E-News April 20, 2016
April 20, 2016
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