E-News April 20, 2016

April  20, 2016

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The FDA issued three draft guidance documents on April 15 concerning the drug compounding standards.

 

 The proposed rules clarify several questions.

 

–describes requirements for compounding drug products for patients after the receipt of a prescription, compounding before the receipt of a prescription, and compounding for office use.

 

— describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded by pharmacists in health system pharmacies for use within the hospital or health system.

 

–clarifies how large-scale compounding sites or outsourcing facilities may practice

 

The documents are on the FDA website for review and comment for 90 days.

 

 

 

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