C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart A—General Labeling Provisions

21 C.F.R. § 201.17

Drugs; location of expiration date

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When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter, it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers are packed in individual cartons, the expiration date may properly appear on the individual carton instead of the immediate product container.

[43 FR 45076, Sept. 29, 1978]
Notes of Decisions
Cited in 1 case, 2008–2008 · leading case: Montgomery v. Wyeth, 540 F. Supp. 2d 933 (E.D. Tenn. 2008).
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Montgomery v. Wyeth, 540 F. Supp. 2d 933 (E.D. Tenn. 2008). “2); 21 C.F.R 201.17; 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.”
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