§ 211.137 Expiration dating.
Cited in 1 FDA warning letterHow BatchGlow handles this
(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]
Cited in FDA warning letters
1 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.
- CDL Services, Inc. dba Technichem · 24 Nov 2025
violation 3: 21 CFR 211.137(a)
How BatchGlow handles this
A formula cannot be approved without its shelf life, and a lot past its expiry date cannot be staged or weighed.
What it asks for, in plain words
- 21 CFR 211.137
- A drug product bears an expiration date set by stability testing and tied to the storage conditions on its label. The FDA does not enforce this for a human OTC drug whose labeling has no dosage limits and that stability data show is stable for at least 3 years.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.