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.
In 2017, the new product form was revised for clarity, reorganized for ease of use, and additional questions were added. Questions on the Drug Supply Chain Security Act (DSCSA) were moved to page one along with “GTIN product information.” The form validates the GTIN to ensure it meets GS1 standards; an error message will show if it is incorrect. A field was added for GLN so companies can add when assigned. An additional write-in field was added to distinguish “selling unit NDC” from “individual unit NDC”. A write-in field for “product therapeutic classification” was also added, along with “country of origin” and if the product is subject to the Trade Agreements Act. The “generic products” section was simplified and a check box for authorized generic was added. Under GTIN product information, a check box was added to note which level of packaging is the saleable unit. Blank boxes were added to allow for additional packaging levels, if needed. A group email box was added for temperature excursions. The automatic formula for cubic volume was added.
REMS information was consolidated onto page two. The material handling classification and transportation section was modified to include “proper shipping name” and the order of questions was changed to be consistent with the Department of Transportation’s (DOT) sequence of the basic description. Listed chemicals were changed to a drop down and additional following questions were added to note if it is a scheduled listed chemical product. The options for “is this product a NIOSH hazardous drug” were modified to include groups.
Note that this form was developed for the introduction of Rx products. 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 or devices.
The new form is available in Excel format.
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.