6505--PuraCap Contract Award Venlafaxine 24HR SA Capsules

The contract awards the supply of Venlafaxine HCL 24HR SA Capsules in multiple strengths and package sizes to the Department of Veterans Affairs through the National Acquisition Center in Hines, Illinois, under solicitation number 36E79726R0010. The scope encompasses end-to-end manufacturing, packaging, labeling, and distribution of pharmaceutical products compliant with FDA cGMP, USP-NF standards, and the Drug Supply Chain Security Act (DSCSA). Key deliverables include unit-of-use packaging with child-resistant safety caps, minimum 120cc cylindrical bottles, 5.25” x 2” labeling space, and mandatory GS1-128 or HIBCC-compliant barcodes meeting ANSI/ISO/IEC Grade C quality standards at the lowest saleable unit, with NDC, lot number, and expiration date encoded in both machine- and human-readable formats. All operations must occur at FDA-inspected facilities, with full disclosure of manufacturing, repackaging, and labeling locations and FEI numbers required. The contract includes a one-year base period with four one-year option periods, exercisable unilaterally by the government, and delivery is governed by FOB origin or destination terms as specified in individual orders, with acceptance occurring at government ordering facilities. Pricing details are not provided in the solicitation, indicating that offerors must submit their own unit and extended prices for each CLIN, with all bids subject to a mandatory 0.5% cost recovery fee. Compliance with VA-specific clauses is required, including FAR 52.212-4 (commercial items), FAR 52.216-21 (requirements), FAR 52.217-9 (options), and VA deviation clauses for commercial services and subcontracting. A Small Business Subcontracting Plan, as outlined in VAAR 852.219-70, is mandatory, and a subcontracting plan template is referenced. Contractors must provide a unique NDC for each product, avoid EULA or TOS indemnification that conflicts with the Anti-Deficiency Act, and certify compliance with Buy American provisions. Payment is processed through Pharmacy Provider Vendor systems, not directly by the government, and invoices must adhere to Prompt Payment Act requirements. Proposals must be submitted electronically via email to designated VA contacts in Word or PDF format, excluding compressed files or faxes, and must include a completed SF-1449 with