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LEVONORGESTREL AND
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The contract specifies the procurement of LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP, a combined hormonal contraceptive packaged in cycles of 28 tablets totaling six cycles per unit, for a total of 168 tablets per package. Each cycle consists of a sequential pattern: six tablets with 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, followed by five tablets with 75 mcg levonorgestrel and 40 mcg ethinyl estradiol, then ten tablets with 125 mcg levonorgestrel and 30 mcg ethinyl estradiol, and finally seven inert tablets. The unit of issue is one package containing 168 tablets, and the total shelf life is 24 months with a minimum of 21 months remaining at the time of receipt by the first government activity. Products must be stored at controlled room temperature between 20°C and 25°C and labeled in strict compliance with Medical Marking Standard No. 1A dated February 4, 2013, which supersedes MIL-STD-129. Packaging must be sealed to prevent damage and shipped in commercial exterior containers ensuring safe delivery at the lowest freight rate to Fort Stewart, Georgia, with delivery required within 20 days under FOB destination terms. The item is regulated by the FDA, manufactured by TEVA PHARMACEUTICALS USA, INC. under NDC 00555-9047-58, and is identified by NSN 6505-01-224-0176. The contract mandates zero variance in quantity, destination inspection and acceptance, and requires a referral to the product specialist via EBS for confirmation prior to award.
General Info
Agency
NAICS
Place of Performance
BLDG 1509 WEST 6TH STREET, FORT STEWART, GA, 31314-5185, USASet-Aside
Documents
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Organization & Contact Information
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-3015
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 7016453665 0001 PG 4.000
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: 4 PG Purchase Request: 7016453665QTY: 4 Delivery: 20 days ADO
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