Pharmacy Reverse Distribution Service

1 Statement of Work (SOW) 1. PROJECT TITLE: Pharmaceutical Reverse Distribution Services 2. BACKGROUND/PURPOSE: The Billings Area Indian Health Service (IHS) pharmacy programs require pharmaceutical reverse distribution services to facilitate the removal and return of expired and soon-to- expire pharmaceutical products, including both controlled and non-controlled substances, to authorized manufacturers or wholesalers for eligible credit. The Contractor must be a U.S. Drug Enforcement Administration (DEA)-registered reverse distributor. Utilization of a qualified reverse distributor minimizes financial losses associated with expired pharmaceuticals and ensures compliance with federal regulations, IHS policy, and DEA requirements governing the handling and disposition of controlled substances. 3. SCOPE: The Contractor shall provide all labor, equipment, materials, packaging, transportation, and documentation necessary to perform on-site pharmaceutical reverse distribution services at designated Billings Area IHS pharmacy locations. Services include, but are not limited to: • On-site inventory of expired and soon-to-expire medications • Secure handling and segregation of controlled and non-controlled substances • Packaging, transportation, and return of eligible pharmaceuticals • Processing of manufacturer or wholesaler credits, when applicable 4. APPLICABLE DOCUMENTS: The Contractor shall comply with all applicable federal, state, and local laws, regulations, and policies, including but not limited to: • Indian Health Service (IHS) Manual, Section 3-7.6C – Disposal of Medication • DEA regulations governing reverse distribution • Controlled Substances Act (21 U.S.C. §§ 801–971) -- 1 of 5 -- 2 • 21 CFR Parts 1300–1321 5. CONTRACTORS RESPONSIBILITIES: The Contractor shall provide reverse distribution services three (3) times per year. The Contractor shall: • Conduct on-site removal of outdated, expired, or soon-to-expire medications during scheduled visits three (3) times per year • Provide compliant packaging materials and prepaid shipping labels for returned pharmaceuticals • Contractor is responsible for making available to the service unit a certificate of receipt, manifest, invoice, or other suitable listing receipt for expired medications received, with the ability to specifically identify all controlled substances. Such record will be made available by the 60th day after the self- service shipment • Accept all non-returnable items, even hazardous drugs, for destruction for no additional charge • Apply returns credit to pharmacy prime vendor account within 120 days of return • Be responsible for all travel, lodging, per diem, fringe benefits, Federal/State/Local taxes, plus any other cost pertinent to the performance of this contract • Maintain strict chain-of-custody procedures for controlled substances • Furnish complete and accurate documentation for each visit, including: o Detailed inventory reports of all returned medications o DEA Form 222 for controlled substances, as required o Certificates of destruction or disposition, when applicable • Ensure all services are performed by properly trained and authorized personnel -- 2 of 5 -- 3 • Coordinate scheduling with the pharmacy to minimize operational disruption Controlled Substance Reconciliation • The Contractor shall reconcile, or assist the pharmacy in reconciling, all controlled substances transferred to the reverse distributor. This includes verification that controlled substances accepted by the Contractor match pharmacy inventory records and documentation, including DEA Form 222 or other required DEA documentation. The Contractor shall provide reconciliation documentation sufficient to support pharmacy recordkeeping and regulatory compliance. • Reconciliation documentation for controlled substances shall be provided to the pharmacy following each on-site pickup. 6. GOVERNMENT-FURNISHED EQUIPMENT AND INFORMATION: The Government will not furnish equipment, materials, or supplies for performance under this contract. The Government will provide: • Facility DEA registration number(s) as required for the lawful transfer of controlled substances 7. PLACE OF PERFORMANCE: The pharmacy reverse distributor will make three (3) on-site visits to: Blackfeet Service Unit: Blackfeet Community Hospital 761 Hospital Drive Browning, MT 59417 Heart Butte Health Station 81 Disney St. Heart Butte, MT 59448 Crow Service Unit: Crow/Northern Cheyenne Hospital 10111 South 7650 East Crow Agency, MT 59023 -- 3 of 5 -- 4 Lodge Grass Health Clinic 418 Harding Ave Lodge Grass, MT 59050 Pryor Health Station 2 Pryor Gap Road Pryor, MT 59066 Fort Belknap Service Unit: Fort Belknap Hospital 670 Agency Main Street Harlem, MT 59527 Fort Peck Service Unit: Verne E. Gibbs Health Center 108 H St E Poplar, MT 59256 Chief Redstone Clinic 550 6th Ave N Wolf Point, MT 59201 Northern Cheyenne Service Unit 420 N. Cheyenne Ave Lame Deer, MT 59044 8. PERIOD OF PERFORMANCE: Base Period: June 1, 2026 – May 31, 2027 Option Year 1: June 1, 2027 – May 31, 2028 Option Year 2: June 1, 2028 – May 31, 2029 Option Year 3: June 1, 2029 – May 31, 2030 Option Year 4: June 1, 2030 – May 31, 2031 9. SECURITY: None. 10. QUALITY ASSURANCE: -- 4 of 5 -- 5 The Contractor shall ensure all services are performed in accordance with DEA regulations and industry best practices. Failure to maintain compliance may result in corrective action or contract remedies in accordance with applicable FAR provisions. 11. INVOICE SUBMISSION AND PAYMENT: Invoices shall be submitted through the Invoicing Processing Platform (IPP), a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis. The use of IPP shall take precedence over previously established invoicing procedures in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests”. The IPP w…