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Sen. Pamela J. Althoff
Filed: 5/7/2013
| | 09800HB0084sam001 | | LRB098 02833 MGM 45570 a |
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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:
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| 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, as defined in Section 356c of the Federal Food, |
| 10 | | Drug, and Cosmetic Act, listed on the drug shortage list |
| 11 | | maintained by the U.S. Food and Drug Administration in |
| 12 | | accordance with Section 356e of the Federal Food, Drug, and |
| 13 | | Cosmetic Act. |
| 14 | | (b) Any person engaged in the wholesale distribution of a |
| 15 | | drug in shortage in this State must be licensed by the |
| 16 | | Department. |
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| | 09800HB0084sam001 | - 2 - | LRB098 02833 MGM 45570 a |
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| 1 | | (c) It is unlawful for any person, other than a |
| 2 | | manufacturer, a manufacturer's exclusive distributor, a third |
| 3 | | party logistics provider, or an authorized distributor of |
| 4 | | record, to purchase or receive a drug in shortage from any |
| 5 | | person not licensed by the Department. This subsection (c) does |
| 6 | | not apply to the return of drugs or the purchase or receipt of |
| 7 | | drugs pursuant to any of the distributions that are |
| 8 | | specifically excluded from the definition of "wholesale |
| 9 | | distribution" in Section 15 of the Wholesale Drug Distribution |
| 10 | | Licensing Act. |
| 11 | | (d) A person found to have violated a provision of this |
| 12 | | Section shall be subject to administrative fines, orders for |
| 13 | | restitution, and orders for disgorgement. |
| 14 | | (e) The Department shall create a centralized, searchable |
| 15 | | database of those entities licensed to engage in wholesale |
| 16 | | distribution, including manufacturers, wholesale distributors, |
| 17 | | and pharmacy distributors, to enable purchasers of a drug in |
| 18 | | shortage to easily verify the licensing status of an entity |
| 19 | | offering such drugs. |
| 20 | | (f) The Department shall establish a system for reporting |
| 21 | | the suspected instances of unscrupulous conduct by |
| 22 | | distributors of a drug in shortage. Reports made through this |
| 23 | | system shall be referred to the Office of the Attorney General |
| 24 | | for further investigation and prosecution. |
| 25 | | (g) The Department shall adopt rules to carry out the |
| 26 | | provisions of this Section.
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