FDA Compliance
• Stability analysis during storage at site; requalification and extension of expiry dates
• Maintenance of required storage conditions
     -Calibration of monitoring and storage equipment
     -Maintenance of monitoring and storage equipment
     -Power backup available in event of outage
     -Responsibilities/consequences in event of excursions / failures
     -Dispensing and shipment - conveyances and how they are climate-controlled
• Handling of complaints
• Liability in event of product decomposition or loss.

DEA Compliance
• Verification that both parties maintain up to date licenses with DEA, over entire course of anticipated storage period; commitment of both parties to prevent lapse of these licenses
• Assurance of secure / controlled access
• Facility and shipping subcontractor and import/export agent criminal background checks - required for anyone involved in product supply chain; justification of employee duties and responsibilities, based on performance, background check and known associates outside of work
    -This also has to be verified and justified for customer company
• Inventory control - accountability
• Liability in event of product loss; recourse of customer
• There is overlap with most or all of the FDA compliance considerations enumerated above