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Pharmaceutical: Clomiphene Citrate (36C77024Q0063)

Waiver type - Procurement: Nonavailability

Agency: VETERANS AFFAIRS, DEPARTMENT OF (3600) • Product Service Code (PSC) : 6505 | Last Modified: 12/13/2024

Procurement Summary

VHA Regional Procurement Office Central intends to procure the pharmaceutical Clomiphene Citrate. The pharmaceutical is to be used by the Leavenworth Consolidated Mail Outpatient Pharmacy (CMOP) to fulfill prescriptions. Based on market research, no domestic sources are available and the pharmaceutical is manufactured in India. Clomiphene Citrate is used for the treatment of ovulatory disfunction, and the pharmaceutical is supplied by the VA CMOP via direct mail order pharmacy services to a Veteran or beneficiary’s place of residence. The Leavenworth CMOP has critically low stock and requires these pharmaceuticals to fulfill veteran prescriptions in support of their medical needs.

Waiver Rationale Summary

Although the Buy American Act is applicable to small business set-asides (FAR 25.101(b)), we will be exercising an exception to the Buy American Act (FAR 25.103(b) Nonavailability) by utilizing a foreign manufacturer, as no domestic end products were discovered during market research. If it is discovered during the solicitation phase that acceptable domestic end products are available to fulfill VA’s requirement, they will be evaluated IAW FAR 25.106

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

No

OMB Determination

Consistent with Policy

Product

DRUGS AND BIOLOGICALS

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Date Submitted

12/10/2024

Procurement Instrument Identifier (PIID)

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

VETERANS AFFAIRS, DEPARTMENT OF