Under DSCSA, a 'product' refers to what?

Under DSCSA, a 'product' refers to what?

• A. A raw chemical that has not been formulated.
• B. A human prescription product in its finished dosage form.
• C. A device used to deliver medication.
• D. Any medical supply.

Answer: (B)

Under DSCSA, the term product refers to the finished dosage form of a drug intended for human use. This is the item that is dispensed to patients—things like a bottle of prescription tablets or an injectable in its final, ready-to-administer form. It carries the drug’s identity in a completed state and is tracked through the supply chain with identifiers and lot numbers. Raw ingredients that haven’t been formulated are not considered products because they aren’t in a finished dosage form. A device that delivers medication is a medical device, not a drug product, and general medical supplies fall outside the drug product scope. So the correct interpretation is a human prescription product in its finished dosage form.

Under DSCSA, the term product refers to the finished dosage form of a drug intended for human use. This is the item that is dispensed to patients—things like a bottle of prescription tablets or an injectable in its final, ready-to-administer form. It carries the drug’s identity in a completed state and is tracked through the supply chain with identifiers and lot numbers. Raw ingredients that haven’t been formulated are not considered products because they aren’t in a finished dosage form. A device that delivers medication is a medical device, not a drug product, and general medical supplies fall outside the drug product scope. So the correct interpretation is a human prescription product in its finished dosage form.