6505--Budesonide/Formoterol INH

The contract pertains to the supply of Budesonide/Formoterol oral inhalers in two strengths—160/4.5 mcg and 80/4.5 mcg—under a requirements-type indefinite-delivery, indefinite-quantity (IDIQ) arrangement administered by the Department of Veterans Affairs through its Pharmaceutical Prime Vendor program. The base performance period is one year, with four optional one-year extension periods, allowing the Government to extend delivery obligations up to five years total. Quantity commitments are fixed at 722,021 canisters annually for the 160/4.5 mcg strength and 220,295 canisters annually for the 80/4.5 mcg strength throughout the base and all option years. Pricing is not pre-determined and will be evaluated based on proposals submitted in response to the solicitation, with award made through a Lowest Price Technically Acceptable (LPTA) process. Offerors must meet strict technical acceptability criteria including FDA approval for the product, compliance with Current Good Manufacturing Practices (cGMP), provision of a unique and valid 11-digit National Drug Code (NDC), and demonstrated responsibility through past performance and facility clearance. Delivery is to VA and Department of Defense Prime Vendor distribution centers, with risk of loss transferring upon delivery to these designated contractors. All supplies must adhere to stringent packaging, labeling, and barcoding specifications aligned with GS1-128 or HIBCC standards, including the mandatory presence of a linear bar code on both outer and immediate containers, and a two-dimensional GS1 Data Matrix barcode on the lowest saleable unit as required by the Drug Supply Chain Security Act. Labels must include exact drug name and strength, the NDC number without over-labeling, and human-readable NDC adjacent to the bar code for compatibility with Veterans Affairs bar code medication administration systems. Stability testing and compliance with USP-NF and cGMP are required throughout the product lifecycle. The contractor must also submit a subcontracting plan under FAR 52.219-9 Alternate II and VAAR 852.219-70, with specific goals for Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB) participation, and is subject to liquidated damages for noncompliance. Multiple FAR and VA-specific clauses govern ethics, whistleblower rights, subcontractor restrictions, system maintenance, and procurement integrity, with all documentation