In a final guidance document, the regulator explains the USP naming and labeling policy for drug products containing salt as an active ingredient, and how the CDER is implementing it, in a bid to eliminate discrepancies between the established name and strength on labels.
The regulator issued guidance explaining how the CDER’s implementation of the United States Pharmacopeia’s (USP’s) Salt Policy will affect drug products containing an active ingredient that’s a salt. The FDA notes it exclusively applies to the monograph title for drug products, and not for drug substances.
According to the FDA, adhering to the USP Salt Policy will “help reduce medication errors” resulting from a disparity between the established name and strength on the label of drug products that contain a salt. The FDA says the policy, “Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations,” affects the development of new drug products because most of the time, a USP monograph title for a new drug product serves as the nonproprietary or “established” name of the related drug product. If a drug product’s label or labeling bears a name that’s inconsistent with the applicable monograph title, it risks being misbranded.
In the document, the FDA goes over the policy, breaking it down into five main points, including that the monograph title for a drug product containing salt as an active ingredient will bear the name of the active moiety rather than the name of the salt when creating a drug product monograph title, and that the strength is expressed in terms of the active moiety rather than salt strength equivalent.
The FDA also explains how the CDER is applying the policy, noting it is being applied to prescription drug products under development for which companies are seeking approval. It’s recommended that the established name of the drug products as determined under the policy be consistently used in all contexts where the established name is used. The document also covers how the CDER is applying exceptions, describing procedures and conditions, and encouraging early communication for a potential exemption.
The regulator goes on to explain how to implement the USP Salt Policy as it relates to product development and labels and labeling information, and notes its nonimpact on active ingredient requirements. The document lists three steps sponsors should follow when developing a drug for which the USP Salt Policy may be relevant, including considering whether the product contains an active ingredient that’s a salt; considering whether the product qualifies for an exemption, and if so, contacting the CDER for preliminary feedback; and developing the product in a way that the name and strength are in accordance with the policy. The FDA also notes the application of the policy doesn’t affect statutory and regulatory requirements for drug products, listing a number of factors to consider when creating labels and labeling, including that the established name of the drug product and the active ingredient should be “correctly displayed throughout the labeling.” Also highlighted are locations in the PI where sponsors should be particularly attentive to the language, including the Highlights section, the Dosage Forms and Strengths section, and the Description section.