Dispensed

No

No

• The drug unit has been dispensed to a subject.
• Drug unit can be selected at site for return to DDF.
• The drug unit is not counted in inventory for re-supply calculation.
• The drug unit can be updated to be either damaged or missing.

Do Not Count

Yes

No

The DNC days are the minimum number of days before the expiration date from which drug unit can be counted as available by the system at either the depot or site.

The DNC date is calculated as:

Current Date < Lot Expiration Date – DNC days

The DNC is a lot status set at the lot level.

• The drug unit is not counted in inventory for re-supply calculation.
• The drug unit is available for shipment order by the depot.
• The drug unit is available to be dispensed at the site.

Do Not Dispense

No

No

Do Not Dispense (to subject based on visit window). The DND days are the number of days prior to the Expiration Date from which study trial supply cannot be dispensed to a subject. The DND date is calculated as:

Current Date < Lot Expiration Date – Days from Expiry (DND)
For drug replacement, the DND is calculated as:

DND = DND from Visit Schedule of the last visit – days elapsed from last visit

• The drug unit is not counted in inventory for re-supply calculation.
• The drug unit is not available for shipment order by the depot.
• The drug unit is not available to be dispensed at the site.

Do Not Ship

Yes

Yes (site only)

Do Not Ship (at site or depot). The DNS days are the minimum number of days prior to the Expiration Date from which a study trial supply shipment order can be requested from a depot. The DNS date is calculated as:

Current Date < Lot Expiration Date – DNS days

• The drug unit is counted in inventory at the site but not the depot for re-supply calculation.
• The drug unit is available for shipment order by the depot.
• The drug unit is available for shipment order by the site.

Expired

No

No

• The drug order has expired.
• The drug unit is not counted in inventory for re-supply calculation.
• The drug unit is not available for either shipment order by depot or dispensing by site.
• The drug unit can be selected at site for return to DDF.
• The drug units can be over-labeled when a new expiration date is applied.

In Transit

No

Yes

• The drug unit has been ordered, shipped by the depot, but has not yet been registered at the depot or site.
• The drug unit is not counted at depot in inventory, but is counted in inventory for re-supply calculation at site.
• The drug unit is raised in a shipment order and shipped by depot.
• The drug unit has not yet been received by site or depot.
• The drug units can be over-labeled when a new expiration date is applied.

Not in Use

No

No

• This status is applied at the lot level.
• The drug unit is not counted in inventory for re-supply calculation.
• The drug unit is not available for shipment order by the depot or dispensing by the site.

Processed for Destruction

No

No

• The drug unit has been selected at site to begin destruction process (a Reconcile Date has been captured).
• Drug unit is not counted in inventory for re-supply calculation.
• The drug unit cannot be dispensed to subject.

Temporarily Unavailable

No

Yes

• This status is applied to drug units that do not meet the other conditions.
• The drug unit is counted in inventory for re-supply calculation.
• The drug unit is not available for either shipment order by depot or dispensing by site.
• The drug unit cannot be selected at site for return to DDF.
• The drug units can be over-labeled when a new expiration date is applied.