Under PDMA, which statement is true about Authorized distributors?

Under PDMA, which statement is true about Authorized distributors?

• A. They are defined as any distributor who purchases directly from manufacturers, regardless of transactions.
• B. They must be independent and not affiliated with manufacturers.
• C. They have a written agreement with manufacturers and must complete at least two transactions within 24 months.
• D. They operate only in non-prescription drugs.

Answer: (C)

Under PDMA, an Authorized distributor of record is defined by a real, formal relationship with a drug manufacturer: the distributor must have a current written agreement with the manufacturer and must have completed at least two transactions with that manufacturer within the previous 24 months. This combination confirms legitimacy and creates traceability in the supply chain, helping manufacturers, regulators, and pharmacies ensure products come from authorized sources and can be tracked for recalls or quality concerns. The two-transaction requirement shows ongoing business activity rather than a one-time or casual purchase, which distinguishes authorized distributors from others. The concept also supports accountability and reduces the risk of counterfeit or diverted drugs. The other statements don’t fit because simply buying directly from a manufacturer isn’t enough without the written agreement and the demonstrated two transactions, and PDMA does not restrict authorized distributors to independence or to non-prescription drugs.

Under PDMA, an Authorized distributor of record is defined by a real, formal relationship with a drug manufacturer: the distributor must have a current written agreement with the manufacturer and must have completed at least two transactions with that manufacturer within the previous 24 months. This combination confirms legitimacy and creates traceability in the supply chain, helping manufacturers, regulators, and pharmacies ensure products come from authorized sources and can be tracked for recalls or quality concerns. The two-transaction requirement shows ongoing business activity rather than a one-time or casual purchase, which distinguishes authorized distributors from others. The concept also supports accountability and reduces the risk of counterfeit or diverted drugs. The other statements don’t fit because simply buying directly from a manufacturer isn’t enough without the written agreement and the demonstrated two transactions, and PDMA does not restrict authorized distributors to independence or to non-prescription drugs.