P09 Performance Work Statement_Repacker_Updated 5-12-26.docx

Department of Veterans Affairs National Consolidated Mail Outpatient Pharmacy (CMOP) Pharmaceutical Repacking Services Performance Work Statement (PWS)

A. BACKGROUND

1. The Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) program serves over seven million enrolled Veterans dispensing more than 120 million prescriptions per year for Department of Veterans Affairs Medical Centers (VAMCs) and Community Based Outpatient Clinics (CBOCs) throughout the United States. Currently, the seven (7) COMP facilities, with a total of nine (9) delivery locations (addresses listed below in Section S), use repacked pharmaceuticals in their automated and semi-automated pharmacy systems to fulfill prescription orders. CMOP has identified the continued need to receive repacked pharmaceuticals from a Food and Drug Administration (FDA) licensed repacker/distributor (Contractor) of oral, solid pharmaceuticals.

2. Repacked pharmaceuticals play a vital role in the fulfillment process by improving the efficiency of CMOP operations, creating faster delivery times to our veteran patients. Fluctuations in the need for pharmaceuticals make it difficult to determine the exact quantities that will be required during the contract terms, however, based off historic data from the previous contract, the Government anticipates a need for approximately 17 million repacked bottles per year.

B. SCOPE

1. The Contractor shall serve as a unit-of-use repacker for pharmaceuticals. Under this program, CMOP will purchase the pharmaceuticals separately from this contract and arrange delivery of the pharmaceuticals to the Contractor for processing. The Contracting Officer (CO), Contracting Officer’s Representative (COR), or a delegated Ordering Officer (OO) within the CMOP will provide instructions to the Contractor for repacking the product into various bottle sizes. The product list may vary through the life of the contract as the CO or OO adds product and package sizes to the program. The Contractor shall receive, validate product, repack, and ship orders submitted by the CO, COR, or OO. If supply chain issues or emergent needs require short-term holding of pharmaceuticals, then the short-term warehousing fees will be negotiated between the Contractor and the Government prior to receiving the pharmaceuticals. Government-Owned pharmaceuticals must be physically segregated from non-Government product. CMOP orders shall not be co-mingled with other Government or non-Government orders. The Contractor shall ship product Free on Board (FOB) Destination to the ordering CMOP(s). All actions by the Contractor under the awarded contract shall be in accordance with applicable Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), Environmental Protection Agency (EPA), Federal, State, and local codes, laws, and/or regulations.

2. Only a warranted CO’s or a delegated OO’s within the CMOP are authorized to order repacking services under this contract. The seven (7) CMOP facilities with nine (9) delivery location facilities and a CMOP National Office that may have delegated OOs.

3. The Contractor will be required to deliver all articles, which are properly ordered during the contract performance period, in accordance with the terms and conditions of the contract. The Contractor will also account for retention samples.

4. The Government has the right to add or subtract CMOP locations at any time during the contract term.

C. GENERAL REQUIREMENTS

1. The Contractor will receive a bulk shipment of pharmaceuticals to be repacked into various count sizes. The Government will procure the pharmaceutical product and have it shipped to the repacking Contractor.

2. The Contractor shall be registered with the FDA, Drug Enforcement Agency (DEA), and licensed to repack oral, solid pharmaceuticals. In addition, the Contractor shall hold a valid, current certificate from the DEA for Class III, Class IV, and Class V controlled substances. The Contractor shall accept shipments of Government-owned pharmaceuticals from an authorized CMOP, the prime pharmaceutical vendor, or alternative open market source to repack into individual bottles per the Performance Work Statement (PWS). All repacked products shall be shipped to the CMOP or designated location on the order. All repacking work shall be accomplished based on information provided within the Task Orders (TOs) issued by each CMOP.

