Attachment 2- Sole Source Justification Approval Medical USP_Redacted.pdf

Controlled by: DLA DCSO – Philadelphia (DCSO-P) CUI Category: PROCURE / SSEL Distribution/Dissemination Controls: FED ONLY

Controlled Unclassified Information (CUI) Source Selection Sensitive Information - See FAR 2.101 & 3.104

CUI

DEFENSE LOGISTICS AGENCY

CONTRACTING SERVICES OFFICE

700 ROBBINS AVENUE

PHILADELPHIA, PENNSYLVANIA 19111-5092

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Upon the basis of the following justification, I hereby approve the issuance of the contractual action described below using other than full and open competition, pursuant to the authority cited herein.

1. IDENTIFICATION OF THE REQUIRING AGENCY AND CONTRACTING

ACTIVITY.

REQUIRING AGENCY:

Defense Logistics Agency (DLA)

Medical Directorate 700 Robbins Avenue Philadelphia, PA 19111

CONTRACTING AGENCY:

DLA Contracting Services Office at Philadelphia (DCSO-P) 700 Robbins Avenue Philadelphia, PA 19111

USP Medicine Supply Map data and User Interface that is unique to a single manufacturer. There are no authorized resellers capable of providing ’s USP Medicine Supply Map Subscription is the only service that will support DLA’s requirements and meet the Government’s needs.

USP Medicine Supply Map Subscription is the only source able to illuminate and assess the sources of FDF, APIs and KSMs for pharmaceuticals essential to DoW’s mission and enable DLA Troop Support Medical to identify and mitigate supply chain sourcing risks for this subscription. Award to any other source would result in unacceptable duplication of effort and cost, including reprogramming labor and higher subscription expenses, y description is essential to meet the Government’s requirements.

Specialized aspects of these monthly reports include the following pharmaceutical support:

FDFs, APIs and KSMs: Illuminates the specific sources of these essential finished pharmaceuticals and raw materials.

Data Review: Monthly or Quarterly meetings between USP technical experts and

DOD/DLA staff to review each month’s data, including insights to inform decisions and mitigation actions.

Technical Support: Provides instructional and technical support to DOD/DLA related to delivery of data.

Other medical data subscriptions are available, but do not have the ability to provide sourcing data, proven expertise, and singular focus to the degree and flexibility of USP.

5. A DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USING THE AUTHORITY CITED.

The DLA Medical Directorate conducted Market Research in March 2026 to compare service offerings of the vendor United States Pharmacopeial Convention, Inc (USP) with alternative solutions existing in the industry. Market Research techniques included a review of Acquisition History for contracts used by the directorate to procure similar services and searching the FedBiz and GSA websites for other vendors with similar data service offerings.

Primary comparative factors used to analyze alternatives included technical service offerings, functional familiarity, and cost to the Medical Directorate.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS POSSIBLE,

INCLUDING WHETHER A NOTICE WAS OR WILL BE PUBLICIZED AS

REQUIRED BY PART 5 AND, IF NOT, WHICH EXCEPTION UNDER PART 5

APPLIES.

In accordance with FAR 5.201(b)(1), a synopsis will be posted to SAM.gov to provide all commercial entities with an opportunity to submit proposals for this requirement.

7. A DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE

As the Contracting Officer, I hereby determine that pricing will be fair and reasonable based on price analysis completed in accordance with FAR 15.404.1. It is anticipated that the Government will use various price analysis techniques, including but not limited to:

(1) Comparison of proposed prices received in response to the RFP. (FAR 15.404-1(b)(1))

(2) Comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items. (FAR 15.404- 1(b)(2)) (3) Use of parametric estimating methods/application of rough yardsticks (such as dollars per pound or per horsepower, or other units) to highlight significant inconsistencies that warrant additional pricing inquiry. (FAR 15.404-1(b)(3))(4) Comparison with competitive published price lists, published market prices of commodities, similar indexes, and discount or rebate arrangements. (FAR 15.404- 1(b)(4))(5) Comparison of proposed prices with independent Government cost estimates.(FAR 15.404-1(b)(5))(6) Comparison of proposed prices with prices obtained through market research for the same or similar items. (FAR 15.404-1(b)(6))(7) Analysis of data other than certified cost or pricing data provided by the offeror. (FAR 15.404- 1(b)(7))

8. THE MARKET RESEARCH CONDUCTED (SEE PART 10) AND THE RESULTS OR A

STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED.

