36E79725R0022_1.docx

36E79725R0022 36E79725R0022

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36E79725R0022 3/18/2025 Chris Carthron / Christopher.Carthron@va.gov

(708) 786-7863 4/1/2025

2:30PM CT

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 325412 1300 Employees N/A N/A X VA & DoD Pharmaceutical Prime Vendors Refer to Attachments A & B, located in Section D.

Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141

VA & DoD Pharmaceutical Prime Vendors Refer to Attachments A & B, located in Section D.

See CONTINUATION Page

HYDROXYCHLOROQUINE SO4 200MG TAB

One award will be made in the aggregate for line items:

1 and 2 To be considered for award, offerors must submit a price for the base year and all four one-year options for both line items.

Prices offered shall not exceed two decimal places.

Offered prices must include the Cost Recovery Fee of 0.5%, as outlined in Scope of Contract. Offerors must list an digit NDC number for each offered drug that is unique to the Offeror's company as outlined in scope of contract. If the offeror is a distributor, the NDC number must be unique to the distributor.

See CONTINUATION Page X X X 1 scan Continuation of SF-1449, Block 3:

The following information shall be entered by the Contracting Officer at the time of contract award according to the timeframes specified in this solicitation’s Section B, Scope of Contract, Section 1.4 Contract Effective Date, Implementation Period, and Ordering Period.

Contract Award/Effective Date: ___________________

Implementation Period: __________________________

Ordering Period (Base Year): _____________________

Offerors shall not enter information into the above fields.

Continuation of SF-1449, Blocks 19 through 24:

To be considered for award, offerors must submit a price for line items 1, and 2 for the base year and all four option years. One award will be made in the aggregate for line items 1 and 2 for the base year and all four option years. Offered prices shall not exceed two decimal places.

Note: NDC is defined as National Drug Code. ANDA is defined as Abbreviated New Drug Application

Line Item 1

Hydroxychloroquine SO4 200mg Tablet, 100 Tablets per Bottle

NDC # __________________

ANDA#_________________

Line Item 2

Hydroxychloroquine SO4 200mg Tablet, 500 Tablets per Bottle

NDC # __________________

ANDA#_________________

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

Please be advised, the following paragraphs are also included in the elsewhere in the solicitation, but are included here for offeror reference.

Proposals will be accepted in Microsoft Word or PDF form via e-mail at Christopher.Carthron@va.gov and Diana.Martinez1@va.gov with a scanned (pdf) copy of the signed SF-1449. Please note that faxed proposals are not acceptable and will be rejected. Please note, zip files and folders are rejected by Department of Veterans Affairs (VA) National Acquisition Center (NAC) servers, and emails with large attachments may not be received. VA suggests that offerors submit their proposals well before the deadline and confirm receipt of all attachments with the Contracting Officer listed on the SF-1449. Reference Federal Acquisition Regulation (FAR) 52.212-1(f) regarding timeliness of submission of offers.

If the offeror is not the manufacturer of the offered items, the offeror shall submit a Letter of Commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of active and inactive ingredients to form drug products, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. This process includes the measuring, mixing, weighing, and compounding both the active and inactive ingredients. The product is then converted into various drug forms, suitable for administration through tablets, capsules, liquids (in the form of solutions, suspensions, emulsions, gels, or injectables), creams, ointments, or aerosols. An acceptable Letter of Commitment is required from all distributor-offerors to be eligible for award. The offeror must maintain the same manufacturer (New Drug Application [NDA]/Abbreviated New Drug Application [ANDA]/Biologics License Application [BLA]) for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award. If the offeror is not a manufacturer, to be eligible for award, offerors must submit a Letter of Commitment that meets all requirements stated in the Addendum to FAR 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services.

One award will be made in the aggregate for both line items for the base year, including all four option years. To be considered for award, offerors must propose a price for line items 1 and 2 for the base year and each option year. Proposals that fail to include a price for the base year and each of the four option years for line items 1 and 2 may be rejected and receive no further consideration.

(Refer to Schedule of Supplies for package size details and estimates)

Offered prices shall include a 0.50% Cost Recovery Fee (See Scope of Contract, Section 12).

The Government will evaluate offers in accordance with the policies and procedures of the FAR Part 12, Part 15, and Part 25.

