacy is located; 377 | |
| 467 | + | (2) Only permit access to authorized pharmacy personnel or 378 | |
| 468 | + | individuals retrieving the prescriptions with a unique identification 379 | |
| 469 | + | system; 380 | |
| 470 | + | (3) Be under video surveillance at all times; 381 | |
| 471 | + | (4) Be capable of maintaining a record of all products that are placed 382 | |
| 472 | + | inside of the secure container, and the date and time each individual 383 | |
| 473 | + | prescription is accessed; and 384 | |
| 474 | + | (5) Comply with any other protocol required by the department to 385 | |
| 475 | + | ensure patient confidentiality, ensure public health and safety and 386 | |
| 476 | + | prevent diversion. 387 Substitute Bill No. 1102 | |
| 614 | 477 | ||
| 615 | - | Public Act No. 23-19 20 of 35 | |
| 616 | 478 | ||
| 617 | - | attained the age of eighteen years.] | |
| 618 | - | Sec. 6. Subsection (a) of section 20-576 of the general statutes is | |
| 619 | - | repealed and the following is substituted in lieu thereof (Effective July 1, | |
| 620 | - | 2023): | |
| 621 | - | (a) The commissioner may, with the advice and assistance of the | |
| 622 | - | commission, adopt regulations, in accordance with chapter 54, to | |
| 623 | - | govern the performance of the commission's duties, the practice of | |
| 624 | - | pharmacy and the business of retailing drugs and devices. Such | |
| 625 | - | regulations may include, but are not limited to, provisions (1) | |
| 626 | - | concerning the licensing of any pharmacist or pharmacy, disciplinary | |
| 627 | - | action that may be taken against a licensee, the conduct of a pharmacist | |
| 628 | - | and the operation of a pharmacy, (2) specifying various classes of | |
| 629 | - | pharmacy licenses issued under section 20-594, as amended by this act, | |
| 630 | - | including, but not limited to, licenses for infusion therapy pharmacies, | |
| 631 | - | [and] nuclear pharmacies and health care institutional pharmacies, and | |
| 632 | - | specifying requirements for operation of pharmacies under the classes | |
| 633 | - | of pharmacy licenses permitted under the regulations, (3) concerning | |
| 634 | - | creation and maintenance of prescription records, and (4) concerning | |
| 635 | - | registration and activities of pharmacy interns, registered pharmacy | |
| 636 | - | technicians and certified pharmacy technicians. | |
| 637 | - | Sec. 7. Section 20-594 of the general statutes is repealed and the | |
| 638 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 639 | - | (a) Except as limited by section 20-596, a pharmacist, health care | |
| 640 | - | institution or any other person may apply to the commission for a | |
| 641 | - | pharmacy license or for renewal of a pharmacy license. | |
| 642 | - | (b) The applicant shall disclose on the application the name and | |
| 643 | - | address of the applicant and the owner of the pharmacy, the name and | |
| 644 | - | street and mailing address of the pharmacy and the name, address and | |
| 645 | - | license number of the pharmacist who manages the pharmacy. The Substitute Senate Bill No. 1102 | |
| 479 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 480 | + | SB.docx } | |
| 481 | + | 14 of 29 | |
| 646 | 482 | ||
| 647 | - | Public Act No. 23-19 21 of 35 | |
| 483 | + | Sec. 5. Section 20-633 of the general statutes is repealed and the 388 | |
| 484 | + | following is substituted in lieu thereof (Effective July 1, 2023): 389 | |
| 485 | + | (a) (1) Any person licensed as a pharmacist under part II of this 390 | |
| 486 | + | chapter may [(1)] administer: [, to an adult, any] 391 | |
| 487 | + | (A) Any vaccine, approved or authorized by the United States Food 392 | |
| 488 | + | and Drug Administration that is listed on the National Centers for 393 | |
| 489 | + | Disease Control and Prevention's Adult Immunization Schedule, [and 394 | |
| 490 | + | (2) on and after July 1, 2022, administer to any person between the ages 395 | |
| 491 | + | of twelve and seventeen, with the consent of such person's parent or 396 | |
| 492 | + | guardian, the influenza vaccine approved by the United States Food 397 | |
| 493 | + | and Drug Administration, provided the administration of any vaccine 398 | |
| 494 | + | under this subsection is conducted pursuant to the order of a licensed 399 | |
| 495 | + | health care provider and in accordance with the regulations 400 | |
| 496 | + | established pursuant to subsection (b) of this section.] to any patient 401 | |
| 497 | + | who is: (i) Eighteen years of age or older; or (ii) at least twelve years of 402 | |
| 498 | + | age but younger than eighteen years of age with (I) the consent of such 403 | |
| 499 | + | patient's parent, legal guardian or other person having legal custody of 404 | |
| 500 | + | such patient, or (II) proof that such patient is an emancipated minor. 405 | |
| 501 | + | (B) Any vaccine not included on the National Centers for Disease 406 | |
| 502 | + | Control and Prevention's Adult Immunization Schedule, provided the 407 | |
| 503 | + | vaccine administration instructions for such vaccine are available on 408 | |
| 504 | + | the National Centers for Disease Control and Prevention's Internet web 409 | |
| 505 | + | site; and 410 | |
| 506 | + | (C) Any vaccine pursuant to a verbal or written prescription of a 411 | |
| 507 | + | prescribing practitioner for a specific patient. 412 | |
| 508 | + | (2) A pharmacist shall make a reasonable effort to review a patient's 413 | |
| 509 | + | vaccination history to prevent any inappropriate use of a requested 414 | |
| 510 | + | vaccine. 415 | |
| 511 | + | (3) All vaccines administered pursuant to this section shall be 416 | |
| 512 | + | administered in accordance with the: (A) Vaccine manufacturer's 417 | |
| 513 | + | package insert or the orders of a prescribing practitioner; and (B) 418 Substitute Bill No. 1102 | |
| 648 | 514 | ||
| 649 | - | commissioner may, by regulation adopted with the advice and | |
| 650 | - | assistance of the commission, in accordance with chapter 54, require | |
| 651 | - | such other information on the application as is necessary for the | |
| 652 | - | department to carry out [its] the department's duties under sections 20- | |
| 653 | - | 570 to 20-630, inclusive. | |
| 654 | - | (c) The department shall, after receipt of an application under this | |
| 655 | - | section, (1) issue, on authorization of the commission, a pharmacy | |
| 656 | - | license to an applicant for a new pharmacy on payment of the fee | |
| 657 | - | required in section 20-601 and on satisfactory evidence to the | |
| 658 | - | commission that the pharmacy will be managed by a pharmacist and | |
| 659 | - | will be operated in accordance with the general statutes and the | |
| 660 | - | regulations adopted by the commissioner in accordance with chapter 54, | |
| 661 | - | and (2) issue a renewal of a pharmacy license to an applicant on | |
| 662 | - | payment of the fee required in section 20-601. | |
| 663 | - | (d) Pharmacy licenses shall expire annually. Pharmacy licenses may | |
| 664 | - | be renewed on application and payment of the fee required in section | |
| 665 | - | 20-601 for a period not to exceed one year. | |
| 666 | - | (e) When a pharmacy is transferred to a new location the pharmacy | |
| 667 | - | license for such pharmacy shall terminate. A pharmacy license that has | |
| 668 | - | been terminated under this subsection may be renewed under the | |
| 669 | - | provisions of subsection (d) of this section and on satisfactory evidence | |
| 670 | - | to the commission that the pharmacy will be managed by a pharmacist | |
| 671 | - | and will be operated in accordance with the general statutes and the | |
| 672 | - | regulations adopted by the commissioner in accordance with chapter 54. | |
| 673 | - | (f) Each pharmacy licensed pursuant to this section shall report to the | |
| 674 | - | department any administrative or legal action commenced against [it] | |
| 675 | - | such pharmacy by any state or federal regulatory agency or | |
| 676 | - | accreditation entity not later than ten business days after receiving | |
| 677 | - | notice of the commencement of such action. Substitute Senate Bill No. 1102 | |
| 678 | 515 | ||
| 679 | - | Public Act No. 23-19 22 of 35 | |
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| 518 | + | 15 of 29 | |
| 680 | 519 | ||
| 681 | - | Sec. 8. Section 20-633b of the general statutes is repealed and the | |
| 682 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 683 | - | (a) As used in this section: | |
| 684 | - | (1) "Medical order" means a written, oral or electronic order by a | |
| 685 | - | prescribing practitioner [, as defined in section 20-14c,] for a drug to be | |
| 686 | - | dispensed by a pharmacy for administration to a patient; | |
| 687 | - | (2) "Prescribing practitioner" has the same meaning as provided in | |
| 688 | - | section 20-14c; | |
| 689 | - | [(2)] (3) "Sterile compounding pharmacy" means a pharmacy [, as | |
| 690 | - | defined in section 20-571, a] or nonresident pharmacy [registered | |
| 691 | - | pursuant to section 20-627,] that dispenses or compounds sterile | |
| 692 | - | pharmaceuticals; | |
| 693 | - | [(3)] (4) "Sterile pharmaceutical" means any dosage form of a drug, | |
| 694 | - | including, but not limited to, parenterals, injectables, surgical irrigants | |
| 695 | - | and ophthalmics devoid of viable microorganisms; and | |
| 696 | - | [(4)] (5) "USP chapters" means chapters 797, 800 and 825 of the United | |
| 697 | - | States Pharmacopeia that pertain to compounding sterile | |
| 698 | - | pharmaceuticals and their referenced companion documents, as | |
| 699 | - | amended from time to time. | |
| 700 | - | (b) (1) (A) If an applicant for a new pharmacy license [pursuant to] | |
| 701 | - | under section 20-594, as amended by this act, intends to compound | |
| 702 | - | sterile pharmaceuticals, the applicant shall file an addendum to [its] the | |
| 703 | - | pharmacy license application such applicant files pursuant to section 20- | |
| 704 | - | 594, as amended by this act, to include sterile pharmaceutical | |
| 705 | - | compounding. The [Department of Consumer Protection] department | |
| 706 | - | shall inspect the proposed pharmacy premises of [the] such applicant | |
| 707 | - | and [the] such applicant shall not compound sterile pharmaceuticals | |
| 708 | - | until [it] such applicant receives notice that the addendum to such Substitute Senate Bill No. 1102 | |
| 520 | + | regulations adopted pursuant to subsection (c) of this section. 419 | |
| 521 | + | (b) A pharmacist who has completed the training required in 420 | |
| 522 | + | regulations adopted pursuant to subsection (c) of this section may 421 | |
| 523 | + | administer an epinephrine cartridge injector, as defined in section 19a-422 | |
| 524 | + | 909, to a patient whom the pharmacist reasonably believes, based on 423 | |
| 525 | + | such pharmacist's knowledge and training, is experiencing 424 | |
| 526 | + | anaphylaxis, regardless of whether such patient has a prescription for 425 | |
| 527 | + | an epinephrine cartridge injector. Such pharmacist, or such 426 | |
| 528 | + | pharmacist's designee, shall call the 9-1-1 emergency telephone 427 | |
| 529 | + | number either before or immediately after suc h pharmacist 428 | |
| 530 | + | administers the epinephrine cartridge injector to such patient. Such 429 | |
| 531 | + | pharmacist shall document the date, time and circumstances in which 430 | |
| 532 | + | such pharmacist administered such epinephrine cartridge injector, and 431 | |
| 533 | + | maintain such documentation for at least three years. 432 | |
| 534 | + | [(b)] (c) The Commissioner of Consumer Protection, in consultation 433 | |
| 535 | + | with the Commissioner of Public Health and the Commission of 434 | |
| 536 | + | Pharmacy, shall adopt regulations, in accordance with the provisions 435 | |
| 537 | + | of chapter 54, to implement the provisions of this section. Such 436 | |
| 538 | + | regulations shall: (1) [require] Require any pharmacist who 437 | |
| 539 | + | administers a vaccine pursuant to this section to successfully complete 438 | |
| 540 | + | an immunization training program for pharmacists; (2) define the basic 439 | |
| 541 | + | requirements of such training program, which shall include training 440 | |
| 542 | + | and instruction in pre-administration education and screening, vaccine 441 | |
| 543 | + | storage and handling, subcutaneous and intramuscular injections, 442 | |
| 544 | + | recordkeeping, vaccine safety, cardiopulmonary resuscitation, basic 443 | |
| 545 | + | cardiac life support and adverse event reporting; (3) identify 444 | |
| 546 | + | qualifying training programs, which are accredited by the National 445 | |
| 547 | + | Centers for Disease Control Prevention, the Accreditation Council for 446 | |
| 548 | + | Pharmacy Education or [other] another appropriate national 447 | |
| 549 | + | accrediting body; and (4) establish a system of control and reporting. 448 | |
| 550 | + | [(c) For purposes of this section, "adult" means a person who has 449 | |
| 551 | + | attained the age of eighteen years.] 450 Substitute Bill No. 1102 | |
| 709 | 552 | ||
| 710 | - | Public Act No. 23-19 23 of 35 | |
| 711 | 553 | ||
| 712 | - | applicant's application has been approved by the department and the | |
| 713 | - | [Commission of Pharmacy] commission. Nothing in this section shall be | |
| 714 | - | construed to affect a licensed hospital's ability to compound sterile | |
| 715 | - | pharmaceuticals for such hospital's patients consistent with federal law. | |
| 716 | - | [(2)] (B) If an existing pharmacy licensed pursuant to section 20-594, | |
| 717 | - | as amended by this act, intends to compound sterile pharmaceuticals for | |
| 718 | - | the first time on or after July 1, 2014, such pharmacy shall [file an] apply | |
| 719 | - | for an addendum [application to its] to such pharmacy's application on | |
| 720 | - | file with the department to include sterile pharmaceutical | |
| 721 | - | compounding. The [Department of Consumer Protection] department | |
| 722 | - | shall inspect the pharmacy premises of such pharmacy and [the] such | |
| 723 | - | pharmacy shall not compound sterile pharmaceuticals until [it] such | |
| 724 | - | pharmacy receives written notice that such addendum application has | |
| 725 | - | been approved by the department and the [Commission of Pharmacy] | |
| 726 | - | commission. | |
| 727 | - | (C) If an existing health care institutional pharmacy licensed | |
| 728 | - | pursuant to section 20-594, as amended by this act, intends to compound | |
| 729 | - | sterile pharmaceuticals for the first time on or after July 1, 2023, such | |
| 730 | - | health care institutional pharmacy shall apply for an addendum to such | |
| 731 | - | health care institutional pharmacy's application on file with the | |
| 732 | - | department to include sterile pharmaceutical compounding. The | |
| 733 | - | department shall inspect the pharmacy premises of such health care | |
| 734 | - | institutional pharmacy, and such health care institutional pharmacy | |
| 735 | - | shall not compound sterile pharmaceuticals until such health care | |
| 736 | - | institutional pharmacy receives written notice that such health care | |
| 737 | - | institutional pharmacy's addendum application has been approved by | |
| 738 | - | the department and the commission. | |
| 739 | - | [(3)] (2) (A) If an applicant for a new nonresident pharmacy | |
| 740 | - | registration intends to compound sterile pharmaceuticals for sale or | |
| 741 | - | delivery in this state, the applicant shall file an addendum to [its] the | |
| 742 | - | registration application such applicant files pursuant to section 20-627 Substitute Senate Bill No. 1102 | |
| 554 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 555 | + | SB.docx } | |
| 556 | + | 16 of 29 | |
| 743 | 557 | ||
| 744 | - | Public Act No. 23-19 24 of 35 | |
| 558 | + | Sec. 6. Subsection (a) of section 20-576 of the general statutes is 451 | |
| 559 | + | repealed and the following is substituted in lieu thereof (Effective July 452 | |
| 560 | + | 1, 2023): 453 | |
| 561 | + | (a) The commissioner may, with the advice and assistance of the 454 | |
| 562 | + | commission, adopt regulations, in accordance with chapter 54, to 455 | |
| 563 | + | govern the performance of the commission's duties, the practice of 456 | |
| 564 | + | pharmacy and the business of retailing drugs and devices. Such 457 | |
| 565 | + | regulations may include, but are not limited to, provisions (1) 458 | |
| 566 | + | concerning the licensing of any pharmacist or pharmacy, disciplinary 459 | |
| 567 | + | action that may be taken against a licensee, the conduct of a 460 | |
| 568 | + | pharmacist and the operation of a pharmacy, (2) specifying various 461 | |
| 569 | + | classes of pharmacy licenses issued under section 20-594, as amended 462 | |
| 570 | + | by this act, including, but not limited to, licenses for infusion therapy 463 | |
| 571 | + | pharmacies, [and] nuclear pharmacies and health care institutional 464 | |
| 572 | + | pharmacies, and specifying requirements for operation of pharmacies 465 | |
| 573 | + | under the classes of pharmacy licenses permitted under the 466 | |
| 574 | + | regulations, (3) concerning creation and maintenance of prescription 467 | |
| 575 | + | records, and (4) concerning registration and activities of pharmacy 468 | |
| 576 | + | interns, registered pharmacy technicians and certified pharmacy 469 | |
| 577 | + | technicians. 470 | |
| 578 | + | Sec. 7. Section 20-594 of the general statutes is repealed and the 471 | |
| 579 | + | following is substituted in lieu thereof (Effective July 1, 2023): 472 | |
| 580 | + | (a) Except as limited by section 20-596, a pharmacist, health care 473 | |
| 581 | + | institution or any other person may apply to the commission for a 474 | |
| 582 | + | pharmacy license or for renewal of a pharmacy license. 475 | |
| 583 | + | (b) The applicant shall disclose on the application the name and 476 | |
| 584 | + | address of the applicant and the owner of the pharmacy, the name and 477 | |
| 585 | + | street and mailing address of the pharmacy and the name, address and 478 | |
| 586 | + | license number of the pharmacist who manages the pharmacy. The 479 | |
| 587 | + | commissioner may, by regulation adopted with the advice and 480 | |
| 588 | + | assistance of the commission, in accordance with chapter 54, require 481 | |
| 589 | + | such other information on the application as is necessary for the 482 Substitute Bill No. 1102 | |
| 745 | 590 | ||
| 746 | - | to include sterile pharmaceutical compounding. [The] Such applicant | |
| 747 | - | shall provide to the department [with] written proof [it] that such | |
| 748 | - | applicant has passed inspection by the appropriate state agency in the | |
| 749 | - | state where such [nonresident pharmacy] applicant is located. Such | |
| 750 | - | [pharmacy] applicant shall not compound sterile pharmaceuticals for | |
| 751 | - | sale or delivery in this state until [it] such applicant receives written | |
| 752 | - | notice that [the] such addendum [application] has been approved by the | |
| 753 | - | department and the [Commission of Pharmacy] commission. | |
| 754 | - | [(4)] (B) If [a] an existing nonresident pharmacy [registered pursuant | |
| 755 | - | to section 20-627] intends to compound sterile pharmaceuticals for sale | |
| 756 | - | or delivery in this state for the first time on or after July 1, 2014, [the] | |
| 757 | - | such nonresident pharmacy shall [file] apply for an addendum to [its] | |
| 758 | - | such nonresident pharmacy's application on file with the department to | |
| 759 | - | include sterile pharmaceutical compounding. [The] Such nonresident | |
| 760 | - | pharmacy shall provide to the department [with] written proof [it] that | |
| 761 | - | such nonresident pharmacy has passed inspection by the appropriate | |
| 762 | - | state agency in the state where such nonresident pharmacy is located. | |
| 763 | - | Such nonresident pharmacy shall not compound sterile | |
| 764 | - | pharmaceuticals until [it] such nonresident pharmacy receives written | |
| 765 | - | notice that [the] such addendum application has been approved by the | |
| 766 | - | department and the [Commission of Pharmacy] commission. | |
| 767 | - | (c) A sterile compounding pharmacy shall comply with the USP | |
| 768 | - | chapters. A sterile compounding pharmacy shall also comply with all | |