3. Pharmaceuticals are typically repacked into various sizes that may include: but not limited to 15-count, 30-count, 45-count, 60-count, 90-count, 120-count, 135-count, 180-count, 270-count, 360-count, 400-count, 625-count, and 950-count. Repacked bulk sizes may include, but are not limited to 1-liter, 2-liter, 3-liter and 4-liter bottles

4. Historical data shows an average of 20 pallets of controlled bulk products and an average of 50 pallets of non-controlled bulk products are sent to be repacked each week. Deliveries take place on Tuesday, Wednesday, Thursday, and every other Friday as needed. The delivery days could change depending on the Government’s needs.

5. The Government may place one or more employees in the Contractor’s facility to observe Contractor’s accountability and repacking practices on behalf of the CMOP. The Contractor shall provide office space for the employee(s), along with desks and chairs. Other office needs for this/these employee(s), e.g., IT equipment, file cabinets, telephone, office supplies, etc.), will be the responsibility of the Government.

6. The Government has the right to add/subtract CMOP locations anytime throughout the contract as needed.

D. USE OF ORDERING OFFICERS

1. The CO will furnish the Contractor with the names of individuals delegated with OO authority by separate letter upon issuance of the contract or agreement. When COs appoint OOs after award, the CO will furnish the Contractor with an updated list of individual OOs authorized to place orders against the contract or agreement. OOs may not negotiate contract terms and conditions, determine price reasonableness, or determine best value. OOs are responsible for issuing and administering orders placed under the contract or agreement identified in the letter of appointment. OOs do not have authority to modify any of the terms and conditions in the contract or agreement. The CO must approve any changes or deviations from the terms and conditions of the contract or agreement in writing prior to placing orders invoking those terms and conditions. The contractor shall accept orders against the contract or agreement only from the CO or authorized OOs and fulfilling orders from persons other than the CO or OO may result in an unauthorized commitment.

2. OOs will be authorized to place Task Orders (TO) against the contract up to $250,000. TOs greater than $250,000 will be the responsibility of a warranted CO at NCO 15.

E. FEDERAL GOVERNMENT HOLIDAYS

1. The Contractor shall disclose any holidays observed in addition to the list below.

F. DEFINITIONS AND ACRONYMS

1. Batch – The production of a product that has the same drug name, strength, expiration date and lot number.

2. Barcode 128 – One-dimensional ("1D") barcode symbol used throughout the ID, inventory, shipping, and distribution chain. Code 128 barcodes are alphanumeric machine-readable symbols. They can be printed with or without human-readable characters.

3. Consolidated Mail Outpatient Pharmacy (CMOP) – Division of the United States Department of Veterans Affairs that provides mail order prescriptions to Veterans. (Current CMOP locations are incorporated in section “S” of the PWS.

4. Contracting Officer (CO) – Government employee with the authority to enter into, administer, terminate contracts, make related determinations and findings, and modifications to a contract.

5. Contracting Officer’s Representative (COR) – Government employee who assists the CO in the technical monitoring or administration of a contract.

6. Contractor – Vendor/Company authorized to provide services awarded under this contract.

7. Controlled Pharmaceutical - A controlled pharmaceutical is a drug or chemical regulated by the Government due to its high potential for abuse, addiction, and physical or psychological dependence. The DEA classifies these drugs into five schedules (I-V) based on their abuse risk and accepted medical use. These substances are tightly monitored regarding their manufacturing, possession, and distribution under legal frameworks like the Controlled Substances Act (CSA).

8. Disasters - As declared by the Federal/State/Local government for a specific situation. Also, when Contractor facilities are unable to provide the requirements of this contract resulting from perils of nature, mechanical or electrical failure, medical epidemic, etc.

9. Drug Supply Chain Security Act (DSCSA) - Enacted by Congress on November 27, 2013. Title II of DQSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

10. Emergency - An unforeseen combination of circumstances or the resulting state that calls for immediate action.

11. Free On-Board Destination (FOB) - The repacker takes delivery of goods being shipped to it by a supplier once the goods arrive at the repacker’s receiving dock.

12. First Databank (FDB) - Part of the Hearst Health network which is the leading provider of drug knowledge that helps healthcare professionals to make precise medication-related decisions worldwide.

