An FDA approved drug is one which is subject to an FDA approved application: New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA). Unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval.
All foreign drug establishments whose products are imported or offered for import into the United States are required to register their establishment with FDA and list all of their drug products in commercial distribution in the United States (See FAQ: If I am required to register my drug facility and list my drug product, how do I proceed? For more details)
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified by Customs of the product’s entry and makes a decision as to its admissibility.
An OTC Drug Product is a product marketed for use by the consumer without the intervention of a health care professional to obtain the product. In addition to marketing under an approved new drug application or abbreviated new drug application, OTC drug products can be marketed in compliance with an OTC monograph regulation. OTC monographs represent regulatory standards for the marketing of non-prescription drug products without an approved new drug application. An OTC drug can be imported into the United States under an NDA, an ANDA, or in compliance with an OTC monograph.
- The OTC monographs and ingredients covered by the monographs are provided in the Status of OTC Rulemakings
An active Pharmaceutical Ingredient (API) is defined as “Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body of humans or other animals.”
- Import Alert #66-66 provides useful guidance on the import of APIs. This guidance includes information on the detention of APIs, when they can be detained without physical examination, and the type of evidence needed to obtain their release.