• The Defense Logistics Agency (DLA) expects pharmaceutical manufacturers to provideCountry of origin for Finished Dose Form (FDF).
• Country of origin for Active Pharmaceutical Ingredients (APIs), as well as Country of origin for Key starting materials (KSM), will be determined by the specificlot production.
• Inclusion of country-specific data is a condition of participation in labeling pilot program, and the goal is to have information specific to labeled lots.
Description
Purpose The Defense Logistics Agency (DLA) Troop Support Medical Supply Chain is conducting market research to identify U.S. or international pharmaceutical manufacturers that are willing to participate in a labeling pilot program. The pilot seeks to explore voluntary inclusion of additional product labeling data for Pharmaceutical Products identifying: Country of origin for the Finished Dose Form (FDF) Country of origin for each Active Pharmaceutical Ingredient (API) Country of origin for each Key starting material (KSM) necessary for the production of each API Given the amount of information requested, inclusion of a QR code or link to additional information, or other methods of making the information accessible, could be considered If the country of origin of the API or KSM can vary by lot produced, DLA would be interested in the information specific to the labeled lot and to any previously produced lots This RFI is issued solely for information and planning purposes. It does not constitute a solicitation, and responses do not commit the Government to any future acquisition or requirement. 2. Background DLA Troop Support Medical is evaluating methods to improve supply chain transparency, enhance traceability, and strengthen operational readiness by increasing visibility into the sourcing of pharmaceutical ingredients. Understanding FDF, API, and KSM origins helps support contingency planning, risk modeling, and alignment with emerging regulatory and strategic sourcing initiatives. The agency is exploring the feasibility of obtaining this information directly from manufacturers through voluntary labeling enhancements on packaging, shipping containers, or supplemental documentation. 3. Scope of Pilot The proposed labeling pilot will focus on a selected subset of generic pharmaceutical products purchased by DLA Troop Support Medical. Participating manufacturers may be asked to provide: API country of manufacture API country of origin (if different) Country of origin for the Finished Dose Form (FDF) Country of origin for each Key starting material (KSM) necessary for the production of each API If the country of origin of the API or KSM can vary by lot produced, DLA would be interested in the information specific to the labeled lot and to any previously produced lots Placement of this information on external packaging, product containers, or accompanying supply chain documentation Given the amount of information requested, inclusion of a QR code or link to additional information, or other methods of making the information accessible, could be considered Estimated production or administrative impact associated with adding these data elements DLA seeks to understand both operational feasibility and industry readiness. 4. Requested Information from Respondents Interested manufacturers are invited to submit a written response addressing the following: A. Company name, CAGE code, point of contact information B. Description of the pharmaceutical produ…
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