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 Β§ 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 Β§ 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 .
Β§ 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 Β§ 211 .166 .
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