| 769 | - | applicable federal and state statutes and regulations. | |
| 770 | - | [(d) An institutional pharmacy within a facility licensed pursuant to | |
| 771 | - | section 19a-490 that compounds sterile pharmaceuticals shall comply | |
| 772 | - | with the USP chapters, and shall also comply with all applicable federal | |
| 773 | - | and state statutes and regulations. Such institutional pharmacy may | |
| 774 | - | request from the Commissioner of Consumer Protection an extension of | |
| 775 | - | time, not to exceed six months, to comply, for state enforcement | |
| 776 | - | purposes, with any amendments to USP chapters, for good cause Substitute Senate Bill No. 1102 | |
| 777 | 591 | ||
| 778 | - | Public Act No. 23-19 25 of 35 | |
| 592 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 593 | + | SB.docx } | |
| 594 | + | 17 of 29 | |
| 779 | 595 | ||
| 780 | - | shown. The commissioner may grant an extension for a length of time | |
| 781 | - | not to exceed six months. Nothing in this section shall prevent such | |
| 782 | - | institutional pharmacy from requesting a subsequent extension of time | |
| 783 | - | or shall prevent the commissioner from granting such extension.] | |
| 784 | - | [(e)] (d) (1) A sterile compounding pharmacy may only provide | |
| 785 | - | patient-specific sterile pharmaceuticals to patients, to practitioners of | |
| 786 | - | medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to | |
| 787 | - | an acute care or long-term care hospital or health care facility licensed | |
| 788 | - | by the Department of Public Health. | |
| 789 | - | (2) If a sterile compounding pharmacy provides sterile | |
| 790 | - | pharmaceuticals without a patient-specific prescription or medical | |
| 791 | - | order, the sterile compounding pharmacy shall also obtain a certificate | |
| 792 | - | of registration from the Department of Consumer Protection pursuant | |
| 793 | - | to section 21a-70, as amended by this act, and any required federal | |
| 794 | - | license or registration. A sterile compounding pharmacy may prepare | |
| 795 | - | and maintain on-site inventory of sterile pharmaceuticals no greater | |
| 796 | - | than a thirty-day supply, calculated from the completion of | |
| 797 | - | compounding, which thirty-day period shall include the period | |
| 798 | - | required for third-party analytical testing, to be performed in | |
| 799 | - | accordance with the USP chapters. | |
| 800 | - | [(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any | |
| 801 | - | area utilized for the compounding of sterile pharmaceuticals or adjacent | |
| 802 | - | space, relocate any space utilized for the compounding of sterile | |
| 803 | - | pharmaceuticals or upgrade or conduct a nonemergency repair to the | |
| 804 | - | heating, ventilation, air conditioning or primary or secondary | |
| 805 | - | engineering controls for any space utilized for the compounding of | |
| 806 | - | sterile pharmaceuticals, the sterile compounding pharmacy shall notify | |
| 807 | - | the Department of Consumer Protection, in writing, not later than forty- | |
| 808 | - | five days prior to commencing such remodel, relocation, upgrade or | |
| 809 | - | repair. Such written notification shall include a plan for such remodel, | |
| 810 | - | relocation, upgrade or repair and such plan shall be subject to Substitute Senate Bill No. 1102 | |
| 596 | + | department to carry out [its] the department's duties under sections 20-483 | |
| 597 | + | 570 to 20-630, inclusive. 484 | |
| 598 | + | (c) The department shall, after receipt of an application under this 485 | |
| 599 | + | section, (1) issue, on authorization of the commission, a pharmacy 486 | |
| 600 | + | license to an applicant for a new pharmacy on payment of the fee 487 | |
| 601 | + | required in section 20-601 and on satisfactory evidence to the 488 | |
| 602 | + | commission that the pharmacy will be managed by a pharmacist and 489 | |
| 603 | + | will be operated in accordance with the general statutes and the 490 | |
| 604 | + | regulations adopted by the commissioner in accordance with chapter 491 | |
| 605 | + | 54, and (2) issue a renewal of a pharmacy license to an applicant on 492 | |
| 606 | + | payment of the fee required in section 20-601. 493 | |
| 607 | + | (d) Pharmacy licenses shall expire annually. Pharmacy licenses may 494 | |
| 608 | + | be renewed on application and payment of the fee required in section 495 | |
| 609 | + | 20-601 for a period not to exceed one year. 496 | |
| 610 | + | (e) When a pharmacy is transferred to a new location the pharmacy 497 | |
| 611 | + | license for such pharmacy shall terminate. A pharmacy license that has 498 | |
| 612 | + | been terminated under this subsection may be renewed under the 499 | |
| 613 | + | provisions of subsection (d) of this section and on satisfactory evidence 500 | |
| 614 | + | to the commission that the pharmacy will be managed by a pharmacist 501 | |
| 615 | + | and will be operated in accordance with the general statutes and the 502 | |
| 616 | + | regulations adopted by the commissioner in accordance with chapter 503 | |
| 617 | + | 54. 504 | |
| 618 | + | (f) Each pharmacy licensed pursuant to this section shall report to 505 | |
| 619 | + | the department any administrative or legal action commenced against 506 | |
| 620 | + | [it] such pharmacy by any state or federal regulatory agency or 507 | |
| 621 | + | accreditation entity not later than ten business days after receiving 508 | |
| 622 | + | notice of the commencement of such action. 509 | |
| 623 | + | Sec. 8. Section 20-633b of the general statutes is repealed and the 510 | |
| 624 | + | following is substituted in lieu thereof (Effective July 1, 2023): 511 | |
| 625 | + | (a) As used in this section: 512 Substitute Bill No. 1102 | |
| 811 | 626 | ||
| 812 | - | Public Act No. 23-19 26 of 35 | |
| 813 | 627 | ||
| 814 | - | department review and approval. If a sterile compounding pharmacy | |
| 815 | - | makes an emergency repair, the sterile compounding pharmacy shall | |
| 816 | - | notify the department of such emergency repair, in writing, not later | |
| 817 | - | than twenty-four hours after such repair is commenced. | |
| 818 | - | (2) If the USP chapters require sterile recertification after such | |
| 819 | - | remodel, relocation, upgrade or repair, the sterile compounding | |
| 820 | - | pharmacy shall provide a copy of [its] such sterile compounding | |
| 821 | - | pharmacy's sterile recertification to the Department of Consumer | |
| 822 | - | Protection not later than five days after the sterile recertification | |
| 823 | - | approval. The recertification shall only be performed by an independent | |
| 824 | - | licensed environmental monitoring entity. | |
| 825 | - | [(g)] (f) A sterile compounding pharmacy shall report, in writing, to | |
| 826 | - | the Department of Consumer Protection any known violation or | |
| 827 | - | noncompliance with viable and nonviable environmental sampling | |
| 828 | - | testing, as defined in the USP chapters, not later than the end of the next | |
| 829 | - | business day after discovering such violation or noncompliance. | |
| 830 | - | [(h)] (g) (1) If a sterile compounding pharmacy initiates a recall of | |
| 831 | - | sterile pharmaceuticals that were dispensed pursuant to a patient- | |
| 832 | - | specific prescription or medical order, the sterile compounding | |
| 833 | - | pharmacy shall notify each patient or patient care giver, the prescribing | |
| 834 | - | practitioner and the Department of Consumer Protection of such recall | |
| 835 | - | not later than twenty-four hours after such recall was initiated. | |
| 836 | - | (2) If a sterile compounding pharmacy initiates a recall of sterile | |
| 837 | - | pharmaceuticals that were not dispensed pursuant to a patient-specific | |
| 838 | - | prescription or a medical order, the sterile compounding pharmacy | |
| 839 | - | shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the | |
| 840 | - | extent such sterile compounding pharmacy possesses contact | |
| 841 | - | information for each such purchaser, (B) the Department of Consumer | |
| 842 | - | Protection, and (C) the federal Food and Drug Administration of such | |
| 843 | - | recall not later than the end of the next business day after such recall Substitute Senate Bill No. 1102 | |
| 628 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 629 | + | SB.docx } | |
| 630 | + | 18 of 29 | |
| 844 | 631 | ||
| 845 | - | Public Act No. 23-19 27 of 35 | |
| 632 | + | (1) "Medical order" means a written, oral or electronic order by a 513 | |
| 633 | + | prescribing practitioner [, as defined in section 20-14c,] for a drug to be 514 | |
| 634 | + | dispensed by a pharmacy for administration to a patient; 515 | |
| 635 | + | (2) "Prescribing practitioner" has the same meaning as provided in 516 | |
| 636 | + | section 20-14c; 517 | |
| 637 | + | [(2)] (3) "Sterile compounding pharmacy" means a pharmacy [, as 518 | |
| 638 | + | defined in section 20-571, a] or nonresident pharmacy [registered 519 | |
| 639 | + | pursuant to section 20-627,] that dispenses or compounds sterile 520 | |
| 640 | + | pharmaceuticals; 521 | |
| 641 | + | [(3)] (4) "Sterile pharmaceutical" means any dosage form of a drug, 522 | |
| 642 | + | including, but not limited to, parenterals, injectables, surgical irrigants 523 | |
| 643 | + | and ophthalmics devoid of viable microorganisms; and 524 | |
| 644 | + | [(4)] (5) "USP chapters" means chapters 797, 800 and 825 of the 525 | |
| 645 | + | United States Pharmacopeia that pertain to compounding sterile 526 | |
| 646 | + | pharmaceuticals and their referenced companion documents, as 527 | |
| 647 | + | amended from time to time. 528 | |
| 648 | + | (b) (1) (A) If an applicant for a new pharmacy license [pursuant to] 529 | |
| 649 | + | under section 20-594, as amended by this act, intends to compound 530 | |
| 650 | + | sterile pharmaceuticals, the applicant shall file an addendum to [its] 531 | |
| 651 | + | the pharmacy license application such applicant files pursuant to 532 | |
| 652 | + | section 20-594, as amended by this act, to include sterile 533 | |
| 653 | + | pharmaceutical compounding. The [Department of Consumer 534 | |
| 654 | + | Protection] department shall inspect the proposed pharmacy premises 535 | |
