U.S. Code of Federal Regulations
Regulations most recently checked for updates: Nov 01, 2024
(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