Regulatory Focus™ > News Articles > FDA Draft Guidance Interprets USP Nomenclature Policy for Salt-Based Drugs

FDA Draft Guidance Interprets USP Nomenclature Policy for Salt-Based Drugs

Posted 02 January 2014 | By Alexander Gaffney, RAC

US regulators have published a new draft guidance intended to assist industry with the naming of drug products which contain salt drug substances in compliance with a monograph policy recently issued by the US Pharmacopoeia (USP) and adopted by FDA's Center for Drug Evaluation and Research (CDER).

As explained in the 26 December 2013 draft guidance, Naming of Drug Products Containing Salt Drug Substances, the intent of USP's new "Salt Policy" is to ensure that salt-based drugs approved under a monograph are subject to a uniform nonproprietary scientific nomenclature. The policy came into effect in May 2013.

"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 its guidance. "The USP Salt Policy also states that USP will base the strength of the product on the active moiety," it added.

While relatively minor in the grand scheme of drug development, the name of a product does have regulatory implications. For example, if a drug fails to adhere to an applicable established monograph, which includes the name a product must bear, that drug can be subject to enforcement action by FDA under the theory that it is misbranded.

The biggest change under the new USP policy is that instead of bearing the name of the salt, it will now bear the name of just the active moiety. For example, "Pharmadrug Hydrochloride Tablet" would be called simply "Pharmadrug Tablet" under the new policy.

In addition, the strength of the drug will be expressed with respect to the active moiety, and no longer just the salt strength equivalent (though FDA may allow that to be used elsewhere), FDA said.

Some exceptions will also be allowed for under the Salt Policy, FDA explained. For example, it permits a drug to be named after the salt if it "conveys vital information from a clinical perspective."

The USP Salt Policy will likely only apply to new drugs-not existing monographs. In the event that changes need to occur in the future, FDA said it will work with USP to "coordinate regarding any necessary retrospective changes."

The agency said it anticipated the new policy being beneficial, particularly toward avoiding medication errors that might otherwise result from a "mismatch of established name and strength."

FDA-not sponsors-will be charged with applying the USP Salt Policy to new products.

Comments on the draft guidance are due by 26 March 2014.

Naming of Drug Products Containing Salt Drug Substances

Federal Register


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