Sec. 1510.10 - Definitions

ยง 1510.10. Definitions

"Act" means the Wholesale Drug Distribution Licensing Act [225 ILCS 120].

"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.

"Department" means the Illinois Department of Financial and Professional Regulation.

"Director" means the Director of the Division of Professional Regulation.

"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.

"Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.

"Prescription drug" means any human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act ( 21 USC 301 et seq.).

"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" or "wholesale distributions" means distribution of prescription drugs to a person other than a consumer or patient, but does not include:

Intracompany sales, defined as any transaction or transfer between any division, subsidiary, parent and/or affiliated or related company under the common ownership and control of a corporate entity;

The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of those organizations;

The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 ( 26 USC 501(c)(3)) to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug among hospitals or other health care entities that are under common control (for purposes of this Section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, or by contract, or otherwise);

The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons (for purposes of this Section, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage);

The sale, purchase or trade of a drug; an offer to sell, purchase or trade a drug; or the dispensing of a drug pursuant to a prescription;

The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives;

The sale, purchase or trade of blood and blood components intended for transfusion; or

The sale of prescription drugs by a pharmacy to practitioners (i.e., licensed physicians, dentists or podiatrists), providing the sales do not exceed 5% of the annual dollar purchases of prescription drugs by the pharmacy and providing the pharmacy maintains a log of sales to practitioners that includes date of sale; practioner's name and address; drug and strength; size of package; and quantity sold.

"Wholesale distributor" means anyone engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.

(Amended at 44 Ill. Reg. 3363, effective March 6, 2020)

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