503A and 503B Outsourcing Facility to Supply TPN and other Sterile Compounded Products

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test Program for Certain Commercial Items.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-03, Effective 12 June 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, Pharmaceutical Preparation Manufacturing, with a small business size standard of 1250 employees.

This acquisition is open to capable businesses of any size. Responses are due by 11:00 a.m., July 24, 2019.

Questions may be submitted by email to the Contract Specialist (Lisa.Schaupp@nih.gov) through July 16, 2019 by 3;00 p.m. E.T.. Answers will be posted by 5:00 p.m. E.T. July 17, 2019.

The National Institute of Health, Office of Purchasing and Contracts, is seeking a 503A and 503B FDA approved Outsourcing Facility capable of independently fulfilling compounding requests for select non patient-specific sterile compounded products, patient specific total 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. Services must be provided in accordance with the specifications of the Performance Work Statement (PWS). Please see the Solicitation Document with Statement of Work attached herein for details of the requirement.

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