The US Food and Drug Administration (FDA) is proposing the creation of two lists of drugs or drug categories that are difficult to compound under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as criteria for inclusion on the lists.
FDA’s proposed rule would implement sections 503A and 503B of the FD&C Act, which contain a list of requirements for drug products to be exempt from certain current good manufacturing practice requirements, adequate directions for use in drug labeling, and drug approval for new drug applications or abbreviated new drug applications. In addition, both sections require the Secretary of Health and Human Services identify a combined drug product has “demonstrable difficulties for compounding.” Drug products in the list of drugs that have demonstrable difficulties for compounding (DDC Lists) “cannot qualify for the statutory exemptions under the applicable section,” FDA said…