13. Immediately – When used in conjunction with a notification requirement, is defined as written notification to the COR or Contracting Officer within one business day of occurrence.

14. Medi-Span - Master Drug Data Base provides pricing and descriptive drug information on name brand, generic, prescription and OTC medications, and herbal products. It includes industry standard identifiers for all brand and generic drugs on the market including National Drug Code (NDC), Universal Product Code (UPC) and Health Related Item (HRI) numbers.

15. Normal Business Hours/Day – For the purposes of this contract, normal business hours/day will be defined as 8:00AM to 5:00PM Local Time, Monday through Friday, excluding Federal holidays.

16. Ordering Officer (OO) - Government employee with the authority to place and administer funded orders against the contract.

17. Product Label (Repacker Label) - This label is the contractor’s label used to mark the product they package in house.

18. Patient Label (Government Label) - This label is the Government’s label used to show the product and dose for the patient to take as directed by the provider.

19. Retention Sample - In pharmaceuticals, is a sample of a finished product that is kept for identification and analysis; also known as witness samples or reference samples. A sample of a fully packaged unit from a batch of finished products. It is stored for identification purposes. For example, presentation, packaging, labelling, patient information leaflet, batch number, expiration date should the need arise during the shelf life of the batch concerned.

20. Quality Control – Actions taken by a Contractor to control the performance of services so that they meet the requirements of the PWS.

21. United States Pharmacopeia (USP) - A scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

G. APPLICABLE CREDENTIALS, CERTIFICATIONS, REGULATIONS AND STANDARDS

1. Contractor shall be FDA registered to repack oral and solid pharmaceuticals and be certified with the Drug Enforcement Agency (DEA) for Class III (narcotic and non-narcotic), Class IV, and Class V controlled substances.

2. Contractor control, accounting, and repacking of pharmaceuticals shall be done using FDA and DEA guidance, regulations and approved procedures, and in accordance with current Good Manufacturing Practices (cGMPs). https://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm2005190.htm

3. The Contractor shall submit to First Databank (FDB), Medi-Span, and Multum the product information pertaining to the products repacked under this contract, including the Contractor's unique National Drug Code(s) (NDC), during the period of contract performance. A New Product Submission Form or submission information can be found by contacting the following:

4. The submission of a new NDC to the First Databank (FDB), Medi-Span, and Multum shall require the Contractor to submit invoices for payment in the same manner as required below in Section R – Invoices.

a. First Databank web address: http://www.fdbhealth.com/solutions/manufacturer-relations

i. Editorial Department: 1-650-872-4566

ii. Email: Editorial_Services@fdbhealth.com;

b. Medi-Span web address: http://www.wolterskluwercdi.com/manufacturers-exchange

i. Data Acquisition Department: 1-800-388-8884

ii. Email: mfgdata@wolterskluwer.com

c. Oracle Cerner Multrum web address: Drug Database solution | Cerner

i. New Form Email: MultumSupport@Cerner.com

ii. Send Update Email: mfgproducts@Cerner.com

d. Contractor shall not assume any liability or responsibility for accuracy of pricing or other data received from Prime Vendor Contract holders that is required to be submitted to third party databases. The purpose of the reports is only to provide necessary information for claims resolution with insurance providers to ensure the lowest cost to Veterans.

e. The Contractor shall supply a weekly report to the COR of new NDC’s registered with either First Databank or Medi-Span.

f. The Contractor shall follow all appropriate requirements as implemented in the Drug Supply Chain Security Act (DSCSA).

H. CONTRACTOR RESPONSIBILITY

1. The Contractor shall schedule work based on the task orders placed in accordance with the terms and conditions of the contract.

2. The Contractor will be provided with a list of CMOP station staff who are to be contacted for virtual receiving of all CMOP pharmaceuticals shipped to the Contractor’s facility. The virtual receiving process shall require a recorded Microsoft Teams meeting with the Contractor. At conclusion of the meeting, once all pallets and totes are accounted for, the Bill of Lading (BOL) will be sent to the appropriate CMOP site for signature. The site will send the signed BOL back to the Contractor. The individual item from the Prime Vendor packing list will be processed by the Contractor and any error or discrepancy shall be reported to the site immediately upon discovery.

