VMI Questions 9 15 2026.pdf

Questions – VMI

DSCSA / Pharmaceutical Licensing Requirements

Q. Can the VA provide additional detail regarding the specific DSCSA, wholesale pharmaceutical licensing, and facility regulatory requirements applicable to this effort?

A. Offerors must comply with all applicable federal, state, and local laws, regulations, licensing requirements, and industry standards governing the purchase, storage, handling, distribution, delivery, and traceability of covered prescription drug products under this requirement.

This includes, as applicable, the Drug Supply Chain Security Act (DSCSA), including requirements for product tracing, package-level product identifiers, verification, suspect/illegitimate product handling, and transactions only with authorized trading partners. Offerors performing wholesale distribution must maintain all required wholesale drug distributor licenses for the jurisdictions in which they conduct regulated distribution activities and must ensure that all applicable facilities maintain required licenses, permits, registrations, and regulatory approvals.

Offerors are responsible for determining and maintaining compliance with requirements applicable to their proposed supply-chain model, including any state-specific pharmacy, wholesale distributor, controlled-substance, storage, handling, and transportation requirements. The Government will evaluate proposed approaches for compliance with the solicitation’s stated requirements; however, the Government does not intend to prescribe a single distribution model or provide a comprehensive jurisdiction-by-jurisdiction licensing matrix

Q. Would the required pharmaceutical license need to be held by the prime contractor, the logistics/warehouse operator, another member of the team, or some combination thereof?

A. The Government does not require that all pharmaceutical licenses be held solely by the prime contractor. Rather, the prime contractor is responsible for ensuring that it and all subcontractors, logistics providers, warehouse operators, and other team members maintain the licenses, registrations, and regulatory approvals required for the functions each performs under their proposed supply-chain model.

Accordingly, if the prime contractor performs wholesale distribution, storage, handling, fulfillment, or other regulated pharmaceutical activities, the prime contractor and/or its applicable facilities must hold the necessary authorizations. If those activities are performed by a subcontractor, third-party logistics provider, warehouse operator, or other team member, that entity and its applicable facility or facilities must hold the licenses and approvals required by applicable federal, state, and local law.

The prime contractor remains responsible for overall contract performance and for ensuring that all proposed team members are appropriately licensed and authorized before performing work under the contract. Offerors should identify the entities and facilities that will perform each supply-chain function and provide documentation of applicable licensure and regulatory compliance as requested in the solicitation.

Offerors shall provide current copies of applicable licenses, registrations, permits, and facility approvals for the prime contractor and each proposed subcontractor or facility before award or before commencing the associated regulated activity, as specified in the solicitation

Q. Additionally, if inventory is distributed among multiple warehouse locations, are the applicable licenses and registrations required separately in each state where the IV fluids are physically stored?

A. Yes. The offeror is responsible for ensuring that each warehouse, distribution center, or other facility used to store, handle, or distribute IV fluids maintains all licenses, registrations, permits, and regulatory approvals required for its specific activities and location.

Accordingly, when inventory is stored at facilities in multiple states, the offeror must ensure compliance with the applicable pharmaceutical wholesale-distribution, third-party logistics, facility, storage, handling, and other regulatory requirements in each state where the products are physically stored, handled, or distributed, as well as in any destination state where licensure is required.

The Government is not prescribing a particular warehousing or distribution model.

However, the prime contractor remains responsible for identifying all proposed storage and distribution facilities and for ensuring that the prime contractor, subcontractors, logistics providers, and warehouse operators maintain all required authorizations before performing regulated activities under the contract. Offerors should describe their proposed facility network and provide applicable licensure and regulatory-compliance documentation as required by the solicitation.

Initial Inventory Purchase / Ownership

Q. Can the VA clarify whether the Government will purchase the initial IV-fluid inventory, or whether the contractor is expected to procure and finance the initial inventory and subsequently invoice the Government?

A. We plan to use a Statement of Objectives (SOO) approach, providing respondents broad flexibility to propose their best solutions and implementation plans. Because this is a new type of procurement, we are open to considering all viable approaches to determine the solution that best meets the Government’s needs. The selected respondent’s proposed approach will be refined in collaboration with the Government and then incorporated into the contract as the Performance Work Statement (PWS).

Product Requirements / Equivalent Products

• 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX

• 0.9% Sodium Chloride Injection, USP, 1000 mL VIAFLEX

• Lactated Ringer’s Injection, USP, 1000 mL VIAFLEX

Q. Are these exact VIAFLEX products required throughout the contract, or may contractors propose equivalent TAA-compliant products from other authorized manufacturers that meet the VA’s technical, shelf-life, DSCSA, and pharmaceutical supply-chain requirements?

A. The referenced VIAFLEX products are intended to establish the Government’s required product characteristics and quality level and are not limited to the named manufacturer. Contractors may propose equivalent products from other authorized manufacturers, provided the proposed products meet or exceed all solicitation requirements, including applicable technical specifications, shelf-life requirements, DSCSA requirements, and pharmaceutical supply-chain requirements.

Offerors proposing an equivalent product must clearly identify the manufacturer and product and provide sufficient supporting documentation demonstrating compliance with all stated salient characteristics and requirements. Proposed alternative products will also be evaluated by the pharmaceutical team for technical acceptability and approval.