S02_JnA_Q0052.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 36C770-26-AP-0159

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-26-AP-0159

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 15 –

Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Ladson (Charleston)

CMOP.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Item Number

Description NDC Quantity Unit of Measure

0001 JASMIEL (J0040) 28-

DAY TABLET

50102-0240-

720 PG

This is an individual brand name justification to support the procurement of the pharmaceutical in the table above. The proposed procurement action will be a firm-fixed-price contract award for the supplies.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Product has been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

4. Description of market research conducted and results or statement why it was not conducted:

In accordance with FAR Part 10, VAAR 810, and VAAM M810, market research has been conducted in support of this acquisition. The procurement packet was received on November 24, 2025, and market research efforts commenced on December 16, 2025.

Market research confirmed that the pharmaceutical is not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP, including searches via Prime Vendor, NAC and FSS. As a result, an open market procurement remains the only option for purchasing the https://www.acquisition.gov/?q=/browse/far/13

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C770-26-AP-0159 pharmaceuticals. This requirement is not for lack of planning, but rather stems from the unavailability of inventory through conventional supply channels.

The Contracting Officer conducted further searches in SBA’s Dynamic Small Business Search (DSBS) utilizing NAICS code 325412 and yielded a total of 1 SD/VOSB and 6 SB concerns who identified as authorized distributors.

A query was performed using the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website to determine the existence of any domestic sources—both large and small business concerns—for the required items. No domestic sources were identified.

To further assess the feasibility of a small business set-aside, a Request for Information (RFI) was posted on December 16, 2025, seeking input from domestic manufacturers, both large and small, regarding their capability to supply the required pharmaceutical. No viable responses were received. Based on this outcome, it has been concluded that no domestic manufacturer currently exist that are capable of supplying the requested pharmaceutical.

Additionally, the Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold, but does not apply to total (non-socioeconomic specific) small business set-asides below the SAT. In accordance with the Non- Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell med/surg items, take ownership or possession of the med/surg via its facilities or via its personnel. However, market research concludes that there are presently no domestic small business concern manufacturers that exist in the commercial marketplace for the requested pharmaceuticals. The CO has confirmed there is no class waiver associated with these pharmaceuticals under NAICS Code 325412. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. Given this information, a socioeconomic specific set-aside may not be feasible as vendors would not be able to comply with the NMR without a waiver of the fourth prong.

Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT. This does not preclude a SD/VOSB from quoting and/or receiving an award as a small business.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Kelley Cunningham Date Contracting Officer Network Contracting Office 15, CMOP Division https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466