Arkansas Pharmacy Laws and Regulations Practice Exam

Is a manufacturer liable for harm caused by a donated drug due to the absence of a package insert or incorrect expiration date?

1. Yes, always

2. Yes, but only within two years of donation

3. No

4. Only if the pharmacy did not provide a warning

The correct answer is: No

A manufacturer is not always liable for harm caused by a donated drug due to the absence of a package insert or incorrect expiration date. This is because although the manufacturer has a responsibility to ensure their products are safe, they are not directly responsible for the distribution and handling of donated drugs. In some cases, other parties such as the pharmacy may share liability for any harm caused. Therefore, option A is incorrect. Option B is also incorrect as the time frame for liability is not limited to two years. Option D is incorrect as the manufacturer can still be held liable even if the pharmacy provided a warning. Therefore, the correct answer to this question is C, as the manufacturer is not automatically liable in this scenario.