The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List
FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.
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The US FDA says new information brought to light by pharmacists and caregivers on compounded oxitriptan prompted the agency to reconsider its decision to exclude the substance from the 503A bulks list. Oxitriptan was placed on the do not compound list in February.
The US FDA has issued question-and-answer guidance to help pharmacies better understand and comply with its final rule establishing its 503A bulks list. The guidance addresses how the agency developed the list of approved bulk drug substances and how to appeal decisions to get substances placed on the list.