Who qualifies as an authorized distributor of record?

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An authorized distributor of record is typically defined as a distributor who has a formal, ongoing relationship with a manufacturer that includes a written agreement. This relationship ensures that the distributor is recognized as a legitimate channel for distributing the manufacturer's products, complying with regulations regarding the distribution of pharmaceuticals.

In this context, having an ongoing relationship indicates that the distributor is not just transacting on a one-off basis but is committed to maintaining a consistent partnership. This status also often means that the distributor is able to supply products under the manufacturer's terms and conditions, which is essential for ensuring quality control and regulatory compliance.

Other options fall short of this definition. A distributor without a written agreement lacks the formal recognition needed to be considered authorized. Similarly, a temporary agreement suggests that the relationship is not secure or enduring, and thus does not meet the criteria for authorized status. Lastly, a distributor who only purchases drugs without any agreements does not establish a connection with the manufacturer that would warrant inclusion as an authorized distributor of record.

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