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.
What this does not cover
stated in the document's own scope- It governs drug labeling, not prescription drug advertising, which is regulated in 21 CFR Part 202.
- Medical-device labeling is in 21 CFR Part 801, not Part 201.
- The prescribing-information format in § 201.57 applies to products described in § 201.56(b)(1); older prescription drugs follow § 201.80 instead.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 201 contains FDA’s labeling regulations for drugs. It sets general provisions for drug labels — the manufacturer, packer or distributor’s name and place of business, adequate directions for use, ingredient statements, the location of the expiration date, and bar codes — and then separate requirements for prescription drugs and for over-the-counter drugs. For human prescription drug and biological products it prescribes the content and format of prescribing information, including the Highlights section, and it defines when a drug is exempt from the requirement to bear adequate directions for use.
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.
Legal basis & how it acquires force
Part 201 is a binding FDA regulation in Title 21 of the Code of Federal Regulations, issued under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; its source note dates the current codification to 40 FR 13998 of 27 March 1975, with many later amendments. Labeling that does not meet it can make a drug misbranded under the Act. eCFR also flags an amendment to § 201.25 (bar codes) published at 91 FR 10770 on 5 March 2026, so the bar-code text should be read against the Federal Register as well as the codified version.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General labeling provisions | Name and place of business, National Drug Code numbers (requested but not required on labels, § 201.2), adequate directions for use (§ 201.5), expiration-date location and bar codes (§ 201.25) |
| Subpart B — Prescription drugs | Statement of identity and net quantity, and the content and format of prescribing information for human prescription drug and biological products (§§ 201.56 and 201.57) |
| Subpart C — Over-the-counter drugs | The principal display panel and the format and content of OTC labeling (§ 201.66), including the Drug Facts layout |
| Subparts D–E — Exemptions | When drugs are exempt from adequate directions for use, including prescription drugs for human use (§ 201.100), and other exemptions such as medical gases |
| Subparts F–G — Specific products | Drug efficacy study disclosures and required warnings or statements for named drug classes |
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.
International alignment
Part 201 connects to the approval regulations: § 201.56 requires prescription labeling to be updated when new information makes it inaccurate, in accordance with §§ 314.70 and 601.12. Prescription drug advertising is regulated separately in 21 CFR Part 202, and establishment registration and the assignment of National Drug Codes are in Part 207. The EU counterpart for human medicines is Title V of Directive 2001/83/EC, which governs labelling and the package leaflet.
21 CFR Part 201: frequently asked questions
Quick answers to common questions about 21 CFR Part 201.
Which prescription drugs must use the format in 21 CFR 201.57?
Products whose NDA, BLA or efficacy supplement was approved between 30 June 2001 and 30 June 2006, was pending on 30 June 2006, or was submitted on or after that date, as set out in § 201.56(b)(1). Other prescription drugs follow § 201.80.
What must prescription drug labeling achieve under § 201.56?
It must summarise the essential scientific information needed for safe and effective use, be informative and accurate and neither promotional in tone nor false or misleading, be based on human experience wherever possible, and be updated when new information makes it inaccurate.
What does "adequate directions for use" mean?
Section 201.5 defines it as directions under which a layperson can use a drug safely and for its intended purposes. Prescription drugs for human use are exempt from that requirement when they meet the conditions in § 201.100.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.