Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Presenter
Julian Chun, PharmD, MBA
Pharmacist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This virtual conference case study review delves into common errors and compliance challenges in drug listing, particularly for repackaged drugs and marketing categories. When a repackager changes its source drug manufacturer, if the new source drug has different distinguishing characteristics like size, shape, color, or imprint, the repackager must delist the current product and create a new listing with a new National Drug Code (NDC). Even if the new source drug’s characteristics match, the listing still requires updates, and the FDA strongly recommends assigning a new NDC for accuracy. The presentations emphasize that repackaged drug listings must exclusively reflect the repackager’s NDC and specific package details throughout the entire content of labeling, including the “how supplied” section and the principal display panel, to avoid common copy-paste errors from source drug information. Furthermore, the sessions highlight critical mistakes in marketing categories, such as citing incorrect application numbers (NDA, ANDA, BLA) or unauthorized use of applications, or improperly citing OTC monographs. Such marketing errors misbrand the drug product and can lead to significant compliance actions, underscoring the necessity of accurate and up-to-date listing data.