P03 - Brand Name J_A - 36C77023Q0448 - Thyroid - Redacted.pdf

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

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

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

Brand Name Only

Acquisition Plan Action ID: 36C770-23-AP-0794

1. Contracting Activity: Department of Veterans Affairs, VISN 15, Leavenworth Concolidated Mail

Order Pharmacy (CMOP). 2237# 760-24-1-050-0004 Leavenworth CMOP, Leavenworth, KS.

2. Brief Description of Supplies/Services required and the intended use/Estimated Amount: This is an individual brand name justification to support the procurement of the two (2) Brand Name Specific pharmaceutical items, in the below table. The proposed procurement action will be a firm-fixed-price contract awarded for the supplies with an estimated cost of .

VA Item

ID

Description Manufacturer Part

Number (MPN) Quantity Uint of

Messurement OEM Unit Price National Drug Code

6203 THYROID 90MG TAB 100CT 00456-0460-01 720 BT Allergan

USA,

Inc.

177.64 00456-0460-01

6204 THYROID 60-65MG (1 GRAIN)

TAB 100CT

00456-0459-01 1008 BT Allergan

USA,

Inc.

107.21 00456-0459-01

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Name Brand Only/Gray Market Requirements” products are the samething as “dispense as written” on a physician prescription. Absolutely no Generic Reservoir quotes will be accepted – Name Brand Only.

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 “Name Brand Only/Gray Market Requirements” products in the VA PRINT NAME. Vendors must provide proof of supply from an authorized MFG distributor. 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.

Last Updated: 02/01/22 Page 2 of 3

4. Description of market research conducted and results or statement why it was not conducted: In accordance with FAR Part 10, VAAR 810, market research has been conducted for this acquisition. A Small Business Administration (SBA), Certified Veteran Small Business page search identified 133 potential SD/VOSB as capable vendors. These are not manufactures, but they are distributors for large business wholesalers. The Government is not allowed to do business using wholesale trade or retail trade NAICS codes, searches must be conducted using the manufacturer NAICS code 325412, Pharmaceutical Preparation Manufacturing diagnostic substance manufacturing. The item (Thyroid 60-65mg (1 Grain) and 90mg Tab) was then searched in the National Acquistion Center for any FSS/GSA/PV contracts – this yielded no resualts. Based on this research and policy, the Rule of Two cannot be met to set the procurement aside for a socioeconomic subcategory of small business;

Last Updated: 02/01/22 Page 3 of 3 however, based on the exception to the NMR for acquisitions under $250K, a small business set-aside is feasible. Although, the NMR applies, due to the time constraints of this acquisition, there is not sufficient time to request an individual waiver to the NMR. This procurement will be solicited as a small business set-aside; and a per-solicitation contracting opportunity will be posted to SAM.gov.

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.

James Hogue Date

Contracting Officer

JAMES

HOGUE

Digitally signed by

JAMES HOGUE

Date: 2023.09.25 07:30:50 -05'00'