| 15 | | - | Section 1. Subdivision (16) of subsection (j) of section 21a-254 of the |
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| 16 | | - | general statutes is repealed and the following is substituted in lieu |
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| 17 | | - | thereof (Effective from passage): |
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| 18 | | - | (16) Each pharmacy, nonresident pharmacy, as defined in section 20- |
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| 19 | | - | 627, outpatient pharmacy in a hospital or institution, and dispenser shall |
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| 20 | | - | report to the commissioner, at least daily, by electronic means or, if a |
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| 21 | | - | pharmacy or outpatient pharmacy does not maintain reco rds |
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| 22 | | - | electronically, in a format approved by the commissioner information |
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| 23 | | - | for all insulin drugs, glucagon drugs, diabetes devices and diabetic |
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| 24 | | - | ketoacidosis devices prescribed and dispensed by such pharmacy or |
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| 25 | | - | outpatient pharmacy, except such reporting requirement shall not apply |
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| 26 | | - | to any veterinarian, licensed under chapter 384, who dispenses insulin |
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| 27 | | - | drugs, glucagon drugs, diabetes devices and diabetic ketoacidosis |
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| 28 | | - | devices for animal patients. Such pharmacy or outpatient pharmacy |
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| 29 | | - | shall report such information to the commissioner in a manner that is |
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| 30 | | - | consistent with the manner in which such pharmacy or outpatient |
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| 31 | | - | pharmacy reports information for controlled substance prescriptions Substitute Senate Bill No. 694 |
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| 19 | + | Section 1. Section 21a-319 of the general statutes is repealed and the 1 |
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| 20 | + | following is substituted in lieu thereof (Effective October 1, 2021): 2 |
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| 21 | + | (a) No certificate of registration shall be issued, maintained or 3 |
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| 22 | + | renewed under this chapter unless or until the applicant has furnished 4 |
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| 23 | + | proof satisfactory to the Commissioner of Consumer Protection that he 5 |
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| 24 | + | or she is licensed or duly authorized to practice his or her profession by 6 |
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| 25 | + | the appropriate state licensing board, commission or registration 7 |
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| 26 | + | agency; or, in the case of a hospital or other institution, by the 8 |
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| 27 | + | appropriate state agency having jurisdiction over the licensure, 9 |
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| 28 | + | registration or approval of such establishment. 10 |
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| 29 | + | (b) The Commissioner of Consumer Protection may change the status 11 |
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| 30 | + | of a controlled substance registration to inactive for any practitioner 12 |
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| 31 | + | who fails to maintain a license, registration or approval of a license to 13 |
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| 32 | + | practice his or her medical profession for a period longer than ninety 14 |
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| 33 | + | days. Such change in license status shall not be considered disciplinary 15 |
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| 34 | + | and the registration shall be reinstated without additional fee, if the 16 |
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| 35 | + | practitioner restores his or her license, registration or approval to 17 |
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| 36 | + | practice his or her profession with the Department of Public Health or 18 Substitute Bill No. 694 |
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| 35 | | - | pursuant to subdivision (4) of this subsection. For the purposes of this |
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| 36 | | - | subdivision, "insulin drug", "glucagon drug", "diabetes devices" and |
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| 37 | | - | "diabetic ketoacidosis device" have the same meanings as provided in |
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| 38 | | - | section 20-616. |
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| 41 | + | 2 of 5 |
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| 42 | + | |
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| 43 | + | associated board or commission, and the reinstatement occurs prior to 19 |
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| 44 | + | the expiration of the controlled substance registration. 20 |
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| 45 | + | Sec. 2. (NEW) (Effective from passage) (a) For purposes of this section, 21 |
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| 46 | + | "epinephrine auto injector" means a prefilled auto injector or similar 22 |
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| 47 | + | automatic injectable equipment used to deliver epinephrine in a 23 |
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| 48 | + | standard dose for emergency first aid response to allergic reactions. 24 |
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| 49 | + | (b) A pharmacist, in his or her professional discretion, may issue a 25 |
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| 50 | + | prescription for not more than two epinephrine auto injectors under the 26 |
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| 51 | + | following conditions: 27 |
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| 52 | + | (1) The pharmacist identifies that the patient requesting such 28 |
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| 53 | + | prescription has received an epinephrine auto injector by prescription 29 |
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| 54 | + | from another pharmacy within the previous two years; 30 |
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| 55 | + | (2) The pharmacist identifies the patient's practitioner specified by 31 |
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| 56 | + | the patient as his or her primary care provider at the time the request is 32 |
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| 57 | + | made; 33 |
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| 58 | + | (3) The pharmacist informs the patient's primary care provider of the 34 |
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| 59 | + | issuance of the prescription not later than seventy-two hours after such 35 |
