“ 10 day rule “ What is the ten day rule ?
All stakeholders in the medicines supply chain such as, wholesalers, pharmacies, hospitals will have to verify and decommission medicinal products when they are supplied to the patient or a healthcare provider who is exempt from decommissioning. These medicinal products can have their status changed and the decommission reversed in certain circumstances. Reversal of decommissioning is only permitted [under Article 13] when:
Once a pack has been “decommissioned” and had its status set to “Inactive” – decommissioned and supplied there is a short period of 10 days during which this process can be reversed and the pack status set back to active.
- Same Location
The reversal is undertaken by the same “person” (i.e. organisation) as the original decommissioning and from the same set of premises
- The 10 day Rule
The reversal takes place not longer than 10 days (240 hours) after the decommissioning
- Not Expired
The product has not expired since the decommissioning.
- Not Recalled
The pack has not been registered as recalled, withdrawn, intended for destruction or stolen during the intervening period
- Not Supplied
The product was not supplied to the public (and thus has not left the premises).
The 10-day rule is crucial to the smooth operation of assembly and dispensing within pharmacies. If products are decommissioned at an early stage, there is a risk that they might not be collected or handed over within the 10-day period. After this, decommissioning cannot be reversed and the product “shall not be returned to sale able stock” [Article 13] thus increasing wastage.
One way around this is to use ” Aggregated codes” generated by pharmacy dispensing systems. See my blog on “ Aggregated codes “