3. The Contractor shall establish processes for performing the receiving inventory function, to include, but not be limited to, accurate counting of product being received. The Contractor shall also be responsible for recording all Drug Supply Chain Security Act DSCSA information and forwarding that information immediately to the ordering office. The CO, OO, and the COR shall be immediately notified of any discrepancies. The Contractor shall have processes which include, but are not limited to, auditable receiving processes and document trails for all products being received. The Contractor shall be compliant with all current and future DSCSA requirements.

4. The Contractor shall have adequate resources to include sufficient space for controlling inventory and segregation of stock. Government-Owned pharmaceuticals must be physically segregated from non-Government product. Orders against this vehicle shall not be co-mingled with any other orders.

5. Controlled pharmaceuticals must be received and stored in a secure and separate location in accordance with FDA, DEA, and EPA regulations.

6. Control, accounting, and repacking shall be accomplished using FDA and DEA approved procedures and in accordance with current Good Manufacturing Practices (cGMPs).

7. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples. Destruction of these stored amounts shall be in accordance with all FDA, DEA, and EPA regulations. Reports of samples stored and subsequent destruction shall be submitted to the appropriate CMOP. Damaged products received prior to the repacking process shall be returned to the ordering CMOP.

8. Contractor shall have a policy in place for initial hiring drug tests, random drug testing, and drug testing when there is reasonable suspicion of impairment.

9. Contractor shall have a plan for contingency operations for disasters, which identifies the ability to provide uninterrupted support under unprecedented situations that cannot be reasonably mitigated and/or contingency conditions. This plan shall be submitted to the evaluation team as a deliverable.

I. GOVERNMENT RESPONSIBILITY

1. A warranted CO or delegated OO within the CMOP Contracting Office, with a warrant or delegation which allows placing delivery orders against existing contracts, will be the delegated authority to place task orders to the Contractor citing the terms and conditions of the contract resulting from this solicitation.

2. The delivery/task order shall:

a. Identify the total number of bottles to be repacked, to include the “mix” required (i.e., 50mg, 30 per bottle; 100mg, 90 per bottle; etc.).

b. Provide the required delivery date for the delivery/task order to be completed.

c. Identify a point of contact at CMOP for the Contractor. Generally, this will be the OO.

d. Identify the exact delivery information for the CMOP(s) where the repacked products are to be delivered.

3. CMOP will make every effort to limit the number of lot numbers to three (3) or less per drug.

4. CMOP will attempt to obtain a single lot number for the stock to be repacked for small production repacking runs which can be less than 100 bottles.

J. PRODUCT CHARACTERISTIC REQUIREMENTS

1. The Contractor shall provide bottles, caps, and labels to repack all medications. Any bottle size requirement changes will be approved by both the Contractor and Contracting Officer. Given the constantly changing environment and advancements in packaging, effective communication between the Government and the Contractor is essential. This process must be adhered to in order to avoid any processing issues.

2. The pharmaceutical bottles shall have the following characteristics:

a. White pharmacy grade high-density polyethylene.

b. Round with no ridges, bowing or protrusions that would prevent them from being horizontally or vertically stacked. (Convex shaped bottles are unacceptable).

c. Must have a flat surface with dimensions of 2’’ W x 5.5’’ L sufficient for applying a label without overlapping.

d. Bottle sizes repacked into are 120cc, 200cc, 300cc, 400cc, 625cc, 1-Liter, 2-Liter, 3-Liter, and 4-Liter.

e. Bottles shall be identified with a number 1-, 2-, or 3-designation for recycling.

f. A tamper-evident seal shall be applied to each bottle. This seal must not be above/over the cap.

g. The Contractor shall supply testing data/certification showing that the cap bottle assembly/unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (CFR) Title 16, Part 1700. (This paragraph does not apply to the bulk up sized bottles, i.e. liter size bottles).

