By Paige Arnold, J.D.
In an effort to ensure clarity and usefulness for health care providers, the FDA made recommendations for the format and content of product title and initial U.S. approval in the "Highlights" of prescription drug and biological products labeling. These FDA recommendations are specific to product title and initial U.S. approval in Highlights and are not applicable to other prescription drug information parts or other types of labeling like container or carton labeling. The draft guidance discusses these requirements for human drug and biological products labels along with other recommendations (Notice, 83 FR 2796, January 19, 2018).
Background. In 2006, the FDA issued labeling rules that established content and prescription drug label information requirements for new drugs used by physicians and other health care providers. The rules required the product information to have three sections: (1) Highlights; (2) Full Prescription Drug Information: Contents; and (3) Full Prescription Information.
The Highlights section must also include specific product title information and the year of initial U.S. approval. Furthermore, the year of initial U.S. approval must be placed directly under the product title.
Recommendations. The FDA provided recommendations of sources for product title and terminology, including drug names, dosage form, route of administration, and controlled substance symbol. In addition, the FDA furnished title format and content guidance of products including basic format, drug names, dosage form, route of administration. In addition, recommendations were made for drug products with special nomenclature considerations such as premixed drugs with infusion solutions or co-packaged drug products, and controlled substance symbols.
The draft guidance also covered recommendations as to what not to include in product title labeling and the implications of product title on container and carton labeling. In an effort to promote consistency, recommendations were made as to items that should not be included in the product title Highlights including slash marks, drug product origin, inactive ingredients or lack thereof, storage conditions, abbreviations and other content and format items.
The FDA noted that there was a difference between product title in Highlights and product title for containers and carton labeling, and several distinctions were listed. However, there was a concern to maintain consistency between the product information for both the product title and container and carton labeling. Finally, recommendations of items to consider in identifying and establishing the year of initial U.S. approval were also made.
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