What issue arises if tamper-resistant packaging is not used?

The emphasis on tamper-resistant packaging is critical for ensuring the safety and integrity of pharmaceutical products. The absence of such packaging can indeed result in a violation of regulations surrounding adulteration or misbranding. This is because tamper-resistant features serve to inform consumers that the product is intact and has not been subjected to tampering, which could compromise safety.

In pharmacy practice, tampering can lead to the alteration of the drug's effectiveness, safety, and quality, which constitutes adulteration as per legal definitions. Additionally, if the packaging does not prevent tampering, it could mislead consumers regarding the product's condition and integrity, leading to claims of misbranding. Hence, without tamper-resistant packaging, a product may not only pose health risks but also fail to comply with legal standards intended to protect consumer safety.