FDA: New drafts compounding, repackaging of human drugs

On 13 February 2015 the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities. The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA (FDA News Release, 13 February 2015).
Click here for the full news release.

If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.