“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The pack has not been registered as recalled, withdrawn, intended for destruction or stolen during the intervening period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 “