21 CFR 211.137 Expiration Dating

Overview:

21 CFR 211.137 mandates that drug products have an expiration date based on stability testing, considering storage conditions. 

It exempts certain products like homeopathic drugs, allergenic extracts, and investigational drugs, with specific requirements for reconstituted products and OTC drugs stable for at least 3 years.

(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]