Fda Guidance Expiration Dating

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Expiration Dating and Stability Testing for Human Drug . . .
Expiration Dates - Questions and Answers | FDA
CFR - Code of Federal Regulations Title 21
Guidance: Expiration Dating of Unit-Dose Repackaged Solid . . .
FDA Guidance for Industry: Expiration Dating of Unit-Dose . . .
FDA Guidance: Expiration Dating of Unit-Dose Repackaged . . .
CFR - Code of Federal Regulations Title 21
Food Product Dating | Food Safety and Inspection Service
21 CFR § 211 .137 - Expiration dating . | CFR | US Law | LII . . .
Expiration dating fda guidance | Rollingtrans
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A . Absence of an Expiration Date . The absence of an expiration date on any drug product packaged after September 29, 1979, except for those drugs specifically exempt by 211 .137 (e), (f), and (g . . .
Can expiration dates be extended? FDA's guidance for industry, "Changes to an Approved NDA or ANDA" explains that the manufacturer of an approved drug product may extend the expiration date . . .
Sec . 211 .137 Expiration dating . (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 . . .
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10 .115) . The guidance represents the current thinking of FDA on " Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products ." It does not establish any rights for any person and is not binding on FDA or the public .
The USFDA recently finalized the guidance for industry entitled " Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products" . This guidance addresses repackaging of prescription and over-the-counter (OTC) solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms .
FDA Guidance : Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products . A new 4-page guidance from FDA comes on the heels of an increase in repackaging drugs for administration as a single dose . Keren Sookne . FDA .
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, . . .
Federal regulations require a "Use-By" date on the product label of infant formula under inspection of the U .S . Food and Drug Administration ( FDA ) . Consumption by this date ensures the formula contains not less than the quantity of each nutrient as described on the label .
§ 211 .137 Expiration dating . (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 .
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Fda Guidance Expiration Dating

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