21 CFR 201.115
New drugs or new animal drugs
21 CFR 201.115 is the regulation titled “New drugs or new animal drugs” in 21 CFR Part 201, Labeling. Since 2021, 134 FDA warning letters have cited it.
- Letters citing it
- 134 since 2021
- Jan 1 to Oct 30, 2026
- 26 against 32 on the same dates in 2025
- Most often cited with
- 21 CFR 201.5, in 90 letters
- Closed out
- 5% 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 201.115 most often, as written in the letters.
- 9 lettersBecause the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
- 6 lettersBecause the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
- 5 lettersBecause the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
The regulation
Read the text of 21 CFR 201.115 (eCFR, as of Sep 1, 2026)
A new drug shall be exempt from section 502(f)(1) of the act:
(a) To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 or 512 of the act or an index listing with respect to such drug under section 572 of the act; or
(b) If no application under section 505 or 512 of the act is approved and no request for addition to the index is granted under section 572 with respect to such drug but it complies with section 505(i), 512(j), or 572(g) of the act and regulations thereunder.
[40 FR 13998, Mar. 27, 1975, as amended at 72 FR 69119, Dec. 6, 2007]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 201.115.
- 21 CFR 201.5Drugs; adequate directions for use90 letters cite both
- 21 CFR 201.128Meaning of “intended uses”50 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers30 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations30 letters cite both
- 21 CFR 211.192Production record review22 letters cite both
- 21 CFR 211.113Control of microbiological contamination21 letters cite both
- 21 CFR 211.42Design and construction features20 letters cite both
- 21 CFR 310.305Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications13 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 201.115 that FDA posted most recently.
- DrugsView Cheap Medicine Shop/www.cheapmedicineshop.comInjectable semaglutide drug products sold onlineIssuedSep 24, 2026PostedOct 6, 2026
- DrugsView Online Generic Medicine/www.onlinegenericmedicine.comSemanat Injection (Semaglutide)IssuedSep 23, 2026PostedOct 6, 2026
- DrugsView Celmadebotulinum toxin type A products marketed as Wonder tox 100 and Wondertox 100 UnitIssuedSep 14, 2026PostedSep 29, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.