102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
HB1721
 
Introduced 2/17/2021, 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.
  


LRB102 13487 CPF 18834 b

 
 
A BILL FOR
 

  
HB1721LRB102 13487 CPF 18834 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 
14    pharmaceutical ingredient, in a searchable form by 
15    proprietary name, such as a brand name, if one is 
16    associated with the drug product, and ingredient name, 
17    such as a generic chemical name; if the country of origin 
18    for a manufacturer varies based on dosage or route of 
19    administration, each country of origin shall be specified 
20    for each such dosage or route of 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 
 
 
HB1721- 2 -LRB102 13487 CPF 18834 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.