101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB4771

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.
LRB101 17711 CPF 69458 b

A BILL FOR

HB4771LRB101 17711 CPF 69458 b
1 AN ACT concerning health.
2 Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4 Section 5. The Illinois Food, Drug and Cosmetic Act is
5amended by adding Section 3.24 as follows:
6 (410 ILCS 620/3.24 new)
7 Sec. 3.24. Active pharmaceutical ingredients. A
8manufacturer of a prescription drug that is sold, offered for
9sale, or distributed in this State, or placed on a formulary to
10be eligible for payment, co-payment, or reimbursement in this
11State, must notify the Department of Public Health of the
12following:
13 (1) the country of origin for the active pharmaceutical
14 ingredient, in a searchable form by proprietary name, such
15 as a brand name, if one is associated with the drug
16 product, and ingredient name, such as a generic chemical
17 name; if the country of origin for a manufacturer varies
18 based on dosage or route of administration, each country of
19 origin shall be specified for each such dosage or route of
20 administration;
21 (2) the Drug Master File number for any angiotensin II
22 receptor blocker and certification that the active
23 ingredient specification contains a nitrosamine

HB4771- 2 -LRB101 17711 CPF 69458 b
1 specification of "Not Detected"; and
2 (3) the Drug Master File number and drug name for any
3 active pharmaceutical ingredient that contains a
4 nitrosamine specification control because the process of
5 manufacture for the active pharmaceutical ingredient makes
6 use of recycled solvents or catalysts.