21 CFR 211.137
Expiration dating
21 CFR 211.137 is the regulation titled “Expiration dating” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 28 FDA warning letters have cited it.
- Letters citing it
- 28 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 6 on the same dates in 2025
- Most often cited with
- 21 CFR 211.165, in 23 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 211.137 most often, as written in the letters.
- 13 lettersYour firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a))
The regulation
Read the text of 21 CFR 211.137 (eCFR, as of Sep 1, 2026)
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166.
(b) Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in § 211.166.
(c) If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products.
(d) Expiration dates shall appear on labeling in accordance with the requirements of § 201.17 of this chapter.
(e) Homeopathic drug products shall be exempt from the requirements of this section.
(f) Allergenic extracts that are labeled “No U.S. Standard of Potency” are exempt from the requirements of this section.
(g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.
(h) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.
[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 60 FR 4091, Jan. 20, 1995]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.137.
- 21 CFR 211.165Testing and release for distribution23 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures23 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit22 letters cite both
- 21 CFR 211.100Written procedures; deviations18 letters cite both
- 21 CFR 201.128Meaning of “intended uses”11 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance9 letters cite both
- 21 CFR 211.188Batch production and control records8 letters cite both
- 21 CFR 211.192Production record review8 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.137 that FDA posted most recently.
- DrugsView Babikian Healthcare Products CJSCOver-the-counter (OTC) drug productsIssuedSep 21, 2026PostedSep 29, 2026
- DrugsView Macau-Union Pharmaceutical LimitedBamboo Pharmacy® Mobility penetrating muscle & joint rub and Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rubIssuedMay 29, 2026PostedJun 9, 2026
- DrugsView Lexia LLCOTC drug products, including an OTC topical pain relief productIssuedApr 7, 2026PostedApr 28, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.