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FDA Encourages Hospitals, States to Get Sterile Products from Registered Outsourcing Facilities


The Food and Drug Administration (FDA) sent letters encouraging purchasers of sterile products to require their compounding venders to register with the agency as outsourcing facilities.

Section 503B of the Drug Quality and Security Act (DSQA) includes a provision that allows outsourcing facilities to voluntarily register with the FDA and be subject to risk-based inspections. In a separate letter to state governors, boards of pharmacy, and boards of health the agency highlighted provisions in the law that allow states to encourage compounding pharmacies that ship sterile products to purchasers in the state to register as outsourcing facilities.

The FDA has also published a list of firms that are registered as outsourcing facilities. This list will be updated weekly.


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