Illinois General Assembly - Bill Status for HB0084

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.

Replaces everything after the enacting clause. Amends the Wholesale Drug Distribution Licensing Act. Sets forth a definition of "drug in shortage". Provides that any person engaged in the wholesale distribution of a drug in shortage must be licensed by the Department of Financial and Professional Regulation. Provides that the provision concerning licensure shall not apply to entities within the normal distribution channel as defined under the Act. Provides that, except with regard to the return of drugs, it is unlawful for any person, other than those licensed as a manufacturer, a manufacturer's exclusive distributor, or an authorized distributor of record, to purchase or receive a drug in shortage from any person not licensed by the Department. Provides that a person found to have violated a provision concerning drugs in shortage shall be subject to administrative fines, orders for restitution, and orders for disgorgement. Requires the Department to (1) create a centralized, searchable database of those entities licensed to sell or distribute a drug in shortage, 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; (2) establish a system for reporting the suspected instances of unscrupulous conduct by distributors of a drug in shortage to the Office of the Attorney General; and (3) adopt rules to carry out the provisions concerning drugs in shortage. Effective immediately.

Replaces everything after the enacting clause. Reinserts the language of the engrossed bill. Changes the definition of "drug in shortage". Provides that any person engaged in the wholesale distribution of a drug in shortage in the State (previously was a drug in shortage without reference to the State) must be licensed by the Department of Financial and Professional Regulation. Provides that, except with regard to the return of drugs, 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 (previously did not include third party logistics providers). Requires the Department to (1) create a centralized, searchable database of those entities licensed to engage in wholesale distribution (previously to "sell or distribute a drug in shortage"), 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; (2) establish a system for reporting the suspected instances of unscrupulous conduct by distributors of a drug in shortage to the Office of the Attorney General; and (3) adopt rules to carry out the provisions concerning drugs in shortage. Effective immediately.

Provides that the Department of Financial and Professional Regulation shall establish a system for reporting the reasonable suspicion that a violation of the Act has been committed by a distributor (was previously "suspected instances of unscrupulous conduct") by distributors of a drug in shortage to the Office of the Attorney General and the appropriate State's Attorney's office (previously excluded the State's Attorney).

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