Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-5-2 - Definitions2.1. Except as otherwise specifically stated in this rule, the definitions set forth in Title 15, Series 1, Section 2 are incorporated by reference as if set forth fully herein, and are fully applicable hereto.2.2. "Affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly: 2.2.1. one business entity controls, or has the power to control, the other business entity; or2.2.2. a third party controls, or has the power to control, both of the business entities.2.3. "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.2.4. "Blood component" means that part of blood separated by physical or mechanical means.2.5. "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.2.6. "Healthcare entity" means any person or entity that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or any wholesale drug distributor. Except as provided in § 203.22(h) and (i) of Chapter 21 of the Code of Federal Regulations (2020), a person cannot simultaneously be a "healthcare entity" and a retail pharmacy or wholesale drug distributor.2.7. "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.2.8. "Outsourcing facility" means a facility engaged in manufacturing by compounding of sterile or non-sterile drugs which has registered with the Federal Food and Drug Administration as an outsourcing facility pursuant to Section 5 03 B of the Federal Drug Quality and Security Act.2.9. "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.2.10. "Third-party logistics provider" means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.2.11. "Wholesale distribution" means distribution of prescription drugs, including directly or through the use of a third-party logistics provider or any other situation in which title, ownership, or control over the prescription drug remains with one person or entity but the prescription drug is brought into this state by another entity on their behalf, to persons other than a consumer or patient, but does not include:2.11.1 Intracompany sales, (which include but are not limited to a transaction or transfer between any division, subsidiary, parent and/or affiliated or related company under the common ownership and control of a corporate entity;)2.11.2. 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, (except that the gross dollar amount shall not exceed five percent of the total prescription drug sales revenue of either the transferor or transferee pharmacy during any consecutive twelve month period);2.11.3. The distribution of drug samples by manufacturers' representatives or distributors' representatives;2.11.4. The sale, purchase, or trade of blood and blood components intended for transfusion;2.11.5. 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;2.11.6. 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 organization;2.11.7- 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 United States Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;2.11.8. 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, voting rights, by contract, or otherwise;2.11.9. Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with § 203.23 of Title 21 of the Code of Federal Regulations (2020); or2.11.10. The sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use (except that the gross dollar amount shall not exceed five percent of the total prescription drug sales revenue of either the transferor or transferee pharmacy during any consecutive twelve month period).2.12. "Wholesale drug distributor" means any person or entity engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own label distributors; private-label distributors; reverse distributors, jobbers; brokers; warehouses, including manufacturers' and distributors' 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/or their providers, health maintenance organizations and other health care providers, and retail and hospital pharmacies that conduct wholesale distributions. A wholesale drug distributor shall not include any for hire carrier or person or entity hired solely to transport prescription drugs.