LEVONORGESTREL AND ETH
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract specifies the procurement of LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP, a hormonal contraceptive medication regulated by the FDA, manufactured by TEVA PHARMACEUTICALS USA, INC. with NDC 00555-9047-58. Each unit consists of six 28-day cycles totaling 168 tablets, formulated in a sequential pattern: six tablets containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol, followed by five tablets with 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol, then ten tablets with 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol, concluding with seven inert tablets. The unit of issue is one package containing 168 tablets, and the product must have a minimum of 21 months of remaining shelf life upon receipt by the government, with a total shelf life of 24 months non-extendable. Storage must be maintained at controlled room temperature, between 20° and 25°C (68° to 77°F), per USP guidelines. All packaging and labeling must strictly comply with Medical Marking Standard No. 1A dated February 4, 2013, superseding MIL-STD-129, and must be commercially packaged to ensure protection during transport. Packaging must be sealed in suitable containers to prevent damage and delivered in commercial shipping containers at the lowest feasible freight rate to the designated delivery point at Fort Stewart, Georgia. Delivery is required within 20 days of contract award, with no variance allowed in quantity, and inspection and acceptance occur at the destination. The shipment must be sent by the fastest traceable means, excluding parcel post, and must adhere to all DLA Master List of Technical and Quality Requirements, which take precedence over other standards such as ASTM D3951. The contract is part of a federal solicitation under SPE2DP-26-T-4311, with the purchasing agency being the Department of Defense through the Medical Supply Chain Pharm FSA.
General Info
Agency
NAICS
Place of Performance
BLDG 1509 WEST 6TH STREET, FORT STEWART, GA, 31314-5185, USSet-Aside
Documents
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Timeline
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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-4311
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 7017626076 0001 PG 1.000
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-QUP:001
IF MATERIAL IS CONSIDERED HAZARDOUS IAW FED-STD-313,
PACKAGE IN ACCORDANCE WITH TQ REQUIREMENT IP025.
IF THE MATERIAL IS NOT CONSIDERED HAZARDOUS, IN ACCORDANCE WITH
FED-STD-313, THE MATERIAL SHALL BE COMMERCIALLY PACKAGED IN ACCORDANCE
WITH ASTM D3951.
All DLA Master List of Technical and Quality Requirements take
SPE2DP-26-T-4311
SECTION B
PR: 7017626076 PRLI: 0001 CONT’D
precedence over ASTM D3951. Mark and label all packaging and packing in accordance with MIL-STD-129. The Unit of Issue (U/I) and Quantity per Unit Pack (QUP) will be as specified in the contract/purchase order. PALLETIZATION SHALL BE IN ACCORDANCE WITH RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
BULK BREAK POINT:
W33RBS
0087 CS BN CO A COMPOSITE
AWCF SSF
BLDG 1509 WEST 6TH STREET
FORT STEWART GA 31314-5185
US
SHIP BY FASTEST TRACEABLE MEANS. DO NOT USE PARCEL POST.
FREIGHT SHIPPING ADDRESS:
W33RBS
0087 CS BN CO A COMPOSITE
AWCF SSF
BLDG 1509 WEST 6TH STREET
FORT STEWART GA 31314-5185
US
MARKFOR
W33RBS
0087 CS BN CO A COMPOSITE
AWCF SSF
BLDG 1509 WEST 6TH STREET
FORT STEWART GA 31314-5185
US
M/F: (TCN) W33RBS62040186
RDD: 217
PROJ: 9GU TP 2
SUPP ADD: W9046W SIG: C
FOR GOVERNMENT USE ONLY: (IPD) 05
DIC: A0A DIST: V ADV: 2A FC: Z9
Need Ship Date:00/00/0000 Original Required Delivery Date:07/29/2026
SPE2DP-26-T-4311 NSN/Part Number: 6505-01-224-0176 Quantity: 1 PG Purchase Request: 7017626076QTY: 1 Delivery: 20 days ADO
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