Expiration dating of unit-dose repackaged liquid drugs

expiration dating of unit-dose repackaged liquid drugs

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...

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 ).

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.

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

What is the shelf life of a drug?

Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. At the pharmacy, beyond-use dates are often put on the prescription bottle label given to the patient.

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

What is the shelf life of biologics?

Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). 8 Biologics are not included in the SLEP program. These results suggest that many drug products may have extended shelf lives beyond their expiration date.

How long does medication last after expiration date?

The expiration date on medication is the date beyond which the manufacturers can no longer guarantee full effectiveness or safe usage. Generally, over-the-counter medicines should have a shelf life of around four or five years. This means they should last around that long after the date they are purchased.

What is the shelf life of a repackaged product?

Where no specific storage conditions are specified, the product should be maintained at controlled room temperatureand in a dry placeduring repackaging. The BUD used for the repackaged product does not exceed 6 months from the date of repackaging. The BUD does not exceed the manufacturers expiration date.

Can a repackager use the manufacturer’s original expiration date?

A repackager may use the manufacturers original expiration date without additional stability testing if the drug product is repackaged into an equivalent container–closure system that is at least as protective as, or more protective than, the original system and complies with criteria established for equivalency.

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 ).

Is it time to reevaluate your liquid product repackaging practices?

If you are or have been repackaging liquid products into unit dose containers, it may be a good time to reevaluate your practices. In addition, “ [P]roducts repackaged by State-licensed pharmacies, Federal facilities, and outsourcing facilities as defined under section 503B of the FD&C Act are also not covered by this guidance”.

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