What is an exception for tamper resistance found in OTC drugs?

Tamper resistance for over-the-counter (OTC) drugs is a critical aspect of ensuring consumer safety and product integrity. Insulin, although typically considered a prescription medication, has specific nuances when it comes to its formulation and distribution. In certain cases, insulin is available without a prescription, particularly for some forms of rapid-acting insulin, especially for managing diabetes in outpatient settings.

The rationale behind insulin being an exception is that it is a critical medication that individuals with diabetes rely on for their survival and management of their condition. Due to its essential nature and the clinical urgency with which a patient may need to access it, tamper resistance regulations can be more flexible. This allows for easier access in emergency situations or for patients who are accustomed to administering their own medication.

In contrast, cough syrups, antibacterials, and alternative medications generally do not have such exceptions, as they do not carry the same immediate risk implications that necessitate rapid consumer access without the need for tamper-resistant packaging. Such medications are often subject to more stringent regulations to ensure that they are not tampered with prior to reaching the consumer, ensuring their safety and efficacy.