[§328-112]  Definitions.  As used inthis part:

“Blood” means whole blood collected from asingle donor and processed either for transfusion or for further manufacturing.

“Blood component” means that part of bloodseparated by physical or mechanical means.

“Common control” means the power to direct orcause the direction of the management and policies of a person or anorganization, whether by ownership of stock, by voting rights, by contract, orotherwise.

“Department” means the department of health exceptwhen otherwise provided.

“Drug sample” means a unit of a prescriptiondrug that is not intended to be sold and is intended to promote the sale of thedrug.

“Manufacturer” means anyone who is engaged inmanufacturing, preparing, propagating, compounding, processing, packaging,repackaging, or labeling a prescription drug.

“Prescription drug” means any human drugrequired by federal or state statutes, regulations, or rules to be dispensedonly by a prescription, including finished dosage forms and active ingredientssubject to section 328-16 or to section 503(b) of the federal Food, Drug, andCosmetic Act.

“Wholesale distribution” means the distributionof prescription drugs to persons other than a consumer or patient, but does notinclude:

(1)  Intracompany sales, defined as any transaction ortransfer between an entity and any division, subsidiary, parent, or affiliatedor related company under common ownership and control;

(2)  The purchase or other acquisition, by a hospitalor other health care entity that is a member of a group purchasingorganization, of a drug for the entity’s own use, from the group purchasingorganization or from other hospitals or health care entities that are membersof the group purchasing organization;

(3)  The sale, purchase, or trade of a drug or anoffer to sell, purchase, or trade a drug by a charitable organization describedin section 501(c)(3) of the Internal Revenue Code of 1986, as amended, to anonprofit affiliate of the organization to the extent otherwise permitted bylaw;

(4)  The sale, purchase, or trade of a drug or anoffer to sell, purchase, or trade a drug among hospitals or other health careentities that are under common control;

(5)  The sale, purchase, or trade of a drug or anoffer to sell, purchase, or trade a drug for emergency medical reasons; forpurposes of this definition the term “emergency medical reasons” includes, butis not limited to, transfers of prescription drugs by a retail pharmacy toanother retail pharmacy to alleviate a temporary shortage, except that thegross dollar value of such transfers shall not exceed five per cent of thetotal prescription drug sales revenue of either the transferor or transfereepharmacy during any period of twelve consecutive months;

(6)  The sale, purchase, or trade of a drug, or anoffer to sell, purchase, or trade a drug, or the dispensing of a drug, pursuantto a prescription;

(7)  The distribution of drug samples bymanufacturers’ representatives or distributors’ representatives; or

(8)  The sale, purchase, or trade of blood and bloodcomponents intended for transfusion.

“Wholesale distributor” means any person orentity engaged in wholesale distribution of prescription drugs, including, butnot limited to, manufacturers; repackers; own-label distributors; jobbers;private label distributors; brokers; warehouses, including manufacturers’ anddistributors’ warehouses, chain drug warehouses, and wholesale drug warehouses;independent wholesale drug traders; prescription drug repackagers; physicians;dentists; veterinarians; birth control and other clinics; individuals;hospitals; nursing homes and their providers; health maintenance organizationsand other health care providers; and retail and hospital pharmacies thatconduct wholesale distributions.  The term “wholesale distributor” shall notinclude any carrier for hire or person or entity hired solely to transportprescription drugs. [L 1992, c 196, pt of §2]

 

Cross References

 

  Wholesale prescription drug distributor licenses, see§461-8.6.