FDA Naming Guidance of Drug Products Containing Salt Drug Substances

Rx-360 has released a summary of the FDA Naming Guidance of Drug Products Containing Salt Drug Substances.

FDA has issued final guidance detailing naming and labeling for drug products that contain an active ingredient that is a salt. The guidance is intended to outline how products with active ingredients that are salts may be affected by CDER's implementation of the USP policy "Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations" (the USP Salt Policy).

The USP Salt Policy, which became effective on 1 May 2013, 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 drug products when creating a drug product monograph title. The USP Salt Policy also states that the strength of the product will be based on the active moiety.

FDA is applying the USP Salt Policy to prescription drug products under development for which approval is sought under Section 505 of the FD&C Act.  Existing drugs will not be impacted at this time unless necessary for safety. The final guidance outlines how CDER is applying the USP Salt Policy and how CDER is applying exemptions. It also discusses how to implement the USP Salt Policy during product development.

To view or download the FDA Guidance, click here.