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| 60 | + | issuance, by either phone, facsimile or electronic transmission; and 36 |
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| 61 | + | (4) The prescription issued by the pharmacist does not have any 37 |
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| 62 | + | refills and is not filled more than once per year. 38 |
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| 63 | + | (c) Nothing in this section shall prevent a pharmacist from verifying 39 |
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| 64 | + | a previous prescription at any pharmacy in any part of the United States, 40 |
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| 65 | + | including any state, district, commonwealth, territory or insular 41 |
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| 66 | + | possession thereof, or any area subject to the legal authority of the 42 |
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| 67 | + | United States of America. 43 |
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| 68 | + | Sec. 3. Subsection (f) of section 20-633b of the general statutes is 44 |
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| 69 | + | repealed and the following is substituted in lieu thereof (Effective from 45 |
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| 70 | + | passage): 46 Substitute Bill No. 694 |
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| 71 | + | |
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| 76 | + | |
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| 77 | + | (f) (1) If a sterile compounding pharmacy plans to remodel [a 47 |
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| 78 | + | pharmacy clean room within the sterile compounding facility] any area 48 |
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| 79 | + | utilized for the compounding of sterile pharmaceuticals or adjacent 49 |
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| 80 | + | space, relocate [a pharmacy clean room within the facility] any space 50 |
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| 81 | + | utilized for the compounding of sterile pharmaceuticals or upgrade or 51 |
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| 82 | + | conduct a nonemergency repair to the heating, ventilation, air 52 |
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| 83 | + | conditioning or primary or secondary engineering controls for [a 53 |
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| 84 | + | pharmacy clean room within the facility] any space utilized for the 54 |
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| 85 | + | compounding of sterile pharmaceuticals, the sterile compounding 55 |
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| 86 | + | pharmacy shall notify the Department of Consumer Protection, in 56 |
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| 87 | + | writing, not later than [ten] forty-five days prior to commencing such 57 |
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| 88 | + | remodel, relocation, upgrade or repair. Such written notification shall 58 |
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| 89 | + | include a plan for such remodel, relocation, upgrade or repair and such 59 |
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| 90 | + | plan shall be subject to department review and approval. If a sterile 60 |
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| 91 | + | compounding pharmacy makes an emergency repair, the sterile 61 |
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| 92 | + | compounding pharmacy shall notify the department of such emergency 62 |
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| 93 | + | repair, in writing, [as soon as possible] not later than twenty-four hours 63 |
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| 94 | + | after such repair is commenced. 64 |
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| 95 | + | (2) If the USP chapters require sterile recertification after such 65 |
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| 96 | + | remodel, relocation, upgrade or repair, the sterile compounding 66 |
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| 97 | + | pharmacy shall provide a copy of its sterile recertification to the 67 |
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| 98 | + | Department of Consumer Protection not later than five days after the 68 |
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| 99 | + | sterile recertification approval. The recertification shall only be 69 |
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| 100 | + | performed by an independent licensed environmental monitoring 70 |
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| 101 | + | entity. 71 |
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| 102 | + | Sec. 4. Subsection (d) of section 20-614 of the general statutes is 72 |
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| 103 | + | repealed and the following is substituted in lieu thereof (Effective from 73 |
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| 104 | + | passage): 74 |
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| 105 | + | (d) Prior to or simultaneous with the dispensing of a drug, [pursuant 75 |
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| 106 | + | to subsection (b) of this section] from a pharmacy licensed pursuant to 76 |
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| 107 | + | this chapter, a pharmacist or other employee of the pharmacy shall, 77 |
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| 108 | + | whenever practicable, offer for the pharmacist to discuss the drug to be 78 |
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| 109 | + | dispensed and to counsel the patient on the usage of the drug, except 79 Substitute Bill No. 694 |
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| 110 | + | |
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| 115 | + | |
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| 116 | + | when the person obtaining the prescription is other than the person 80 |
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| 117 | + | named on the prescription form or electronic record or the pharmacist 81 |
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| 118 | + | determines it is appropriate to make such offer in writing. Any such 82 |
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| 119 | + | written offer shall include an offer to communicate with the patient 83 |
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| 120 | + | either in person at the pharmacy or by telephone. 84 |
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| 121 | + | Sec. 5. Subsection (a) of section 21a-70 of the general statutes is 85 |
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| 122 | + | repealed and the following is substituted in lieu thereof (Effective July 1, 86 |
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| 123 | + | 2021): 87 |
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| 124 | + | (a) As used in this section: (1) "Drugs", "devices" and "cosmetics" have 88 |
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| 125 | + | the same meanings as defined in section 21a-92, "wholesaler" or 89 |
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| 126 | + | "distributor" means a person, including, but not limited to, a medical 90 |
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| 127 | + | device and oxygen provider, a third-party logistics provider, a virtual 91 |
