FDA Proposes More Restrictive Expiration Dating For Repackaged Solid Oral Drugs
FDA has proposed to tighten proposed limits on the use of oral solid drugs from one year to just six months after they're repackaged into unit doses, except under certain circumstances, in line with USP standards on expiration dating.
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The US FDA will not enforce expiration dating requirements for unit-dose repackaging if repackagers follow an alternative approach outlined in final guidance.
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 FDA's draft guidance would harmonize enforcement policies on expiration dating with USP standards.
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