| 655 | + | of [the] such applicant and [the] such applicant shall not compound 536 | |
| 656 | + | sterile pharmaceuticals until [it] such applicant receives notice that the 537 | |
| 657 | + | addendum to such applicant's application has been approved by the 538 | |
| 658 | + | department and the [Commission of Pharmacy] commission. Nothing 539 | |
| 659 | + | in this section shall be construed to affect a licensed hospital's ability to 540 | |
| 660 | + | compound sterile pharmaceuticals for such hospital's patients 541 | |
| 661 | + | consistent with federal law. 542 | |
| 662 | + | [(2)] (B) If an existing pharmacy licensed pursuant to section 20-594, 543 Substitute Bill No. 1102 | |
| 846 | 663 | ||
| 847 | - | was initiated. | |
| 848 | - | [(i)] (h) Each sterile compounding pharmacy [and each institutional | |
| 849 | - | pharmacy within a facility licensed pursuant to section 19a-490] shall | |
| 850 | - | prepare and maintain a policy and procedure manual. The policy and | |
| 851 | - | procedure manual shall comply with the USP chapters. | |
| 852 | - | [(j)] (i) Each sterile compounding pharmacy shall report to the | |
| 853 | - | Department of Consumer Protection any administrative or legal action | |
| 854 | - | commenced against [it] such sterile compounding pharmacy by any | |
| 855 | - | state or federal regulatory agency or accreditation entity not later than | |
| 856 | - | five business days after receiving notice of the commencement of such | |
| 857 | - | action. | |
| 858 | - | [(k)] (j) Notwithstanding the provisions of [subdivisions (3) and (4)] | |
| 859 | - | subdivision (2) of subsection (b) of this section, a sterile compounding | |
| 860 | - | pharmacy that is a nonresident pharmacy shall provide to the | |
| 861 | - | Department of Consumer Protection proof that [it] such nonresident | |
| 862 | - | pharmacy has passed an inspection in such nonresident pharmacy's | |
| 863 | - | home state, based on the USP chapters. Such nonresident pharmacy | |
| 864 | - | shall submit to the Department of Consumer Protection a copy of the | |
| 865 | - | most recent inspection report with [its] such nonresident pharmacy's | |
| 866 | - | initial nonresident pharmacy application and shall submit to the | |
| 867 | - | department a copy of [its] such nonresident pharmacy's most recent | |
| 868 | - | inspection report every two years thereafter. If the state in which [the] | |
| 869 | - | such nonresident pharmacy is located does not conduct inspections | |
| 870 | - | based on standards required in the USP chapters, such nonresident | |
| 871 | - | pharmacy shall provide satisfactory proof to the department that [it] | |
| 872 | - | such nonresident pharmacy is in compliance with the standards | |
| 873 | - | required in the USP chapters. | |
| 874 | - | [(l)] (k) A practitioner, as specified in subdivision (1) of subsection | |
| 875 | - | [(e)] (d) of this section, a hospital or a health care facility that receives | |
| 876 | - | sterile pharmaceuticals shall report any errors related to such Substitute Senate Bill No. 1102 | |
| 877 | 664 | ||
| 878 | - | Public Act No. 23-19 28 of 35 | |
| 665 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 666 | + | SB.docx } | |
| 667 | + | 19 of 29 | |
| 879 | 668 | ||
| 880 | - | dispensing or any suspected adulterated sterile pharmaceuticals to the | |
| 881 | - | Department of Consumer Protection. | |
| 882 | - | [(m)] (l) (1) For purposes of this subsection, a "designated pharmacist" | |
| 883 | - | means a pharmacist responsible for overseeing the compounding of | |
| 884 | - | sterile pharmaceuticals and the application of the USP chapters, as said | |
| 885 | - | chapters pertain to sterile compounding. | |
| 886 | - | (2) Any pharmacy licensed pursuant to section 20-594, as amended | |
| 887 | - | by this act, [or institutional pharmacy licensed pursuant to section 19a- | |
| 888 | - | 490] that provides sterile pharmaceuticals shall notify the department of | |
| 889 | - | [its] such pharmacy's designated pharmacist. | |
| 890 | - | (3) The designated pharmacist shall be responsible for providing | |
| 891 | - | proof [he or she] such designated pharmacist has completed a program | |
| 892 | - | approved by the commissioner that demonstrates the competence | |
| 893 | - | necessary for the compounding of sterile pharmaceuticals, in | |
| 894 | - | compliance with all applicable federal and state statutes and | |
| 895 | - | regulations. | |
| 896 | - | (4) The designated pharmacist shall immediately notify the | |
| 897 | - | department whenever [he or she] such designated pharmacist ceases | |
| 898 | - | such designation. | |
| 899 | - | (5) Nothing in this section shall prevent a designated pharmacist | |
| 900 | - | from being the pharmacy manager. | |
| 901 | - | [(n)] (m) The Commissioner of Consumer Protection may adopt | |
| 902 | - | regulations, in accordance with chapter 54, to implement the provisions | |
| 903 | - | of this section. | |
| 904 | - | Sec. 9. Subsections (a) and (b) of section 21a-65 of the general statutes | |
| 905 | - | are repealed and the following is substituted in lieu thereof (Effective July | |
| 906 | - | 1, 2023): Substitute Senate Bill No. 1102 | |
| 669 | + | as amended by this act, intends to compound sterile pharmaceuticals 544 | |
| 670 | + | for the first time on or after July 1, 2014, such pharmacy shall [file an] 545 | |
| 671 | + | apply for an addendum [application to its] to such pharmacy's 546 | |
| 672 | + | application on file with the department to include sterile 547 | |
| 673 | + | pharmaceutical compounding. The [Department of Consumer 548 | |
| 674 | + | Protection] department shall inspect the pharmacy premises of such 549 | |
| 675 | + | pharmacy and [the] such pharmacy shall not compound sterile 550 | |
| 676 | + | pharmaceuticals until [it] such pharmacy receives written notice that 551 | |
| 677 | + | such addendum application has been approved by the department and 552 | |
| 678 | + | the [Commission of Pharmacy] commission. 553 | |
| 679 | + | (C) If an existing health care institutional pharmacy licensed 554 | |
| 680 | + | pursuant to section 20-594, as amended by this act, intends to 555 | |
| 681 | + | compound sterile pharmaceuticals for the first time on or after July 1, 556 | |
| 682 | + | 2023, such health care institutional pharmacy shall apply for an 557 | |
| 683 | + | addendum to such health care institutional pharmacy's application on 558 | |
| 684 | + | file with the department to include sterile pharmaceutical 559 | |
| 685 | + | compounding. The department shall inspect the pharmacy premises of 560 | |
| 686 | + | such health care institutional pharmacy, and such health care 561 | |
| 687 | + | institutional pharmacy shall not compound sterile pharmaceuticals 562 | |
| 688 | + | until such health care institutional pharmacy receives written notice 563 | |
| 689 | + | that such health care institutional pharmacy's addendum application 564 | |
| 690 | + | has been approved by the department and the commission. 565 | |
| 691 | + | [(3)] (2) (A) If an applicant for a new nonresident pharmacy 566 | |
| 692 | + | registration intends to compound sterile pharmaceuticals for sale or 567 | |
| 693 | + | delivery in this state, the applicant shall file an addendum to [its] the 568 | |
| 694 | + | registration application such applicant files pursuant to section 20-627 569 | |
| 695 | + | to include sterile pharmaceutical compounding. [The] Such applicant 570 | |
| 696 | + | shall provide to the department [with] written proof [it] that such 571 | |
| 697 | + | applicant has passed inspection by the appropriate state agency in the 572 | |
| 698 | + | state where such [nonresident pharmacy] applicant is located. Such 573 | |
| 699 | + | [pharmacy] applicant shall not compound sterile pharmaceuticals for 574 | |
| 700 | + | sale or delivery in this state until [it] such applicant receives written 575 | |
| 701 | + | notice that [the] such addendum [application] has been approved by 576 Substitute Bill No. 1102 | |
| 907 | 702 | ||
| 908 | - | Public Act No. 23-19 29 of 35 | |
| 909 | 703 | ||
| 910 | - | (a) A licensed manufacturer or licensed wholesaler may sell | |
| 911 | - | hypodermic needles and syringes only to the following: (1) To a licensed | |
| 912 | - | manufacturer, licensed wholesaler or licensed pharmacy; (2) to a | |
| 913 | - | physician, dentist, veterinarian, embalmer, podiatrist or scientific | |
| 914 | - | investigator licensed to practice in this state; (3) to a person in charge of | |
| 915 | - | a care-giving institution, as defined in [subdivision (3) of] section 20-571, | |
| 916 | - | as amended by this act, incorporated college or scientific institution, but | |
| 917 | - | only for use by or in such care-giving institution, college or institution | |
| 918 | - | for medical or scientific purposes; (4) to a person in charge of a licensed | |
| 919 | - | or registered laboratory, but only for use in that laboratory for scientific | |
| 920 | - | and medical purposes; (5) to a farmer but only for use on the farmer's | |
| 921 | - | own animals or poultry; (6) to a business authorized in accordance with | |
| 922 | - | the regulations adopted under section 21a-66 to purchase hypodermic | |
| 923 | - | needles and syringes but only for legitimate industrial or medical use | |
| 924 | - | within that business; and (7) to a syringe services program established | |
| 925 | - | pursuant to section 19a-124. | |
| 926 | - | (b) Except as provided in subsection (a) of this section, no licensed | |
| 927 | - | manufacturer, licensed wholesaler or licensed pharmacist shall sell and | |
| 928 | - | no person shall buy a hypodermic needle or syringe except upon a | |
| 929 | - | prescription of a prescribing practitioner, as defined in [subdivision (28) | |
| 930 | - | of] section 20-571, as amended by this act, in a quantity greater than ten. | |
| 931 | - | Any such prescription shall be retained on file by the seller for a period | |
| 932 | - | of not less than three years and shall be accessible to any public officer | |
| 933 | - | engaged in the enforcement of this section. Such a prescription shall be | |
| 934 | - | valid for one year from the date thereof and purchases and sales may be | |
| 935 | - | made thereunder during such period, provided the seller shall confirm | |
