New HDA Resources Available: Recall Guidelines and Standard Product Form

August 04, 2021

Earlier this month, HDA published two new resources for supply chain stakeholders to ensure the proper handling of new products moving through the supply chain and removal of products that are recalled or need to be withdrawn.

Both are available as complimentary downloads from HDA’s website to assist trading partners with these complex processes.


Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)

To ensure new pharmaceutical products are received, handled and stored appropriately while moving through the supply chain, HDA has updated the standardized fields to help distributors and other downstream trading partners collect this critical information correctly.

The 2021 edition of the form clarifies existing fields, better reflects common commercial and regulatory information required for new item setup and can now be used for medical devices, among other changes.

Along with this update, a shortened version of the form is also available for use if new product packaging or other factors necessitate the change of Global Trade Item Numbers (GTIN) or Global Location Numbers (GLN) for existing products. This allows manufacturers to comply with Drug Supply Chain Security Act (DSCSA)  requirements without needing to fill out a brand-new form.

Why is the short form important?
  • Going forward, as manufacturers start to send data, a distributor cannot receive that Electronic Product Code Information Services (EPCIS) data without GTIN, GLN or Global Company Prefix (GCP) information in their database. That file will fail and will require that it be resent after the master data is corrected.
  • New packaging information is often not sent to the correct department and frequently does not include all the required GTIN information. This creates an inefficient and time-consuming process for manufacturers and distributors.

Through the creation of the “New Product Short Form,” HDA hopes to create a simple process to send updated information to the correct contacts in a timely fashion, limiting technical rework and unnecessary resources on duplicative efforts.

The standard form, short form and instructions are now available to download here.


HDA Guidelines for Trading Partners on Downstream Product Actions

The HDA Returns Task Force rewrote the association’s product withdrawal and recall guidelines to include new FDA guidance and provide insights and best practices since the document was last published in 2007. The guidelines delve into trading partner procedures, responsibilities and processes involved in removing products from the supply chain. The document includes recommendations for not only product recalls, but all downstream trading partner actions, with recommendations for internal/external communications. Based on current FDA guidance for all products, the guidelines aim to clearly articulate requirements and best practices for downstream product actions within the supply chain to improve compliance, safety and security. The current FDA guidance includes significant policy developments to enhance product identification and traceability.

These guidelines include:
  • Key concepts around recalls, withdrawals and downstream trading partner actions;
  • How to prepare for and initiate a recall or downstream action;
  • FDA Guidance on “Product Recalls, Including Removals and Corrections: Guidance for Industry” (March 2020);
  • Sample cost calculations, with worksheets; and,
  • Communications best practices with trading partners and sub accounts.
Visit HDA’s website to download the new guidelines.

For more information, contact HDA’s Director, Industry Relations, Jaidalyn Rand. Visit HDA’s website to view additional resources and publications for supply chain stakeholders.