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 HDA Standard Rx Product Information Form was updated in 2024 to include:

• A drop-down in the product information section to specify if FDA has approved an NDA for a new product under 505(b)(1), 505(b)(2), or not applicable;
• A yes/no question in the GTIN and HIBCC product information section to indicate if a package level assigned a GTIN is RFID tagged; and,
• A HCPCS J-Code field to the Pharmacy Order/Bill Unit section, used by Medicare and other managed care entities to identify injectable drugs not self-administered.
   

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)