| 936 | - | the continued need for such sales with such practitioner at least every | |
| 937 | - | six months if sales continue to be made thereunder. Hypodermic | |
| 938 | - | needles and syringes in a quantity of ten or less without a prescription | |
| 939 | - | may be provided or sold at retail only by the following: (1) By a | |
| 940 | - | pharmacy licensed in accordance with section 20-594, as amended by | |
| 941 | - | this act, and in such pharmacy only by a licensed pharmacist or under Substitute Senate Bill No. 1102 | |
| 704 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 705 | + | SB.docx } | |
| 706 | + | 20 of 29 | |
| 942 | 707 | ||
| 943 | - | Public Act No. 23-19 30 of 35 | |
| 708 | + | the department and the [Commission of Pharmacy] commission. 577 | |
| 709 | + | [(4)] (B) If [a] an existing nonresident pharmacy [registered 578 | |
| 710 | + | pursuant to section 20-627] intends to compound sterile 579 | |
| 711 | + | pharmaceuticals for sale or delivery in this state for the first time on or 580 | |
| 712 | + | after July 1, 2014, [the] such nonresident pharmacy shall [file] apply for 581 | |
| 713 | + | an addendum to [its] such nonresident pharmacy's application on file 582 | |
| 714 | + | with the department to include sterile pharmaceutical compounding. 583 | |
| 715 | + | [The] Such nonresident pharmacy shall provide to the department 584 | |
| 716 | + | [with] written proof [it] that such nonresident pharmacy has passed 585 | |
| 717 | + | inspection by the appropriate state agency in the state where such 586 | |
| 718 | + | nonresident pharmacy is located. Such nonresident pharmacy shall not 587 | |
| 719 | + | compound sterile pharmaceuticals until [it] such nonresident 588 | |
| 720 | + | pharmacy receives written notice that [the] such addendum 589 | |
| 721 | + | application has been approved by the department and the 590 | |
| 722 | + | [Commission of Pharmacy] commission. 591 | |
| 723 | + | (c) A sterile compounding pharmacy shall comply with the USP 592 | |
| 724 | + | chapters. A sterile compounding pharmacy shall also comply with all 593 | |
| 725 | + | applicable federal and state statutes and regulations. 594 | |
| 726 | + | [(d) An institutional pharmacy within a facility licensed pursuant to 595 | |
| 727 | + | section 19a-490 that compounds sterile pharmaceuticals shall comply 596 | |
| 728 | + | with the USP chapters, and shall also comply with all applicable 597 | |
| 729 | + | federal and state statutes and regulations. Such institutional pharmacy 598 | |
| 730 | + | may request from the Commissioner of Consumer Protection an 599 | |
| 731 | + | extension of time, not to exceed six months, to comply, for state 600 | |
| 732 | + | enforcement purposes, with any amendments to USP chapters, for 601 | |
| 733 | + | good cause shown. The commissioner may grant an extension for a 602 | |
| 734 | + | length of time not to exceed six months. Nothing in this section shall 603 | |
| 735 | + | prevent such institutional pharmacy from requesting a subsequent 604 | |
| 736 | + | extension of time or shall prevent the commissioner from granting 605 | |
| 737 | + | such extension.] 606 | |
| 738 | + | [(e)] (d) (1) A sterile compounding pharmacy may only provide 607 | |
| 739 | + | patient-specific sterile pharmaceuticals to patients, to practitioners of 608 Substitute Bill No. 1102 | |
| 944 | 740 | ||
| 945 | - | the pharmacist's direct supervision; (2) by a syringe service program | |
| 946 | - | established pursuant to section 19a-124; and (3) by a health care facility | |
| 947 | - | or a licensed health care practitioner for use by their own patients. | |
| 948 | - | Sec. 10. Subsection (a) of section 21a-70 of the general statutes is | |
| 949 | - | repealed and the following is substituted in lieu thereof (Effective July 1, | |
| 950 | - | 2023): | |
| 951 | - | (a) As used in this section: (1) "Drugs", "devices" and "cosmetics" have | |
| 952 | - | the same meanings as defined in section 21a-92, "wholesaler" or | |
| 953 | - | "distributor" means a person, including, but not limited to, a medical | |
| 954 | - | device and oxygen provider, a third-party logistics provider, a virtual | |
| 955 | - | manufacturer or a virtual wholesale distributor, as such terms are | |
| 956 | - | defined in section 20-571, as amended by this act, whether within or | |
| 957 | - | without the boundaries of the state of Connecticut, who supplies drugs, | |
| 958 | - | devices or cosmetics prepared, produced or packaged by | |
| 959 | - | manufacturers, to other wholesalers, manufacturers, distributors, | |
| 960 | - | hospitals, prescribing practitioners, as defined in [subdivision (28) of] | |
| 961 | - | section 20-571, as amended by this act, pharmacies, federal, state or | |
| 962 | - | municipal agencies, clinics or any other person as permitted under | |
| 963 | - | subsection (h) of this section, except that: (A) A retail pharmacy or a | |
| 964 | - | pharmacy within a licensed hospital that supplies to another such | |
| 965 | - | pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or | |
| 966 | - | V controlled substance normally stocked by such pharmacies to provide | |
| 967 | - | for the immediate needs of a patient pursuant to a prescription or | |
| 968 | - | medication order of an authorized practitioner, (B) a pharmacy within a | |
| 969 | - | licensed hospital that supplies drugs to another hospital or an | |
| 970 | - | authorized practitioner for research purposes, (C) a retail pharmacy that | |
| 971 | - | supplies a limited quantity of a noncontrolled drug or of a schedule II, | |
| 972 | - | III, IV or V controlled substance for emergency stock to a practitioner | |
| 973 | - | who is a medical director of a chronic and convalescent nursing home, | |
| 974 | - | of a rest home with nursing supervision, of a hospice inpatient facility | |
| 975 | - | licensed pursuant to section 19a-491 or of a state correctional institution, Substitute Senate Bill No. 1102 | |
| 976 | 741 | ||
| 977 | - | Public Act No. 23-19 31 of 35 | |
| 742 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 743 | + | SB.docx } | |
| 744 | + | 21 of 29 | |
| 978 | 745 | ||
| 979 | - | and (D) a pharmacy within a licensed hospital that contains another | |
| 980 | - | hospital wholly within [its] such licensed hospital's physical structure | |
| 981 | - | that supplies to such contained hospital a quantity of a noncontrolled | |
| 982 | - | drug or a schedule II, III, IV, or V controlled substance normally stocked | |
| 983 | - | by such hospitals to provide for the needs of a patient, pursuant to a | |
| 984 | - | prescription or medication order of an authorized practitioner, receiving | |
| 985 | - | inpatient care on a unit that is operated by the contained hospital, or | |
| 986 | - | receiving outpatient care in a setting operated by the contained hospital | |
| 987 | - | and such drug or substance is administered on-site by the contained | |
| 988 | - | hospital, shall not be deemed a wholesaler under this section; (2) | |
| 989 | - | "manufacturer" means (A) a person, whether within or without the | |
| 990 | - | boundaries of the state of Connecticut, who produces, prepares, | |
| 991 | - | cultivates, grows, propagates, compounds, converts or processes, | |
| 992 | - | directly or indirectly, by extraction from substances of natural origin or | |
| 993 | - | by means of chemical synthesis or by a combination of extraction and | |
| 994 | - | chemical synthesis, or who packages, repackages, labels or relabels a | |
| 995 | - | container under such manufacturer's own or any other trademark or | |
| 996 | - | label any drug, device or cosmetic for the purpose of selling such items, | |
| 997 | - | or (B) a sterile compounding pharmacy, as defined in section 20-633b, | |
| 998 | - | as amended by this act, that dispenses sterile pharmaceuticals without | |
| 999 | - | a prescription or a patient-specific medical order; (3) "drug", "device" | |
| 1000 | - | and "cosmetic" have the same meanings as provided in section 21a-92; | |
| 1001 | - | and (4) "commissioner" means the Commissioner of Consumer | |
| 1002 | - | Protection or [his or her] the commissioner's designee. | |
| 1003 | - | Sec. 11. Subsection (k) of section 21a-106 of the general statutes is | |
| 1004 | - | repealed and the following is substituted in lieu thereof (Effective July 1, | |
| 1005 | - | 2023): | |
| 1006 | - | (k) If it is a legend drug, as defined in [subdivision (16) of] section 20- | |
| 1007 | - | 571, as amended by this act, that is not administered, dispensed, | |
| 1008 | - | prescribed or otherwise possessed or distributed in accordance with | |
| 1009 | - | federal and state laws and regulations; Substitute Senate Bill No. 1102 | |
| 746 | + | medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to 609 | |
| 747 | + | an acute care or long-term care hospital or health care facility licensed 610 | |
| 748 | + | by the Department of Public Health. 611 | |
| 749 | + | (2) If a sterile compounding pharmacy provides sterile 612 | |
| 750 | + | pharmaceuticals without a patient-specific prescription or medical 613 | |
| 751 | + | order, the sterile compounding pharmacy shall also obtain a certificate 614 | |
| 752 | + | of registration from the Department of Consumer Protection pursuant 615 | |
| 753 | + | to section 21a-70, as amended by this act, and any required federal 616 | |
| 754 | + | license or registration. A sterile compounding pharmacy may prepare 617 | |
| 755 | + | and maintain on-site inventory of sterile pharmaceuticals no greater 618 | |
| 756 | + | than a thirty-day supply, calculated from the completion of 619 | |
| 757 | + | compounding, which thirty-day period shall include the period 620 | |
| 758 | + | required for third-party analytical testing, to be performed in 621 | |
| 759 | + | accordance with the USP chapters. 622 | |
| 760 | + | [(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any 623 | |
| 761 | + | area utilized for the compounding of sterile pharmaceuticals or 624 | |
| 762 | + | adjacent space, relocate any space utilized for the compounding of 625 | |
| 763 | + | sterile pharmaceuticals or upgrade or conduct a nonemergency repair 626 | |
| 764 | + | to the heating, ventilation, air conditioning or primary or secondary 627 | |
