SOW Controlled Substance Waste.pdf

1 | P a g e Emergency Pharmacy Service

State of Need

Date: June 25, 2025

Background:

This Veterans Health Administration (VHA) directive establishes policy for national and local emergency pharmacy caches comprised of life-saving pharmaceuticals and medical supplies for use in response to catastrophic public health emergencies. These caches are known as Department of Veterans Affairs (VA) All-Hazards Emergency Caches (AHEC). Veterans Integrated Service Network (VISN) or VA medical facility supplies used for emergency operations related to manmade disasters or emergencies and natural disasters (e.g., floods, hurricanes, earthquakes) are covered under this directive.

General Information:

The purpose of this contract is to provide destruction services to maintain compliance with VHA Directive 1108.01 and Title 21 Code of Federal Regulations and provide proper disposal of controlled substances that are deemed damaged, expired, returned through the mail, unusable, or otherwise unwanted that are lawfully possessed by registrant. Disposal of controlled substance stock held for destruction are required to be completed at least quarterly. A DEA-licensed destruction company is needed for a scheduled one time pick up to meet this requirement.

Objectives/Requirements:

Any contractor that has the legal authority to destroy controlled substance and must have the legal DEA licensures to perform this task at the time of service. Services required under this contract shall be performed in accordance with Federal Laws including but not limited to Title 21 Code of Federal Regulations. Contractor shall be compliant with any requirements of the VA as listed in this contract.

Contractor shall provide a representative to perform duties for the on-site pick up of expired or unusable controlled substances at Emergency Pharmacy Services (EPS) located in Hines, IL.

Scope of Work:

EPS is seeking a contractor to perform controlled substance destruction. Contractor will have in date licensures as required by the Drug Enforcement Administration (DEA) for controlled substance destruction at the time of service. All regulatory licensures pertaining to the scope of this contract shall be provided upon request. Contractor will have valid DEA 222 form to retain custody of product.

Contractor’s representative will have legal authority as outline by power of attorney privileges to authorize chain of custody for designated controlled substance.

All containers with designated products for destruction shall be opened and will be verified in the presence of the contractor’s representative and COR. The COR and contractor’s representative will sign appropriate document listing all controlled substances to be transferred from EPS’s controlled substance vault to a certified processing plant for destruction. The contractor’s representative will provide a signed receipt for DEA Form 222 for all CII products taken at the time of transfer. The DEA Form 222 will include

2 | P a g e drug name, dosage form, strength, quantity, and date of transfer. Once the on-site contractor representative verifies the count with the COR and completes the paperwork of the transfer, the contractor’s representative will assume responsibility of those products. The contractor’s representative shall prepare shipping containers to remove the designated products out of inventory. Prior to sealing shipping containers, the COR will review with contractor’s representative during the on-site service, a list of items to validate no discrepancies between the pharmacy’s list of items and contractors list of items. Contractor will be responsible for boxing all items acquired by the pharmacy and arranging for pick-up by a transportation carrier. The on-site contractor representative will arrange for immediate pick up by a trusted carrier or will have a DEA compliant transport process. The DEA registered contractor who destroys the controlled substance must submit a DEA Form 41 to the DEA when the controlled substances have been destroyed. The DEA Form 41 should not be used to document the transfer of controlled substances from the pharmacy to the contractor. A copy of the DEA Form 41 shall be sent to pharmacy point along with a certificate of destruction.

Contractor will pack and ship the following products from EPS’ location at Hines, IL:

Product NDC Lot Qty per syringe

Original Expiration Date

SLEP

Expiration Date SLEP Cycle

MORPHINE SO4

10MG/ML INJ 00409-1893-01 39640CL 23990 3/01/2024 31-Mar-25 2024-21 (CYCLE 1)

MORPHINE SO4

10MG/ML INJ 00409-1893-01 23710LL 1210 11/01/2014 31-May-25 2023-26 (CYCLE 5)

MORPHINE SO4

10MG/ML INJ 00409-1893-01 24550LL 4000 12/01/2014 31-May-25 2023-26 (CYCLE 5)

MORPHINE SO4

10MG/ML INJ 00409-1893-01 25695LL 950 1/01/2015 31-May-25 2023-26 (CYCLE 5)

MORPHINE SO4

10MG/ML INJ 00409-1893-01 HR0327 13000 09/30/2025

Place of Performance Department of Veterans Affairs Emergency Pharmacy Services, CMOP (Great Lakes) - Hines 1st Avenue, 1 Block North of Cermak, Bldg. 37 Hines, IL 60141-5000 Dock Hours of Operation: Monday to Friday, 7:00am to 2:00pm

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Hours of Coverage The onsite service will be completed within one (1) business day. The Contractor is to arrange an appointment with the COR during normal hours of operation (Monday to Friday 7am to 2pm).

Contractor will make arrangement for on-site service within 15 days of contract award. Service must be completed within 30 days of contract award date.

Federal personnel and facility will not be available for drop-off/pickup on the following Federal holidays:

New Year’s Day, January 1 Martin Luther King, Jr Day – the 3rd Monday in January Washington’s Birthday – the 3rd Monday in February Memorial Day – the last Monday in May Juneteenth- June 19 Independence Day, July 4 Labor Day – the first Monday in September Columbus Day – the second Monday in October Veterans Day – November 11 Thanksgiving Day – the 4th Thursday in November Christmas Day- December 25

Note: If the established date falls on a Sunday, then the succeeding Monday is observed holiday; if the date falls on a Saturday, then the preceding Friday is observed.

Travel Contractor will be responsible for all travel required for on-site service

On-site Access The COR shall provide contractor’s representative access into government facility. Contractor’s representative shall check in with photo ID at the CMOP front desk and wear guest pass during the on-site service. Contractor’s representative will only gain access inside the government’s facility and designated locations within the facility under EPS COR’s direct supervision.

Supplies and Services:

The contractor will be fully licensed to perform the work and shall take responsibility to complete details of the contract from start to finish. The responsibilities of the contractor will include the ability to provide on-site services and off-site destruction and provide all equipment, materials, and labor needed to arrange for proper disposal of designated, Schedule II controlled substances pharmaceuticals. The contractor will bring all necessary supplies including equipment or software for their own use to perform their work for onsite pick-up. The contractor will be responsible for their supplies and equipment including any loss or damage. The contractor will be responsible for packaging products if shipping through carrier, including but not limited to generating shipping labels and packaging.

Contractor will not be provided government issued computers, printers or phones to complete service.

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Reporting requirements The contractor will submit documentation pertaining to the completion of service to the COR.

Contractor will submit tracking information to the assigned COR. The COR will be the final recipient of all documentation and will notify the Contracting Officer if service is “unacceptable”. The contractor will work with Contracting Officer and the COR for an appropriate resolution to “unacceptable” product/service within an agreed upon timeframe. If contractor is unable to meet scheduled pickup date, the contractor must communicate delays to the CO, and the COR immediately.

Hines EPS COR:

Rachel Joseph, Pharm D.

Facility Program Manager, Emergency Pharmacy Service Pharmacy Benefits Management- Great Lakes CMOP (765) Veterans Health Administration U.S. Department of Veterans Affairs 5000 S 5th Ave, Bldg. 37 - Dock #14; Hines, IL 60141-5000 Mobile: 708-714-7587 Email: Rachel.Joseph@va.gov