Bill Text: IL HB4771 | 2019-2020 | 101st General Assembly | Introduced
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.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2020-02-18 - Referred to Rules Committee [HB4771 Detail]
Download: Illinois-2019-HB4771-Introduced.html
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1 | AN ACT concerning health.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Illinois Food, Drug and Cosmetic Act is | |||||||||||||||||||
5 | amended by adding Section 3.24 as follows:
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6 | (410 ILCS 620/3.24 new) | |||||||||||||||||||
7 | Sec. 3.24. Active pharmaceutical ingredients. A | |||||||||||||||||||
8 | manufacturer of a prescription drug that is sold, offered for | |||||||||||||||||||
9 | sale, or distributed in this State, or placed on a formulary to | |||||||||||||||||||
10 | be eligible for payment, co-payment, or reimbursement in this | |||||||||||||||||||
11 | State, must notify the Department of Public Health of the | |||||||||||||||||||
12 | following: | |||||||||||||||||||
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 |
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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.
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