21 CFR 211.137: Expiration dating

Requires drug products to bear expiration dates based on stability testing and tied to labeled storage conditions, with separate dating for reconstituted products, subject to exemptions such as homeopathic and investigational products.

Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart G, Packaging and Labeling Control

of drug-manufacturing 483s since 2023 cite this section at least once

How FDA words it

The opening lines investigators use most when they cite 211.137, from the 483s we hold.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.Most used

Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.211.137(b)

Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations.211.137(d)

Cited over time

483s citing 211.137, by year

Most citations in 2019. Bars are relative to the busiest year. *2026 to date.

Recent 483s citing 211.137

See all 483s citing 211.137

The regulation text

§ 211.137 Expiration dating.

(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]

Questions

What does 21 CFR 211.137 require?

How often is 211.137 cited in Form 483s?

It appears in about 2% of the drug-manufacturing 483s we hold from 2023 onward.

How do FDA investigators word a 211.137 observation?

The most common opening is: “Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.”

Which sections are cited alongside 211.137?

In the same 483s, investigators most often also cite 211.192 (Production record review), 211.165 (Testing and release for distribution), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance).