Carbidopa/Levodopa

Added: Nov 01, 2017 1:47 pm Page 1 of 2

The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 15, CMOP Acquisitions, Leavenworth, KS has a requirement to procure CARBIDOPA 25mg/LEVODOPA 100mg SA TAB 1,000 CT Bottles pharmaceuticals for multiple Consolidated Mail Outpatient Pharmacy facilities nationwide. This is a Standard solicitation. Items must be delivered before NLT 5 Days after the Award is issued.



Product Service Code is 6505 (Drugs and Biologicals); the NAICS code for this solicitation is 325412 (Pharmaceutical Preparation Manufacturing).



All responsible open market sources may submit a quotation, which

if timely received by offer due date/time specified on Standard Form (SF) 1449 of solicitation, shall be considered by this agency. Please refer to attached Solicitation and Solicitation Attachment 1 (Quote Spreadsheet) for further detail.



No phone calls please. Please direct any technical questions in writing prior to offer due date/time to Frank Tarara, Contracting Specialist, at frank.tarara@va.gov



A general description of items are listed below,



Description

Qty

Preferred National Drug Code

CARBIDOPA 25/ LEVODOPA 10000MG SA TAB 1000 CT (C0620)





62756-461-88





0378-0088-01



No solicitation packages will be mailed, or faxed. Responses must be concise and be specifically directed to the requirement referenced above and as detailed on the solicitation. It is the vendor's responsibility to monitor https://www.fbo.gov for amendments to this solicitation, if applicable.



Vendors shall be registered and active at the System for Award Management (SAM) at https://www.sam.gov at time of offer.



This is a Total Service Disabled Veteran Owned Small Business (SDVOSB) Set-Aside.



The VA follows requirements specified by the U.S. Food & Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA). Vendors shall have proper Wholesale Drug Distributor state-issued license at time of offer.



Please refer to Section E of Solicitation for Quote Submittal Instructions and Evaluation Factors.













(m) Instructions for Quote Submittal



Technical questions shall be addressed via e-mail only to Doug Reed, Contracting Specialist, at frank.tarara@va.gov by Offer Due Date/Time specified in Block 8 of SF 1449.



Pricing, Copy of State-Issued Wholesale Drug Distributor License, and Signed Standard Form (SF 1449) of Solicitation shall be e-mailed to Frank Tarara, Contracting Specialist, at frank.tarara@va.gov by Offer Due Date/Time specified on Block 8 of SF 1449:



Vendors shall submit pricing on Solicitation Attachment 1 (Quote Spreadsheet)



Pricing submitted shall be on Microsoft Excel format of Quote Spreadsheet. Alternate formats, including PDF format, will not be accepted. Vendors proposing alternate National Drug Codes (NDC) for items and/or alternate delivery dates for items shall list these on the Quote Spreadsheet.



Vendors shall submit copy of State-Issued Wholesale Drug Distributor License



VA follows U.S. Food & Drug Administration (FDA) and Drug Supply Chain Security Act (DSCSA) regulations to ensure reputable, properly licensed wholesale drug distributors.



For DSCSA purposes, generally any entity that engages in the distribution of a drug to a person other than a consumer or patient or receipt of a drug by a person other than the consumer or patient is considered a wholesale distributor. See section 581(29) & 503(e)(4)) of the DSCSA. If the entity is actually buying and selling the drugs, they are conducting activities that constitute wholesale distribution and should be licensed as a wholesale distributor. If the entity is actually buying and selling the drugs, they are conducting activities that constitute wholesale distribution and shall be licensed as a wholesale distributor.



Third party logistics providers (3PL) are not eligible to submit a quote. A 3PL is defined in the DSCSA as an entity which provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product nor have responsibility to direct the sale. Because the Government is seeking firms to procure drugs for the VA, by definition, 3PLs do not take ownership nor have the responsibility to direct the sale of the drugs. Therefore, 3PLs are not eligible.



This is also applicable in regards to vendors citing drop shipment provisions of the DSCSA as the reason for licensure not required. Section 582(f) of the FD&C Act exempts wholesale distributors who, do not physically handle or store product, from certain provisions of section 582 involving product tracing and product identifiers. While the drop shipment description may apply to the awardee(s), it does not exempt them from the requirement that they be licensed as wholesale distributors.



3) Vendors shall sign and submit SF 1449 of solicitation. By signing, vendor acknowledges all solicitation amendments (if applicable) and certifies IAW FAR 52.209-5 (Representation by Corporations Regarding An Unpaid Tax Liability or Felony Conviction Under Any Federal Law) that Vendor:



Does not have any unpaid Federal tax liability that has been assessed and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.

Vendor, including its officers or agents acting on its behalf, have not been convicted of a felony criminal violation under a Federal or State law within the preceding 24 months

(End of Provision)