DEFENSE LOGISTICS AGENCY (DLA) REQUEST FOR INFORMATION (RFI): COUNTRY OF ORIGIN AND API SOURCE DISCLOSURE FOR GENERIC PHARMACEUTICAL PRODUCTS

Defense Logistics Agency (DLA) Request for Information (RFI): Country of Origin and API Source Disclosure for Generic Pharmaceutical Products

1. Purpose

In response to proposed legislation, the Defense Logistics Agency (DLA) is issuing this Request for Information (RFI) to gather data from industry regarding the manufacturing origin and active pharmaceutical ingredient (API) sourcing for generic pharmaceutical products. This RFI is for market research and planning only and does not constitute a solicitation or a commitment by the Government.

2. Background

DLA is evaluating supply chain transparency and potential country‑of‑origin disclosure requirements for generic pharmaceuticals. Proposed legislation (summarized below) request that generic medicine include specific additional labeling requirements. As part of this effort, DLA seeks detailed information on manufacturing locations of finished dosage forms and the county of origin for each API used in the listed products. In addition, DLA also seeks general respondent feedback on the impact of proposed updated label requirements.

Proposed Legislation: Country of Origin Labeling Requirements for Generic Medicine Purchases

(a) Definitions

• Generic drug: As defined in 21 CFR 423.4
• Active pharmaceutical ingredient: As defined in 21 CFR 207.1

(b) Country of Origin Disclosures Offerors providing generic drugs to the Government would be required to:

1. Identify the country in which the finished generic drug was manufactured and the country of origin for each API, including its relative weight percentage.
2. Ensure packaging discloses the manufacturing country and API country of origin, either on the label, with the label, or via barcode, QR code, or other electronic access method.

3. Requested Information

Respondents are asked to provide the following “Country of Origin Disclosure” information for their generic pharmaceutical products:

A. Country of Origin Disclosure

• Country where the finished dosage form is manufactured
• For each API:
  • Country of origin
  • Relative weight percentage in the finished dosage form

B. Packaging Disclosure

• Indicate whether current packaging includes:
  • The manufacturing country
  • API country‑of‑origin information
• If not, state whether such information can be added and identify feasible disclosure methods (e.g., label, package insert, barcode/QR code, or other electronic access method)

C. Capability, Willingness, and Potential Impacts

DLA also requests respondent feedback on the feasibility of meeting the proposed disclosure and labeling requirements, including:

• Whether your organization can support these requirements
• Whether your organization would be willing to implement them
• Any operational, regulatory, supply chain, or cost impacts that DLA should be aware of
• Any barriers or constraints that would prevent your organization from providing the requested information or implementing the labeling requirements

Respondents may include any additional comments or considerations relevant to the proposed requirements.

4. Response Format

Responses may be submitted in any reasonable format. DLA encourages:

• A product‑level table or matrix
• Supporting documentation, if available
• Clear identification of proprietary or business‑sensitive information

5. Submission Instructions

• Submit responses electronically to the point of contact listed in the SAM notice.
• Include company name, CAGE code, point of contact, and email address.
• Responses are requested by the date specified in the SAM posting.

6. Disclaimer

This RFI is issued solely for information and planning purposes. It does not constitute a solicitation or a commitment by the Government. The Government will not reimburse any costs incurred in responding to this RFI.