S02_JA_Q0242 - CO SIGNED_Redacted.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 4 Acquisition ID#36C770-25-AP-0578

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: 36C770-25-AP-0578

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting

Office (NCO) 15 –Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Charleston CMOP.

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

ITEM

NUMBER IMFN DESCRIPTION NDC QTY

UNIT OF

MEASURE

PACKAGING

MULTIPLE

IGCE

PRICE

TOTAL IGCE

PRICE

0001 13707 CARBOXYMETHYLCELLULOSE NA 0.25% OPH SOLN 15ML 58790-0001-15 6360 BT 15ML

This is an individual brand name justification to support the procurement of the over the counter (OTC) item listed in the table above. The proposed procurement action will be a firm-fixed-price contract award for the OTC pharmaceutical.

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.

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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 for this acquisition. The procurement packet was received on May 2, 2025. Market research was conducted beginning May 15,2025, for the upcoming acquisition.

A CMOP wide Sources Sought Notice was published on sam.gov under the identifier 36C77025Q0124 on January 21,2025 and archived on April 6, 2025, requesting domestic manufacturers of multiple pharmaceuticals (including CARBOXY- METHYLCELLULOSE NA 0.25% OPH SOLN 15ML). No vendors responded that they were capable of manufacturing a domestic supply of the identified product that could meet the CMOP's needs.

Market research confirms that this pharmaceutical is not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime vendor, NAC, and FSS: an open market procurement is the only option that remains purchasing this pharmaceutical. The requirement is not for lack of planning but due to inventory not being available via normal supply chains.

The CMOP Medication Image Library, the National Institutes of Health (NIH) U.S.

National Library of Medicine DailyMed and the manufacturer’s websites were searched using the listed NDC (58790-0001-15) in the above chart. The purpose of the searches is to determine the manufacturer and if there are any domestic sources available (both large and small business concerns) within the marketplace. The

Revision: 01 Effective Date: 11/15/2024 Page 3 of 4 Acquisition ID#36C770-25-AP-0578 search on the CMOP image library for NDC confirmed 58790-0001-15 is manufactured by Akorn Consumer Health. The query on DailyMed website affirmed Prestige Consumer Healthcare Inc as manufacturer of the product and the country of origin is Switzerland; per product labeling shown on DailyMeds. Akorn Consumer Health is out of business as of Feb 2023 and is now Prestige Consumer Healthcare Inc. The product is packaged by MedTech Products, Inc. Product details (usage) was explored further on DailyMeds and the OEM specific websites.

A search was conducted within the DSBS VetCert database to determine if there are service disabled, veteran-owned business (SDVOSB) or a veteran owned, small business (VOSB) who identify as manufacturers of utilizing NAICS code 325412 and yielded a total of 4 SDVOSB/VOSBs who identified as manufacturers; however, these SDVOSB/VOSBs are distributors for large businesses. There are no known SD/VOSB manufacturers for the required pharmaceutical. The requested NDC manufacturer was then specifically searched within the database. Prestige Consumer Healthcare Inc. and MedTech Products, Inc. were not found in the SBA database.

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 CFR121.406(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 pharmaceuticals, take ownership or possession of the pharmaceutical 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 pharmaceutical. The CO has confirmed there is no class waiver associated for 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.

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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.

Sarah Fry Kelly Mann Contract Specialist Contracting Officer

SARAH FRY

Digitally signed by

SARAH FRY

Date: 2025.05.28 12:27:04 -05'00'

KELLY MANN

Digitally signed by KELLY

MANN

Date: 2025.05.28 13:07:50 -05'00'