Regulatory Focus™ > News Articles > FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances

FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances

Posted 16 June 2015 | By Alexander Gaffney, RAC

FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances

The US Food and Drug Administration (FDA) has finalized a new policy detailing how manufacturers of drug products containing salts should name their products.


The guidance document, Naming of Drug Products Containing Salt Drug Substances, was first released in draft form in December 2013 following the May 2013 implementation of the US Pharmacopoeia's (USP) monograph on naming new drug products, Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.

Both FDA and USP's policies apply to a subset of drugs containing "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," FDA explains in the guidance. "The USP Salt Policy also states that USP will base the strength of the product on the active moiety."

In other words, a solid drug containing a salt would be called "newdrug" and not "newdrug hydrochloride," FDA explained by way of a hypothetical example.

FDA Guidance

FDA's guidance is focused on how regulators plan to implement USP's naming policy. FDA said it intends to apply the policy to all new prescription drug products approved under Section 505 of the Federal Food, Drug and Cosmetic Act (i.e. all drugs). Existing drugs will not be impacted at this time unless specific safety concerns are raised, FDA and USP have confirmed.

While a narrow group of criteria will permit some drug substances to obtain exemptions from the policy, such as when the salt is therapeutically important, FDA will need to approve each exemption, the guidance explains. Early consultation with regulators is key, FDA added.

FDA said it believes the new policy will benefit patients.

"CDER's application of the USP Salt Policy should help avoid medication errors that could result from a mismatch of established name and strength (e.g., the name includes the salt but the strength is based on active moiety)," it explained. "In addition, we anticipate that the policy will make it easier for healthcare practitioners to calculate an equivalent dose when transferring patients from one dosage form to another (e.g., calculating dose from an injection to a tablet), even if the products contain active ingredients that are different salts, because the strengths and names both will be based on the active moiety."


Naming of Drug Products Containing Salt Drug Substances (FR)

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