225 ILCS 120/15
As used in this Act:
"Address of record" means the designated address recorded by the Department in the applicant's application file or licensee's license file maintained by the Department's licensure maintenance unit.
"Authentication" means the affirmative verification, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree has occurred.
"Authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to exist between a wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with the following:
"Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by physical or mechanical means.
"Board" means the State Board of Pharmacy of the Department of Financial and Professional Regulation.
"Chain pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of the drugs to a group of chain or mail order pharmacies that have the same common ownership and control. Notwithstanding any other provision of this Act, a chain pharmacy warehouse shall be considered part of the normal distribution channel.
"Co-licensed partner or product" means an instance where one or more parties have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the FDA's implementation of the Prescription Drug Marketing Act.
"Department" means the Department of Financial and Professional Regulation.
"Drop shipment" means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug or that manufacturer's co-licensed product partner, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor or by an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities whereby the wholesale distributor or chain pharmacy warehouse takes title but not physical possession of such prescription drug and the wholesale distributor invoices the pharmacy, chain pharmacy warehouse, or other person authorized by law to dispense or administer such drug to a patient and the pharmacy, chain pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor or from an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities.
"Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
"Email address of record" means the designated email address recorded by the Department in the applicant's application file or the licensee's license file, as maintained by the Department's licensure maintenance unit.
"Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale, or a facility of a third-party logistics provider where prescription drugs are stored or handled.
"FDA" means the United States Food and Drug Administration.
"Manufacturer" means a person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" set forth in the FDA's regulations and guidances implementing the Prescription Drug Marketing Act. "Manufacturer" does not include anyone who is engaged in the packaging, repackaging, or labeling of drugs only to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
"Manufacturer's exclusive distributor" means anyone who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug. A manufacturer's exclusive distributor must be licensed as a wholesale distributor under this Act and, in order to be considered part of the normal distribution channel, must also be an authorized distributor of record.
"Normal distribution channel" means a chain of custody for a prescription drug that goes, directly or by drop shipment, from (i) a manufacturer of the prescription drug, (ii) that manufacturer to that manufacturer's co-licensed partner, (iii) that manufacturer to that manufacturer's third-party logistics provider, or (iv) that manufacturer to that manufacturer's exclusive distributor to:
"Person" means and includes a natural person, partnership, association, corporation, or any other legal business entity.
"Pharmacy distributor" means any pharmacy licensed in this State or hospital pharmacy that is engaged in the delivery or distribution of prescription drugs either to any other pharmacy licensed in this State or to any other person or entity including, but not limited to, a wholesale drug distributor engaged in the delivery or distribution of prescription drugs who is involved in the actual, constructive, or attempted transfer of a drug in this State to other than the ultimate consumer except as otherwise provided for by law.
"Prescription drug" means any human drug, including any biological product (except for blood and blood components intended for transfusion or biological products that are also medical devices), required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to Section 503 of the Federal Food, Drug and Cosmetic Act.
"Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding that completed by the pharmacist responsible for dispensing the product to a patient.
"Secretary" means the Secretary of the Department of Financial and Professional Regulation.
"Suspicious order" includes, but is not limited to, an order of a controlled substance of unusual size, an order of a controlled substance deviating substantially from a normal pattern, and orders of controlled substances of unusual frequency as defined by 21 U.S.C. 802.
"Third-party logistics provider" means anyone who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition.
"Wholesale distribution" means the distribution of prescription drugs to persons other than a consumer or patient, but does not include any of the following:
225 ILCS 120/15