South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Disable ads (and more) with a membership for a one time $4.99 payment

Prepare for the South Carolina MPJE with flashcards and multiple choice questions. Each question offers hints and explanations to enhance your understanding. Get exam-ready today!

Practice this question and more.

How many business days must companies notify the FDA of any serious adverse drug reactions (ADRs)?

10 business days
15 business days
30 business days
45 business days

The correct answer is: 15 business days

The correct answer is that companies must notify the FDA of any serious adverse drug reactions (ADRs) within 15 business days. This requirement is outlined as part of the regulations governing the reporting of adverse events to ensure that drug safety is monitored effectively. By establishing a 15 business day timeline for reporting serious ADRs, the FDA can quickly assess potential safety issues associated with pharmaceutical products, later prompting further investigations or actions if necessary. This 15-day requirement reflects the urgency involved in addressing serious ADRs to protect public health while balancing the need for thoroughness in evaluating reported incidents. Understanding this timeline is crucial for compliance and emphasizes the importance of monitoring drug safety in the pharmaceutical industry.