| 765 | + | engineering controls for any space utilized for the compounding of 628 | |
| 766 | + | sterile pharmaceuticals, the sterile compounding pharmacy shall notify 629 | |
| 767 | + | the Department of Consumer Protection, in writing, not later than 630 | |
| 768 | + | forty-five days prior to commencing such remodel, relocation, upgrade 631 | |
| 769 | + | or repair. Such written notification shall include a plan for such 632 | |
| 770 | + | remodel, relocation, upgrade or repair and such plan shall be subject to 633 | |
| 771 | + | department review and approval. If a sterile compounding pharmacy 634 | |
| 772 | + | makes an emergency repair, the sterile compounding pharmacy shall 635 | |
| 773 | + | notify the department of such emergency repair, in writing, not later 636 | |
| 774 | + | than twenty-four hours after such repair is commenced. 637 | |
| 775 | + | (2) If the USP chapters require sterile recertification after such 638 | |
| 776 | + | remodel, relocation, upgrade or repair, the sterile compounding 639 | |
| 777 | + | pharmacy shall provide a copy of [its] such sterile compounding 640 | |
| 778 | + | pharmacy's sterile recertification to the Department of Consumer 641 Substitute Bill No. 1102 | |
| 1010 | 779 | ||
| 1011 | - | Public Act No. 23-19 32 of 35 | |
| 1012 | 780 | ||
| 1013 | - | Sec. 12. Subsection (e) of section 21a-115 of the general statutes is | |
| 1014 | - | repealed and the following is substituted in lieu thereof (Effective July 1, | |
| 1015 | - | 2023): | |
| 1016 | - | (e) In the promulgation of regulations under the provisions of this | |
| 1017 | - | section applicable to prescribing practitioners, care-giving institutions, | |
| 1018 | - | and correctional and juvenile training institutions, as defined in | |
| 1019 | - | [subdivision (7) of] section 20-571, as amended by this act, the | |
| 1020 | - | Commissioner of Consumer Protection shall act in place of the director. | |
| 1021 | - | Existing regulations shall continue in effect unless superseded by action | |
| 1022 | - | of said commissioner pursuant to this subsection. | |
| 1023 | - | Sec. 13. Subsection (j) of section 21a-249 of the general statutes is | |
| 1024 | - | repealed and the following is substituted in lieu thereof (Effective July 1, | |
| 1025 | - | 2023): | |
| 1026 | - | (j) A pharmacy may sell and dispense controlled substances upon the | |
| 1027 | - | prescription of a prescribing practitioner, as defined in [subdivision (28) | |
| 1028 | - | of] section 20-571, as amended by this act. | |
| 1029 | - | Sec. 14. Section 38a-492a of the general statutes is repealed and the | |
| 1030 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 1031 | - | Each individual health insurance policy providing coverage of the | |
| 1032 | - | type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section | |
| 1033 | - | 38a-469, delivered, issued for delivery, renewed, amended or continued | |
| 1034 | - | in this state shall provide coverage for hypodermic needles or syringes | |
| 1035 | - | prescribed by a prescribing practitioner, as defined in [subdivision (28) | |
| 1036 | - | of] section 20-571, as amended by this act, for the purpose of | |
| 1037 | - | administering medications for medical conditions, provided such | |
| 1038 | - | medications are covered under the policy. Such benefits shall be subject | |
| 1039 | - | to any policy provisions that apply to other services covered by such | |
| 1040 | - | policy. | |
| 1041 | - | Sec. 15. Section 38a-518a of the general statutes is repealed and the Substitute Senate Bill No. 1102 | |
| 781 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 782 | + | SB.docx } | |
| 783 | + | 22 of 29 | |
| 1042 | 784 | ||
| 1043 | - | Public Act No. 23-19 33 of 35 | |
| 785 | + | Protection not later than five days after the sterile recertification 642 | |
| 786 | + | approval. The recertification shall only be performed by an 643 | |
| 787 | + | independent licensed environmental monitoring entity. 644 | |
| 788 | + | [(g)] (f) A sterile compounding pharmacy shall report, in writing, to 645 | |
| 789 | + | the Department of Consumer Protection any known violation or 646 | |
| 790 | + | noncompliance with viable and nonviable environmental sampling 647 | |
| 791 | + | testing, as defined in the USP chapters, not later than the end of the 648 | |
| 792 | + | next business day after discovering such violation or noncompliance. 649 | |
| 793 | + | [(h)] (g) (1) If a sterile compounding pharmacy initiates a recall of 650 | |
| 794 | + | sterile pharmaceuticals that were dispensed pursuant to a patient-651 | |
| 795 | + | specific prescription or medical order, the sterile compounding 652 | |
| 796 | + | pharmacy shall notify each patient or patient care giver, the 653 | |
| 797 | + | prescribing practitioner and the Department of Consumer Protection 654 | |
| 798 | + | of such recall not later than twenty-four hours after such recall was 655 | |
| 799 | + | initiated. 656 | |
| 800 | + | (2) If a sterile compounding pharmacy initiates a recall of sterile 657 | |
| 801 | + | pharmaceuticals that were not dispensed pursuant to a patient-specific 658 | |
| 802 | + | prescription or a medical order, the sterile compounding pharmacy 659 | |
| 803 | + | shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the 660 | |
| 804 | + | extent such sterile compounding pharmacy possesses contact 661 | |
| 805 | + | information for each such purchaser, (B) the Department of Consumer 662 | |
| 806 | + | Protection, and (C) the federal Food and Drug Administration of such 663 | |
| 807 | + | recall not later than the end of the next business day after such recall 664 | |
| 808 | + | was initiated. 665 | |
| 809 | + | [(i)] (h) Each sterile compounding pharmacy [and each institutional 666 | |
| 810 | + | pharmacy within a facility licensed pursuant to section 19a-490] shall 667 | |
| 811 | + | prepare and maintain a policy and procedure manual. The policy and 668 | |
| 812 | + | procedure manual shall comply with the USP chapters. 669 | |
| 813 | + | [(j)] (i) Each sterile compounding pharmacy shall report to the 670 | |
| 814 | + | Department of Consumer Protection any administrative or legal action 671 | |
| 815 | + | commenced against [it] such sterile compounding pharmacy by any 672 Substitute Bill No. 1102 | |
| 1044 | 816 | ||
| 1045 | - | following is substituted in lieu thereof (Effective July 1, 2023): | |
| 1046 | - | Each group health insurance policy providing coverage of the type | |
| 1047 | - | specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 38a- | |
| 1048 | - | 469, delivered, issued for delivery, renewed, amended or continued in | |
| 1049 | - | this state shall provide coverage for hypodermic needles or syringes | |
| 1050 | - | prescribed by a prescribing practitioner, as defined in [subdivision (28) | |
| 1051 | - | of] section 20-571, as amended by this act, for the purpose of | |
| 1052 | - | administering medications for medical conditions, provided such | |
| 1053 | - | medications are covered under the policy. Such benefits shall be subject | |
| 1054 | - | to any policy provisions that apply to other services covered by such | |
| 1055 | - | policy. | |
| 1056 | - | Sec. 16. Subdivision (1) of subsection (b) of section 53a-13 of the | |
| 1057 | - | general statutes is repealed and the following is substituted in lieu | |
| 1058 | - | thereof (Effective July 1, 2023): | |
| 1059 | - | (b) (1) It shall not be a defense under this section if such mental | |
| 1060 | - | disease or defect was proximately caused by the voluntary ingestion, | |
| 1061 | - | inhalation or injection of intoxicating liquor or any drug or substance, | |
| 1062 | - | or any combination thereof, unless such drug was prescribed for the | |
| 1063 | - | defendant by a prescribing practitioner, as defined in [subdivision (28) | |
| 1064 | - | of] section 20-571, as amended by this act, and was used in accordance | |
| 1065 | - | with the directions of such prescription. | |
| 1066 | - | Sec. 17. Section 19a-112h of the general statutes is repealed and the | |
| 1067 | - | following is substituted in lieu thereof (Effective from passage): | |
| 1068 | - | (a) The Commissioner of Public Health shall establish and contract | |
| 1069 | - | for the administration of a [program using AIDS Services funding to | |
| 1070 | - | provide financial assistance to victims of sexual assault for drugs | |
| 1071 | - | prescribed by a physician for nonoccupational post -exposure | |
| 1072 | - | prophylaxis for human immunodeficiency virus consistent with | |
| 1073 | - | recommendations of the National Centers for Disease Control and Substitute Senate Bill No. 1102 | |
| 1074 | 817 | ||
| 1075 | - | Public Act No. 23-19 34 of 35 | |
| 818 | + | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2023SB-01102-R01- | |
| 819 | + | SB.docx } | |
| 820 | + | 23 of 29 | |
| 1076 | 821 | ||
| 1077 | - | Prevention and the state of Connecticut Technical Guidelines for Health | |
| 1078 | - | Care Response to Victims of Sexual Assault. The commissioner shall | |
| 1079 | - | give priority for benefits under the program established pursuant to this | |
| 1080 | - | section to sexual assault victims who are uninsured or underinsured | |
| 1081 | - | and for whom the program is a payer of last resort. The commissioner | |
| 1082 | - | shall issue a request for proposal totaling twenty-five thousand dollars | |
| 1083 | - | annually to which a qualified organization may apply to administer the | |
| 1084 | - | program.] state-wide human immunodeficiency virus pre-exposure | |
| 1085 | - | prophylaxis and post-exposure prophylaxis drug assistance program | |
| 1086 | - | using appropriated AIDS Services funding, provided such funding is | |
| 1087 | - | equal to or greater than twenty-five thousand dollars annually. The | |
| 1088 | - | program shall provide financial assistance to individuals at risk of | |
| 1089 | - | acquiring human immunodeficiency for the purchase of pre-exposure | |
| 1090 | - | and post-exposure prophylaxis for human immunodeficiency virus | |
| 1091 | - | prescribed by a licensed physician consistent with the recommendations | |
| 1092 | - | of the National Centers for Disease Control and Prevention. For the | |
