S299--FY27 Pharmaceutical Reverse Distribution Services

Responses will assist the Government in determining the appropriate acquisition strategy, including potential small business set-aside determinations under FAR Part 19 and 38 U.S.C. §§ 8127 8128 (VA Rule of Two). 2. BACKGROUND The Orlando VA Health Care System (OVAHCS) is required by federal regulation to remove all controlled and non-controlled substances that are expired, recalled, or otherwise determined to be unusable from active stock. These substances must be stored separately until destroyed, reverse distributed, or transferred to a DEA-licensed vendor for destruction, in accordance with 21 CFR Part 1317. OVAHCS is seeking to expand its current destruction-only capability to include pharmaceutical reverse distribution services for non-controlled substances that would otherwise result in lost manufacturer credit opportunities and incomplete inventory lifecycle control, while maintaining destruction capability for both controlled and non-controlled medications across all OVAHCS sites. The intended outcomes include: Recovery of financial credit for eligible non-controlled medications that are reverse distributed. Improved inventory management and reduced waste. Full lifecycle accountability for all medications. Strengthened compliance with VA, DEA, and federal requirements. 3. DESCRIPTION OF REQUIREMENT The Government is seeking a contractor licensed by the Drug Enforcement Administration (DEA) to provide flat-fee services to collect, transport, reverse distribute, and/or destroy controlled (Schedules I V) and non-controlled medications at OVAHCS facilities. Fees shall not be calculated as a percentage of credit returns under any circumstances. 3.1 Scope Highlights The Contractor shall provide: On-site processing of Schedule I V controlled substances and non-controlled substances (including expired, recalled, due-to-expire, or otherwise unusable medications). A minimum of four (4) on-site visits per calendar year at the Outpatient Clinics and Orlando VA Medical Center, with additional visits as directed by the COR. Response within ten (10) business days of a COR request. All shipping instructions, forms, labels, postage, DEA-approved tamper-proof pouches, and boxes required for shipment to the Contractor's central processing facility. Chain-of-custody documentation, including DEA Form 41 for controlled substances, signed by the Pharmacist, Accountable Officer, and Contractor representative. Manufacturer return coordination, credit reconciliation, and Drug Supply Chain Security Act (DSCSA) compliance. A toll-free (800) number and a web-based service request ordering system. A web-based reporting portal that captures collection date, site, drug name, formulation/strength, NDC, quantity, manufacturer, estimated return value, actual return value, and status of each reverse distribution pickup. Initial orientation and training on all applicable reports and web-based systems. A written Substance Collection Plan and Substance Contingency Plan. 3.2 Applicable Regulatory Framework The Contractor shall comply with all applicable federal, state, and local regulations, including but not limited to: Controlled Substances Act (CSA) 21 CFR Part 1317 (DEA regulations for disposal of controlled substances) Drug Supply Chain Security Act (DSCSA) 21 CFR (Food & Drugs), 29 CFR (Hazardous Materials), 40 CFR (Environment), 49 CFR (Transportation) EPA, OSHA, FDA, DEA requirements 41 U.S.C. Chapter 67 (Service Contract Labor Standards) All applicable VA policies and facility-specific security requirements 3.3 Places of Performance Facility Address City State ZIP Orlando VAMC at Lake Nona Inpatient 13800 Veterans Way Orlando FL 32827 Orlando VAMC at Lake Nona Outpatient 13800 Veterans Way Orlando FL 32827 Lake Baldwin VA Clinic 5201 Raymond Street Orlando FL 32803 Daytona Beach VA Clinic 1776 North Williamson Blvd Daytona Beach FL 32117 Viera VA Clinic 2900 Veterans Way Viera FL 32940 3.4 Historical Collection Frequency Orlando VAMC at Lake Nona (Inpatient & Outpatient): Monthly Lake Baldwin VA Clinic: Monthly to Quarterly Daytona Beach VA Clinic: Monthly to Quarterly Viera VA Clinic: Monthly to Quarterly Historically each site received approximately 4 12 collection visits per year. Per-shipment weight data is not available. 3.5 Anticipated Period of Performance One (1) base year plus two (2) 12-months option periods, anticipated award date is approximately December 2026. Actual periods will be established in the resulting solicitation. 4. INFORMATION REQUESTED FROM RESPONDENTS Interested and capable sources are requested to submit a capabilities statement not to exceed ten (10) pages (excluding certifications and licensing documentation), addressing the following: 4.1 Company Information Company name, address, point of contact (name, title, phone, email), and Unique Entity Identifier (UEI). Business size and socioeconomic status under NAICS 424210 (Size Standard: 250 employees). Identify all applicable categories: Service-Disabled Veteran-Owned Small Business (SDVOSB) verified in SBA VetCert Veteran-Owned Small Business (VOSB) verified in SBA VetCert Women-Owned Small Business (WOSB) / EDWOSB HUBZone Small Business 8(a) Certified Small Business Other than Small Confirmation of active registration in the System for Award Management (SAM.gov). 4.2 Technical Capability Provide a narrative describing the respondent's ability to fulfil the requirement, addressing at minimum: Current DEA registrant status (Schedules II V) and copies of all applicable DEA registrations. Federal, state, local licenses and permits that are held for the interstate transport, storage, and destruction of controlled and non-controlled hazardous and non-hazardous pharmaceuticals (DEA, DOT, EPA, FDA, OSHA, and applicable state authorities). Description of the respondent's central processing/destruction facility, including environmental and hazardous waste compliance systems. Approach to on-site collection, chain of custody, DEA Form 41 processing, and packaging. Description of the web-based service request ordering system and reporting portal, including reconciliation capabilities for expected vs. received credits. Manufacturer return coordination and credit reconciliation approach, including how credits are routed to the Prime Vendor or the VA. DSCSA compliance approach. Approach to responding within ten (10) business days of a COR service request. 4.3 Past Performance Provide up to two (2) examples of similar work (federal, state, or commercial) performed within the last five (5) years. For each, include: Customer name and point of contact (with current phone/email) Contract number (if applicable) Period of performance Total dollar value Brief description of scope, number of sites serviced, and geographic coverage Whether the work was performed as prime or subcontractor 4.4 Contract Vehicles Identify any existing federal contract vehicles under which this requirement could be procured (e.g., GSA Schedule, VA FSS, NASA SEWP, other IDIQ), including contract numbers. 4.5 Small Business Participation If not a small business, describe anticipated small business subcontracting opportunities and approach for meeting FAR 52.219-9 goals. https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_9 4.6 Market Feedback (Optional but Encouraged) Recommended NAICS code and rationale if different from 424210. Comments on the draft PWS structure, technical feasibility, or ambiguities. Comments on the flat-fee pricing model. Recommended minimum on-site response time. Any concerns regarding the geographic distribution of sites or historical collection frequency. 5. ADDITIONAL INFORMATION No solicitation document exists currently. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents will not be notified of the results of this market research. Any resulting solicitation will be publicized separately on SAM.gov (https://sam.gov). Questions regarding this notice should be directed via email to the Contract Specialist listed above; questions received by telephone will not receive a response. RESPONSE INSTRUCTIONS Format: Microsoft Word or Adobe PDF. Font no smaller than 11-point. Page limit: 10 pages excluding licenses, certifications, and the SAM.gov registration confirmation. Subject Line: "Sources Sought Response [Company Name] 36C24827Q0037". Submit to: [email protected]. Response Due: November 18, 2026, EDT. Responses received after the due date and time may not be considered. Telephonic responses will not be accepted. Proprietary information should be clearly marked.