Five Rivers RX is making public comments on the Puerto Rico Department of Health’s proposed regulation Number 156B titled For the Operation of Establishments that Manufacture, Distribute, and Dispatch Medications in Puerto Rico.
Five Rivers RX supports the aim of Puerto Rico Act 273-2018 which seeks to expedite the importation process and lower the cost of medicines in Puerto Rico by speeding consumer access to medicines upon approval by federal authorities and reducing the burdens associated with product registration. To ensure the implementation of these regulations furthers these objectives, the proposed regulations should be clarified – without these clarifications, the proposed regulations may unnecessarily increase regulatory burdens and potentially limit access to medicines, particularly generic drugs, in Puerto Rico.