Under the Drug Supply Chain Security Act, what is required when a pharmacy sells a drug to another entity for distribution?

Study for the FIPA 2 Exam 3. Hone your skills with flashcards and multiple choice questions, each question with hints and explanations. Prepare for your exam confidently!

Multiple Choice

Under the Drug Supply Chain Security Act, what is required when a pharmacy sells a drug to another entity for distribution?

Explanation:
Under DSCSA, when a pharmacy sells a drug to another entity for distribution, it must transfer track-and-trace information—the transaction information, transaction history, and transaction statement—to the downstream party and keep records of the transaction for six years. This requirement ensures clear provenance of the product as it moves through the supply chain and supports recalls and safety investigations. The idea that no tracking data is required, or that the record-keeping period is shorter, or that tracking applies only to biologics, contradicts the law's scope and duration.

Under DSCSA, when a pharmacy sells a drug to another entity for distribution, it must transfer track-and-trace information—the transaction information, transaction history, and transaction statement—to the downstream party and keep records of the transaction for six years. This requirement ensures clear provenance of the product as it moves through the supply chain and supports recalls and safety investigations. The idea that no tracking data is required, or that the record-keeping period is shorter, or that tracking applies only to biologics, contradicts the law's scope and duration.

Subscribe

Get the latest from Passetra

You can unsubscribe at any time. Read our privacy policy