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Title 21 CFR reference

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United States • Title 21 CFR • Part 202

Part 202PART 202—PRESCRIPTION DRUG ADVERTISING

This part of the CFR outlines the regulations for prescription drug advertising, focusing on the content, presentation, and disclosure requirements to ensure advertisements are truthful and not misleading. It details requirements for ingredient information, proprietary vs. established names, and the mandatory inclusion of a brief summary of side effects, contraindications, and effectiveness.

What this part covers

  • Prescription drug advertisements must present ingredient information in a specific order and format, matching the product's label.
  • Proprietary names must be accompanied by established names, with specific rules on prominence and frequency of use in advertisements.
  • Advertisements cannot imply unique effectiveness for common substances or overstate the role of inert ingredients.
  • A true statement of information regarding side effects, contraindications, and effectiveness must be included in all advertisements, with specific exemptions for reminder ads and bulk-sale drugs.
  • The brief summary must be accurate and consistent with the drug's approved labeling, covering indications, effectiveness, side effects, and contraindications.
  • Advertisements for drugs approved after specific dates must adhere to uses and information in their approved labeling.
  • Advertisements for older drugs or those not covered by new drug applications must recommend uses for which the drug is generally recognized as safe and effective or has substantial evidence of effectiveness.

Sections in Part 202

§ 202.1

Prescription-drug advertisements.

(a)(1) The ingredient information required by section 502(n) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names. (2) The order of listing of ingredients in the advertisement shall be the same as the order of listing of ingredients on the label of the product, and the information presented in the advertisement concerning the quantity of each such ingredient shall be the same as the corresponding information on the label of the product. (3) The advertisement shall not employ a fanciful proprietary name for the drug or any ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition, when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name. (4) The advertisement shall not feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation. (5) The advertisement…

Regulatory Context

This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

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