Expiration Dating

The guidelines for GMP require that the drug expiration date is noted on the label. Moreover, if the drug product is to be reconstituted at the time of use, the label must include the expiration dates for the reconstituted and un-reconstituted drug product.

Examples of FDA Warning Letters

Failure to ensure that strict control is exercised over labeling issued for use in drug product labeling operations as required by 21 CFR § 211.125(a). Your firm does not exercise adequate controls over the labeling issuance and labeling operation of the drug products being handled at your facility. Your firm’s personnel were not aware of the labeling requirements set forth by the abovementioned regulation.

Failure to ensure that written procedures are designed and followed to assure that correct labels, labeling, and packaging materials are used for drug products as required by 21 CFR § 211.130. Your firm had not established or implemented procedures to assure that correct labels were applied to your . . . products.

Failure to control labeling operations to prevent labeling mix-ups and to document the labeling used in the DHR as required by 21 CFR § 820.120(d). For example, implant . . . was manufactured and released on 10/28/08 with labeling that indicated that the device was non-sterile. However, this implant was returned to . . . for sterilization and the sterilization record found in the device history record (DHR) for this implant shows that the implant was sterilized on 11/5–6/07. The sterilization record was signed off on 11/8/07, and the product was shipped on 11/18/07. The only label included with this DHR indicates that the product was labeled as nonsterile.

Other Examples of FDA Warning Letters

Your product labeling specifies a 10-day use limit under the “Warnings” heading in the “Drug Facts” panel (that is, “Stop use and ask a doctor if . . . pain gets worse or lasts more than 10 days”) but this warning appears only within the Drug Facts panel of the retail package. Its placement within the perimeter of the Drug Facts panel suggests that it applies exclusively to the analgesic use discussed in that panel. It is contradicted by the statement elsewhere on the labeling “For calcium, adults and children 12 years and over, take up to 4 caplets per day . . . ,” without any limitation on duration indicated.

Your product labeling warns against use by children and teens, to prevent Reye’s syndrome (that is, “Warning—Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.”), but this warning appears only within the “Drug Facts” panel of the retail package. Its placement within the perimeter of the Drug Facts panel suggests that it applies exclusively to the analgesic use discussed in that panel. It is contradicted by the statement elsewhere on the labeling “For calcium, adults and children 12 years and over, take up to 4 caplets per day . . . ,” without any warning that there are circumstances where it is not appropriate for children and teenagers to take the product.

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