Acknowledgement of Amendments. The following amendments are acknowledged as part of this solicitation. (Please complete if applicable)

The System for Award Management (SAM) is the Official U.S. Government system for registering to do business with the federal government, completing company representations and certifications, listing contract opportunities, and more. Contractors should go to www.sam.gov to find their information. Training tools are available on the SAM website for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually.

Subcontracting Plan Requirements: Pursuant to the requirements of 15 U.S.C. § 644, all other than small business concerns are required to have an approved subcontracting plan for contracts valued over $750,000 before the Government can award a contract (see FAR 52.219-9 and VAAR 852.219-70 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment “D” includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan.

As prescribed in FAR Subpart 42.15, VA evaluates contractor performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).

SCOPE OF CONTRACT

1. INTRODUCTION

1.1 Background. All Ordering Activities under the VA and all Ordering Activities under the Department of Defense (DoD) acquire their pharmaceutical requirements through their respective Pharmaceutical Prime Vendor (PPV) Programs, hereafter referred to as the VA PPV Program and DoD PPV Program or jointly as PPV Programs. The PPV Programs are separate contracts which establish the fees for the distribution of pharmaceutical products that are distributed through the PPV Programs on Federal Government (i.e., Federal Supply Schedules, National Standardization) contracts. A contract resulting from this solicitation establishes the VA National Contract prices for the products listed in the schedule of supplies that will be distributed through the PPV Programs. Section 2.1, “Government Participants” lists the PPV Program participants that will be authorized users of the contract resulting from this solicitation. The contractor shall follow all appropriate requirements as implemented in Drug Supply Chain Security Act (DSCSA). See Section 7 of the Scope of Contract for DSCSA details.

1.2 Purpose and Objectives. The purpose of this solicitation is to establish a supply source that will provide the drugs listed in the schedule for purchase through the PPV Programs. The total annual estimated usage for VA, Federal Health Care Center (FHCC), State Veterans Homes (SVH) - Option 2, DoD, Indian Health Service (IHS), and Bureau of Prisons (BOP) appears on the Schedule of Supplies section of this Solicitation. The objective of such a contract is to ensure availability and consistency of product for nationwide usage and to obtain volume-based, committed-use pricing.

1.3 Government Purchase Compliance. VA, FHCC, SVH (Option 2), DoD, IHS, and BOP will purchase their requirements for the strengths of the drugs listed in the schedule through the PPV Programs except when: (1) the contracted items are unavailable to meet the needs of the Government, or (2) an alternate is requested by the prescribing healthcare provider, or (3) additionally, IHS will not participate if the awardee does not have a Centers of Medicare or Medicaid (CMS) reimbursable product(s). In the event that exception 1, 2, or 3 applies, these instances will be considered exceptions to FAR 52.216-21, Requirements. VA’s PPV contract has ordering lock-out procedures in place to support VA contract compliance and to prevent purchases of non-contract products. Participants of the VA PPV Program include VA, FHCC, SVH (Option 2), IHS, and BOP. DoD manages compliance through individual facility tracking reports.

1.4 Contract Effective Date, Implementation Period, and Ordering Period.

(A) Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF-1449 and notifies the offeror (contractor) of award.

(B) Implementation Period. The timeframe beginning on the Contract Effective Date and ending at the start of the Ordering Period in which PPVs begin placing orders with the contractor for delivery to the multiple PPV distribution centers is the Implementation Period.

Contractors will be allowed a maximum of a 60-day Implementation period (but may be shorter than 60 calendar days if mutually agreed between the contractor and the Government), if the contract is awarded after July 24, 2025 If the contract is awarded prior to July 24, 2025, the Implementation period will begin when the contract is awarded and end on September 22, 2025.

There are approximately 31 VA PPV Distribution Centers and approximately 25 DoD PPV Distribution Centers located nationwide. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements with the PPVs have been executed with sufficient time to permit the PPVs to begin timely distribution of Government orders by the expiration of the contract implementation period. The current PPVs are listed as attachments “A” and “B” of this solicitation. The current PPVs may change and the contractor will be notified of any changes in PPV contractors during the term of the contract resulting from this solicitation. Payment terms, time and place of delivery to PPV distribution centers and other business-to-business agreement terms shall be agreed upon between the PPV contractors and the contractor awarded a contract from this solicitation. While it is a requirement that the contractor establish a business-to-business agreement with the PPVs, the Government is not a party to this business-to-business agreement and does not negotiate for either the Contractor or PPVs. The Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPVs by 15 calendar days before commencement of the Ordering Period. Failure or refusal to reach agreement with the PPVs and maintain an agreement with the PPVs throughout the entire contract period shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions-Commercial Products and Commercial Services, Termination for Cause.

