FDA seeks to update compounding guidance for hospital pharmacies

The FDA is seeking to revise its guidance on compounded drugs for hospitals and health systems, removing a rule that stated they could only distribute compounded drugs to facilities within a 1-mile radius of the pharmacy. 

The agency said Oct. 6 that it wants to  make the change in response to many comments it's received from health systems that the 1-mile radius rule was unreasonable considering many health systems need to supply compounded drugs to its facilities outside of that range. 

The new proposed guidance says compounded drugs can be administered to patients as long as the drugs are within the hospital or health system and that the drugs must be used or discarded within 24 hours of them leaving the pharmacy. 

The agency said the update would ensure that patients that need them have access to compounded drugs, which are given to patients whose medical needs can't be met with an FDA-approved drug. 

The FDA is still encouraging hospitals and health systems to have procedures in place to get nonpatient-specific compounded drugs from outsourcing facilities and to consider registering their own pharmacies as outsourcing facilities. 

The agency will consider any comments received on the proposed rule before finalizing the guidance update. 

Read the full news release here.

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