The FDA has proposed adding five new substances to the list of bulk drug substances that can be compounded by licensed pharmacists and physicians, according to Regulatory Focus.
This is the first time the FDA has sought to expand its list of compoundable substances since finalizing the criteria it will use to determine which bulk products can be used under Section 503A of the Federal Food, Drug and Cosmetic Act.
The five drug substances the FDA proposed adding to the list are glutaraldehyde, glycolic acid, L-citrulline, pyruvic acid and trichloroacetic acid.
The FDA also determined that another 26 bulk drug substances are not appropriate for compounding under the FD&C Act.
Last week, the FDA also identified nine bulk drug substances it says should not be compounded by outsourcing facilities under section 503B of FD&C Act after determining there is no clinical need for those substances to be compounded.
Read the full report here.