Question

According to the FDA, the guidelines for stability testing are outlined in:

• A. 1 CFR $\S$ 11.16
• B. 11 CFR $\S$ 21.61
• C. 21 CFR $\S$ 211.166
• D. 31 CFR $\S$ 321.196

Hint:

Title 21 CFR focuses on the FDA. Within it, Section 211.166 explicitly outlines stability testing protocols within cGMP guidelines.

Answer 1

The Correct Option is C

Understanding the Concept: The Code of Federal Regulations (CFR) contains codified federal regulations in the United States. Title 21 of the CFR is dedicated to rules overseen by the Food and Drug Administration (FDA). Regulatory Framework Evaluation:
• Title 21 CFR Part 211 outlines Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals.
• Within this part, Section 211.166 specifically details the regulatory requirements for Stability Testing. It mandates that written stability testing programs must be established to evaluate the expiration dates and storage conditions of drug products.
• Other titles (such as Title 1, Title 11, or Title 31) fall under different federal administrative agencies entirely unrelated to pharmaceutical cGMP or FDA mandates. Therefore, 21 CFR $\S$ 211.166 is the correct regulatory citation.