|FDA Budget Request Slashed… But On Hold|
FDA Budget Request Slashed… But On Hold
As previously reported, the FDA requested $25 million in the 2015
budget to “enhance compounding oversight activities in FY2015.” Due to
the fact that the registration by outsourcing facilities (OFs) -- a new
registration type included in the Drug Quality & Security Act -- is
not mandatory, FDA protests in its budget request that it cannot rely
upon the fees that OFs might provide. In addition, the DQSA specifically
states that fees obtained through the registration of OFs may only be
used to oversee OFs. FDA is not supposed to use these funds to oversee
compounding pharmacies that do not choose to register with FDA as an OF.
Not satisfied with an extra $25 million, the FDA Office of Regulatory Affairs
also asked for almost $7 million in additional funding for field
activities including “conducting additional inspections of high-risk
human drug compounding pharmacies including sterile compounding
facilities that seek to qualify for the exemptions under section 503A
and facilities that register as OFs under section 503B.”
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