New Exposure Limits For Excipients Applauded While Loss Of Old Potency Limits Bemoaned
The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufactures.
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Next year, generic drug manufacturers will finally get some of the improvements they have been asking for in the US FDA’s Inactive Ingredient Database, such as being able to access the maximum daily intake (MDI) for each excipient. This information is helpful to industry in formulating products.
A US FDA official has announced that major revisions are underway to address problems with the agency’s Inactive Ingredient Database. These include replacing potency limits with a maximum daily exposure limit and adopting standard terminology for routes of administration. In its current form, the IID has been a source of confusion for industry.
The pharma industry says major problems continue with FDA’s Inactive Ingredient Database, including listing inaccurate potencies and using different names for the same excipient. A recent update has some firms in a ‘panic’ to reformulate products for pending ANDAs because of lowered potency limits or outright removal of some excipients from the database.