63 Pa. Stat. § 391.3

Current through Pa Acts 2024-53, 2024-56 through 2024-111

Section 391.3 - [Effective 4/14/2025] 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, or regulations promulgated under either, to be dispensed only by a prescription, including finished dosage forms and active ingredients subject tosection 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:

(1) Intracompany sales or joining together of five or fewer pharmacies to place a direct order of medicine from the pharmaceutical manufacturer.

(2) 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 such organizations.

(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.

(4) 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.

(5) The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons, including transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.

(6) 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.

(7) The distribution of drug samples by manufacturers' representatives or distributors' representatives.

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

(9) The sale of minimal quantities of prescription drugs by a retail pharmacy to licensed practitioners for use within their practice when the sales do not exceed 5% of that retail pharmacy's total annual prescription drug sales.

"Virtual manufacturer." A person with a place of business located in this Commonwealth in the business of manufacturing and distributing a drug or medical device that:

(1) Holds the drug or device approval and label code or is otherwise identified on the product label from the United States Food and Drug Administration.

(2) At no time takes physical possession of any drug or device in this Commonwealth.

"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, virtual 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.

63 P.S. § 391.3

Amended by P.L. (number not assigned at time of publication) 2024 No. 101,§ 1, eff. 4/14/2025.

1992, Dec. 14, P.L. 1116, No. 145, § 3, imd. effective. Amended 1999, Nov. 10, P.L. 489, No. 44, § 1, imd. effective.

This section is set out more than once due to postponed, multiple, or conflicting amendments.