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General Assembly Raised Bill No. 1355
January Session, 2025
LCO No. 5153
Referred to Committee on GENERAL LAW
Introduced by:
(GL)
AN ACT CONCERNING PRESCRIPTION DRUGS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective from passage) (a) As used in this section: 1
(1) "Component" means any active or nonactive ingredient of a drug 2
product; 3
(2) "Nonsterile compounded pharmaceutical product" means a drug 4
product produced by compounding one or more components; and 5
(3) "Nonsterile compounding pharmacy" means a pharmacy that is 6
licensed pursuant to section 20-594 of the general statutes and dispenses 7
nonsterile compounded pharmaceutical products. 8
(b) The Commissioner of Consumer Protection, in consultation with 9
the Commission of Pharmacy, shall adopt regulations, in accordance 10
with the provisions of chapter 54 of the general statutes, to: 11
(1) Ensure that nonsterile compounding pharmacies are able to 12
engage in nonsterile compounding (A) in accordance with (i) the laws 13
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and regulations of this state, and (ii) all applicable provisions of United 14
States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – 15
Nonsterile Preparations, as amended from time to time, and (B) to 16
maintain patients' ability to readily access nonsterile compounded 17
pharmaceutical products that include (i) levonorgestrel, mifepristone or 18
misoprostol as an active ingredient, or (ii) an active ingredient that is 19
similar to levonorgestrel, mifepristone or misoprostol; and 20
(2) Provide for the Department of Consumer Protection, or one or 21
more public-private partnerships between the department and one or 22
more private entities, to import levonorgestrel, mifepristone and 23
misoprostol as a drug product and as a component, and to import drug 24
products and components that are similar to levonorgestrel, 25
mifepristone and misoprostol, to ensure that patients are able to readily 26
access drug products, including, but not limited to, nonsterile 27
compounded pharmaceutical products, that include (A) levonorgestrel, 28
mifepristone or misoprostol as an active ingredient, or (B) an active 29
ingredient that is similar to levonorgestrel, mifepristone or misoprostol. 30
(c) Notwithstanding the requirements of sections 4-168 to 4-172, 31
inclusive, of the general statutes, in order to effectuate this section, prior 32
to adopting regulations pursuant to subsection (b) of this section, the 33
Commissioner of Consumer Protection shall issue policies and 34
procedures to implement the provisions of this section that shall have 35
the force and effect of law. The commissioner shall post all policies and 36
procedures on the Department of Consumer Protection's Internet web 37
site and submit such policies and procedures to the Secretary of the State 38
for posting on the eRegulations System, at least fifteen days prior to the 39
effective date of any such policy or procedure. Any such policy or 40
procedure shall no longer be effective upon the earlier of either the 41
adoption of the policy or procedure as a final regulation under section 42
4-172 of the general statutes or forty-eight months after the effective date 43
of this section, if such regulation has not been submitted to the 44
legislative regulation review committee for consideration under section 45
4-170 of the general statutes. 46
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Sec. 2. Section 21a-70i of the general statutes is repealed and the 47
following is substituted in lieu thereof (Effective from passage): 48
(a) On and after October 1, 2023, a pharmaceutical manufacturer that 49
employs a pharmaceutical representative shall register annually with 50
the department as a pharmaceutical marketing firm, in a form and 51
manner prescribed by the commissioner. No pharmaceutical 52
manufacturer shall authorize an individual to perform the duties of a 53
pharmaceutical representative on such manufacturer's behalf unless 54
such manufacturer has obtained a pharmaceutical marketing firm 55
registration from the department pursuant to this section. Registrations 56
issued pursuant to this section shall expire annually on June thirtieth. 57
(b) The nonrefundable fee for registration as a pharmaceutical 58
marketing firm and for annual renewal of such registration shall be one 59
hundred fifty dollars. Any pharmaceutical marketing firm that fails to 60
renew its registration on or before June thirtieth shall pay a late fee of 61
one hundred dollars for each year that such firm did not renew, in 62
addition to the annual renewal fee required under this section. 63
(c) On the date of its initial registration, and annually thereafter, each 64
pharmaceutical marketing firm shall provide to the department a list of 65
all pharmaceutical representatives employed or compensated by such 66
firm. Each pharmaceutical marketing firm shall notify the department, 67
in a form and manner prescribed by the commissioner, of each 68
individual who is no longer employed or compensated as a 69
