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FDA Guidance of OTC Drug

Aug 11 2022

To market OTC Drug products in the U.S, There are two pathways which is submitting a New Drug Application (NDA) for FDA approval and using the OTC Drug Monograph process.

New Drug Application (NDA)

The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

OTC Drugs Monograph

An OTC monograph drug is a nonprescription, over-the-counter (or OTC) drug that may be marketed without an approved drug application and eastablishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category (sunscreen, antacid, etc) is generally recognized as safe and effective (GRASE) for its intended use.

Establishment Registration & Product Listing

  • Registration renewal occurs between October 1 and December 31 each year

  • Listing updates may occur at any time in the calendar year

FDA requires establishment registration to all OTC Drug manufacturers, with certain exemptions, and it is also require to list each drug manufacture at their establishment intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December.

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote patient safety.

  • The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters)

  • Contact information of someone responsible for receiving FDA communications related to that establishment

  • All applicable business operations that establishment performs

  • For foreign establishments, the name and DUNS of a U.S. agent and all importers

All registered establishments must list all drugs they produce for U.S. commercial distribution under their own labeler code. This includes active pharmaceutical ingredient manufacturers, other bulk drug manufacturers, contract manufacturers, repackers and relabelers.

NDC Number

Drugs are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as the FDA’s universal product identifier for drugs. NDCs should not be assigned to non-drug products such as medical devices and medical foods. Submission of NDC is required at the time of drug listing with FDA.

Registration of a drug establishment or drug wholesaler or assignment of a registration number or assignment of NDC number does not in any way denote approval of the company or its products.

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