(C) Ordering Period. The Ordering Period begins at the expiration of the Implementation Period. The base year Ordering Period will be in effect for the period of one (1) year. During this period, Government participants place orders with the PPVs, who ship product to the Government participants. The PPVs shall order product from the Contractor and the Contractor shall ship to the PPVs in accordance with the terms of the Contractor and PPV business-to-business agreements. Failure to provide awarded product meeting all solicitation/contract requirements by the ordering period start date may result in contract termination in accordance with FAR 52.212-4(m), Contract Terms and Conditions-Commercial Products and Commercial Services, Termination for Cause.

(D) At the time of contract award, the Contracting Officer shall indicate the contract Effective Date, Implementation Period, and Ordering Period on Page 2 of the SF-1449, in accordance with the timeframes specified in this section.

1.5 Contract Duration. The contract resulting hereunder will be in effect for the duration of the Implementation Period described in Section 1.4 plus one (1) year Ordering Period with four (4) one (1) year pre-priced option (ordering) periods that may be exercised unilaterally by the Government in accordance with FAR 17.207 and FAR 52.217-9.

1.6 Special Contract Considerations. As discussed in Section 1.2, this solicitation establishes a supply source to provide the drugs listed in the schedule for purchase through the PPV programs. Additionally, as outlined in Section 1.4, the awarded offeror (contractor) under this solicitation must reach and maintain a business-to-business agreement with the respective PPV programs for the duration of the contract. Because the PPV programs distribute the supplies sourced from this solicitation, special contract considerations apply.

Under this resulting contract, the contractor will be receiving payments from the PPV programs instead of directly from the Government. Due to this unique payment structure, contractors are not permitted to assign their rights to receive payment under this contract. Additionally, disputes arising between a contractor and any authorized Government Prime Vendor(s) do not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the contractor to the Government ordering facilities. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV programs.

2. EXTENT OF OBLIGATION

2.1 Government Participants. The contractor shall provide the products specified in the schedule at the prices awarded herein for the facilities/agencies below:

· All Department of Veterans Affairs (VA) facilities

· All Ordering Activities under the Department of Defense (DoD) Pharmaceutical Prime Vendor Program

· All Indian Health Service (IHS) facilities

· All Bureau of Prisons (BOP) facilities

· Captain James A. Lovell Federal Health Care Center (FHCC)

· All Option 2 State Veteran Homes (See Section 2.2 State Veteran Homes)

A database of all facilities authorized to use the VA PPV Program may be downloaded from the National Acquisition Center’s web site at http://www.va.gov/oal/business/nc/ppv.asp.

2.2 State Veteran Homes (SVHs). There are numerous SVHs that have entered into sharing agreements with VA Medical Centers (VAMCs). The SVHs with sharing agreements that participate in the VA PPV Program are identified as being one of two types: Option 1 or Option 2.

Option 1: The SVH orders pharmaceuticals directly from the VA PPV and pays the VA PPV for all items purchased. An Option 1 SVH is not eligible for national contract prices awarded under this solicitation unless it is specifically named in the scope of contract or added after award by mutual agreement between the contractor and the Government.

Option 2: The VAMC authorizes the SVH’s order, and the VAMC makes payment to the VA PPV for all pharmaceuticals ordered by the SVH. An Option 2 SVH is eligible for the national contract prices awarded under this solicitation.

2.3 Consolidated Mail Outpatient Pharmacies (CMOPs) (VA ONLY) and Tricare Mail Order Pharmacies (TMOPs) (DoD ONLY). Many drugs are prescribed and mailed directly to patients’ homes in three-month or 90-day supply and VA CMOPs/DoD TMOPs may place an initial order with the VA PPV/DoD PPV contractor for up to 30% of the estimated VA/DoD annual contract quantities immediately upon the commencement of the ordering period. An initial order of up to 30% of the estimated VA/DoD annual contract quantities may be placed by the VA PPV/DoD PPV contractor with the contractor awarded a contract under this solicitation to fulfill the CMOP and/or TMOP 30% initial order requirements.