3. The bottle caps shall have the following characteristics:

a. Shall not exceed the diameter of the bottle.

b. Shall be of convertible design to allow user to convert it from child-resistant to non-child resistant with hand applied pressure to the outer ring of the cap when the cap is on the bottle. 540 count bottles or less will be required to have a child-resistant cap.

c. Shall be imprinted with the “MyHealtheVet” logo or other logos that will be alternated at the discretion of the CO in accordance with the attached logo specifications (see Attachment 2A.) No more than four logos will be required.

d. The imprint must be of high-quality resolution, visible under the cap surface, and be approved for use by the CO.

e. All bottle and cap combinations shall meet or exceed the USP standards for moisture permeability and light resistance.

4. The product labels shall have the following characteristics:

a. Shall not exceed 3.5 mils thickness (for affixed labels).

b. Directly printed labels may be used but shall be machine readable and non-smudging.

c. Labels must not peel off or be damaged in automated machinery.

d. Centered in bottle label area to ensure barcode readability.

2. The product labels shall include the following:

a. The product label must be of a material that will allow a patient label to adhere to it.

b. Fill size and strength for quick recognition. The generic name shall be bold font and a larger font than other printed label information (See Attachment 2).

c. Drug name positioned such that after applying the patient label the product can still be identified. The product name, strength and package size shall be printed twice on the label: once in the middle of the label and once on the extreme left-hand side vertically. Font size for both label locations is to be the same. The Government requires the 2D BAR Code (Q/R) type automated information data carrier required by the DSCSA along with the Barcode 128 (1D) on the Label.

d. Bar codes shall be clear and defined with no break in the bar code graphics. A sufficient amount of clear white space needs to be around the bar code, so numbers and/or letters do not interfere with the bar code.

e. The Government requires one vertical linear 1D Bar Code on the left side of the label and one 2D Bar Code on the right side of the label. The Manufacturer Lot Number, Repacked Batch Number, Expiration Date, and NDC number shall appear as human readable language adjacent to the bar code.

f. State storage conditions.

g. Indicate the “Manufactured By” name and “Packaged By” name and address.

h. The statement, "Warning: May be habit forming", where applicable, the controlled drug substances symbol required by DEA, and the name and quantity or proportion of any substance as required.

i. Boxes or cases shall be clearly marked with a product label as described in (2d) above. Case quantity shall be stamped on the outside of each case if it contains less than the standard container capacity (e.g.: 40 bottles in a box or case that holds 100) than would be expected. Inside the case, each 10-pack should be shrink wrapped for easy handling and filling of automated equipment. This is essential for controlled substance audits that are required daily.

3. Upcoming DSCSA requirements such as, but not limited to, serialization shall be incorporated by the Contractor on the dates required by the DSCSA. The Contractor will comply and be in inspectable compliance with all current and future DSCSA requirements.

K. PLACEMENT OF TASK/DELIVERY ORDERS

1. The OO or CO shall provide repacking instructions to the Contractor at time of order and are responsible for administration of their repacking orders.

2. Currently, CMOP is using both a consolidated ordering function and an individual site level ordering function. The consolidated order is a high-volume repacking order being placed from the CMOP National Office with delivery to multiple CMOP facilities. Orders may be placed by an OO at one CMOP with delivery directly to that CMOP.

L. ORDERING SYSTEM - WEB BASED

1. The Contractor must have the ability to provide CMOP with a secure web-based ordering system. Only COs or OOs may be granted logins, unique for each individual.

2. The ordering system shall be able to provide real-time confirmation within the system when an order is placed. The system shall cancel items that cannot be filled. The confirmation should indicate the cancelled items.

M. ORDERING SYSTEM – MANUAL

1. When the order has shipped from the Contractor facility, an email shall be sent within 24 hours to the individual placing the order unless otherwise indicated identifying the complete shipment, projected delivery date, and tracking number. The Contractor shall include in the subject line the individual ordering CMOPs PO number. This email shall also include a comma separated variable (CSV) file as an attachment, which will include the following minimum data fields:

Manual ordering methods may include facsimile (fax), email, or in writing delivered by standard delivery methods (e.g.: USPS, UPS, etc.). Every order shall be in writing and electronically signed by the CO or OO. ORAL ORDERS ARE NOT AUTHORIZED.

