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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 11, 2014 FBO #4612
DOCUMENT

65 -- OPEN MARKET PHARMACEUTICALS HINES - Attachment

Notice Date

7/9/2014
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25514Q1354
 

Response Due

7/16/2014
 

Archive Date

9/14/2014
 

Point of Contact

MELISSA BRAU
 

E-Mail Address

8-4762<br
 

Small Business Set-Aside

N/A
 

Description

Statement of Requirements For the purchase of (15) Pharmaceutical(s) for Hines IL FUNDING VA FORM 2237 765-14-3-021-0685 CONTRACT DELIVERY TERMS Deliver entire purchased amount within 15 days after award The Government reserves the right to cancel any quantities NOT delivered on or before __15___ days after award of the contract. CONTRACT DURATION One time buy. ADDITIONAL TERMS: Any alternate NDCs the offerors wish to propose shall be listed on the attached spreadsheet (where applicable). Other than alternate NDCs, offerors shall list below any proposed alternate terms or conditions to this solicitation (e.g. delivery terms, bottle counts, etc ¦) in order for Offeror to successfully fulfill the terms of the resultant contract. The proposed alternate terms or conditions shall be reviewed by the Contracting Officer and, if accepted, shall be included in the contract terms upon signatures from both parties. Once the proposed terms or conditions are approved by both parties, they shall become a binding part of the contract and Offeror shall be responsible for all requirements set forth in the resultant contract. Alternate terms and conditions proposed elsewhere will not be considered and will not be included in any resultant contract and may result in the offer being removed from further consideration. AS508 BAR CODING (MAY 2012) All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements. The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 Data Bar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)). The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this clause prior to shipping pharmaceutical products to any Government Prime Vendor or authorized ordering activity under this contract. The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap should contain the bar code. The bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack. When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in "ladder orientation" on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date, the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed. AS1335 THERAPEUTIC EQUIVALENCE (FEB 2007) Only products that have received under the Federal Food, Drug and Cosmetic Act a therapeutic equivalence code of "A" by the Food and Drug Administration will be considered, unless all drugs in the family group are "B" rated. In that case, no award will be made other than to the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence. AS1344 RECALLS (NOV 2013) If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug Administration (FDA); or, if FDA withdraws their approval to manufacture any drug that is included on this contract, the following action shall immediately be taken by the contractor: Forward two copies of the recall notification along with any pertinent information to: 1)Director, CMOP Acquisitions Veterans Health Administration Network Contracting Office (NCO15) 3450 South 4th Street Leavenworth, KS 66048-5012 Fax Number (913) 758-4732 2)Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax Number (708) 786-7894 3) Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865 4) CMOP address shown in Block 15 of the SF 1449. AS1527 NATIONAL DRUG CODES (MAY 2009) Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) number unique to the offeror (e.g., 00012-3456-78) for each product proposed, in the space provided following each item in Part I, "Schedule of Supplies and Prices" of the solicitation. The first five numbers of the eleven-digit NDC number for each product proposed shall identify the offeror. Offers that fail to provide the information required by this clause by the solicitation closing date shall be rejected and shall receive no further consideration. OTHER REQUIREMENTS Offerors must state the exact name of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number for all items offered; the NDC number must be specific to the offering company and to the drug being supplied. Any package size ordered below 500 count will be considered to be for Unit of Use issue and will require a Safety/Child Proof cap. Glass bottles are not acceptable. The expiration dates of the pharmaceutical(s) are to be no less than __14___ months from date of delivery. Any substitution of packaging sizes must be approved in writing by the Contracting Officer. Any change that deviates from the specific item requested must be approved by the Contracting Officer in writing. For example, the replacement of capsules for tablets or suspended action for extended release items will require approval beforehand. Offered items must be end products that are U.S.-made or from designated countries in accordance with FAR 52.225-5, Trade Agreements. End products from any other country will not be considered unless no other acceptable offers are received. If the pre-approved alternate NDC is provided by the Vendor, and if the unit size is different from the original unit requested, then the Vendor must also adjust the final quantity accordingly, e.g.: 1 bottle @1000 to 10 bottles @ 100, noting the change. For reconciliation purposes, all shipments shall reference the original VA obligation/order number even if purchased product is from another partnered company. All shipments shall come with a packing slip identifying NDC, PRODUCTS, and LINE ITEM NUMBERS from the purchase order. Documentation shall include Vendor's point of contact for reporting noted discrepancies, damages, or incorrect product. Invoice price must match purchase order price. Failure to supply this information may cause a delay with payment. All like product shall be packaged and shipped together. Breakable items shall be packaged appropriately with blister pack or bubble wrap. Vendor shall provide a return authorization and pickup for any damaged products or incorrect products received within one week of request. If an offeror cannot deliver all product as ordered, the Government reserves the right to terminate for cause and award to the next-lowest bidder.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25514Q1354/listing.html)
 

Document(s)

Attachment
 

File Name: VA255-14-Q-1354 VA255-14-Q-1354_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1482607&FileName=VA255-14-Q-1354-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1482607&FileName=VA255-14-Q-1354-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03420051-W 20140711/140710023641-3d8508c91d9cf72e752f70636490d3f5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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