ANNEX E Glossary of Terms

Abbreviated New Drug Application (ANDA)	simplified submission permitted for a duplicate of an already approved drug. ANDAs are for products with the same or very closely related active ingredients, dose form, strength, administration route, use, and labeling as a product that has already been shown to be safe and effective.
Bulk drug substance	any substance represented for use in a drug and when in the manufacturing, processing, or packaging of a drug becomes an active ingredient of a finished dosage form. This does not include intermediates used in the synthesis of such substances.
Commercial distribution	any distribution of a human drug except for investigational use and any distribution of an animal drug or an animal feed bearing or containing an animal drug for noninvestigational uses, but the term does not include internal or interplant transfer of a bulk drug substance between registered domestic establishments within the same parent, subsidiary, and/or affiliate company.
Distributor	distributes a product under a custom or own label. The product is manufactured and labeled by a registered establishment.
Drug product salvaging	the act of segregating drug products that may have been subjected to improper storage conditions, such as extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation, for the purpose of returning some of all of the products to the marketplace.
Establishment	a place of business under one management at one general physical location. The term includes, among others, independent laboratories that engage in control activities for a registered drug establishment (e.g., consulting laboratories), manufacturers of medicated feeds and of vitamin products that are drugs in accordance with section 201(g) of the act, human blood donor centers, and animal facilities used for the production or control testing of licensed biologicals, and establishments engaged in drug product salvaging.
Importer/Broker	firm that arranges for the importation of foreign articles and who usually guarantees proper custody and handling of the shipment in addition to maintaining the records of importation. Importers who are also the initial distributors of medical devices are required to register with the Center for Devices and Radiological Health.
Imprint Code	any single letter or number or any comtination of letter(s) and numbers assigned by a drug firm to a specific drug product.
Investigational New Drug Application (IND)	application that a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including structural formula, animal test results, and manufacturing information.
Labeler/Relabeler	establishment which affixes the original label to a product or changes in any way the labeling on a product without affecting the product or its container.
Manufacturing or processing	manufacture, preparation, propagation, compounding, or processing of a drug or drugs and is the making by chemical, physical, biological, or other procedures any articles that meet the definition of drugs. The term includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process. The term also includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package to further distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.
New Drug Application (NDA)	application requesting FDA approval to market a new drug for human use in interstate commerce.
Package Size	describe the unit or number of units which make up a trade package.
Package	an entity which cannot be broken or subdivided by a distributor or wholesaler.
Packer/Repacker	establishment packs a product or products into different containers without making any change in the form of the product. This includes packers of raw agricultural products and medicinal gas repackers.
Representative sampling of advertisements	typical advertising material (excluding labeling) that gives a balanced picture of promotional claims used for the drug, e.g., if more than one medical journal advertisement is used but the promotional content is essentially identical, only one need be submitted.
Representative sampling of other labeling	typical labeling material (excluding labels and package inserts) that gives a balanced picture of promotional claims used for the drug, e.g., if more than one brochure is used but the promotional content is essentially identical, only one need be submitted.