What is the consequence of failing to distribute a PPI?

The consequence of failing to distribute a Patient Package Insert (PPI) is classified as misbranding. Patient Package Inserts are required for certain medications, particularly those that present a significant risk or require specific patient education, such as hormonal contraceptives and other drugs. The purpose of a PPI is to provide essential information regarding the medication, including its uses, potential side effects, and precautions.

Failure to distribute a PPI when it is mandated by law constitutes misbranding because it misleads or fails to inform the consumer fully about the product they are receiving. The law seeks to ensure that patients are adequately informed so they can make safe and effective choices regarding their medications.

In this context, misbranding is a violation of federal and state regulations, leading to potential enforcement actions by regulatory authorities. While negligence, loss of license, and administrative fines can occur in various circumstances related to practice standards or violations, the specific violation for not providing a PPI aligns directly with the definition of misbranding. This highlights the importance of compliance with labeling requirements to ensure that patients receive full and accurate information about their medications.