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Bulk Pharmaceuticals Task Force Alarmed at Reduction in Compliance Inspections

May 29, 2014

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued a letter to the Food and Drug Administration (FDA) asking that the agency ensure the frequency of inspections for any domestic Active Pharmaceutical Ingredient (API) manufacturer remains consistent.  

The letter addresses the Department of Health and Human Services FY 2015 FDA budget justification disclosing that the FDA would be scaling back the number of domestic API inspections by nearly 40 percent in favor of elevating the number of foreign inspections. This could result in the failure of a number of compliant API manufacturers to receive safety inspections in a timely manner and not meet the agency's Generic Drug User Fee Amendments (GDUFA) commitment of inspecting domestic API manufacturers within a three-year cycle.  

“We support the goal of inspection parity for both foreign and domestic API manufacturing facilities and ensuring that the FDA has the resources it needs to successfully conduct these inspections,” said John DiLoreto, executive director of BPTF. “We are simply asking the agency to ensure that, in conformance with its obligations expressed in the GDUFA Commitment Letter, the frequency of safety inspections is not compromised. The negotiated GDUFA inspection goal is to increase the frequency of foreign facility inspections, not to reduce the inspection frequency of domestic facilities.”

The BPTF is actively engaged in promoting and advocating for drug safety by increasing the number of FDA inspectors and foreign inspections through the implementation of an inspections fee schedule for generic drug and drug ingredient importers as needed to offset the costs to conduct such inspections.  

The BPTF is an association within SOCMA that represents the interests of the manufacturers of active pharmaceutical ingredients, excipients, and intermediates.  

SOCMA is the leading trade association of the specialty batch and custom manufacturing chemical industry in the U.S. Founded in 1921, SOCMA represents approximately 220 member companies worldwide.