Drugmakers laud the US Food and Drug Administration’s (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders, on the other hand, argue that the agency failed to follow rulemaking requirements and that the rule will negatively impact smaller outsourcing facilities.
FDA’s recently proposed a rule to implement sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which contain a list of requirements for drug products to be exempt from certain current good manufacturing practice (cGMP) requirements, adequate directions for use in drug labeling, and drug approval for new drug applications or abbreviated new drug applications when compounded…
