A1 - SOW.pdf
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- Attached to
- Pharmacy Reverse Distribution Service for the Northern Cheyenne Service Unit, Lame Deer, Montana
- Solicitation number
- 75H70926Q00003
About this file
This is a Statement of Work (SOW) for Pharmacy Reverse Distribution Services at the Northern Cheyenne Service Unit (NCSU) Pharmacy in Lame Deer, Montana. The contractor must provide quarterly removal services (four times per year) for expired and outdated medications, including non-controlled substances, controlled substances, and pharmaceuticals classified as hazardous waste. The contractor is responsible for all personnel, supervision, equipment, materials, transportation, and documentation necessary to perform removal, transport, processing, credit reconciliation (if applicable), and documentation of expired medications and pharmaceutical hazardous waste.
Key contractor responsibilities include conducting on-site quarterly removals; providing appropriate packaging materials and prepaid shipping labels compliant with all regulatory requirements; arranging pickup and removal of expired controlled substances through a DEA-registered reverse distributor; providing complete documentation including completed DEA Form 222 for controlled substances and inventory/reconciliation reports; and identifying, segregating, packaging, labeling, manifesting, transporting, and disposing of hazardous waste pharmaceuticals in compliance with EPA, RCRA, and DOT regulations. The contractor must comply with IHS Manual Chapter 7, DEA regulations, RCRA, EPA regulations (40 CFR Parts 260–273, including Subpart P if applicable), DOT regulations, and all applicable federal, state, and local laws. The contract performance period runs from April 1, 2026 through March 31, 2027 (base period) with four option years extending through March 31, 2031. The government will provide only the DEA registration number necessary for controlled substance returns, with no government-furnished equipment or materials. Security requirements are not applicable.
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| File | Type | Posted |
|---|---|---|
| Sol_75H70926Q00003.pdf | ||
| A2 - Price Schedule.xlsx | XLSX spreadsheet |
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Text version
STATEMENT OF WORK (SOW)
1. Project Title
Pharmacy Reverse Distribution Services
2. Background and Purpose
The Northern Cheyenne Service Unit (NCSU) Pharmacy, located in Lame Deer, Montana, is unable to return medications to the wholesaler within six (6) months of their expiration date. Additionally, controlled substances must be returned and disposed of through a reverse distributor registered with the Drug Enforcement Administration
(DEA) in accordance with federal regulations. Certain pharmaceutical products may also meet the definition of hazardous waste under the Resource Conservation and Recovery
Act (RCRA) and applicable Environmental Protection Agency (EPA) regulations, requiring proper identification, handling, transport, and disposal.
NCSU Pharmacy has contracted with a qualified reverse distributor to mitigate total financial loss associated with expired medications, ensure proper handling and disposal of controlled substances, and ensure compliant management of pharmaceutical hazardous waste in accordance with Indian Health Service (IHS), DEA, EPA, and other applicable federal and state regulatory requirements.
3. Scope of Work
The Contractor shall provide all personnel, supervision, equipment, materials, transportation, documentation, and any other resources necessary to perform the removal, transport, processing, credit reconciliation (if applicable), and documentation of expired and outdated medications and pharmaceutical hazardous waste from NCSU Pharmacy.
Services shall include non-controlled substances, controlled substances, and pharmaceuticals classified as hazardous waste, in accordance with applicable DEA, EPA, federal, state, and IHS regulations.
4. Applicable Documents
The Contractor shall comply with the most current versions of the following:
• Indian Health Service (IHS) Manual, Chapter 7; Section 3-7.6C – Guidance for the
Disposal of Medication
• DEA regulations governing reverse distribution and controlled substances
• Resource Conservation and Recovery Act (RCRA)
• Environmental Protection Agency (EPA) regulations governing hazardous waste pharmaceuticals (40 CFR Parts 260–273, including Subpart P, if applicable)
• U.S. Department of Transportation (DOT) regulations for transport of hazardous materials
• All other applicable federal, state, and local laws and regulations
5. Contractor Responsibilities
NCSU Pharmacy utilizes reverse distribution services on a quarterly basis for removal of expired medications and to obtain eligible credit for outdated medications.
The Contractor shall:
a) Quarterly Removal Services
Conduct on-site removal of outdated and expired medications four (4) times per year
(quarterly).
b) Packaging and Shipping
Provide appropriate packaging materials and prepaid shipping labels for the return of outdated medications in compliance with all regulatory requirements.
c) Controlled Substances Handling
Arrange for pickup and removal of expired controlled substances through a DEA-registered Reverse Distributor.
d) Documentation and Compliance
Provide complete and accurate documentation for all returned medications, including but not limited to:
• Completed DEA Form 222 for controlled substances
• Inventory and reconciliation reports
e) Hazardous Waste Identification and Disposal
• Identify pharmaceuticals that meet the definition of hazardous waste under EPA regulations.
• Ensure proper segregation, packaging, labeling, manifesting (if required), transport, and disposal of hazardous waste pharmaceuticals.
• Provide hazardous waste manifests and certificates of destruction or disposal documentation as required by federal and state regulations.
• Comply with all EPA, RCRA, DOT, and applicable state environmental requirements.
All documentation must comply with DEA regulations and applicable federal requirements.
6. Government-Furnished Equipment and Information
NCSU Pharmacy will not furnish equipment or materials for the performance of this contract.
The Government will provide:
• DEA registration number necessary for controlled substance returns
7. Place of Performance
Northern Cheyenne Service Unit
420 N. Cheyenne Ave
Lame Deer, MT 59043
8. Period of Performance
Base Period:
April 1, 2026 – March 31, 2027
Option Year 1:
April 1, 2027 – March 31, 2028
Option Year 2:
April 1, 2028 – March 31, 2029
Option Year 3:
April 1, 2029 – March 31, 2030
Option Year 4:
April 1, 2030 – March 31, 2031
9. Security Requirements
Not Applicable (N/A)
File details come from the government source that posted it. Updated .