FDA Guidance on Insanitary Conditions at Compounding Facilities

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA released new draft guidance addressing insanitary conditions at 503A and 503B drug compounding facilities. The guidance includes numerous examples of conditions considered insanitary for both sterile and non-sterile facilities and procedures to “assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions.” Though 503A compounders are not required to register with FDA, and are primarily overseen by States, the document includes parameters for working more closely with State regulatory agencies. [For more on FDA’s guidance and enforcement activity in compounding see IPQ’s Monthly Update for March/April 2014 and search “pharmacy compounding” at IPQpubs.com.]
[/membership]