FDA Issues Guidance on Naming of Salt Drug Substances

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-19-2015 17:58


The US Food and Drug Administration (FDA) has issued final guidance, Naming of Drug Products Containing Salt Drug Substances, to assist companies in understanding how products with active ingredients that are salts may be affected by the FDA's Center for Drug Evaluation and Research's implementation of the US Pharmacopeia (USP) policy entitled, "Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations" (i.e., the USP Salt Policy).

The US Salt Policy is a naming and labeling policy applicable to drug products that contain an active ingredient that is a salt. The policy stipulates that USP will use the name of the active moiety, instead of the name of the salt, for such a drug product when creating a drug product monograph title. The USP Salt Policy also states that USP will base the strength of the product on the active moiety. The policy allows for exceptions under specified circumstances.

The USP Salt Policy became effective on May 1, 2013, and USP is now applying it to all new drug product monographs for products that contain an active ingredient that is a salt. It affectsthe development of new drug products because a USP monograph title for a new drug product, in most instances, serves as the nonproprietary or “established” name of the related drug product. A drug product with a label or labeling that contains a name that is inconsistent with the applicable monograph title risks being misbranded. The USP Salt Policy only applies to the monograph titles for drug products. The policy will not apply to the titles of monographs for drug substances (active ingredients). Accordingly, the names of active ingredients (e.g., salts) will not be affected.

The guidance applies to prescription drug products approved under the Federal Food, Drug, and 23 Cosmetic Act (FD&C Act). This guidance does not address implementation of the USP Salt 24 Policy for nonprescription drug products or biological products licensed under the Public Health 25 Service Act (PHS Act).

Source: FDA


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