NORGESTREL AND ETHINYL

NORGESTREL AND ETHINYL ESTRADIOL TABLETS
NORGESTREL 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, FOR ORAL ADMINISTRATION. 28-DAY REGIMEN. UNIT OF ISSUE IS A
PACKAGE CONTAINING 6 BLISTER CARD DISPENSERS. EACH BLISTER CARD
DISPENSER CONTAINING 21 ACTIVE AND 7 INACTIVE TABLETS EQUALING 28
TABLETS. THEREFORE, EACH PACKAGE CONTAINS A TOTAL OF 168 TABLETS..
EACH OF THE TWENTY-ONE ACTIVE TABLTETS CONTAINS 0.3 MG NORGESTREL WITH
0.03 MG ETHINYL ESTRADIOL, USP. TOTAL SHELF LIFE IS 24 MONTHS.. THERE
SHALL BE A MINIMUM OF 21 MONTHS OF REMAINING SHELF LIFE AT THE TIME OF
RECIPT BY THE FIRST GOVERNMENT ACTIVITY.. STORE AT 20º TO 25°C (68° TO
77º F) [SEE USP CONTROLLED ROOM TEMPERATURE]. LABELING AND MARKING MUST
IN ACCORDANCE WITH MEDICAL MARKING STANDARD NO. 1A DATED 4 FEBRUARY 2013
. 3/25/2015
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. ‘Regulation (xxx,xxxx), Class (I, II, or III). Even though a 510(K) (is/is not) required, it is necessary to meet other requirements for marketing. These include: Registration and Listing, Labeling, or GMP’s.’
MERCURY OR MERCURY CONTAINING COMPOUNDS SHALL NOT BE INTENTIONALLY ADDED TO<(>,<)> OR COME IN DIRECT CONTACT WITH<(>,<)> ANY HARDWARE OR SUPPLIES FURNISHED UNDER THIS CONTRACT. EXCEPTION: FUNCTIONAL MERCURY USED IN BATTERIES, FLUORESCENT LIGHTS, REQUIRED INSTRUMENTS; SENSORS OR CONTROLS; WEAPON SYSTEMS; AND CHEMICAL ANALYSIS REAGENTS SPECIFIED BY NAVSEA. PORTABLE FLUORESCENT LAMPS AND PORTABLE INSTRUMENTS CONTAINING MERCURY SHALL BE SHOCK PROOF AND CONTAIN A SECOND BOUNDARY OF CONTAINMENT OF THE MERCURY OR MERCURY COMPOUND. (IAW NAVSEA 5100-003D). . 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. 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.
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPE2DP-27-T-0348
SECTION B
SPECIFIED IN THE PROCUREMENT DOCUMENT.
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 •••••@•••••.•••Sign up to see this detail. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
TEVA PHARMACEUTICALS USA, INC. 3V8D7 P/N NDC00555-9049-58
MAYNE PHARMA COMMERCIAL LLC 4HH72 P/N NDC51862-0564-06
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 7019117431 0001 PG 1.000
NSN/MATERIAL:6505011479542
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-27-T-0348
SECTION B
PR: 7019117431 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:
W50YEF
W6YR USALRCTR FT HOOD
III CORPS TACTICAL AREA AWCF SSF
BLDG 4925 SANTA FE AVE
FORT HOOD TX 76544
US
SHIP BY TRACEABLE MEANS. DO NOT USE PARCEL POST.
FREIGHT SHIPPING ADDRESS:
W50YEF
W6YR USALRCTR FT HOOD
III CORPS TACTICAL AREA AWCF SSF
BLDG 4925 SANTA FE AVE
FORT HOOD TX 76544
US
MARKFOR
W50YEF
W6YR USALRCTR FT HOOD
III CORPS TACTICAL AREA AWCF SSF
BLDG 4925 SANTA FE AVE
FORT HOOD TX 76544
US
M/F: (TCN) W50YEF62890078
RDD: 303
PROJ: TP 3
SUPP ADD: W9046W SIG: C
FOR GOVERNMENT USE ONLY: (IPD) 12
DIC: A0A DIST: V ADV: 2A FC: Z9
Need Ship Date:00/00/0000 Original Required Delivery Date:11/16/2026
SPE2DP-27-T-0348 NSN/Part Number: 6505-01-147-9542 Quantity: 1 PG Purchase Request: 7019117431QTY: 1 Delivery: 20 days ADO