Expiration dating of unit-dose repackaged drugs compliance policy guide

expiration dating of unit-dose repackaged drugs compliance policy guide

Does unit-dose repackaging affect stability studies and expiration dates?

The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products.

When is a drug product out of compliance with 21 CFR?

Any drug product intended for reconstitution and not bearing an expiration date for the unreconstituted product and another expiration date for the product after reconstitution is considered to be out of compliance with 211.137 (c). There must be separate stability studies to support each expiration date. STABILITY TESTING (21 CFR 211.166)

Why are there different rules for Drug expiration dates?

Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences. EXPIRATION DATING (21 CFR 211.137) A. Absence of an Expiration Date

What is the FDAs guidance on repackaged products?

This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

Does unit-dose repackaging affect stability studies and expiration dates?

The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products.

Can FDA enforce the stability and expiration dates on repackaged liquid dosage forms?

Because of the inherent stability risks, FDA does not intend to exercise enforcement discretion regarding the stability and expiration dating requirements in 21 CFR 211.137 and 211.166 for repackaging liquid dosage forms.” (See FR notice here ).

How long is the shelf life of a repackaged drug?

For unit-dose repackaged products, U.S. Pharmacopeial Convention (USP) General Chapter <1178> recommends that the expiration date “not exceed (1) 6 months from the date of repackaging; or (2) the manufacturers expiration date; or (3) 25% of the time between the date of repackaging and the expiration date shown on...

What is the FDAs guidance on repackaged products?

This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

2. How are expiration dates established? FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.

Is the expiration date of a medication guaranteed?

What is the latest FDA guidance on drug repackaging?

[1/12/2017] Today, FDA issued a final guidance that describes policies concerning repackaging of certain drug products by state-licensed pharmacies, federal facilities, and outsourcing facilities. FDA also issued a revised draft guidance that describes policies concerning mixing, diluting, and repackaging licensed biological products.

What is drug repackaging and how does it work?

This guidance explains that FDA regards repackaging generally as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container, without further manipulation.

What is the FDA’s guidance on unit-dose repackaging?

FDA issues new unit-dose repackaging guidance Posted 30 July 2020 | By Kari Oakes Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.

Is repackaging of human drug products by pharmacies and outsourcing facilities binding?

Repackaging of certain human drug products by pharmacies and outsourcing facilities contains nonbinding recommendations. The U.S. Food and Drug Administration issued a Feb. 2015 Guidance for Industry titled, “ Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities, ” that is being distributed for comment purposes only.

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