Illinois Administrative Code › Title 68 - PROFESSIONS AND OCCUPATIONS › Part 1510 - WHOLESALE DRUG DISTRIBUTION LICENSING ACT › Subpart A - GENERAL PROVISIONS › Section 1510.10 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"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.