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USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule

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. The rule would create two lists for drugs with demonstrable difficulties for compounding (DDC lists) and, therefore, cannot be exempted from full regulatory oversight.

More information on the Regulatory Focus Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 octobre 2024). USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12ja1


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