Which CFR parts govern drug labeling content and labeling claims?

• A. 21 CFR Part 203 (Labeling) and 21 CFR Part 204 (Advertising)
• B. 21 CFR Part 210 (Labeling) and 21 CFR Part 211 (Advertising)
• C. 21 CFR Part 201 (Labeling) and 21 CFR Part 202 (Advertising)
• D. 21 CFR Part 201 (Advertising) and 21 CFR Part 202 (Labeling)

Answer: (C)

Understanding how labeling content and labeling claims are regulated helps explain the correct framework. Drug labeling content—the information that must appear on the label, such as active ingredient, dosing, directions for use, and safety warnings—is governed by 21 CFR Part 201. Drug advertising and promotional claims—the material used to promote the drug and the claims it may make, along with the required risk information—are governed by 21 CFR Part 202. This separation ensures that the label provides essential, consistent information, while promotional materials are evaluated for truthfulness and balance. The other CFR pairings relate to areas like manufacturing controls, not labeling content and labeling claims, so they don’t fit the regulatory structure as defined.