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They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.
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22 Repackaged Product Background The draft guidance, CPG 7132.b11, specifies conditions where it may be possible to assign up to 12 months expirationdating to non-sterile solid and liquid oral dosage form drug products repackaged into unit dose containers for Class A, without conducting new stability studies.