2. The Contractor shall not procure the drugs to be repacked. Each CMOP shall provide the Contractor with the drug to be repacked. The shipment of the product to be repacked by the Contractor shall be arranged and underwritten by CMOP and shall be by a conveyance deemed appropriate by the CMOP that meets all FDA and/or USP requirements for safe and secure transit of the material. (See Section M, “Product Handling” below for information on the responsibilities toward return shipment to the CMOP.)

3. The Contractor shall provide a reconciliation that details the destination of each tablet/capsule that is received (the contents of each bulk bottle) including if any are kept as samples, are a manufacturer overage/shortage or are unusable due to breakage or contamination and if the breakage/contamination was caused by the manufacturer or Contractor.

4. The Contractor shall provide a packing list and detailed contractor invoice for all items in a shipment.

5. The products will be purchased in the most economical count size. CMOP will not necessarily purchase the stock to be repacked in the largest count package available if a smaller count package is more economical. When the Pharmaceutical Prime Vendor (PPV) contract is used by the CMOP for ordering, the PPV Contractor may ship the product to the repacking Contractor and will bill the CMOP for the product.

N. PRODUCT HANDLING

1. Pharmaceuticals shall be received by the Contractor directly from a CMOP, a prime Vendor contractor, or alternative source pharmaceutical supplier. These pharmaceuticals are Government-Owned property. Immediately upon receipt of Government-Owned property, the Contractor shall log and reconcile the invoice for all products received and report any damage or discrepancies to the ordering facility as well as verifying DSCSA transaction information within 24 hours of receipt. Contractor shall report to the order CMOP via email and provide the signed and dated invoice/packing slip that accompanied the shipment, verifying all items listed were received and detailing any discrepancies.

2. The Contractor shall be responsible for reporting within 48 hours to the ordering CMOP when an excess of three lot numbers for a single drug is received.

3. The Contractor is responsible for product if it is damaged while in the Contractor’s possession. These pharmaceuticals will be repacked into unit-of-use sizes by direction of the CO, OO, or as defined by the order.

4. Pharmaceutical product retention shall be handled as defined in CFR Title 21, Section 211.

5. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples.

6. Product shall be processed and repacked and delivered into unit-of-use sizes in accordance with the instructions provided by the CO or OO no later than ten (10) calendar days after receipt of pharmaceuticals, or as agreed upon between the Contractor and the CO or OO. Shipments to the requested CMOP are to be sent FOB Destination.

7. Finished products shipped on pallets shall be shrink-wrapped. All pallets shall be wrapped using black shrink wrap to encapsulate the pallet and containers.

8. Pallets shall contain a packing slip identifying contents as well as an itemized invoice alphabetized line by line.

9. Controlled substances shall be wrapped separately from other portions of a shipment.

10. No more than 100 bottles per box or case.

11. A maximum weight of 25 pounds per box or case.

12. No “mix” of fill sizes, strengths, or drugs in any one box or case.

13. All partially filled boxes, as well as partial deliveries, must be clearly marked and placed at the top of each shipping pallet used.

14. Destruction of retained samples, controls, and excess and/or damaged product shall be done in accordance with applicable regulations, including but not limited to any required by the DEA, FDA, and EPA. Within fourteen (14) calendar days after destruction, the Contractor shall provide a Certificate of Destruction to the CO, COR, and OO.

15. The Contractor is responsible for and will reimburse the ordering CMOP for any Government property spilled, lost, or damaged while in their possession. CMOP will be reimbursed for the price paid for the unusable product.

