Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

US Compounding, Inc., a human drug compounding outsourcing facility, argues that succinylcholine chloride should be added to the FDA's 503B bulk drug substances list. They contend that there is a significant clinical need for a preservative-free formulation to treat patients with sensitivities to parabens found in commercially available products.

The Outsourcing Facilities Association (OFA), representing FDA-registered 503B outsourcing facilities, supports including succinylcholine chloride on the 503B Bulks List. They argue that a clinical need exists because commercial products contain paraben preservatives that can cause severe allergic reactions in certain patient populations.