# 21 C.F.R. § 201.1 (2026): Drugs; name and place of business of manufacturer, packer, or distributor

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_1

## Section

- **Citation:** 21 C.F.R. § 201.1 (2026)
- **Heading:** Drugs; name and place of business of manufacturer, packer, or distributor
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 201: LABELING / Subpart A: General Labeling Provisions / § 201.1: § 201.1   Drugs › name and place of business of manufacturer, packer, or distributor.

## Text

city, country, and any applicable mailing code. The street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply to consumer commodity labels developed or revised after July 1, 1969. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including the invoice).
(j) If a person manufactures, packs, or distributes a drug or drug product at a place other than the person's principal place of business, the label may state the principal place of business in lieu of the actual place where such drug or drug product was manufactured or packed or is to be distributed, unless such statement would be misleading.
(k) Paragraphs (b), (c), (d), (e), and (f) of this section, do not apply to the labeling of drug components.
(l) A drug product is misbranded under section 502(a) of the act if its labeling identifies a person as manufacturer, packer, or distributor, and that identification does not meet the requirements of this section.
(m) This section does not apply to biological drug products that are subject to the requirements of section 351 of the Public Health Service Act, 42 U.S.C. 262.
[45 FR 25775, Apr. 15, 1980; 45 FR 72118, Oct. 31, 1980, as amended at 48 FR 37620, Aug. 19, 1983; 81 FR 60212, Aug. 31, 2016; 89 FR 51767, June 18, 2024]

## Nearby sections

- [21 C.F.R. § 201.1 (2026) § 201.1   Drugs; name and place of business of manufacturer, packer, or distributor.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_1.md)
- [21 C.F.R. § 201.2 (2026) § 201.2   Drugs and devices; National Drug Code numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_2.md)
- [21 C.F.R. § 201.5 (2026) § 201.5   Drugs; adequate directions for use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_5.md)
- [21 C.F.R. § 201.6 (2026) § 201.6   Drugs; misleading statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_6.md)
- [21 C.F.R. § 201.10 (2026) § 201.10   Drugs; statement of ingredients.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_10.md)
- [21 C.F.R. § 201.15 (2026) § 201.15   Drugs; prominence of required label statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_15.md)
- [21 C.F.R. § 201.16 (2026) § 201.16   Drugs; Spanish-language version of certain required statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_16.md)
- [21 C.F.R. § 201.17 (2026) § 201.17   Drugs; location of expiration date.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_17.md)
- [21 C.F.R. § 201.18 (2026) § 201.18   Drugs; significance of control numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_18.md)
- [21 C.F.R. § 201.19 (2026) § 201.19   Drugs; use of term “infant”.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_19.md)
- [21 C.F.R. § 201.20 (2026) § 201.20   Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_20.md)
- [21 C.F.R. § 201.21 (2026) § 201.21   Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_21.md)
- [21 C.F.R. § 201.22 (2026) § 201.22   Prescription drugs containing sulfites; required warning statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_22.md)
- [21 C.F.R. § 201.23 (2026) § 201.23   Required pediatric studies.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_23.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_1. Check the current official text before relying on it. Not legal advice.