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.

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 FDA’s new guidance on expiration dates?

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.

What is the beyond-use date for repackaged drugs?

The US Pharmacopoeia allows a beyond-use date for repackaged medicines in customized patient medication packages of 60 days, or the remaining of the original expiration date, unless the original manufacturer’s product labeling indicates otherwise [7].

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.

Can a manufacturer extend the expiration date of a drug product?

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 expiration date of repackaging products?

Good Repackaging Practices recommends that the expiration date “not exceed (1) 6 months from the date of repackaging; or (2) the manufacturer’s expiration date; or (3) 25% of the time

When does FDA not intend to take action on repackaged drugs?

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.” Drugs must meet five criteria, including that the drug’s original labeling does not caution against repackaging.

What is the bud date for repackaged tablets?

According to the guidance, FDA wants the BUD for those repackaged tablets to be the earliest of A date in accordance with the in-use time stated in the products FDA-approved labeling, and The expiration date on the large container.

Related posts: