FDA Eases Expiration Date Requirements for Repackaged Solid Oral Dosage Drugs

August 10, 2017

In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses.

The agency said it will not take enforcement action under expiration dating requirements for such drugs if they are assigned an expiration date no more than six months from the date of repackaging. The FDA said it will not take action if five conditions are met.

The products must also meet the following conditions: meet class A or Class B standards, indicate dugs sensitive to light, unopened original packaging, repackaging described in the original labeling, and warning against repacking.

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