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General Assembly Substitute Bill No. 262
January Session, 2021
AN ACT REQUIRING MAN UFACTURERS OF BRAND NAME
PRESCRIPTION DRUGS T O PROVIDE SAMPLES OF SUCH DRUGS
TO MANUFACTURERS OF GENERIC PRESCRIPTION DRUGS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective October 1, 2021) (a) As used in this section: 1
(1) "Eligible product developer" means a person who seeks to develop 2
an application for the approval of a drug under subsections (b) and (j) 3
of Section 505 of the federal Food, Drug and Cosmetic Act or the 4
licensing of a biological product under Section 351 of the federal Public 5
Health Service Act, and (2) "wholesale acquisition cost" means the 6
manufacturer's list price for a brand-name drug or a generic drug per 7
person, year or course of treatment, when sold to wholesalers or direct 8
purchasers in the United States, not including discounts or rebates, for 9
the most recent month for which information is available. 10
(b) A manufacturer or wholesaler registered under chapter 417 of the 11
general statutes shall make a drug manufactured or developed by such 12
manufacturer or wholesaler and distributed in this state available for 13
sale in this state to an eligible product developer for purposes of 14
conducting testing required to support an application by such eligible 15
product developer for approval of a drug under subsections (b) and (j) 16
of Section 505 of the federal Food, Drug and Cosmetic Act, or the 17
licensing of a biological product under Section 351 of the federal Public 18
Health Service Act. Such manufacturer or wholesaler shall make the 19 Substitute Bill No. 262
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drug available for sale to such eligible product developer at a price not 20
greater than the wholesale acquisition cost of the drug and without any 21
restriction that would block or delay the eligible product developer's 22
application in a manner inconsistent with Section 505-1(f)(8) of the 23
federal Food, Drug and Cosmetic Act. 24
(c) An eligible product developer that receives a drug at a price not 25
greater than the wholesale acquisition cost for such drug pursuant to 26
this section shall charge consumers in this state the same price or less 27
for the drug manufactured by such eligible product developer. 28
(d) A manufacturer or wholesaler registered under chapter 417 of the 29
general statutes shall not be liable for injuries alleged to have been 30
caused by the failure of the eligible product developer to include 31
adequate safety warnings on a product's label or by a defect in the 32
product's design if (1) such manufacturer or wholesaler has made the 33
product distributed in this state available to an eligible product 34
developer in accordance with the provisions of this section, and (2) the 35
product was not manufactured or sold by such manufacturer or 36
wholesaler. 37
(e) A violation of any of the provisions of subsection (b) or (c) of this 38
section shall be deemed an unfair or deceptive trade practice under 39
subsection (a) of section 42-110b of the general statutes. 40
This act shall take effect as follows and shall amend the following
sections:
Section 1 October 1, 2021 New section
GL Joint Favorable Subst. -LCO
JUD Joint Favorable
APP Joint Favorable