21 CFR 330.3
Imprinting of solid oral dosage form drug products
21 CFR 330.3 is the regulation titled “Imprinting of solid oral dosage form drug products” in 21 CFR Part 330, Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 330.3 (eCFR, as of Sep 1, 2026)
A requirement to imprint an identification code on solid oral dosage form drug products is set forth under part 206 of this chapter.
[58 FR 47959, Sept. 13, 1993]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 330.3.
- 21 CFR 201.128Meaning of “intended uses”1 letter cites both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling1 letter cites both
- 21 CFR 210.3Definitions1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.166Stability testing1 letter cites both
- 21 CFR 211.22Responsibilities of quality control unit1 letter cites both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1 letter cites both
- 21 CFR 310.545Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses1 letter cites both
Latest letters citing it
The letter citing 21 CFR 330.3 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.