Registering with the FDA as an outsourcing facility allows a pharmacy to do what?

Registering with the FDA as an outsourcing facility enables a pharmacy to compound sterile products without the requirement of receiving patient-specific prescriptions. This designation allows the facility to prepare large quantities of compounded medications that can be distributed to healthcare facilities for administration to patients, in contrast to traditional pharmacies that typically must process prescriptions for individual patients.

This flexibility is essential for outsourcing facilities, as it facilitates the efficient production of sterile compounded drugs, which may be necessary for hospital settings or in situations where there is a shortage of specific medications. The need for these facilities arises from the demand for compounded sterile products that are tailored to the needs of various patient populations, especially when commercially available alternatives are insufficient.

In sum, the registration with the FDA significantly broadens the scope of practice for outsourcing facilities, allowing them to meet healthcare demands without directly relying on individual prescriptions.