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| Public Act 098-0355 | ||||
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AN ACT concerning public health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Wholesale Drug Distribution Licensing Act is | ||||
amended by adding Section 200 as follows: | ||||
(225 ILCS 120/200 new) | ||||
Sec. 200. Drugs in shortage. | ||||
(a) For the purpose of this Section, "drug in shortage" | ||||
means a drug, as defined in Section 356c of the Federal Food, | ||||
Drug, and Cosmetic Act, listed on the drug shortage list | ||||
maintained by the U.S. Food and Drug Administration in | ||||
accordance with Section 356e of the Federal Food, Drug, and | ||||
Cosmetic Act. | ||||
(b) Any person engaged in the wholesale distribution of a | ||||
drug in shortage in this State must be licensed by the | ||||
Department. | ||||
(c) It is unlawful for any person, other than a | ||||
manufacturer, a manufacturer's exclusive distributor, a third | ||||
party logistics provider, or an authorized distributor of | ||||
record, to purchase or receive a drug in shortage from any | ||||
person not licensed by the Department. This subsection (c) does | ||||
not apply to the return of drugs or the purchase or receipt of | ||||
drugs pursuant to any of the distributions that are | ||||
specifically excluded from the definition of "wholesale | ||
distribution" in Section 15 of the Wholesale Drug Distribution | ||
Licensing Act. | ||
(d) A person found to have violated a provision of this | ||
Section shall be subject to administrative fines, orders for | ||
restitution, and orders for disgorgement. | ||
(e) The Department shall create a centralized, searchable | ||
database of those entities licensed to engage in wholesale | ||
distribution, including manufacturers, wholesale distributors, | ||
and pharmacy distributors, to enable purchasers of a drug in | ||
shortage to easily verify the licensing status of an entity | ||
offering such drugs. | ||
(f) The Department shall establish a system for reporting | ||
the reasonable suspicion that a violation of this Act has been | ||
committed by a distributor of a drug in shortage. Reports made | ||
through this system shall be referred to the Office of the | ||
Attorney General and the appropriate State's Attorney's office | ||
for further investigation and prosecution. | ||
(g) The Department shall adopt rules to carry out the | ||
provisions of this Section. | ||
(h) Nothing in this Section prohibits one hospital pharmacy | ||
from purchasing or receiving a drug in shortage from another | ||
hospital pharmacy in the event of a medical emergency.
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Section 99. Effective date. This Act takes effect upon | ||
becoming law.
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