Pharmaceutical manufacturers have generally produced drugs at large fixed-location facilities, but some are now developing smaller, mobile drug manufacturing processes that can be deployed to multiple locations, including at the point of care, such as at a hospital or clinic.
These novel distributed manufacturing (DM) and point-of-care (POC) manufacturing technologies have the potential to improve the reliability and robustness of the drug supply chain. The U.S. Food and Drug Administration is keenly interested in these technologies because they could potentially provide flexibility for drug manufacturers to enable a rapid and localized response to change demand and increase timely access to quality drugs for U.S. patients.
For example, a healthcare facility could be interested in using a POC manufacturing technology to meet the specific needs of its patients, or DM units could be deployed at a location following a public health emergency to meet local demand for certain drugs.
Though there are currently no FDA-approved drugs being manufactured using DM or POC technology, the agency is proactively evaluating our existing risk-based regulatory framework as it applies to these technologies. The agency recognizes feedback from drug manufacturers and other stakeholders involved in the development of DM and POC technologies is critical to help inform the FDA’s evaluation of our existing regulatory framework.
