21 CFR 330.2
Pregnancy-nursing warning
21 CFR 330.2 is the regulation titled “Pregnancy-nursing warning” in 21 CFR Part 330, Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 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 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.
- 02021
- 02022
- 22023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 330.2 (eCFR, as of Sep 1, 2026)
A pregnancy-nursing warning for OTC drugs is set forth under § 201.63 of this chapter.
[47 FR 54758, Dec. 3, 1982]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 330.2.
- 21 CFR 201.128Meaning of “intended uses”2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 310.545Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses2 letters cite both
- 21 CFR 201.15Drugs; prominence of required label statements1 letter cites both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling1 letter cites both
- 21 CFR 207.41Who must list drugs and what drugs must they list?1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.165Testing and release for distribution1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 330.2 that FDA posted most recently.
- DrugsView Elemental Herbs Inc. d/b/a ALL goodALL good Goop Skin Recovery BalmIssuedOct 20, 2023PostedNov 21, 2023
- DrugsView Skyless, LLCOTC topical analgesic ointmentsIssuedJan 23, 2023PostedFeb 28, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.