The Committee discussed five bulk drug substances nominated for inclusion on the section 503A Bulks List.
- Diindolylmethane - Treatment of cancer
- Glycolic acid - Hyperpigmentation (including melasma) and photodamaged skin
- Trichloroacetic acid - Common warts and genital warts
- Kojic acid - Hyperpigmentation and as a chelating agent to promote wound healing
- Vasoactive intestinal peptide - A condition described as “chronic inflammatory response syndrome”
The Committee also discussed drug products that employ transdermal and topical delivery systems, which were nominated for the Difficult to Compound List.