Bill Text: IL HB3882 | 2011-2012 | 97th General Assembly | Introduced
Bill Title: Creates the Life-Saving Drug Shortage Prevention Act. Provides that a notification to the Director of Public Health shall be required from a manufacturer of a drug concerning a discontinuance, interruption, or adjustment of the manufacture of a drug that would likely result in a shortage. Provides that the notification shall be required at least 6 months prior to the date of the discontinuance or planned interruption or adjustment, and in the case of any other interruption or adjustment a notification shall be required as soon as possible. Provides that the Director may modify the time frames. Provides that the Director shall implement evidence-based criteria for identifying drugs that may be vulnerable to a shortage, and sets forth certain criteria. Sets forth provisions concerning public notification. Effective immediately.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Failed) 2013-01-08 - Session Sine Die [HB3882 Detail]
Download: Illinois-2011-HB3882-Introduced.html
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1 | AN ACT concerning public 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 1. Short title. This Act may be cited as the | |||||||||||||||||||
5 | Life-Saving Drug Shortage Prevention Act.
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6 | Section 5. Purpose. In order to prevent the shortages of | |||||||||||||||||||
7 | drugs in this State, the General Assembly finds that creating a | |||||||||||||||||||
8 | system for notifying the Department of Public Health concerning | |||||||||||||||||||
9 | the discontinuance or interruption of the manufacture of a drug | |||||||||||||||||||
10 | is necessary.
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11 | Section 10. Definitions. In this Act. | |||||||||||||||||||
12 | "Adjustment", with respect to the notification | |||||||||||||||||||
13 | requirements of this Act, means an adjustment related to the | |||||||||||||||||||
14 | supply or raw materials and active pharmaceutical ingredients, | |||||||||||||||||||
15 | product capabilities, and business decisions that may affect | |||||||||||||||||||
16 | the manufacture of a drug. "Adjustment" includes any other | |||||||||||||||||||
17 | adjustments as determined appropriate by the Director. | |||||||||||||||||||
18 | "Department" means the Department of Public Health. | |||||||||||||||||||
19 | "Director" means the Director of Public Health. | |||||||||||||||||||
20 | "Drug" has the same meaning as defined in the Illinois | |||||||||||||||||||
21 | Food, Drug and Cosmetic Act. | |||||||||||||||||||
22 | "Drug shortage" or "shortage", when used with respect to a |
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1 | drug, means a period of time when the total supply of all | ||||||
2 | versions of a drug available at the user level will not meet | ||||||
3 | the current demand for the drug at that user level. | ||||||
4 | "Notification" means the required reporting of a | ||||||
5 | manufacturer of a drug to the Director of a discontinuance, | ||||||
6 | interruption, or adjustment of the manufacture of a drug that | ||||||
7 | would likely result in a shortage.
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8 | Section 15. Notifications. | ||||||
9 | (a) A notification to the Director shall be required from a | ||||||
10 | manufacturer of a drug concerning a discontinuance, | ||||||
11 | interruption, or adjustment of the manufacture of a drug that | ||||||
12 | would likely result in a shortage. | ||||||
13 | (b) The notification required under subsection (a) of this | ||||||
14 | Section shall be required at least 6 months prior to the date | ||||||
15 | of the discontinuance or planned interruption or adjustment, | ||||||
16 | and in the case of any other interruption or adjustment a | ||||||
17 | notification shall be required as soon as possible. | ||||||
18 | (c) The Director may modify the time frames depending on | ||||||
19 | the type of interruption or adjustment or any other factor as | ||||||
20 | determined to be appropriate.
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21 | Section 20. Identification of potential shortages.
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22 | (a) The Director shall implement evidence-based criteria | ||||||
23 | for identifying drugs that may be vulnerable to a shortage. The | ||||||
24 | criteria shall be based on the following: |
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1 | (1) the number of manufacturers of the drug; | ||||||
2 | (2) the sources of raw materials and active ingredients | ||||||
3 | for the drug; | ||||||
4 | (3) the supply chain characteristics of the drug; and | ||||||
5 | (4) the availability of therapeutic alternatives to | ||||||
6 | the drug. | ||||||
7 | (b) Using the criteria established in subsection (a) of | ||||||
8 | this Section, the Director shall determine if a drug may be | ||||||
9 | vulnerable to a shortage and notify the manufacturer of the | ||||||
10 | drug of this determination.
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11 | Section 25. Public notification.
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12 | (a) The Director shall make available to the public | ||||||
13 | up-to-date notifications of any shortage or adjustments | ||||||
14 | concerning which a notification is required. | ||||||
15 | (b) The information to the public regarding the | ||||||
16 | notifications shall be displayed on the Department's Internet | ||||||
17 | website. | ||||||
18 | (c) Notification information shall be distributed to | ||||||
19 | appropriate health care provider and patient organizations by | ||||||
20 | the Department to the maximum extent practicable. | ||||||
21 | (d) The Director shall honor the privacy of proprietary | ||||||
22 | information submitted in the notifications and exclude such | ||||||
23 | information from the public notification.
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24 | Section 99. Effective date. This Act takes effect upon | ||||||
25 | becoming law.
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