2.4 Estimated Quantities. The quantities in the schedule reflect the combined usage of all VA (inclusive of FHCC and Option 2 SVH), DoD, IHS, and BOP activities currently participating in the PPV Programs. These estimated annual requirements do not include those of any other Government agency, including those currently participating in the VA PPV Program (e.g. Immigration and Customs Enforcement, Option 1 State Veteran’s Homes). The estimated usage cited in the Schedule is the Government’s total estimated usage for the strengths listed. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.

3. PRODUCT REGISTRATION

Product information pertaining to all items offered under this solicitation, including the offeror’s unique National Drug Code(s) (NDC), must be submitted to First Databank, Medispan and Multum no later than 5 calendar days after notification of contract award. The awarded contractor shall notify the Contracting Officer if there are any issues delaying registration. A New Product Submission Form can be obtained by contacting First Databank at (800) 633-3453, extension 566, or information can be obtained at http://www.fdbhealth.com/solutions/manufacturer-relations/. Medispan information can be obtained at https://www.wolterskluwer.com/en/solutions/medi-span. A New Product Submission Form can be obtained by emailing MultumSupport@Cerner.com. All new products and product updates should be sent to Cerner Multum at mfgproducts@cerner.com.

4. NATIONAL CONTRACT ITEM BACKORDERS

A contract awarded under this solicitation will be the Government’s primary source of supply (See FAR 52.216-21 Requirements). The Government’s ability to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this paragraph is to provide guidance to the awarded offeror (contractor) regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, consideration of this paragraph shall not waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4(m) Termination for Cause.

For purposes of this contract, a backorder occurs when the PPVs issue an order with the contractor, and the complete order quantity is not delivered to the PPVs within 15 calendar days after receipt of order. This includes initial CMOP orders. If a national contract item is backordered by the PPVs, the Contracting Officer will investigate the backorder to determine if the national contract contractor bears responsibility for the backorder. The awarded contractor shall inform the Contracting Officer within four calendar days after a backorder occurs. In addition to informing the Contracting Officer of the backorder, the contractor shall provide an estimated date when the backorder will be shipped, and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate a national contract backorder situation. If the contracting officer determines that the contractor bears responsibility for the backorder, and the contractor is not able to provide a solution that is acceptable to the Government, (i.e., acceptable solution to the backorder, in lieu of Termination for Cause), the parties agree that the Government may buy against the contractor by acquiring the same or similar items from another source and billing the contractor for any excess procurement costs. In other words, if the Government must purchase product from another vendor because of a national contract backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the contract price within 30 calendar days after receipt of notification. The contractor shall also provide written verification to the Contracting Officer when credits or reimbursement have been made within 30 calendar days from date of reimbursement. After a backorder incident occurs for which the Contractor is responsible, the Government’s decision to enter into a buy-against agreement described above will not deprive the Government of its right under FAR 52.212-4(m) to terminate the contract for a breach of the buy-against agreement, for a subsequent contractor-caused backorder, or for any other sufficient cause.

5. PACKAGING REQUIREMENTS

Offerors must state the exact name and strength of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number for all items offered; the NDC number must be specific to the offering company and to the drug being supplied. The successful offeror/contractor's label with its unique NDC shall be the only label on the product. Contractors shall not affix their label over another label on the product. All bottles of 400 tablets/capsules or less must have a safety-cap capable of having the outer part of the cap deshelled and/or a convertible cap to produce a non-safety cap child resistant closure. All tablets/capsules must be compatible with automated dispensing units (Baxter ATC Canisters, Optifill, etc.). Glass bottles are not acceptable. Items are identified in the Schedule of Supplies and in Attachment C. By submitting an offer in response to this solicitation, the offeror certifies that all offered products have passed any required stability testing for all proposed package sizes.

6. BAR CODING

All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GS1 or HIBCC HIBC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.

The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS), or Universal Product Code (UPC) (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN).

The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this section prior to shipping pharmaceutical products to any Government Prime Vendor under this contract.

The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap must contain the bar code.

If applicable, the bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.

When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. The Drug Supply Chain Security Act (DSCSA) now requires a two-dimensional data matrix bar code (GS-1 data matrix bar code preferred) for each product down to the lowest saleable package size (see Section 7, below, for additional DSCSA requirements); however, the Food and Drug Administration (FDA) bar code rule for linear bar codes still applies to all packaging as stated above. A human readable number must be placed adjacent (preferably below) the encoded bar code to ensure product is usable with VA Bar Code Medication Administration (BCMA) in the event the bar code is in some way damaged.

