The information conveyed about new products has critical downstream implications that can affect the appropriate receiving, handling and storage at the distributor’s facility and farther along the healthcare supply chain. With member input, HDA has developed a standardized format for the information about new pharmaceutical products.
The 2020 form was updated to better reflect common commercial and regulatory information required for new item setup. The form can now be used for medical devices in addition to pharmaceutical products. Further, the serialization section of the form was streamlined and levels of packaging were changed for clarity. Common fields requested by trading partners, such as allergen information, were also added. Fields on waste characteristics also were added to reflect regulatory changes. A full list of changes is in the instructions.Note that this form was developed for the introduction of Rx products and devices. There may be other information relevant for the introduction of OTC products (e.g., other bases for marketing) not referenced on this form. At this time, HDA does not have plans to develop one specific to OTC products.
You may download the entire .zip file by clicking "Download .zip File" or download the form and instructions individually by clicking the separate files below:
For form questions, contact Justine Freisleben at (703) 885-0277.