Signed P00003 SPE2D222D0146 Levalbuterol HCL.pdf

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Attached to
Levalbuterol HCL Solution Federal contract opportunity
Solicitation number
SPE2D221R0116
Issued by
Defense Logistics Agency Troop Support Medical

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File Type Posted
P00002 SPE2D2-22-D-0146 Option Year 1 Modification.pdf PDF
SF30_SPE2D222D0146P00001.PDF PDF
Signed Levalbuterol HCL Solution Award SPE2D222D0146.pdf PDF

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1 CONTRACT I CODE:

AMENDMENT OF SOLICITATIONMODIFICATION OF CONTRACT:
3 EFFECTIVE DA TE See Blk 16C:
X:
9B DATED SEE ITEM 11:
10B DATED SEE ITEM 13 2022AUG 31:
CODE 3V8D7 FACILITY CODE:
or c By separate letter or telegram which includes a reference to the solicitation and amendment numbers FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE:
12 ACCOUNTING AND APPROPRIATION DATA If required:
13 THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTSORDERS:
IN ITEM 10A:
Row1:
C THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF FAR 522124c:
XRow1:
D OTHER Specify type of modification and authority:
E IMPORTANT Contractor D is not 0 is required to sign this document and return:
15A NAME AND TITLE OF SIGNER Type or print 16A NAME AND TITLE OF CONTRACTING OFFICER Type or print:
JASON WRAY:
15C DATE SIGNED 16B UNITED STATES OF AMERICA:
2023-08-23T11:06:38-0400
WRAY.JASON.CHRISTOPHER.1238740742
CONTINUATION SHEET:
REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D222D0146 P00003:
PAGE 2 OF 2 PAGES:
1 This modification hereby revises Solicitation page number 24 paragraph 17 Labeling within the Statement of Work to include Drug Supply Chain Security Act language as referenced below 17 Labeling All pharmaceutical products provided under this contract shall include bar code labeling at the unitofuse package level The bar code labeling must be in a linear format that conforms to all GSl128 formerly EANUCC or Health Industry Business Communication Council HIBCC Health Industry Bar Code HIBC supplier labeling standards The bar code syrnbology must comply with all GSl 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 GSl128 formerly EANUCC GSl DataBar formerly RSS or Universal Product Code if the UPC contains the National Drug Code or NOC The bar code must encode the NDC either alone or within the GSl 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 overwrap the overwrap 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 required that bar code labeling also include the lot number and expiration date If two separate distinctive bar codes are used one for NOC and the other for lot numberexpiration date the lot number and expiration date bar code must not be in close proximity to the NOC barcode or in a format that may be confused with the NDC bar code When applicable all Healthcare Distribution Management Association HOMA guidelines shall be followed Drug Supply Chain Security Act DCSA The contractor shall follow all appropriate requirements as implemented in the Drug Supply Chain Security Act DCSA including all applicable traceability and licensing requirements 2 All other terms and conditions remain unchanged:

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