Bill Text: IL HB1721 | 2021-2022 | 102nd General Assembly | Introduced

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Bill Title: Amends the Illinois Food, Drug and Cosmetic Act. Requires a manufacturer of a prescription drug that is sold, offered for sale, or distributed in this State, or placed on a formulary to be eligible for payment, co-payment, or reimbursement in this State, to notify the Department of Public Health of specified information concerning active pharmaceutical ingredients.

Sponsorship: Bipartisan Bill

Status: (Introduced - Dead) 2021-04-23 - Rule 19(a) / Re-referred to Rules Committee [HB1721 Detail]

Download: Illinois-2021-HB1721-Introduced.html

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102ND GENERAL ASSEMBLY State of Illinois 2021 and 2022 HB1721 Introduced , by Rep. Deanne M. Mazzochi SYNOPSIS AS INTRODUCED:
410 ILCS 620/3.24 new
Amends the Illinois Food, Drug and Cosmetic Act. Requires a manufacturer of a prescription drug that is sold, offered for sale, or distributed in this State, or placed on a formulary to be eligible for payment, co-payment, or reimbursement in this State, to notify the Department of Public Health of specified information concerning active pharmaceutical ingredients.
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A BILL FOR
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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Illinois Food, Drug and Cosmetic Act is
amended by adding Section 3.24 as follows:
(410 ILCS 620/3.24 new)
Sec. 3.24. Active pharmaceutical ingredients. A
manufacturer of a prescription drug that is sold, offered for
sale, or distributed in this State, or placed on a formulary to
be eligible for payment, co-payment, or reimbursement in this
State, must notify the Department of Public Health of the
following:
(1) the country of origin for the active
pharmaceutical ingredient, in a searchable form by
proprietary name, such as a brand name, if one is
associated with the drug product, and ingredient name,
such as a generic chemical name; if the country of origin
for a manufacturer varies based on dosage or route of
administration, each country of origin shall be specified
for each such dosage or route of administration;
(2) the Drug Master File number for any angiotensin II
receptor blocker and certification that the active
ingredient specification contains a nitrosamine

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specification of "Not Detected"; and
(3) the Drug Master File number and drug name for any
active pharmaceutical ingredient that contains a
nitrosamine specification control because the process of
manufacture for the active pharmaceutical ingredient makes
use of recycled solvents or catalysts.