Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)
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 developed a standardized format for the information about new pharmaceutical and medical device products.
The 2021 form was updated to clarify existing fields and 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 and a drop-down menu was added to identify medical device class. Further, the form clarifies that product and quantity information should be based on the saleable quantity or pieces. Under the DSCSA section, Global Company Prefix was added along with the source manufacturer for repackaged product. 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.
The new form is available in Excel format. Additionally, for updates to DSCSA information like GTIN, GLN or GCP, a short form is available so that information can also be conveyed to trading partners in a consistent way prior to receipt of that product.
You may download the entire file of documents by clicking "Download" or retrieve the forms and instructions by clicking the links below:
HDA Standard Rx Product Information Form Instructions (.doc)
HDA Standard Rx Product Information Form (.xlsm)
HDA Standard Rx Product Information Short Form (.xlsm)