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. A short version of the form (updated in 2023) is also available for partners to make updates to DSCSA information for existing products — like DSCSA exemption status, GTIN, GLN or GCP — to convey this information to trading partners without needing to complete a new form.
The 2021 long 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.
You may download the entire file of documents by clicking "Download" or retrieve the forms and instructions individually 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 Instructions (.doc)
HDA Standard Rx Product Information Short Form (.xlsm)