{"id":39713,"date":"2020-01-16T22:05:06","date_gmt":"2020-01-16T22:05:06","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/serialization\/"},"modified":"2020-02-03T13:54:49","modified_gmt":"2020-02-03T13:54:49","slug":"serialization","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-drugs\/serialization\/","title":{"rendered":"New U.S. FDA Product Identifiers for Prescription Drugs (Serialization)"},"content":{"rendered":"
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New U.S. FDA Product Identifiers for Prescription Drugs (Serialization)<\/h2>\n[\/vc_column_text][vc_column_text]Manufacturers, Packers, and Repackagers of human prescription drug products are required under the Drug Supply Chain Security Act (DSCSA) to affix or imprint a product identifier (often referred to as a serialized National Drug Code, or \u201csNDC\u201d) to each package and homogenous case of a product that is intended to be introduced in a transaction into commerce by\u00a0November 28, 2018<\/strong>.\u00a0 This process is known as \u201cserialization\u201d.\u00a0 FDA may consider prescription drug products misbranded if they fail to bear the product identifier after the deadline.<\/p>\n

FDA has advised that listings for prescription drugs that do not bear product identifiers should\u00a0not<\/u><\/strong>\u00a0be certified as unchanged for 2019 during the upcoming renewal period.\u00a0 Industry should submit a new sampling of the labeling incorporating the product identifier as an update to their listing.<\/p>\n

Registrar Corp can provide guidance on FDA\u2019s new product identifier requirements and update drug listings on your behalf.\u00a0 \u00a0Complete the form below for more information:[\/vc_column_text][vc_column_text]