Section 657.20.12. Compounding copies of an approved drug.

Latest version.

A pharmacy or outsourcing facility may only compound preparations that are essentially copies of approved drugs if the compounded preparation is changed to produce for an individual patient a clinically significant difference to meet a medical need as determined and authorized by the prescriber. A pharmacy or outsourcing facility may compound a preparation that is essentially a copy of an approved drug if the approved drug is identified as currently in shortage on the FDA drug shortages database published on the FDA Web site, http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
[ARC 2194C, IAB 10/14/15, effective 11/18/15]

                    
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