C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart G—Packaging and Labeling Control

21 C.F.R. § 211.137

Expiration dating

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(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]
Notes of Decisions
Cited in 4 cases, 1984–2014 · leading case: Nat'l Ass'n of Pharm. Mfrs. v. Dep't of Health & Human Servs., 586 F. Supp. 740 (S.D.N.Y. 1984).
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Nat'l Ass'n of Pharm. Mfrs. v. Dep't of Health & Human Servs., 586 F. Supp. 740 (S.D.N.Y. 1984). · cites it 2× “21 C.F.R. § 211.137 . Plaintiffs contend that these regulations are invalid because they constitute informational requirements rather than requirements as to manufacturing practices.”
Montgomery v. Wyeth, 540 F. Supp. 2d 933 (E.D. Tenn. 2008). “17; 21 C.F.R. 211.137. In an affidavit, Plaintiff states neither the pills she purchased nor the bottle containing the pills had an expiration date (Court File No.”
United States ex rel. Fox Rx, Inc. v. Omnicare, Inc., 38 F. Supp. 3d 398 (S.D.N.Y. 2014). “See 21 C.F.R. § 211.137 . According to the SAC, the expiration date effectively establishes a shelf-life for the drug.”
United States v. Articles of Drug, 634 F. Supp. 435 (N.D. Ill. 1986). “See 21 C.F.R. §§ 211.137 , 431.20. In an affidavit attached to Amexchem’s Memorandum in Opposition to the United *473 States’ Motion for Stay, Dali states that, if the court were to grant a stay, Amexchem would additionally lose approximately $18,-000 per month because of loss…”
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