(1) "Full line wholesaler" means any wholesaler authorized by the board to possess and sell legend drugs, controlled substances (additional registration required see WAC 246-879-080
) and nonprescription drugs (over-the-counter - OTC see WAC 246-879-070
) to a licensed pharmacy or other legally licensed or authorized person.
(2) "Over-the-counter only wholesaler" means any wholesaler authorized by the board to possess and sell nonprescription (OTC) drugs to any outlets licensed for resale.
(3) "Controlled substances wholesaler" means a licensed wholesaler authorized by the board to possess and sell controlled substances to a licensed pharmacy or other legally licensed or authorized person.
(4) "Export wholesaler" means any wholesaler authorized by the board to export legend drugs and nonprescription (OTC) drugs to foreign countries.
(5) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
(6) "Blood component" means that part of the blood separated by physical or mechanical means.
(7) "Drug sample" means a unit of prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
(8) "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, provided that a pharmacist compounding drugs to be dispensed from the pharmacy in which the drugs are compounded pursuant to prescriptions for individual patients shall not be considered a manufacturer.
(9) "Prescription drug" means any drug required by state or 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.
(10) "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not include:
(a) 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:
(b) The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives; or
(c) The sale, purchase, or trade of blood and blood components intended for transfusion.
(d) Intracompany sales, being 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, unless such transfer occurs between a wholesale distributor and a health care entity or practitioner.
(e) 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 retail pharmacy to another retail pharmacy or practitioner to alleviate a temporary shortage, except that the gross dollar value of such transfers shall not exceed five percent of the total prescription drug sale revenue of either the transferor or transferee pharmacy during any twelve consecutive month period.
(11) "Wholesale distributor" means anyone engaged in wholesale distribution of 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.
[Statutory Authority: RCW 18.64.005
. WSR 92-15-069 (Order 289B), § 246-879-010, filed 7/14/92, effective 8/14/92. Statutory Authority: RCW 18.64.005
and chapter 18.64A
RCW. WSR 91-18-057 (Order 191B), recodified as § 246-879-010, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005
(11) and 69.41.075
. WSR 82-06-042 (Order 165), § 360-21-010, filed 3/2/82.]