21 CFR 1.74
Human drugs
21 CFR 1.74 is the regulation titled “Human drugs” in 21 CFR Part 1, General Enforcement Regulations. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.100, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 1.74 most often, as written in the letters.
- 1 letterthere appear to be discrepancies in the electronic import entry submissions for your products, specifically regarding the failure to correctly declare your drug product listing
The regulation
Read the text of 21 CFR 1.74 (eCFR, as of Sep 1, 2026)
In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for drugs, including biological products and eligible prescription drugs as defined in § 251.2 of this chapter that are imported or offered for import under section 804 of the Federal Food, Drug, and Cosmetic Act, intended for human use that are regulated by the FDA Center for Drug Evaluation and Research.
(a) For a drug intended for human use that is not an eligible prescription drug covered under paragraph (b) of this section:
(1) Registration and listing. The Drug Registration Number and the Drug Listing Number of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register and list the drug under part 207 of this chapter. For the purposes of this section, the Drug Registration Number that must be submitted at the time of entry filing in ACE is the unique facility identifier of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The unique facility identifier is the identifier submitted by a registrant in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug Listing Number is the National Drug Code number of the human drug article being imported or offered for import.
(2) Drug application number. For a drug intended for human use that is the subject of an approved application under section 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the new drug application or abbreviated new drug application. For a biological product regulated by the FDA Center for Drug Evaluation and Research that is required to have an approved biologics license application, the number of the applicable application.
(3) Investigational new drug application number. For a drug intended for human use that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act, the number of the investigational new drug application.
(b) For an eligible prescription drug as defined in § 251.2 of this chapter that is imported or offered for import under section 804 of the Federal Food, Drug, and Cosmetic Act:
(1) Registration and listing. The Drug Registration Number and the Drug Listing Number. For the purposes of this section, the Drug Registration Number that must be submitted in ACE is the unique facility identifier submitted by the Foreign Seller registrant under § 251.9 of this chapter in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug Listing Number is the National Drug Code number that the Importer will use when relabeling the eligible prescription drug as required in § 251.13 of this chapter.
(2) Drug application number. The number of the new drug application or abbreviated new drug application for the counterpart FDA-approved drug.
(3) Lot or control number. The lot or control number assigned by the manufacturer of the eligible prescription drug.
(4) FDA Quantity. FDA Quantity, which is the quantity of each eligible prescription drug in an import line delineated by packaging level, including the type of package from the largest packaging unit to the smallest packaging unit; the quantity of each packaging unit; and the volume and/or weight of each of the smallest of the packaging units.
(5) Pre-Import Request number. The Pre-Import Request number assigned by FDA.
[85 FR 62125, Oct. 1, 2020, as mended at 86 FR 17060, Apr. 1, 2021]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1.74.
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.166Stability testing2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2 letters cite both
- 21 CFR 211.160General requirements1 letter cites both
- 21 CFR 211.165Testing and release for distribution1 letter cites both
- 21 CFR 211.180General requirements1 letter cites both
- 21 CFR 211.182Equipment cleaning and use log1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 1.74 that FDA posted most recently.
- DrugsView Guangdong Bisutang Biotechnology Co., Ltd.OTC drug products, including sunscreenIssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim SirketiOTC drug productsIssuedMar 12, 2025PostedMar 18, 2025
- DrugsView Catwalk Cosmetic Laboratories Pty Ltd.OTC drug products including (b)(4) CreamIssuedNov 21, 2024PostedNov 26, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.