Rep. Jack D. Franks
Filed: 3/11/2013
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1 | AMENDMENT TO HOUSE BILL 84
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2 | AMENDMENT NO. ______. Amend House Bill 84 by replacing | ||||||
3 | everything after the enacting clause with the following:
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4 | "Section 5. The Wholesale Drug Distribution Licensing Act | ||||||
5 | is amended by adding Section 200 as follows: | ||||||
6 | (225 ILCS 120/200 new) | ||||||
7 | Sec. 200. Drugs in shortage. | ||||||
8 | (a) For the purpose of this Section, "drug in shortage" | ||||||
9 | means a drug listed on the drug shortage list maintained by the | ||||||
10 | U.S. Food and Drug Administration in accordance with Section | ||||||
11 | 356e of the federal Food, Drug, and Cosmetic Act. | ||||||
12 | (b) Any person engaged in the wholesale distribution of a | ||||||
13 | drug in shortage must be licensed by the Department. This | ||||||
14 | subsection (b) shall not apply to entities within the normal | ||||||
15 | distribution channel as defined under Section 15 of this Act. | ||||||
16 | (c) It is unlawful for any person, other than those |
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1 | licensed as a manufacturer, a manufacturer's exclusive | ||||||
2 | distributor, or an authorized distributor of record, to | ||||||
3 | purchase or receive a drug in shortage from any person not | ||||||
4 | licensed by the Department. This subsection (c) does not apply | ||||||
5 | to the return of drugs. | ||||||
6 | (d) A person found to have violated a provision of this | ||||||
7 | Section shall be subject to administrative fines, orders for | ||||||
8 | restitution, and orders for disgorgement. | ||||||
9 | (e) The Department shall create a centralized, searchable | ||||||
10 | database of those entities licensed to sell or distribute a | ||||||
11 | drug in shortage, including manufacturers, wholesale | ||||||
12 | distributors, and pharmacy distributors, to enable purchasers | ||||||
13 | of a drug in shortage to easily verify the licensing status of | ||||||
14 | an entity offering such drugs. | ||||||
15 | (f) The Department shall establish a system for reporting | ||||||
16 | the suspected instances of unscrupulous conduct by | ||||||
17 | distributors of a drug in shortage. Reports made through this | ||||||
18 | system shall be referred to the Office of the Attorney General | ||||||
19 | for further investigation and prosecution. | ||||||
20 | (g) The Department shall adopt rules to carry out the | ||||||
21 | provisions of this Section.
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22 | Section 99. Effective date. This Act takes effect upon | ||||||
23 | becoming law.".
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