Definition

In the US, the prescribing information (PI) that accompanies the drug and is intended for healthcare professionals. Contains full prescribing and safety information.

Example

The US package insert includes indications, dosage, contraindications, warnings, and adverse reactions as approved in the NDA/BLA.

Regulatory source

21 CFR 201.100, 201.57

Common mistakes

Distributing promotional material that contradicts or minimises information in the package insert.

Inspector question

How do you ensure all promotional and medical materials are consistent with the approved labeling?

Related terms