Importing Active Pharmaceutical Ingredients

May 2001

The Food and Drug Administration ("FDA") recently published Import Alert #66-66 restricting the importation of Active Pharmaceutical Ingredients ("APIs") based on its belief that a large volume of bulk chemicals used as APIs in human medicines are entering the country without proper FDA labeling. The FDA has seen two types of violations by importers: (1) importers are furnishing New Drug Application ("NDA") or Investigational New Drug ("IND") numbers that do not cover the particular source of the imported API; and (2) importers may be entering APIs under certain NDA or IND numbers even though they are not authorized to do so.

In order to prevent these types of violations, the Import Alert authorizes local FDA Districts to detain, without physical examination, imported merchandise produced by certain foreign manufacturers. A list of these manufacturers can be found in the Import Alert or can be supplied to you by a BRC attorney. Once merchandise is detained, an importer can facilitate its release by providing the FDA evidence that the API is (1) intended for pharmacy compounding that meets the requirements of section 503Aof the Food Drug and Cosmetic Act; (2) intended for use in the manufacture, processing, or repacking of an over?the?counter product or prescription product that does not require an NDA; (3) a new animal drug, or intended for use in the manufacture, processing, or repacking of a new animal drug, subject to an NADA; (4) intended for use in the manufacture, processing, or repacking of a human drug that is itself the subject of an approved NDA, and that the API is from the appropriate source; or (5) it is covered by IND requirements at 21 C.F.R. § 312.110(a).

An importer may prevent its merchandise from being detained by learning about and providing to the FDA additional information that the agency now requires for imported APIs. Prior to the issuance of Import Alert #66-66, the FDA required the following information for the import of APIs: product name, manufacturer, shipper, country of origin, FDA product code and National Drug Code/Drug Listing number. With the release of this alert, the FDA now requires all of the above information as well as the Central File Number ("CFN"), final destination of the API and the application number (Abbreviated New Drug Application Number; New Drug Application Number; Investigational New Drug Number; Investigational New Animal Drug Number). Importers and brokers alike should be aware that it is their obligation to indicate at time of entry whether merchandise is subject to FDA review. Chemical importers who may not believe that their imports are subject to FDA rules should review their merchandise to determine what products are subject to FDA review, and should discuss these issues with their broker. Indicating at time of entry that merchandise is subject to FDA review when it is not can cause problems, just as indicating that merchandise is not subject to FDA review when in fact it is can cause problems.