It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date; the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Alliance (HDA) guidelines (formerly HDMA) shall be followed.

7. DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) REQUIREMENTS

Title II of the Drug Quality and Security Act (DQSA), known as the DSCSA, applies to all drug products, with the exception of those listed on the DSCSA exemption list: Title II of the Drug Quality and Security Act | FDA. As part of the requirement of the DSCSA, drug products are required to provide serialized DSCSA Transaction Information and Transaction Statements using GS1 industry standard Electronic Product Code Information Services (EPCIS) files following the GS1 US Implementation Guideline: The GS1 US DSCSA Implementation Suite (gatewaychecker.com) in order to transmit the files needed for tracking.

DSCSA also requires that all trading partners of manufacturers, wholesale distributors, dispensers, and repackagers meet applicable requirements for being authorized trading partners. The National Association of Boards of Pharmacy (NABP) has established a trading partner directory, which is a repository of authorized trading partners that can be accessed to authenticate authorized trading partners in real time. All VA and other participating agency pharmacies will be entered in this directory as authorized trading partners using unique identifiers. Current and prospective trading partners of the VA other participating agencies are required to complete a registration prior to selling pharmaceuticals to these agencies. Neither the Government, nor the vendors will be charged a fee to participate in the directory.

DSCSA drug products are required to provide the serialized DSCSA Transaction Information and Transaction Statement required for the interoperable electronic DSCSA system using GS1 industry standard EPCIS files following the GS1 US Implementation Guideline. Suppliers establishing an EPCIS connection for DSCSA will need to inform their trading partners of the master data for the Global Trade Item Number (GTIN) and Global Location Numbers (GLNs) that they utilize. These are necessary to establish the EPCIS connection in addition to being able to transmit the file using AS2 or another method. This onboarding must be complete as product may not be purchased or sold without the serial DSCSA Transaction Information. Registration and valid status in the National Association of Boards of Pharmacy (NABP) Trading Partner Directory is required also for all VA contract holders pursuant to DSCSA.

8. NATIONAL DRUG CODES

Offerors shall provide a separate and distinct 11-digit NDC Number unique to the offeror (e.g., 00012-3456-78) for each product proposed, in the space provided following each item in block 20 of the SF-1449, “Schedule of Supplies and Prices” of the solicitation. The first five numbers of the 11-digit NDC number for each product proposed shall identify the offeror.

Offerors must provide their own labeler code, to be used in the NDC number for the offered items. If an offeror is a dealer/distributor and does not have a labeler code, it must apply and be approved with the FDA for its own labeler code prior to making an offer under this solicitation. Offers that fail to provide the information required by this paragraph by the solicitation closing date may be rejected and receive no further consideration.

9. DRUG APPLICATION

By signing this solicitation, the offeror certifies that it has on file (if any of the following are required by the FDA for the offered drugs): an FDA approved New Drug Application (NDA), an approved abbreviated NDA (ANDA), or an approved Biologics License Application (BLA), as appropriate for the items offered in response to the solicitation.

10. RECALLS

If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the FDA; or, if FDA withdraws its approval to manufacture any drug that is included on this contract, the contractor shall immediately forward the recall notification, along with any pertinent information via email to the assigned Contracting Officer and to the following:

Erika Moreno Chief, Pharmaceutical Division (003B6C3) VA National Acquisition Center National Contract Service 1st Ave., 1 Block North of Cermak Rd., Bldg. 37 P.O. Box 76, Hines, IL 60141 Erika.Moreno@va.gov

Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Patientlevelrecalls@va.gov

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 NCPS@va.gov Phone Number: (734) 930-5890

All Government Prime Vendors that were sent shipments of the affected product(s) shall also be provided a copy of the recall notification along with any pertinent information.

11. COVERED DRUGS

Should a covered drug (as defined in 38 U.S.C. § 8126(h)(2)) be proposed and awarded as a result of this solicitation, the awarded prices shall meet the requirements of 38 U.S.C. § 8126 and shall apply to all Government participants listed in Section 2.1 of the Scope of Contract, regardless of whether the participant is covered under the law. Therefore, prices for the base year and all option years shall not exceed the annually established Federal Ceiling Price (FCP), plus the 0.5% Cost Recovery Fee (CRF).

