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FDA Drug Labeling and Ingredient Requirement

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.

FDA Drug Labeling

To request a quote about "FDA Drug Labeling and Ingredient Requirement" submit US FDA Registration Help form or call us at +1 929-376-7870 to speak with one of our agents for help.

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Contact Info:
Address:82 Nassau St,New York,NY 10038,USA
Phone: +1 929-376-7870

  Service & Fees: 

  • Current Label's Review & Assessment, Free
  • FDA Compliant Labeling Review, 745 USD
  • FDA Compliant New Label Content, Free
  •    Sixty Days Label reviews and Modifications, Free Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.

U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info