Additions to Bulk Drug Compounding Rule

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA is proposing to place six additional substances into the 503A bulk drugs list that can be used in compounding and may qualify for an exemption from certain sections of the act. The proposed rule also identifies four bulk drug substances that FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking. The deadline for electronic or written comments on the bulk drug substances list is March 16, 2017.
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