Office Use and the Section 503A
Prescription Requirement
• Section 503A states that certain provisions of
the FD&C Act “shall not apply to a drug product
if the drug product is compounded for an
identified individual patient based on the
receipt of a valid prescription order or a
notation (emphasis added), approved by the
prescribing practitioner, on the prescription order
that a compounded product is necessary for the
patient” (section 503A(a))
source: http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm491054.pdf
source: http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm491054.pdf
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