| 1093 | - | purposes of this subsection, "financial assistance" includes, but need not | |
| 1094 | - | be limited to, payments for out-of-pocket costs, copayments, | |
| 1095 | - | coinsurance, and up to full cost payments toward a deductible for | |
| 1096 | - | individuals who are underinsured and for whom the program is the | |
| 1097 | - | payer of last resort. | |
| 1098 | - | (b) The commissioner shall give priority for benefits under the | |
| 1099 | - | program established pursuant to this section to individuals who have | |
| 1100 | - | an increased risk of acquiring human immunodeficiency virus or who | |
| 1101 | - | have had a recent exposure to such virus, but are unable to purchase | |
| 1102 | - | pre-exposure and post -exposure prophylaxis for human | |
| 1103 | - | immunodeficiency virus and for whom the program is a payer of last | |
| 1104 | - | resort. | |
| 1105 | - | (c) The commissioner may adopt regulations in accordance with the | |
| 1106 | - | provisions of chapter 54 to implement the provisions of this section. The | |
| 1107 | - | commissioner may implement policies and procedures necessary to Substitute Senate Bill No. 1102 | |
| 822 | + | state or federal regulatory agency or accreditation entity not later than 673 | |
| 823 | + | five business days after receiving notice of the commencement of such 674 | |
| 824 | + | action. 675 | |
| 825 | + | [(k)] (j) Notwithstanding the provisions of [subdivisions (3) and (4)] 676 | |
| 826 | + | subdivision (2) of subsection (b) of this section, a sterile compounding 677 | |
| 827 | + | pharmacy that is a nonresident pharmacy shall provide to the 678 | |
| 828 | + | Department of Consumer Protection proof that [it] such nonresident 679 | |
| 829 | + | pharmacy has passed an inspection in such nonresident pharmacy's 680 | |
| 830 | + | home state, based on the USP chapters. Such nonresident pharmacy 681 | |
| 831 | + | shall submit to the Department of Consumer Protection a copy of the 682 | |
| 832 | + | most recent inspection report with [its] such nonresident pharmacy's 683 | |
| 833 | + | initial nonresident pharmacy application and shall submit to the 684 | |
| 834 | + | department a copy of [its] such nonresident pharmacy's most recent 685 | |
| 835 | + | inspection report every two years thereafter. If the state in which [the] 686 | |
| 836 | + | such nonresident pharmacy is located does not conduct inspections 687 | |
| 837 | + | based on standards required in the USP chapters, such nonresident 688 | |
| 838 | + | pharmacy shall provide satisfactory proof to the department that [it] 689 | |
| 839 | + | such nonresident pharmacy is in compliance with the standards 690 | |
| 840 | + | required in the USP chapters. 691 | |
| 841 | + | [(l)] (k) A practitioner, as specified in subdivision (1) of subsection 692 | |
| 842 | + | [(e)] (d) of this section, a hospital or a health care facility that receives 693 | |
| 843 | + | sterile pharmaceuticals shall report any errors related to such 694 | |
| 844 | + | dispensing or any suspected adulterated sterile pharmaceuticals to the 695 | |
| 845 | + | Department of Consumer Protection. 696 | |
| 846 | + | [(m)] (l) (1) For purposes of this subsection, a "designated 697 | |
| 847 | + | pharmacist" means a pharmacist responsible for overseeing the 698 | |
| 848 | + | compounding of sterile pharmaceuticals and the application of the 699 | |
| 849 | + | USP chapters, as said chapters pertain to sterile compounding. 700 | |
| 850 | + | (2) Any pharmacy licensed pursuant to section 20-594, as amended 701 | |
| 851 | + | by this act, [or institutional pharmacy licensed pursuant to section 19a-702 | |
| 852 | + | 490] that provides sterile pharmaceuticals shall notify the department 703 | |
| 853 | + | of [its] such pharmacy's designated pharmacist. 704 Substitute Bill No. 1102 | |
| 1108 | 854 | ||
| 1109 | - | Public Act No. 23-19 35 of 35 | |
| 1110 | 855 | ||
| 1111 | - | administer the provisions of this section while in the process of adopting | |
| 1112 | - | such policies and procedures as regulations, provided notice of intent to | |
| 1113 | - | adopt regulations is published on the eRegulations System not later than | |
| 1114 | - | twenty days after the date of implementation. Policies and procedures | |
| 1115 | - | implemented pursuant to this section shall be valid until the time final | |
| 1116 | - | regulations are adopted. | |
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| 857 | + | SB.docx } | |
| 858 | + | 24 of 29 | |
| 859 | + | ||
| 860 | + | (3) The designated pharmacist shall be responsible for providing 705 | |
| 861 | + | proof [he or she] such designated pharmacist has completed a program 706 | |
| 862 | + | approved by the commissioner that demonstrates the competence 707 | |
| 863 | + | necessary for the compounding of sterile pharmaceuticals, in 708 | |
| 864 | + | compliance with all applicable federal and state statutes and 709 | |
| 865 | + | regulations. 710 | |
| 866 | + | (4) The designated pharmacist shall immediately notify the 711 | |
| 867 | + | department whenever [he or she] such designated pharmacist ceases 712 | |
| 868 | + | such designation. 713 | |
| 869 | + | (5) Nothing in this section shall prevent a designated pharmacist 714 | |
| 870 | + | from being the pharmacy manager. 715 | |
| 871 | + | [(n)] (m) The Commissioner of Consumer Protection may adopt 716 | |
| 872 | + | regulations, in accordance with chapter 54, to implement the 717 | |
| 873 | + | provisions of this section. 718 | |
| 874 | + | Sec. 9. Subsections (a) and (b) of section 21a-65 of the general 719 | |
| 875 | + | statutes are repealed and the following is substituted in lieu thereof 720 | |
| 876 | + | (Effective July 1, 2023): 721 | |
| 877 | + | (a) A licensed manufacturer or licensed wholesaler may sell 722 | |
| 878 | + | hypodermic needles and syringes only to the following: (1) To a 723 | |
| 879 | + | licensed manufacturer, licensed wholesaler or licensed pharmacy; (2) 724 | |
| 880 | + | to a physician, dentist, veterinarian, embalmer, podiatrist or scientific 725 | |
| 881 | + | investigator licensed to practice in this state; (3) to a person in charge 726 | |
| 882 | + | of a care-giving institution, as defined in [subdivision (3) of] section 20-727 | |
| 883 | + | 571, as amended by this act, incorporated college or scientific 728 | |
| 884 | + | institution, but only for use by or in such care-giving institution, 729 | |
| 885 | + | college or institution for medical or scientific purposes; (4) to a person 730 | |
| 886 | + | in charge of a licensed or registered laboratory, but only for use in that 731 | |
| 887 | + | laboratory for scientific and medical purposes; (5) to a farmer but only 732 | |
| 888 | + | for use on the farmer's own animals or poultry; (6) to a business 733 | |
| 889 | + | authorized in accordance with the regulations adopted under section 734 | |
| 890 | + | 21a-66 to purchase hypodermic needles and syringes but only for 735 Substitute Bill No. 1102 | |
| 891 | + | ||
| 892 | + | ||
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| 895 | + | 25 of 29 | |
| 896 | + | ||
| 897 | + | legitimate industrial or medical use within that business; and (7) to a 736 | |
| 898 | + | syringe services program established pursuant to section 19a-124. 737 | |
| 899 | + | (b) Except as provided in subsection (a) of this section, no licensed 738 | |
| 900 | + | manufacturer, licensed wholesaler or licensed pharmacist shall sell and 739 | |
| 901 | + | no person shall buy a hypodermic needle or syringe except upon a 740 | |
| 902 | + | prescription of a prescribing practitioner, as defined in [subdivision 741 | |
| 903 | + | (28) of] section 20-571, as amended by this act, in a quantity greater 742 | |
| 904 | + | than ten. Any such prescription shall be retained on file by the seller 743 | |
| 905 | + | for a period of not less than three years and shall be accessible to any 744 | |
| 906 | + | public officer engaged in the enforcement of this section. Such a 745 | |
| 907 | + | prescription shall be valid for one year from the date thereof and 746 | |
| 908 | + | purchases and sales may be made thereunder during such period, 747 | |
| 909 | + | provided the seller shall confirm the continued need for such sales 748 | |
| 910 | + | with such practitioner at least every six months if sales continue to be 749 | |
| 911 | + | made thereunder. Hypodermic needles and syringes in a quantity of 750 | |
| 912 | + | ten or less without a prescription may be provided or sold at retail 751 | |
| 913 | + | only by the following: (1) By a pharmacy licensed in accordance with 752 | |
| 914 | + | section 20-594, as amended by this act, and in such pharmacy only by a 753 | |
| 915 | + | licensed pharmacist or under the pharmacist's direct supervision; (2) 754 | |
| 916 | + | by a syringe service program established pursuant to section 19a-124; 755 | |
| 917 | + | and (3) by a health care facility or a licensed health care practitioner for 756 | |
| 918 | + | use by their own patients. 757 | |
| 919 | + | Sec. 10. Subsection (a) of section 21a-70 of the general statutes is 758 | |
| 920 | + | repealed and the following is substituted in lieu thereof (Effective July 759 | |
| 921 | + | 1, 2023): 760 | |
| 922 | + | (a) As used in this section: (1) "Drugs", "devices" and "cosmetics" 761 | |
| 923 | + | have the same meanings as defined in section 21a-92, "wholesaler" or 762 | |
| 924 | + | "distributor" means a person, including, but not limited to, a medical 763 | |
| 925 | + | device and oxygen provider, a third-party logistics provider, a virtual 764 | |
| 926 | + | manufacturer or a virtual wholesale distributor, as such terms are 765 | |
| 927 | + | defined in section 20-571, as amended by this act, whether within or 766 | |
| 928 | + | without the boundaries of the state of Connecticut, who supplies 767 | |
| 929 | + | drugs, devices or cosmetics prepared, produced or packaged by 768 Substitute Bill No. 1102 | |
| 930 | + | ||
| 931 | + | ||
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| 934 | + | 26 of 29 | |
| 935 | + | ||
| 936 | + | manufacturers, to other wholesalers, manufacturers, distributors, 769 | |
| 937 | + | hospitals, prescribing practitioners, as defined in [subdivision (28) of] 770 | |
| 938 | + | section 20-571, as amended by this act, pharmacies, federal, state or 771 | |
