Drugs | APIs/Bulks

An Active Pharmaceutical Ingredients or API is the ingredient in a finished drug that has the intended therapeutic effect. FDA regulates APIs as drugs because they are drug components. FDA also regulates inactive drug ingredients, but with far less focus or stringency.

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FDA monitors APIs to ensure they meet the quality and purity characteristics that they purport, or are represented, to possess. When a chemical is classified as an API, it is subject to FDA's good manufacturing practices (GMP) regulations.

FDA has taken the position currently that the FDCA and FDA regulations require the conclusion that all APIs are necessarily misbranded because they cannot meet the statutory and regulatory requirement to bear adequate directions for use. No one uses APIs in the form in which they are manufactured and distributed for further processing. However, FDA has established drug labeling exemptions for APIs as long as the drug ingredient is used for certain specific functions (clinical trials under a valid Investigational New Drug (IND) application, for further manufacturing or processing into an FDA approved drug, for pharmacy compounding, for chemical testing, research and analysis, and for law enforcement or training and teaching purposes).

When an imported API arrives in the U.S., FDA follows certain import procedures designed to ensure that the API was manufactured by a drug facility that is in compliance with FDA drug establishment registration regulations and is an appropriate source for the API. FDA ensures that the drug is listed with FDA and that an applicable drug labeling exemption exists. These procedures can cause delays in active pharmaceutical ingredient importation; however, many foreign drug manufacturers import APIs into the U.S. every day.

FDAImports.com, LLC is very familiar with the FDA's API importation procedures, the drug labeling, drug facility registration and drug listing regulations, and the application of the FDA's drug labeling exemptions. As a result, FDAImports.com, LLC regularly helps all types and sizes of drug manufacturers, drug importers and drug distributors and compounding pharmacies successfully import APIs into the U.S.

Failing to comply with the FDA regulations related to API manufacturing, API labeling and importing APIs can result in FDA import detentions, FDA Import Alerts, and FDA import refusals. In many cases, FDA detains imported API shipments improperly. This happens because the international drug manufacturing industry has become so complex that FDA registration, FDA listing and FDA approval systems are not able to adequately account for the many companies that may be involved in bringing a drug to market. FDAImports.com, LLC often is called upon to obtain FDA release of a detained imported API shipment. FDAImports.com, LLC is able to find The Way Through for your API importation or API distribution in a manner that reduces the risk that FDA will significantly intervene in the API importation.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.