Overview:
On September 8,2022, FDA published the draft of a guideline that provides recommendations on the content and format of the statement of identity and the drug’s strength, that are both required on the labeling of human nonprescription drug products (OTC drugs).
Introduction:
The main purpose of the guideline is to ensure consistency in the content and format of the statement of identity and strength of OTC drugs, that will help consumers selecting the appropriate product, when making comparison between them.
Purpose of the guideline is:
- Ensure consistency in the content
- Format of the statement of identity
- Strength of OTC drug
That will help consumers selecting the appropriate product, when making comparison between them.
Features on OTC drugs labeling:
- Name
- Clear Pharmacological information
- Identity statement should be placed on the principal display panel (PDP) of the OTC drug and should be followed by the strength of the drug, shown in bold.
It is important to underline that the FDA proposed guideline doesn’t apply to the labeling of OTC monograph drugs
FDA recommended identity statement settings
The statement of identity is one of the principal features on OTC drugs labeling. It consists of the drug’s established name, followed by an accurate statement of the general pharmacological category(ies) or the drug’s principal intended action(s). It is an important information because it tells the consumer what the drug is and for what it can be used. Example of statement of identity “clotrimazole cream, antifungal”.
According to FDA recommendations, the statement of identity should be placed on the principal display panel (PDP) of the OTC drug and should be at least half the size of the most prominent printed matter on the PDP. Furthermore, it should be followed by the strength of the drug, that should be presented in bold face type as well. FDA recommends using one of the following configurations of the statement of identity:
[Established Name] [Pharmacological Category] [Strength] |
[Established Name] [Pharmacological Category] [Strength] |
[Established Name] [Pharmacological Category] [Strength] |
Blog: Updated – Upcoming Complex PSGs
FDA updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the agency’s plans for issuing new or revised PSGs in the coming year for complex generic drug products as defined in the GDUFA II Commitment Letter.
For more Information:
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