FDA Pushes for Removal, Addition of Substances to 503A Bulks List

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FDA proposal 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:

  • Brilliant Blue G, also known as Coomassie Brilliant Blue G-250, as a dye used in staining for visualization during ophthalmic procedures
  • Cantharidin (for topical use only) for the treatment of warts and molluscum contagiosum
  • Diphenylcyclopropenone (for topical use only) for the treatment of alopecia areata and nongenital warts
  • N-acetyl-D-glucosamine (for topical use only) for the treatment of hyperpigmentation and other skin conditions
  • Squaric acid dibutyl ester (for topical use only) for the treatment of alopecia areata and recalcitrant nongenital warts
  • Thymol iodide (for topical use only) for ulcerations and skin infections, as well as an intrapleural treatment for pleural effusions

The products that would be removed are:

  • Oxitriptan (evaluated as a treatment for depression and insomnia)
  • Piracetam (evaluated as a treatment for enhancing cognitive skills)
  • Silver protein mild (for use as an anti-infective agent for ophthalmic use)
  • Tranilast (for the treatment of allergic disorders, arthritis, dry eye syndrome, keloids, and hypertrophic scars.)

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.

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