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LEVONORGESTREL AND
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This contract pertains to the procurement of levonorgestrel and ethinyl estradiol tablets, USP, specifically supplied by Teva Pharmaceuticals USA, Inc. The product consists of six cycles per package, with each cycle containing 28 tablets in a prescribed sequence of varying doses of levonorgestrel and ethinyl estradiol, followed by inert tablets. Each package contains 168 tablets in total, with a shelf life of 24 months, requiring at least 21 months remaining upon receipt by the government. Storage conditions must be maintained between 20° to 25°C, and the product is regulated by the FDA, with specific labeling and packaging standards mandated, including adherence to Medical Marking Standard No. 1A. The contract specifies that packaging must protect the product from damage and be suitable for safe transportation to the delivery point within 20 days after order. The procurement follows Defense Logistics Agency (DLA) requirements, including specific quality and technical stipulations from the DLA Master List. All packaging and packing must comply with commercial standards and MIL-STD-2073-1E for preparation, ensuring acceptance by common carriers. Inspection and acceptance both occur at the destination. The contract calls for six packages to be delivered with no quantity variance allowed, and the procurement is managed through the Medical Supply Chain Pharmacy FSA under the Department of Defense, with direct contact available for contract clarifications.
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Full Description
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS,USP
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
.
RX ONLY
.
CONSISTS OF 6 CYCLES TOTAL WITH 28 TABLETS PER CYCLE COMPACT CONTAINING
IN SEQUENCE:
6 TABLETS LEVONORGESTREL 0.050 MG (50 MCG) AND ETHINYL ESTRADIOL 0.030
MG (30 MCG) FOLLOWED BY
5 TABLETS LEVONORGESTREL 0.075 MG (75 MCG) AND ETHINYL ESTRADIOL 0.040
MG (40 MCG) FOLLOWED BY
10 TABLETS LEVONORGESTREL 0.125 MG (125 MCG) AND ETHINYL ESTRADIOL 0.030
MG (30 MCG) FOLLOWED BY
7 TABLETS OF INERT INGREDIENTS
.
UNIT OF ISSUE IS A PACKAGE CONTAINING 168 EACH. (6 CYCLES OF 28 TABLETS
EACH).
.
TOTAL SHELF LIFE IS 24 MONTHS.
.
THERE SHALL BE A MINIMUM OF 21 MONTHS OF REMAINING SHELF LIFE
AT THE TIME OF RECEIPT BY THE FIRST GOVERNMENT ACTIVITY.
.
STORE AT 20° 25°C (68 ° 77°F). [SEE USP CONTROLLED ROOM
TEMPERATURE.]
.
LABELING AND MARKING MUST IN ACCORDANCE WITH
MEDICAL MARKING STANDARD NO. 1A DATED 4 FEBRUARY 2013
.
3/8/2016
.
.
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description. 1 PG = 168 EA 1 PG = 168 EA
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS SPECIFIED IN THE PROCUREMENT DOCUMENT.
SPE2DP-26-T-3333
SECTION B
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
RS016: Shelf-life requirement RS001 for a TYPE I (CODE M) item with a shelf life of 24 months (non-extendable) applies to this item.
TEVA PHARMACEUTICALS USA, INC. 3V8D7 P/N NDC00555-9047-58
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7016705555 0001 PG 6.000
NSN/MATERIAL:6505012240176
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6505-01-224-0176 Quantity: 6 PG Purchase Request: 7016705555QTY: 6 Delivery: 20 days ADO