Industry Terms Glossary

Latest Industry Terms Added

Wholesale Distributor

Any person engaged in wholesale distribution of prescription 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.

Wholesale distribution

Distribution of prescription drugs to persons other than a consumer or patient, but does not include: (1) Intracompany sales; (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 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; (6) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug under a prescription executed in accordance with section 503(b) of the act; (7) The distribution of drug samples by manufacturers' and authorized distributors' representatives; (8) The sale, purchase, or trade of blood or blood components intended for transfusion; (9) Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with 203.23; or (10) The sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use.

Unauthorized Distributor

A distributor who does not have an ongoing relationship with a manufacturer to sell or distribute its products.

Shelf-Life

The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.

Serious Adverse Reaction

Any reaction occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious adverse reactions when, based upon appropriate medical judgment, they may jeopardize the patient or subject, and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.