FDA drug compounding and repackaging

FDA has issued five draft documents related to drug compounding and repackaging. These are:

1.      Entities considering whether to register with the FDA as an outsourcing facility under section 503B of the FD&C Act

2.      Repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility

3.      Mixing, diluting or repackaging specific biological products outside the scope of an approved BLA

4.      Adverse event reporting for outsourcing facilities. under section 503B of the FD&C Act

5.      A draft MOU under section 503A of the FD&C Act describing the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state.

The five draft documents can be accessed here.

Posted by Tim Sandle