pharmaceutical representative or who was hired or compensated as a 70
pharmaceutical representative after the date on which such firm 71
provided such annual list, not later than two weeks after such individual 72
leaves employment or was hired or otherwise compensated. 73
[(d) The department shall prominently post on its Internet web site 74
the most recent list provided by each pharmaceutical marketing firm 75
pursuant to subsection (c) of this section.] 76
[(e)] (d) Any person who is not identified to the department pursuant 77
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to subsection (c) of this section shall not perform the duties of a 78
pharmaceutical representative on behalf of the pharmaceutical 79
marketing firm. 80
[(f)] (e) Not later than July 1, 2024, and annually thereafter, each 81
pharmaceutical marketing firm shall provide the commissioner with the 82
following information regarding the performance for the previous 83
calendar year of each of its pharmaceutical representatives identified to 84
the department pursuant to subsection (c) of this section at any time 85
during the previous calendar year, in a form and manner prescribed by 86
the commissioner: 87
(1) The aggregate number of contacts such pharmaceutical 88
representative had with prescribing practitioners and pharmacists; 89
(2) The specialty of such prescribing practitioner and each pharmacist 90
with whom such pharmaceutical representative made contact; 91
(3) Whether product samples, materials or gifts of any value were 92
provided to a prescribing practitioner or such practitioner's staff in a 93
prescribing practitioner's office or to a pharmacist; and 94
(4) An aggregate report of all free samples, by drug name and 95
strength, in a form and manner prescribed by the commissioner. 96
[(g)] (f) The department shall annually compile a report on the 97
activities of pharmaceutical marketing firms in the state. Not later than 98
December 31, 2024, and annually thereafter, the department shall post 99
such report on its Internet web site and submit such report to the 100
Secretary of the Office of Policy and Management. 101
Sec. 3. (NEW) (Effective from passage) (a) A veterinarian licensed in 102
accordance with the provisions of chapter 384 of the general statutes 103
may authorize a person to dispense a prescription veterinary drug, 104
provided: 105
(1) The prescription veterinary drug is dispensed (A) upon the lawful 106
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written or oral order of the veterinarian acting in the course of the 107
veterinarian's professional practice, as required under Section 503(f) of 108
the Federal Food, Drug and Cosmetic Act, as amended from time to 109
time, (B) in accordance with all applicable state and federal laws and 110
regulations concerning the dispensing of prescription veterinary drugs, 111
and (C) for an animal for which the veterinarian, or another veterinarian 112
in the same practice who is licensed in accordance with the provisions 113
of chapter 384 of the general statutes and has access to the animal's 114
medical records, has established a veterinarian-client-patient 115
relationship; and 116
(2) The person is working under the direct supervision of the 117
veterinarian or another veterinarian described in subparagraph (C) of 118
subdivision (1) of this subsection. 119
(b) A veterinarian who authorizes a person to dispense a prescription 120
veterinary drug in accordance with the provisions of subsection (a) of 121
this section shall be responsible for ensuring that all applicable 122
requirements for dispensing such prescription veterinary drug are 123
satisfied. 124
(c) The Commissioner of Public Health, in consultation with the 125
Connecticut Board of Veterinary Medicine and the Commissioner of 126
Consumer Protection, may adopt regulations, in accordance with the 127
provisions of chapter 54 of the general statutes, to implement the 128
provisions of this section. 129
This act shall take effect as follows and shall amend the following
sections:
Section 1 from passage New section
Sec. 2 from passage 21a-70i
Sec. 3 from passage New section
Statement of Purpose:
To (1) require the Commissioner of Consumer Protection to adopt
regulations to (A) ensure that nonsterile compounding pharmacies are
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able to engage in nonsterile compounding of drug products that include
levonorgestrel, mifepristone, misoprostol or a similar component as an
active ingredient, and (B) provide for the Department Consumer
Protection, or one or more public-private partnerships, to import
levonorgestrel, mifepristone, misoprostol and similar drug products
and components, (2) eliminate a provision requiring the department to
prominently post on its Internet web site certain information concerning
pharmaceutical representatives, and (3) authorize certain persons
working under the direct supervision of veterinarians to dispense
prescription veterinary drugs.
[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
underlined.]