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USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling

Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling guidelines "Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products" and "Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products" which are open for comments.


Guidance: Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products


In this guideline, recommendations are made for the labeling of sodium, potassium, and phosphorus in human prescription and over-the-counter (OTC) medicines.


Its recommendations apply to orally ingested products as well as injectable medications that contain 5 mg or more sodium, potassium, or elemental phosphorus per maximum dose.

Guidance: Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products


The purpose of nonprescription drug product labels is to enable consumers to select appropriate and use the nonprescription drug product safely and effectively without medical supervision.


The statement of identity is one of the principal features of nonprescription drug product labeling and consists of the established name for the nonprescription drug product if one exists, followed by an accurate statement of the general pharmacological category or the principal intended action(s) of the drug product.


Consistent content and format of the statement of Identity and strength on the product’s principal display panel (PDP) may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection.


In this draft guidance, recommendations are given for the content and format of the statement of identity required on nonprescription human drugs and also provides recommendations on the inclusion of the drug product’s strength on the labeling.


As part of this draft guidance, manufacturers, packers, distributors, applicants, relabelers, and sponsors are advised to ensure that statements of identity and strength for human nonprescription drugs are consistent in content and format.






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