FDA Extends Expiration Dating Of Repackaged Drugs To One Year

The agency proposes revising a 1984 guideline that provided a six-month maximum expiration date for nonsterile, unit-dose repackaged drugs without additional stability studies. FDA's draft guidance would harmonize enforcement policies on expiration dating with USP standards.

FDA is extending the allowable expiration date for nonsterile, unit-dose repackaged drugs without additional stability studies from six months to one year.

The agency will refrain from taking enforcement action against repackaging firms that fail to provide certain stability studies if the expiration date on the repackaged drug does not exceed one year from the date of repackaging or the expiration date on the original manufacturer's container, whichever is earlier, FDA said in a May 31 ^FDL-1 draft guidance.

The draft guidance revises a 1984 Compliance Policy Guide, which provided for six-month expiration dating. At the time it was adopted, the CPG was comparable to U.S. Pharmacopeia standards on beyond-use dating of nonsterile, unit-dose repackaged drugs.

In 2000, USP revised its standards on non-sterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers to one year from the date the drug is repackaged or the expiration date on the manufacturer's container, whichever is earlier.

The draft guidance would make FDA's enforcement policy under current Good Manufacturing Practices regulations comparable to USP's standards.

"We have considered the USP revision to its beyond-use standard and believe that similar conditions are appropriate...for expiration dating," the agency said.

- Brian Marson