Tuesday, April 5, 2016

What 503A Says about Office Use:

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

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