Revisions would add 6 bulk drug substances and remove 4 substances that can be used in compounding.
The FDA has created a new proposed rule that adds 6 bulk drug substances to an existing list of substances that can be used in compounding. It has also proposed the removal of 4 other bulk drug substances from the list.
The 6 new inclusions would be:
The products that would be removed are:
If the rule is finalized, the 6 bulk drug substances will be the first to be included on the 503A bulks list. The FDA’s Pharmacy Compounding Advisory Committee has met 3 times this year to discuss new additions and removals.
“Because of the amount of time that had passed between the publication of the 1999 proposed rule and the enactment of the Drug Quality Security Act, FDA felt it was necessary to begin again to develop the 503A Bulks List,” FDA officials said in a statement.
The FDA will be open to receiving comments on the proposed rule for 90 days.