16. Finished products that are received at the CMOP that are damaged, including missing or damaged caps, damaged bottles, missing or damaged labels that cannot be barcode scanned or are otherwise illegible shall be returned to the Contractor for identification of the drug content and proper disposal. The damaged product will be credited back to CMOP for the cost of the product plus repacking fee. If 10% or more of a batch is received damaged, the Contractor shall also pay for expedited shipment of replacement product.

O. REPORTS

Controlled Substance - Vendor Address, phone number, fax number, DEA number, Bill to, Sold To, Ship to, Batch Number, NDC Drug Name, Bottle Type, Lot Number, Expiration date, Pill Count, Containers Shipped, Units Shipped, Standard Price, Volume Price, 1 Lot Price, and Extended Price. Adding a Batch label data spreadsheet with the following minimum information: PO Number, shipper, ID, Description, NDC, Pill Count, Qty Completed, Quantity into F/G Inv, Quantity Packaged to QA, Quantity Destroyed, Quantity to Warehouse-RM, Total Received in Packaging, Difference.

P. ESTIMATED QUANTITIES

NOTE: It is not always possible for CMOP to obtain a single lot number for the stock to be repacked, and small production repacking runs which can be less than 100 bottles.

1. The Government anticipates a total of approximately 17 million repacked bottles per year, consisting of oral, solid pharmaceutical tablets and/or capsules. This estimate is based on historic data from the previous repacking contract. The anticipated use will include, but not be limited to, bottle counts previously stated. Estimated quantities are expected to remain stable for the base ordering period.

2. During the contract period, there is likelihood that the volume may change, upward or downward, although total change cannot be estimated due to the size of the served patient population being in constant flux and other variable factors, including but not limited to fluctuations in need for repacking certain oral solid pharmaceuticals which could be based on alternative availability. Therefore, it is impossible to determine the exact quantities that will be required during the contract term, nor the quantities that may be required by each CMOP.

3. The following is an estimated volume, based on historic data, for each bottle size that has been used in prior repacking activity. Past use does not guarantee future volume, although it will show an approximate relative pattern of the usage per size. The volume below is based on usage averages and will not total 100%.

120cc Bottles: > 70%, estimated at > approximately 15,000,000 – 17,500,000 bottles 200cc Bottles: < 15%, estimated at < approximately 1,900,000 – 2,300,000 bottles 300cc Bottles: < 7%, estimated at < approximately 600,000 – 800,000 bottles 400cc Bottles: < 5%, estimated at < approximately 700,000 – 900,000 bottles 625cc Bottles: < 2%, estimated at < approximately 100,000– 200,000 bottles 950cc Bottles: < 2%, estimated at < approximately 70,000– 90,000 bottles 1,000cc Bottles: <1%, estimated at < approximately 500 – 250 bottles 2,000cc Bottles: <1%, estimated at < approximately 12,000 – 14,000 bottles 3,000cc Bottles: <1%, estimated at < approximately 500 – 250 bottles 4,000cc Bottles: <2%, estimated at < approximately 3500 – 6500 bottles

4. The Contractor shall be required to deliver all articles that are properly ordered during the contract term, in accordance with the terms and conditions of the contract.

Q. DELIVERY

1. Delivery is required within ten (10) calendar days of receipt of an order and the product to be repacked, although voluntary, earlier deliveries are generally acceptable. If the seventh calendar day falls on a weekend or Federal holiday, then delivery may be made on the next normal business day for the CMOP.

2. Delivery of repacked items shall be shipped via a dedicated Location to Location (LTL) or full truck with no other non-government products in the truck to the requesting or ordering CMOP site. This will include a tamper evident seal on the truck door with the tamper evident seal number logged on the bill of lading (BOL). This will provide chain of custody and is a pharma shipping practice essential to maintaining positive control of all pharmaceuticals and accountability.

