Signed SPE2D223D0009 P00001.pdf
PDF 2 MB Posted
- Attached to
- Sumatriptan Succinate Tablets Federal contract opportunity
- Solicitation number
- SPE2D223R0003
About this file
This modification amends a solicitation for pharmaceutical products. The amendment revises the statement of work to include Drug Supply Chain Security Act requirements for bar code labeling on unit-of-use, outside container, and immediate container packaging. Bar codes must encode the National Drug Code and include the lot number and expiration date. Proper placement, size, and quality standards are specified. The contractor must follow all Drug Supply Chain Security Act traceability and licensing requirements.
The related opportunity is an award notice for sumatriptan succinate tablets under Solicitation Number SPE2D223R0003 issued by the Defense Logistics Agency Troop Support Medical.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| SF30_SPE2D223D0009P00007.pdf | ||
| SPE2D223D0009 P00005 SIGNED MOD.pdf | ||
| Signed_SF30_SPE2D223D0009P00002_Option 1_Sumatriptan.pdf | ||
| Signed Award SPE2D2-23-D-0009 Sumatriptan Succinate Tablets.pdf |
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Text version
8/24/2023
| 1 CONTRACT I CODE: | |
| 2 AMENDMENTMODIFICATION NO P00001: | |
| 3 EFFECTIVE DATE See Blk 16C: | |
| X: | |
| 9A AMENDMENT OF SOLICITATION NO: | |
| 98 DATED SEE ITEM 11: | |
| X_2: | |
| CODE 1HT23 FACILITY CODE: | |
| 10B DATED SEE ITEM 13 2023 JUL 25: | |
| 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: | |
| 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: | |
| Sonia De La Rosa Vice President Corporate Development Strategy 158: | |
| 2023-08-24T08:57:55-0400 | |
| WRAY.JASON.CHRISTOPHER.1238740742 |
| 16C DATE SIGNED: |
| CONTINUATION SHEET REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D223D0009 I P00001 PAGE 2 OF 2 PAGES 1 This modification hereby revises Solicitation page number 27 paragraph 17 Labeling within the Statement of Work to include Drug Supply Chain Security Act language as referenced below l 7 Labeling All pharmaceutical products provided under this contract shall include bar code labeling at the unitofuse pacage level The bar code labeling must be in a linear formac thac conforms co all GSl128 formerly EANUCC or Health Industry Business Communication Council HIBCC Health Industry Bar Code HIBC supplier labeling standards The bar code symbology must comply with all GSl or HIBCC parameters including buc noc limited co symbology cype or encoded pattern bar and space dimensions and tolerances and allowable ratio of wide co 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 NDC The bar code muse encode the NDC either alone or within the GSl data structure Global Trade Item Number GTIN The bar code printing muse 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 co shipping pharmaceutical products to any Government prime vendor or authorized ordering activicy under this contract The bar code must be on Ihe 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 che 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 furchermore the bar code muse remain intacc under normal conditions of use thus it should not be printed across the perforations of a blister pack When applicable co the sywbology used bar codes shall be surrounded by sufficient quiet zone so chat 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 cwo separate distinctive bar codes are used one for NDC and the other for lot nuwberexpiration date the lot number and expiration date bar code must not be in close proximity co 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 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 ocher terms and conditions remain unchanged: |
| CONTINUATION SHEET: |
| REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D223D0009 I P00001: |
| PAGE 2 OF 2 PAGES: |
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