U.S. FDA Registration & Labeling Compliance Assistance

FDA Drug Labeling and Ingredient Requirement  

Regardless of the manufacturing origin, all of the drugs that are in the U.S. market must comply with the Federal Food Drug and Cosmetic Act (FDCA). 'Intended use' of a drug article is the primary factor in defining which FDA regulations will be applicable for specific drug label.

The information allowed on a drug label is likely to be determined by the FDA drug classification, for example prescription (Rx), API, etc . The 'labeling' as the term is defined by the Food Drug and Cosmetic Act (FDCA) exceeds just the printed label on the drug package and will encompass accompanying inner-packing information, pamphlets, marketing materials and seller websites. Claims that surpass the approval, or the applicable FDA regulation will cause the drug to leap into an unapproved category.

Labeling issues are often the primary cause of delays in FDA approvals, import alerts and detentions. FDA Listing Inc. drug labeling experts will first analyze your label by cross checking against applicable U.S. federal regulatory databases and FDA labeling guidelines. Next, we will will provide you with comprehensive FDA compliant labeling review in an all-inclusive report that suggests the proper format and is ready to be used on the drug packaging. Click the start button to request for free initial labeling assessment and FDA compliant drug labeling review.