| 939 | + | municipal agencies, clinics or any other person as permitted under 772 | |
| 940 | + | subsection (h) of this section, except that: (A) A retail pharmacy or a 773 | |
| 941 | + | pharmacy within a licensed hospital that supplies to another such 774 | |
| 942 | + | pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or 775 | |
| 943 | + | V controlled substance normally stocked by such pharmacies to 776 | |
| 944 | + | provide for the immediate needs of a patient pursuant to a prescription 777 | |
| 945 | + | or medication order of an authorized practitioner, (B) a pharmacy 778 | |
| 946 | + | within a licensed hospital that supplies drugs to another hospital or an 779 | |
| 947 | + | authorized practitioner for research purposes, (C) a retail pharmacy 780 | |
| 948 | + | that supplies a limited quantity of a noncontrolled drug or of a 781 | |
| 949 | + | schedule II, III, IV or V controlled substance for emergency stock to a 782 | |
| 950 | + | practitioner who is a medical director of a chronic and convalescent 783 | |
| 951 | + | nursing home, of a rest home with nursing supervision, of a hospice 784 | |
| 952 | + | inpatient facility licensed pursuant to section 19a-491 or of a state 785 | |
| 953 | + | correctional institution, and (D) a pharmacy within a licensed hospital 786 | |
| 954 | + | that contains another hospital wholly within [its] such licensed 787 | |
| 955 | + | hospital's physical structure that supplies to such contained hospital a 788 | |
| 956 | + | quantity of a noncontrolled drug or a schedule II, III, IV, or V 789 | |
| 957 | + | controlled substance normally stocked by such hospitals to provide for 790 | |
| 958 | + | the needs of a patient, pursuant to a prescription or medication order 791 | |
| 959 | + | of an authorized practitioner, receiving inpatient care on a unit that is 792 | |
| 960 | + | operated by the contained hospital, or receiving outpatient care in a 793 | |
| 961 | + | setting operated by the contained hospital and such drug or substance 794 | |
| 962 | + | is administered on-site by the contained hospital, shall not be deemed 795 | |
| 963 | + | a wholesaler under this section; (2) "manufacturer" means (A) a person, 796 | |
| 964 | + | whether within or without the boundaries of the state of Connecticut, 797 | |
| 965 | + | who produces, prepares, cultivates, grows, propagates, compounds, 798 | |
| 966 | + | converts or processes, directly or indirectly, by extraction from 799 | |
| 967 | + | substances of natural origin or by means of chemical synthesis or by a 800 | |
| 968 | + | combination of extraction and chemical synthesis, or who packages, 801 | |
| 969 | + | repackages, labels or relabels a container under such manufacturer's 802 | |
| 970 | + | own or any other trademark or label any drug, device or cosmetic for 803 Substitute Bill No. 1102 | |
| 971 | + | ||
| 972 | + | ||
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| 975 | + | 27 of 29 | |
| 976 | + | ||
| 977 | + | the purpose of selling such items, or (B) a sterile compounding 804 | |
| 978 | + | pharmacy, as defined in section 20-633b, as amended by this act, that 805 | |
| 979 | + | dispenses sterile pharmaceuticals without a prescription or a patient-806 | |
| 980 | + | specific medical order; (3) "drug", "device" and "cosmetic" have the 807 | |
| 981 | + | same meanings as provided in section 21a-92; and (4) "commissioner" 808 | |
| 982 | + | means the Commissioner of Consumer Protection or [his or her] the 809 | |
| 983 | + | commissioner's designee. 810 | |
| 984 | + | Sec. 11. Subsection (k) of section 21a-106 of the general statutes is 811 | |
| 985 | + | repealed and the following is substituted in lieu thereof (Effective July 812 | |
| 986 | + | 1, 2023): 813 | |
| 987 | + | (k) If it is a legend drug, as defined in [subdivision (16) of] section 814 | |
| 988 | + | 20-571, as amended by this act, that is not administered, dispensed, 815 | |
| 989 | + | prescribed or otherwise possessed or distributed in accordance with 816 | |
| 990 | + | federal and state laws and regulations; 817 | |
| 991 | + | Sec. 12. Subsection (e) of section 21a-115 of the general statutes is 818 | |
| 992 | + | repealed and the following is substituted in lieu thereof (Effective July 819 | |
| 993 | + | 1, 2023): 820 | |
| 994 | + | (e) In the promulgation of regulations under the provisions of this 821 | |
| 995 | + | section applicable to prescribing practitioners, care-giving institutions, 822 | |
| 996 | + | and correctional and juvenile training institutions, as defined in 823 | |
| 997 | + | [subdivision (7) of] section 20-571, as amended by this act, the 824 | |
| 998 | + | Commissioner of Consumer Protection shall act in place of the 825 | |
| 999 | + | director. Existing regulations shall continue in effect unless superseded 826 | |
| 1000 | + | by action of said commissioner pursuant to this subsection. 827 | |
| 1001 | + | Sec. 13. Subsection (j) of section 21a-249 of the general statutes is 828 | |
| 1002 | + | repealed and the following is substituted in lieu thereof (Effective July 829 | |
| 1003 | + | 1, 2023): 830 | |
| 1004 | + | (j) A pharmacy may sell and dispense controlled substances upon 831 | |
| 1005 | + | the prescription of a prescribing practitioner, as defined in 832 | |
| 1006 | + | [subdivision (28) of] section 20-571, as amended by this act. 833 Substitute Bill No. 1102 | |
| 1007 | + | ||
| 1008 | + | ||
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| 1011 | + | 28 of 29 | |
| 1012 | + | ||
| 1013 | + | Sec. 14. Section 38a-492a of the general statutes is repealed and the 834 | |
| 1014 | + | following is substituted in lieu thereof (Effective July 1, 2023): 835 | |
| 1015 | + | Each individual health insurance policy providing coverage of the 836 | |
| 1016 | + | type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of 837 | |
| 1017 | + | section 38a-469, delivered, issued for delivery, renewed, amended or 838 | |
| 1018 | + | continued in this state shall provide coverage for hypodermic needles 839 | |
| 1019 | + | or syringes prescribed by a prescribing practitioner, as defined in 840 | |
| 1020 | + | [subdivision (28) of] section 20-571, as amended by this act, for the 841 | |
| 1021 | + | purpose of administering medications for medical conditions, 842 | |
| 1022 | + | provided such medications are covered under the policy. Such benefits 843 | |
| 1023 | + | shall be subject to any policy provisions that apply to other services 844 | |
| 1024 | + | covered by such policy. 845 | |
| 1025 | + | Sec. 15. Section 38a-518a of the general statutes is repealed and the 846 | |
| 1026 | + | following is substituted in lieu thereof (Effective July 1, 2023): 847 | |
| 1027 | + | Each group health insurance policy providing coverage of the type 848 | |
| 1028 | + | specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 849 | |
| 1029 | + | 38a-469, delivered, issued for delivery, renewed, amended or 850 | |
| 1030 | + | continued in this state shall provide coverage for hypodermic needles 851 | |
| 1031 | + | or syringes prescribed by a prescribing practitioner, as defined in 852 | |
| 1032 | + | [subdivision (28) of] section 20-571, as amended by this act, for the 853 | |
| 1033 | + | purpose of administering medications for medical conditions, 854 | |
| 1034 | + | provided such medications are covered under the policy. Such benefits 855 | |
| 1035 | + | shall be subject to any policy provisions that apply to other services 856 | |
| 1036 | + | covered by such policy. 857 | |
| 1037 | + | Sec. 16. Subdivision (1) of subsection (b) of section 53a-13 of the 858 | |
| 1038 | + | general statutes is repealed and the following is substituted in lieu 859 | |
| 1039 | + | thereof (Effective July 1, 2023): 860 | |
| 1040 | + | (b) (1) It shall not be a defense under this section if such mental 861 | |
| 1041 | + | disease or defect was proximately caused by the voluntary ingestion, 862 | |
| 1042 | + | inhalation or injection of intoxicating liquor or any drug or substance, 863 | |
| 1043 | + | or any combination thereof, unless such drug was prescribed for the 864 Substitute Bill No. 1102 | |
| 1044 | + | ||
| 1045 | + | ||
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| 1048 | + | 29 of 29 | |
| 1049 | + | ||
| 1050 | + | defendant by a prescribing practitioner, as defined in [subdivision (28) 865 | |
| 1051 | + | of] section 20-571, as amended by this act, and was used in accordance 866 | |
| 1052 | + | with the directions of such prescription. 867 | |
| 1053 | + | This act shall take effect as follows and shall amend the following | |
| 1054 | + | sections: | |
| 1055 | + | ||
| 1056 | + | Section 1 July 1, 2023 20-571 | |
| 1057 | + | Sec. 2 July 1, 2023 New section | |
| 1058 | + | Sec. 3 July 1, 2023 New section | |
| 1059 | + | Sec. 4 July 1, 2023 New section | |
| 1060 | + | Sec. 5 July 1, 2023 20-633 | |
| 1061 | + | Sec. 6 July 1, 2023 20-576(a) | |
| 1062 | + | Sec. 7 July 1, 2023 20-594 | |
| 1063 | + | Sec. 8 July 1, 2023 20-633b | |
| 1064 | + | Sec. 9 July 1, 2023 21a-65(a) and (b) | |
| 1065 | + | Sec. 10 July 1, 2023 21a-70(a) | |
| 1066 | + | Sec. 11 July 1, 2023 21a-106(k) | |
| 1067 | + | Sec. 12 July 1, 2023 21a-115(e) | |
| 1068 | + | Sec. 13 July 1, 2023 21a-249(j) | |
| 1069 | + | Sec. 14 July 1, 2023 38a-492a | |
| 1070 | + | Sec. 15 July 1, 2023 38a-518a | |
| 1071 | + | Sec. 16 July 1, 2023 53a-13(b)(1) | |
| 1072 | + | ||
| 1073 | + | Statement of Legislative Commissioners: | |
| 1074 | + | In Section 2(b)(1), Subparas. (A) and (B) were rewritten for clarity; in | |
| 1075 | + | Section 2(b)(2) and (c)(1), "to a patient" was deleted for conciseness; in | |
| 1076 | + | Section 4(e), "provisions" was substituted for "regulations providing" | |
| 1077 | + | for consistency with standard drafting conventions; in Section 4(e)(5), | |
| 1078 | + | "ensure" was added before "public" for clarity; in Section 5(a)(3), | |
| 1079 | + | "upon" was deleted for clarity; in Section 8(b)(1)(C), "addendum" was | |
| 1080 | + | added before "application" for consistency; in Section 8(d)(1), "to" was | |
| 1081 | + | added before "practitioners" for consistency; and in Section 8(j), "to" | |
| 1082 | + | was added after "provide" for consistency. | |
| 1083 | + | ||
| 1084 | + | GL Joint Favorable Subst. | |
| 1117 | 1085 |