Attention is directed to the fact that although 38 U.S.C. § 8126 applies to all covered drugs, competitively negotiated and awarded prices for the base year and any option years exercised by the Government will govern unless the annually established FCP results in a price lower than competitively awarded contract prices. In this instance, the contract shall be modified to reflect the lower annually established FCP, plus the 0.5% CRF.

Both parties (Offeror and VA) understand the VA National Contract Service will obtain FCPs from VA’s Pharmacy Benefits Management (PBM). The parties agree the FCP will be calculated pursuant to the requirements of 38 U.S.C. § 8126 and any related requirements contained in the contractor’s Master Agreement, Pharmaceutical Pricing Agreement, and relevant VA Dear Manufacturer Letters. Refer to the VA Federal Supply Schedule (FSS) website at https://www.fss.va.gov/ and Public Law 102-585 (Veterans Health Care Act of 1992) page on the VA FSS website at https://www.va.gov/opal/nac/fss/publicLaw.asp for further information and a list of published Dear Manufacturer Letters.

Contractors submitting a proposal for a covered drug are required to complete the following paragraph:

MASTER AGREEMENTS AND PHARMACEUTICAL PRICING AGREEMENTS

In compliance with 38 U.S.C. § 8126, Offerors of covered drug products (including biologics) must state below whether they currently have a Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA), that includes the offered drug products/NDCs, in place with the Department of Veterans Affairs (VA) and confirm that the proposed covered drug products are present on the Offeror’s FSS contract or interim agreement.

_____ YES, Offeror has an MA and PPA (inclusive of the proposed drug products/NDCs) in place with VA FSS and proposed drugs are present on Offeror’s FSS contract/interim agreement.

_____ NO, Offeror does not have an MA and PPA (inclusive of the proposed drug products/NDCs) in place with VA FSS and/or products are not present on Offeror’s FSS contract/interim agreement.

Offers of covered drugs (including biologics that fall within 21 CFR § 600.3) will only be considered for award if the Offeror has an executed MA and PPA (which includes the proposed drug products/NDCs) on file with the VA National Acquisition Center, FSS (in accordance with 38 U.S.C. § 8126(h)(4)(B)). Furthermore, in order to be considered for award under this solicitation, all proposed covered drug products/NDCs must be present on the Offeror’s FSS contract or interim agreement by the solicitation due date and time. Offers failing to meet these criteria will be rejected and receive no further consideration.

12. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS

12.1 Quarterly Sales Reports. The Contractor shall report all contract sales under this contract and submit collected Cost Recovery Fees as follows:

(A) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). A Cost Recovery Fee equivalent to 0.5 % of the current contract price shall be collected from all contract users. The 0.5 % Cost Recovery Fee shall be imbedded in the awarded contract prices, and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line item price offered. The reported contract sales shall include the Cost Recovery Fee and each quarterly report shall show the total Cost Recovery Fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice.

(B) Contract sales reports are due to the Contracting Officer within 30 calendar days following the completion of each reporting quarter or completion of the contract, whichever occurs first. A report is required even when no billings or invoices are issued or no orders are received during the contract period.

(C) The sales report signed by an authorized representative of the contractor shall be emailed to the Contracting Officer.

(D) In addition to the submission of quarterly sales reports due to the Contracting Officer within 30 calendar days after the end of each reporting quarter, contractors shall provide copies of sales reports simultaneously with contractor’s Cost Recovery Fee payment submissions via email to: AMMHINBOCFISCAL@VA.GOV.

12.2 The 0.5% Cost Recovery Fee amount shall be paid electronically via Collections Information Repository (CIR)/Automated Clearing House (ACH). CIR/ACH credit instructions will be provided to the contractor upon contract award. When the contractor has multiple national contracts, the fee may be consolidated into one electronic payment. When the electronic payment is made, the contractor shall submit an email to AMMHINBOCFISCAL@VA.GOV to identify the contract number (or numbers, if the payment covered multiple contracts) included, dollar amount remitted for each contract number, and reporting quarter. The Cost Recovery Fee payment is due to the VA Fiscal Division at the same time the sales report is due to the Contracting Officer (i.e., within 30 calendar days following the completion of each reporting quarter or completion of the contract).