The DLA Medical Directorate conducted Market Research in March 2026 to compare service offerings of the vendor (USP) with alternative solutions existing in the industry.

Market Research techniques included a review of Acquisition History for contracts used by the directorate to procure similar services and searching the FedBiz and GSA websites for other vendors with similar data service offerings. Primary comparative factors used to analyze alternatives included technical service offerings, functional familiarity, and cost to the Medical Directorate.

Results of the market research conducted were as follows:

Alternative subscription services considered were Exiger Inc. and Qyobo.

Exiger Inc. (https://www.exiger.com)

Exiger is a multiple supply chain technology provider to the U.S. Government. Exiger’s supply chain platform provides sourcing visibility across the U.S. pharmaceutical supply chain for FDFs and APIs. Exiger’s capabilities are limited to data from commercial sources and do not fully support sourcing of KSMs. The DLA Troop Support Medical Directorate has used Exiger for approximately three years as DLA expanded its pharmaceutical supply chain risk management efforts. DLA Troop Support subject matter experts note that Exiger multiple-supply chain focus lessens its capabilities to provide the singular pharmaceutical concentration required by DLA Troop Support.

Exiger’s capabilities are limited to sourcing data from commercial sources for FDFs and

KPIs and does not fully support sourcing of KSMs. Exiger provides a ridged capability with limited aptitude and skill to tailor products to customer requirements. Troop Support Medical Directorate has determined that it has maximized the capabilities of Exiger to meet DoW needs. In addition, Oyobo’s multiple-supply chain focus lessens its capabilities to provide the singular pharmaceutical concentration required by DLA Troop Support.

Qyobo (https://www.qyobo.com)

Qyobo is a data service company that specializes in collecting and analyzing vast amounts of fragmented data and transforms it into actionable information for multiple supply chains. Oyobo provides a proactive risk mitigation capability by identifying the sources of FDFs and APIs. Oyobo’s capabilities are limited to data from commercial sources and does not fully support sourcing of KSMs.

Although the Qyobo tool provides valuable components of pharmaceutical data, it does not offer the specific capabilities that provide sources of KSMs. While Oyobo purports more flexibility in tailoring its capabilities to meet DLA’s needs, the effort comes at additional costs and the results are unproven. In addition, Oyobo’s multiple-supply chain focus lessens its capabilities to provide the singular pharmaceutical concentration required by DLA Troop Support.

o Market Research Recommendation

Due to the complex and sophisticated nature of this pharmaceutical sourcing requirement, the government feels confident in asserting and justifying that USP is the only vendor that can provide the necessary data and singular pharmaceutical focus to enable the required degree of finished product and raw materials sourcing illumination. USP’s ability to drill down to the sources of KSMs sets it apart from other solutions. These detailed data are essential to DLA Troop Support Medical’s pharmaceutical supply chain risk mitigation efforts.

While the other sources reviewed can satisfy parts of the government requirement, there is only one responsible source and no other supplies or services that will satisfy all the program requirements.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION

N/A.

10. LISTING OF THE SOURCES, IF ANY, THAT EXPRESSED, AN INTEREST IN

THE ACQUISITION IN WRITING.

United States Pharmacopeial Convention, Inc. (USP)

11. A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO

REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS

REQUIRED:

At this time, USP Medicine Supply Map Subscription is the only service that will support DLA’s requirements and meet the Government’s needs. However, DLA has exercised, and continues to exercise, competition as often as possible and is required to conduct ongoing reviews to keep abreast of new technology, both in industry and the Government. As a continuing effort, DLA utilizes a variety of vendors, manufacturers, and contracts to fulfill its requirements and will continue the practice of surveying the market to ensure full and open competition to the maximum extent practicable.

12. CONTRACTING OFFICER CERTIFICATION THAT THE JUSTIFICATION IS

ACCURATE AND COMPLETE TO THE BEST OF THE CONTRACTING OFFICER’S

KNOWLEDGE AND BELIEF.

Technical/Requirements Certification:

Pursuant to FAR 6.104(b), I hereby certify that the information provided for which I am responsible and which form a basis for this justification are complete and accurate.

Contracting Certification:

Pursuant to FAR 6.104(a)(12) and FAR 6.104-2(a), I hereby certify that this