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 Section 21a-319 of the general statutes is repealed and the 1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