SAM #NOI-OD-26-000037

Sole Source Procurement for Compounded Parenteral Nutrition and Renal Replacement Therapy Products at NIH Clinical Center

The National Institutes of Health (NIH) Clinical Center is seeking a sole source provider for compounded parenteral nutrition and renal replacement therapy products to support patient care. - Government Buyer: - Agency: Department of Health and Human Services (HHS), National Institutes of Health (NIH) - Sub-agency: NIH Clinical Center, Pharmacy Department - Contracting Office: NIH OLAO - OEM and Vendor: - Central Admixture Pharmacy Services, Inc. (CAPS, Inc.) is the sole Original Equipment Manufacturer (OEM) and provider for these products in the U.S. - Products/Services Requested: - Compounded Total Parenteral Nutrition (TPN) and other compounded sterile products - Compounded renal replacement therapy products - Includes both non-patient-specific sterile compounded products and patient-specific formulations - Services provided under 503A and/or 503B compounding standards - No specific part numbers or quantities provided - Unique/Notable Requirements: - Sole source justification due to CAPS, Inc. being the only manufacturer and distributor able to meet NIH Clinical Center's requirements - Firm-fixed-price contract for a one-year period - Products must support direct patient care at the NIH Clinical Center - Place of Performance: - NIH Clinical Center, Bethesda, MD

Description

The purpose of this acquisition is to contract with a source for select non-patient-specific sterile compounded products and patient specific parenteral nutrition and renal replacement therapy that meet the quality expectations to provide to National Institutes of Health Clinical Center (NIH CC) patients on an ongoing basis. 

•             Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies

•             NAICS Code: 325412 – Pharmaceutical Preparation Manufacturing

•             Place of Performance: NIH Clinical Center, Bethesda, MD 20892 USA

POTS: 26-000037

Description:

This is a notice of intent, not a request for a quotation.  A solicitation document will not be issued, and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a one-year contract to Central Admixture Pharmacy Services, Inc. (CAPS, Inc.), located at PO. BOX 780404, Philadelphia, PA 19178, on a firm fixed price sole source award basis for the purchase of compounded TPN and other compounded products for patient care.

The proposed vendor, CAPS Inc., is the Original Manufacturer and has not designated other distributors for compounded products in the U.S.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Huda Malik, Contract Specialist via email to huda.malik@nih.gov by May 26, 2026 by 3 pm EST.

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