Signed SPE2D223D0010 P00001.pdf

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Attached to
Tolterodine Tartrate ER 24HR Capsules
Solicitation number
SPE2D223R0001
Issued by

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This is a contract modification notice for SPE2D223D0010 that revises the statement of work to include Drug Supply Chain Security Act labeling requirements. The modification requires bar code labeling at the unit level that complies with GS1 or HIBC standards, including the NDC and lot number/expiration date. Barcodes must remain intact under normal conditions of use and be placed on both immediate containers and outer packaging. All Healthcare Distribution Management Association guidelines must also be followed.

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT ,

1. CONTRACT I� CODE

I

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO.

I

5. PROJECT NO. (If applicable)

P00001 See Blk. 16C See Block 14

6. ISSUED BY CODE SPE2D2 7. ADMINISTERED BY (If other than Item 6) CODE I SPE2D2

DLA TROOP SUPPORT DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB MEDICAL SUPPLY CHAIN FSGB 700 ROBBINS AVENUE

PHILADELPHIA PA 19111 700 ROBBINS AVENUE

USA PHILADELPHIA PA 19111

Initiator: Phyllis Daraio USA PHPHAC7 Tel: 215-737-7941 FAX: 215-737-5226 Email: PHYLLIS.DARAIO@DLA.MIL

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

GOLDEN STATE MEDICAL SUPPLY INC

5187 CAMINO RUIZ

CAMARILLO CA 93012-8601 10A. MODIFICATION OF CONTRACT/ORDER NO.

USA

SPE202-23-D-0010

10B. DATED (SEE ITEM 13)

2023 AUG 10

CODE 1HT23 FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

D The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers D is extended, D is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning _____ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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 PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES ( such as changes in paying office, appropriation date, etc. ) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103 (b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

X FAR 52.212-4(c)

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor D is not, 0 is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

See Continuation Sheet

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 1 OA, as heretofore changed, remains unchanged and in full force and effect.

15A NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACT/NG OFFICER (Type or print)

Sonia De La Rosa, Vice President Corporate Development & Strategy to sign)

Previous edition unusable

JASON WRAY

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of Contracting Officer)

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

8/24/2023

1 CONTRACT I CODE:
2 AMENDMENTMODIFICATION NO P00001:
3 EFFECTIVE DATE See Blk 16C:
X:
9A AMENDMENT OF SOLICITATION NO:
9B DATED SEE ITEM 11:
X_2:
10B DATED SEE ITEM 13 2023 AUG 10:
CODE 1HT23 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:
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:
JASON WRAY:
undefined:
to sign:
2023-08-24T08:59:00-0400
WRAY.JASON.CHRISTOPHER.1238740742
16C DATE SIGNED:
CONTINUATION SHEET REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D223D0010 P00001 PAGE 2 OF 2 PAGES l This modificacion hereby revises Solicication page number 28 paragraph 17 Labeling wchin the Statement of Work co include Drug Supply Chain Securicy Act language as referenced below 1 7 Labeling All pharmaceutical produces 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 Comunication Council HIBCC Health Industry Bar Code HIBC supplier labeling standards The bar code symbology must comply with all GSl or EIBCC parameters including buc not limiced co symbology type or encoded pattern bar a1d space dmensions a1d tolerances and allowable ratio of wiCe to narrow elements The bar code may be any linear bar code symbology such as GSl128 formerly EANUCC GSl DataBar formery RSS or Universal Produce Code if the UPC contains che Nacional Drug Code or NDC The bar code muse encode the NDC either alone or withn the GSl daca structure Global Trade Item umber GTIN The bar code princing muse be AJ11erican National Standards Instituce ANS International Organization for Standardization ISO IEC quality grade C or better Ma1ufacturers and packagers must ensure that production runs include an initial verification check as well as routine audits to ensure the bar code is prnted clearly and consistently to meet the qualicy standard of grade C or better Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specfied in this clause prior to shipping pharmaceutcal products to any Government prime vendor or auchorized ordering activity under this contract The bar code must be on the outside container or wrapper of the medication as well as on che immediate container unless che bar code is readily visible and machine readable chrough the outside container or wrapper When the bar code is not easily machine readable chrough the overwrap che overwrap should contain the bar code The bar code muse go on each cell of 2 blister pack Furthermore the bar code must remain intact under normal conditions of use thus it should not be princed across the perforations of a blister pack When applicable co 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 noc be placed solely on outer packagng It is requred that bar code labei1g also include the lot nunber and expiration dace If cwo separace Ciscinctve bar codes are used one for NOC and ce other for loc numberexpiracion date the lot number and expiration date bar code muse not be in close proxmity co che NDC barcode or in a format thac may be confused with the NOC bar code When applicable all Healthcare Distribution Management Association HOMA guidelines shall be followed Drug Supply Chain Security Act DCSA The contraccor shall follow all appropriate requirements as implemented in che Drug Supply Chain Securit Act DCSA including all applicable traceability and licensing requirements 2 All other terms and conditions remain unchanged:
CONTINUATION SHEET:
REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D223D0010 P00001:
PAGE 2 OF 2 PAGES:

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