3. Emergency deliveries are FOB Destination and apply to repacked drugs requiring expedited delivery to ensure facilities have enough stock until the next scheduled delivery day. The Contractor shall provide a minimum of two monthly emergency deliveries for each delivery account at no additional charge. Emergency deliveries shall be made within 48 hours after receipt of order. Contractor shall indicate the number of emergency deliveries offered at no additional charge beyond the two required by this contract. The Contractor shall specify any additional charges (if applicable) per delivery trip, for emergency orders which exceed the two per month shipment limitation. Additional emergency order delivery charges in excess of the two no charge deliveries shall be charged at a flat rate per delivery trip. These deliveries shall be approved by the CO or COR before being used.

4. Each CMOP is entitled to two emergency deliveries per month. Any emergency order in excess of two per month are subject to an expedited fee paid by the CMOP.

5. Partial Deliveries - The vendor shall notify the ordering facility of any partial shipments and the delivery of shipments by the scheduled date shown on each partial order delivery order will be completed and accepted as authorized by the OO of the ordering facility.

R. INVOICES

1. Contractor shall submit invoices for payment to the office shown on each individual delivery or order. Any partial deliveries, when approved by the OO, shall be separately invoiced for each delivery made from the over-arching order, not invoiced as a single delivery.

2. The Contractor shall submit First Databank (FDB), Medi-Span, and Multum invoices for payment to the office shown on each individual order.

3. A detailed version of the invoice containing the following information shall be submitted to a designated CMOP contact on the same date as the electronic version is submitted to the FSC:

a. Vendor name, address, DEA number, phone number, invoice number, date, sold to information, contract information, order date, ship date, and invoice date.

b. Complete purchase order number assigned by CMOP for goods or services. To ensure prompt payment, please contact the VA facility to ensure that the assigned purchase order number is current and correct.

c. Itemized description of goods or services to include:

· Batch number

· Drug Name

· Contractor NDC

· Bottle type (120cc, 250cc, etc.)

· Lot Number

· Expiration date

· Pill Count (number per bottle)

· Containers Shipped (per batch)

· Number of tablets in the batch

· Standard price (repacking fee)

· Volume Price (repacking discounted price based on pre-determined volume)

· Lot Price (repacking discounted price if there is only one lot per drug strength)

· Extended Price (total for each batch)

· Total of all containers shipped

· Total of all tablets shipped

· Total price for all batches

d. Discount or net terms

4. Each invoice must be reconciled to the line-item level. Invoices shall be separated into three areas as follows:

a. Total product price

b. Total handling fee

c. Invoice grand total

d. Aggregated price by individual drug repack total.

S. SUPPORTED FACILITIES

1. The following facilities are eligible to order from the resultant contract:

760 - Leavenworth, KS CMOP

**Shawnee facility estimated to be fully operational by first quarter of FY26.

761 - Chelmsford, MA

VA CMOP Chelmsford - 761

Hours of Ops:

10 Industrial Avenue

5:30AM-3:00PM

Chelmsford, MA 01824-3610

762 - Tucson, AZ

VA CMOP Tucson - 762

Hours of Ops:

3675 Britannia Drive

3:00AM-12:00AM

Tucson, AZ 85706-5041

763 - Lancaster, TX

VA CMOP Lancaster - 763

Hours of Ops:

2962 S. Longhorn Drive

6:00AM-4:30PM

Lancaster, TX 75134-2118

764 - Murfreesboro, TN – SJ & EF

VA CMOP Murfreesboro – 764

Hours of Ops:

5171 Sam Jared Drive

6:30AM-5:00PM

Murfreesboro, TN 37130-1382

And 3209 Elam Farms Parkway Murfreesboro, TN 37127-8830

765 - Hines, IL (Great Lakes CMOP)

VA CMOP Hines - 765

Hours of Ops:

5th and Roosevelt, Building 37 NW Dock 18

5:00AM-12:00AM

Hines, IL 60141-3030

766 - Charleston, SC

VA CMOP Charleston - 766

Hours of Ops:

4136 Carolina Commerce Parkway

5:30AM-11:30PM

Ladson, SC 29456

Mon - Fri

770 - VA CMOP National Office

VA CMOP National Office - 700

23501 W 84th Street Shawnee, KS 66227

2. This list may be changed after award by modification to include new facilities or to delete existing facilities.