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| 128 | + | manufacturer or a virtual wholesale distributor, as such terms are 92 |
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| 129 | + | defined in section 20-571, whether within or without the boundaries of 93 |
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| 130 | + | the state of Connecticut, who supplies drugs, devices or cosmetics 94 |
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| 131 | + | prepared, produced or packaged by manufacturers, to other 95 |
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| 132 | + | wholesalers, manufacturers, distributors, hospitals, prescribing 96 |
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| 133 | + | practitioners, as defined in subdivision (24) of section 20-571, 97 |
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| 134 | + | pharmacies, federal, state or municipal agencies, clinics or any other 98 |
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| 135 | + | person as permitted under subsection (h) of this section, except that: (A) 99 |
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| 136 | + | A retail pharmacy or a pharmacy within a licensed hospital that 100 |
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| 137 | + | supplies to another such pharmacy a quantity of a noncontrolled drug 101 |
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| 138 | + | or a schedule II, III, IV or V controlled substance normally stocked by 102 |
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| 139 | + | such pharmacies to provide for the immediate needs of a patient 103 |
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| 140 | + | pursuant to a prescription or medication order of an authorized 104 |
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| 141 | + | practitioner, (B) a pharmacy within a licensed hospital that supplies 105 |
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| 142 | + | drugs to another hospital or an authorized practitioner for research 106 |
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| 143 | + | purposes, (C) a retail pharmacy that supplies a limited quantity of a 107 |
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| 144 | + | noncontrolled drug or of a schedule II, III, IV or V controlled substance 108 |
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| 145 | + | for emergency stock to a practitioner who is a medical director of a 109 |
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| 146 | + | chronic and convalescent nursing home, of a rest home with nursing 110 |
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| 147 | + | supervision, of a hospice inpatient facility licensed pursuant to section 111 |
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| 148 | + | 19a-491 or of a state correctional institution, and (D) a pharmacy within 112 Substitute Bill No. 694 |
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| 149 | + | |
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| 155 | + | a licensed hospital that contains another hospital wholly within its 113 |
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| 156 | + | physical structure that supplies to such contained hospital a quantity of 114 |
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| 157 | + | a noncontrolled drug or a schedule II, III, IV, or V controlled substance 115 |
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| 158 | + | normally stocked by such hospitals to provide for the needs of a patient, 116 |
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| 159 | + | pursuant to a prescription or medication order of an authorized 117 |
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| 160 | + | practitioner, receiving inpatient care on a unit that is operated by the 118 |
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| 161 | + | contained hospital, or receiving outpatient care in a setting operated by 119 |
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| 162 | + | the contained hospital and such drug or substance is administered on-120 |
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| 163 | + | site by the contained hospital, shall not be deemed a wholesaler under 121 |
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| 164 | + | this section; (2) "manufacturer" means (A) a person, whether within or 122 |
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| 165 | + | without the boundaries of the state of Connecticut, who produces, 123 |
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| 166 | + | prepares, cultivates, grows, propagates, compounds, converts or 124 |
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| 167 | + | processes, directly or indirectly, by extraction from substances of 125 |
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| 168 | + | natural origin or by means of chemical synthesis or by a combination of 126 |
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| 169 | + | extraction and chemical synthesis, or who packages, repackages, labels 127 |
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| 170 | + | or relabels a container under such manufacturer's own or any other 128 |
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| 171 | + | trademark or label any drug, device or cosmetic for the purpose of 129 |
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| 172 | + | selling such items, or (B) a sterile compounding pharmacy, as defined 130 |
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| 173 | + | in section 20-633b, as amended by this act, that dispenses sterile 131 |
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| 174 | + | pharmaceuticals without a prescription or a patient-specific medical 132 |
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| 175 | + | order; (3) "drug", "device" and "cosmetic" have the same meanings as 133 |
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| 176 | + | provided in section 21a-92; and (4) "commissioner" means the 134 |
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| 177 | + | Commissioner of Consumer Protection or his or her designee. 135 |
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| 178 | + | This act shall take effect as follows and shall amend the following |
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| 179 | + | sections: |
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| 180 | + | |
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| 181 | + | Section 1 October 1, 2021 21a-319 |
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| 182 | + | Sec. 2 from passage New section |
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| 183 | + | Sec. 3 from passage 20-633b(f) |
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| 184 | + | Sec. 4 from passage 20-614(d) |
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| 185 | + | Sec. 5 July 1, 2021 21a-70(a) |
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| 186 | + | |
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| 187 | + | Statement of Legislative Commissioners: |
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| 188 | + | Section 2(b) was reorganized for clarity. |
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| 189 | + | Substitute Bill No. 694 |
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| 190 | + | |
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| 191 | + | |
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| 196 | + | GL Joint Favorable Subst. |
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