USA – FDA issues guidance documents on labeling drug identity, constituents

The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the guidance document addresses the statement of identity and drug strength for OTC products and the other relates to the quantification of sodium, potassium and phosphorus and prescription and OTC drugs.

Identify and strength labeling

In draft guidance issued on 8 September 2022, FDA offered recommendations for the content and format of the required statement of identity and drug strength, both of which must appear in a prominent way on the principal display panel (PDP) for all human nonprescription drug products.

“Consistent content and format of the statement of identify and drug strength may aid consumers in comparing different nonprescription drugs and assist consumers in selecting an appropriate product,” FDA said in a statement.

The statement of identity includes the drug’s established name and a statement of its general pharmacological category or its intended principal action. OTC monograph drug products should use the statement of identity contained in the monograph. However, if the OTC monograph statement of identity is not consistent with the draft guidance, FDA does not intend to take action against companies who follow the guidance, provided the drug product is marketed in compliance with all other applicable statues and regulations, including other requirements of the OTC drug monograph…