02-392-1 Me. Code R. § 1-36

Current through 2024-51, December 18, 2024
Section 392-1-1-36 - Wholesale distribution

"Wholesale distribution" is the distribution of prescription drugs by wholesale distributors to persons other than consumers or patients, but does not include:

1. Intra company sales, which include any internal sales transaction or transfer with any division, subsidiary, parent and affiliated or related company under the common ownership and control as the transferor;
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 1954 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; 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;
5. 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;
6. The sale of a drug by a retail pharmacy to licensed practitioners for office use when the total annual dollar volume of prescription drugs sold to licensed practitioners does not exceed five (5) percent of that pharmacy's total annual prescription drug sales;
7. 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;
8. The distribution of drug samples by manufacturers' representatives or distributors' representatives;
9. The sale, purchase or trade of blood and blood components intended for transfusion; or
10. Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with 21 CFR §203.23.

02-392 C.M.R. ch. 1, § 1-36