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FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four

 
• By Joanne S. Eglovitch

FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and is unchanged from a proposed rule. The agency allows six bulk drug substances to be compounded by traditional pharmacies and rejects four that it had considered for inclusion, overruling the objections of pharmacy groups that argued for retaining them on the compounding list.  

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A final rule the US FDA issued on Feb. 19 allows six bulk drug substances to be compounded by traditional pharmacies and rejects four, despite calls from pharmacy groups to add them to the list.

This rule, the first to list drugs permitted for bulk compounding since the Drug Quality Security Act took effect in...

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