Compounding Issues
In line with FDA’s statement, pharmacists are reminded that 20 CSR
2220-2.200(9) provides:
Compounding of drug products that are commercially available
in the marketplace or that are essentially copies of commercially
available Federal [Food and] Drug Administration (FDA) approved
drug products is prohibited. There shall be sufficient
documentation within the prescription record of the pharmacy
of the specific medical need for a particular variation of a commercially
available compound.
quoted from Kentucky Board of Pharmacy June 2013 Newsletter
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