Labeling
The labelling requirements for human drug products: what must appear on the label and in the labelling, the content and format of prescription-drug labelling, and the rule that a drug is misbranded if its labelling is false or misleading in any particular.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
The label and labelling of human drugs, including the Physician Labeling Rule format for prescription products (Highlights, Contents, Full Prescribing Information) and Subpart B general labelling provisions. Advertising is governed separately by 21 CFR Part 202; device labelling by 21 CFR Part 801.
Key requirements
- Content and format of labelling for human prescription drug products under §201.56 and §201.57
- Adequate directions for use, and the prescription-drug exemption in §201.100
- §201.10 — a drug is misbranded if its labelling is false or misleading in any particular, including by omission
- Pregnancy and lactation labelling content under the §201.57(c)(9) subsections
Implementation tips
- Treat labelling artwork as a change-controlled regulated output, proofed against the approved text at release — artwork error is a recurring recall cause, not a marketing detail
- Translations are a regulated activity: verify meaning back to the approved source, not just linguistic quality
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
21 CFR Part 201: frequently asked questions
Quick answers to common questions about 21 CFR Part 201.
What is 21 CFR Part 201?
21 CFR Part 201 — Labeling — is a regulation issued by the Food and Drug Administration (United States). The labelling requirements for human drug products: what must appear on the label and in the labelling, the content and format of prescription-drug labelling, and the rule that a drug is misbranded if its labelling is false or misleading in any particular.
Who does 21 CFR Part 201 apply to?
The label and labelling of human drugs, including the Physician Labeling Rule format for prescription products (Highlights, Contents, Full Prescribing Information) and Subpart B general labelling provisions. Advertising is governed separately by 21 CFR Part 202; device labelling by 21 CFR Part 801.
What are the key requirements of 21 CFR Part 201?
FDA 21 CFR Part 201 requires, among other things: Content and format of labelling for human prescription drug products under §201.56 and §201.57; Adequate directions for use, and the prescription-drug exemption in §201.100; §201.10 — a drug is misbranded if its labelling is false or misleading in any particular, including by omission; Pregnancy and lactation labelling content under the §201.57(c)(9) subsections.
When was 21 CFR Part 201 last updated?
The current version of 21 CFR Part 201 dates from April 2016.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.