Cost Recovery Fee payments shall not be combined with any Industrial Fund Fee payments. Contractors shall remit separately any Industrial Fund Fee payments in support of any of the Contractor’s Federal Supply Schedule contracts.

12.3 The Government reserves the right to inspect without further notice, such records of the Contractor as pertain to sales under any contract resulting from this solicitation. Willful failure or refusal to furnish the required reports, or falsification thereof, shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions - Commercial Products and Commercial Services, Termination for Cause.

12.4 Failure to remit the full amount of the Cost Recovery Fee within 30 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of FAR Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR 52.212-4(i)(6)). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the Cost Recovery Fee, the Government shall have, in addition to the rights and remedies described in this section, all other rights and remedies permitted by Federal law and statutes.

13. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

13.1 The FDA is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for human drugs, pharmaceutical products, biologics, medical devices, chemical products, medical cylinder oxygen, reagents, diagnostics, test kits and sets included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Section 13.7 below will be considered for award. Before a contract can be awarded, any successful offeror’s manufacturing, packaging, and any other applicable facilities shall have a current acceptable cGMP status with the FDA, or shall have had an acceptable report from the last FDA facility inspection on record for the product type offered. In the absence of a current cGMP evaluation for any of the identified facilities, an offeror is required to include with its proposal documentation on the acceptable outcome of an FDA facility inspection that occurred within two years prior to submission of the offer.

13.2 If at any time during the life of the contract, the contractor’s facility (or the source from which the contractor obtains any of the products offered on this contract), or the facility that packages the product offered in this contract is notified of violations or potential violations by the FDA, is issued a Form FDA 483, or is issued an FDA Warning Letter highlighting a failure to meet FDA cGMPs (21 CFR Part 210 and 211), the awarded contractor shall inform the Contracting Officer within 15 calendar days of the notice. At which time, the Contracting Officer will apply the procedures outlined in Section 13.3 below. Non-timely notification may result in a negative past performance rating and/or be grounds for contract termination in accordance with FAR 52.212-4(m), Contract Terms and Conditions-Commercial Products and Commercial Services, Termination for Cause.

13.3 The Contracting Officer will review the contractor’s (or its source’s) unacceptable cGMP status with appropriate VHA clinical staff and will either: 1) instruct the contractor to stop the shipment of products listed on this contract that were manufactured and/or packaged in a facility with unacceptable cGMP status, or 2) authorize the contractor to continue to supply such contract products for 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, provided that the products have not been subjected to a consumer-level recall. An additional 90 calendar day extension may be authorized at the discretion of the Contracting Officer. Contractors are cautioned that products that were manufactured and /or packaged in a facility with unacceptable cGMP status and then shipped without written authorization from the Contracting Officer shall be returned to the contractor at the contractor’s risk and expense. The contractor shall have corrected all significant cGMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to unacceptable status by the end of the 90-calendar day authorization period and any extensions of such period granted by the Contracting Officer. Additionally, the contractor is responsible for keeping the Contracting Officer informed of all corrections made and shall provide the Contracting Officer with: 1) written documentation of the correction plan, 2) Notification from FDA of acceptance of plan, and 3) a copy of any reinspection requests and subsequent reinspection reports, upon availability. If FDA’s evaluation of contractor’s (or its source’s) compliance efforts and/or re-inspection of the non-compliant facility does not result in an acceptable rating by the FDA within 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, or by the end of a Contracting Officer’s authorization period (whichever is the greater period of time), the contract may be terminated for cause in accordance with FAR 52.212-4(m). The contractor’s (or its source’s) failure to correct the cGMP deficiencies in a timely manner shall not constitute or give rise to any “excusable delays” pursuant to FAR 52.212-4(f). (Nothing in this section shall be read as limiting the recognized grounds upon which a Contracting Officer may terminate this contract or delete products pursuant to the applicable sections contained in the contract.)

13.4 The contractor shall use only the FDA-inspected manufacturing facilities provided in Section 13.7, below, for the duration of the contract, unless substitution of manufacturing facilities is approved by the Contracting Officer. In case of any manufacturing facility relocation or substitution of manufacturing facilities, the contractor shall immediately notify the Contracting Officer of the pending change, and the contractor shall request approval from the Contracting Officer to supply the contracted products from the new location. If the change is approved by the Contracting Officer, after an inquiry to the FDA for cGMP status of the new location, approval will be provided by means of a formal contract modification.

13.5 If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses.