§ 391.3. Definitions
Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 63 P.S. Professions and Occupations (State Licensed)
63 P.S. § 391.3
§ 391.3. Definitions
The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:
“Blood.” Whole blood collected from a single donor and processed either for transfusion or further manufacturing.
“Blood component.” That part of blood separated by physical or mechanical means.
“Common control.” The power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract or otherwise.
“Department.” The Department of Health of the Commonwealth.
“Drug sample.” A unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
“Intracompany sales.” A transaction or transfer between any division, subsidiary, parent or affiliated or related company under the common ownership and control of a corporate entity.
“License.” A wholesale prescription drug distributor license.
“Manufacturer.” Any entity engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug.
“Prescription drug.” Any human drug required by Federal law, the act of April 14, 1972 (P.L. 233, No. 64), known as The Controlled Substance, Drug, Device and Cosmetic Act,1 or regulations promulgated under either, 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 (52 Stat. 1040, 21 U.S.C. § 503(b)).
“Wholesale distribution of prescription drugs.” Distribution in interstate commerce of prescription drugs to persons other than a consumer or patient, and distribution by a manufacturer, who is a licensee under this act, of prepackaged dialysis supplies and solutions directly to a self-administering dialysis patient, who is under the care of a physician, at the patient's residence. Notwithstanding the foregoing, the phrase does not include:
(3) 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 1986 (Public Law 99-514, 26 U.S.C. § 501(c)(3)) to a nonprofit affiliate of the organization to the extent otherwise permitted by law.
“Wholesale distributor of prescription drugs.” A person who operates a facility from which a person engages in the wholesale distribution of prescription drugs, including, but not limited to, manufacturers, repackers, own-label distributors, private-label distributors or jobbers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses and wholesale drug warehouses, independent wholesale drug traders and retail pharmacies that conduct wholesale distributions.
1992, Dec. 14, P.L. 1116, No. 145, § 3, imd. effective. Amended 1999, Nov. 10, P.L. 489, No. 44, § 1, imd. effective.
35 P.S. § 780-101 et seq.
63 P.S. § 391.3, PA ST 63 P.S. § 391.3
Current through 2023 Regular Session Act 32. Some statute sections may be more current, see credits for details.
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