HB0084enr 98TH GENERAL ASSEMBLY

HB0084 Enrolled LRB098 02833 RPM 32842 b

AN ACT concerning public health.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

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.

Section 99. Effective date. This Act takes effect upon becoming law.