Basic Industry Terminology

Entity Description of activity
Manufacturer Manufactured the product. Approved application holder, or co-licensed partner of the approved application holder who obtained the product directly from the application holder or person who manufactured the product. Affiliate of manufacturer who obtained the product directly from the application holder or person who manufactured the product.
Repackager Ows or operates an establishment that repacks and relabels a product or package for future sale or distribution without a further transaction.
Wholesale Distributer Engaged in distribution of a drug to, or receipt of a drug by, a person other than a consumer or patient, with certain exceptions.
Third Party logistics Provider ( 3PL) Provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesaler distributor or dispense of a product, but does not take ownership of the product, not have responsibility to direct the sale or disposition of the product.
3T/T3 Transaction Information/Transaction History/Transaction Statement
TH- Transaction History: Single document starting with manufacturer • Includes Transaction Information for each transaction going back to the manufacturer Special versions of Transaction History possible for Direct Purchase wholesale distribution operations Electronic or paper (initially) • Electronic format required starting in 2017
TI- Transaction Information: • NDC • Product Name • Strength • Dosage Form • Container Size • Number of Containers • Lot Number (optional in certain scenarios) • Transaction Date (business transaction) • Shipment Date (if >24 hrs. from Trans Date) • Transfer From Party (business name & address) • Transfer To Party (business name & address) • Wholesaler Contact Information (for Drop Shipment)
TS- Transaction Statement: Statement attesting that party transferring ownership: • Is authorized and registered • Received product from authorized, registered party • Received Transaction Information and a Transaction Statement from the prior owner • Did not knowingly ship suspect or illegitimate product • Had systems and processes in place to comply with verification requirements • Did not knowingly provide false transaction info • Did not knowingly alter the transaction history
Multi-Tenant (Public Cloud/Shared Instance)
Single tenant (Private Cloud/Separate Instance)
CAPA Corrective & Preventive Action
API Active Pharmaceutical Ingredient
Dispenser Retail pharmacy, hospital pharmacy, or group of chain pharmacies under common ownership and control that do not act as a wholesale distributor. Person authorized by law to dispense or administer prescription drugs. Affiliated warehouses or distribution centers of a dispense under common ownership and control that do not act as a wholesale distributor.
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