[A fine line between legal and illegal oral drug repackaging].

In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists' recommendations and criteria. The conclusion is that the regulations need to be rewritten to establish minimum single-dose oral drug criteria for dispensing hospitals-regulations that cover infrastructure, equipment, and professionals complying with good practices in oral drug repackaging. A proposal is offered to implement an official Mexican standard that regulates single-dose repackaging and unifies concepts, criteria, and means of verification, while the pharmaceutical industry would be responsible for the technology and resources for single-dose drug packaging designed for the health sector.