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Frequently Asked Questions on "Outsourcing Facilities"

 

Q: Are "outsourcing facilities" (as defined by Section 503B of the federal Drug Quality and Security Act) required to obtain a pharmacy permit?

A: In some circumstances, yes.  This guidance document details the circumstances in which a 503B outsourcing facility must obtain (or maintain) a pharmacy permit.

 

 

Q: Are “outsourcing facilities" (as defined by Section 503B of the federal Drug Quality and Security Act) required to obtain a permit from any other North Carolina agency?

A: Yes.  All outsourcing facilities must obtain a permit from the North Carolina Department of Agriculture’s Food and Drug Protection Division.  More information here.

 

 

 

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