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ALBUTEROL SULFATE INHA

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SPE2DP-26-T-4353Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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Albuterol Sulfate Inhalation Aerosol with HFA is a prescription-only medication for oral inhalation, delivering 108 micrograms of albuterol sulfate per actuation, equivalent to 90 micrograms of albuterol base, supplied in an 8.5-gram canister containing 200 metered doses. The product must be stored at room temperature between 59°F and 77°F (15°C and 25°C), protected from extreme heat or cold, with specific warnings against puncturing, exposing to temperatures above 120°F, or spraying into the eyes. It has a non-extendable shelf life of 24 months and is classified as a TYPE I (CODE M) item under the Federal supply system. Labeling must include the National Stock Number, manufacturer date, expiration or retest date, contract number, and lot number, in compliance with the Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must meet commercial standards, with each unit sealed in a protective container and shipped in suitable exterior packaging to ensure safe delivery via common carrier. The product is regulated by the FDA and subject to Hazard Communication Standard requirements, mandating submission of Safety Data Sheets and compliant HCS labels aligned with 29 C.F.R. 1910.1200 prior to award, along with employee training on updated chemical labeling protocols. The contract specifies delivery of three units FOB destination within 20 days, with no variance allowed in quantity, and inspection and acceptance occurring at the delivery point. The NSN is 6505-01-543-6562, and the solicitation details identify Teva Pharmaceuticals USA, Inc. and Perrigo Direct Inc. as potential suppliers under procurement number SPE2DP-26-T-4353.

General Info

Albuterol sulfate inhaler, 108 mcg/actuation, 200 doses, 24-month shelf life, stored at 59–77°F, FDA-regulated, FOB destination delivery in 20 days.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN PHARM FSAView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

BLDG 5505A WICKHAM AVE, FORT CAMPBELL, KY, 42223-5000, US

Set-Aside

NONE

Documents

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN PHARM FSA
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Defense → MEDICAL SUPPLY CHAIN PHARM FSA
View Agency Profile
Office AddressUS
Contacts
JAMES MARIANI
contact@example.gov
+1 (555) 000-0000

Full Description

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ALBUTEROL SULFATE INHALATION AEROSOL W/H
ALBUTEROL SULFATE INHALATION AEROSOL W/HFA
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
. FOR PRESCRIPTION ONLY, FOR ORAL INHALATION. DOSAGE FORMS AND
STRENGTHS: INHALATION AEROSOL: EACH ACTUATION DELIVERS 108 MCG OF
ALBUTEROL SULFATE (ACTIVE INGREDIENT) FROM THE ACTUATOR MOUTHPIECE
(EQUIVALENT TO 90 MCG OF ALBUTEROL BASE).. SUPPLIED IN 8.5 GRAM
CANISTER CONTAINING 200 ACTUATIONS (METERED INHALATIONS). UNIT OF ISSUE
IS EACH
STORAGE: STORE AT ROOM TEMPERATURE BETWEEN 59° F AND 77° F (15° C AND
25° C). AVOID EXPOSURE TO EXTREME HEAT AND COLD. SHAKE THE CANISTER WELL
BEFORE USE. DO NOT PUNCTURE THE CANISTER. DO NOT STORE THE CANISTER NEAR
HEAT OR A FLAME. TEMPERATURES ABOVE 120° F MAY CAUSE THE CANISTER TO
BURST. DO NOT THROW THE CANISTER INTO A FIRE OR AN INCINERATOR. AVOID
SPRAYING IN YOUR EYES.
. LABELING AND MARKING: MUST INCLUDE: NATIONAL STOCK NUMBER MANUFACTURER
DATE OF MANUFACTURER, EXPIRATION DATE OR RETEST DATE CONTRACT NUMBER LOT
NUMBER.
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.
Hazard Communication Standard Notice:
Effective June 1, 2015, Federal Standard No. 313-E, Material Safety Data, Transportation Data and Disposal Data for Hazardous Materials Furnished to Government Activities, establishes the requirement for preparation and submission of Safety Data Sheets (SDS) in lieu of Material Safety Data Sheets (MSDS) by suppliers who provide hazardous materials to government activities.
The Occupational Safety and Health Administration (OSHA) has modified its Hazard Communication Standard (HCS) to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals. As a result of this change, GSA revised Federal Standard No. 313-E requiring Safety Data Sheets for classifying chemicals and communicating the applicable information on labels.
In accordance with the revised standard after June 1, 2015:
1. Suppliers will be required to submit, to the contracting officer for
SPE2DP-26-T-4353
SECTION B
review and approval prior to award, safety data sheets consistent with the requirements found at 29 C.F.R. 1910.1200 for hazardous materials delivered to the Government.
2. Suppliers will also be required to submit, to the contracting officer for review and approval prior to award, Hazardous Communication Standard (HCS) labels in accordance with 29 C.F.R. 1910.1200 requirements or current Consumer Product Safety Act (CPSA), Federal Hazardous Substance Act (FHSA) labels when subject to labeling requirements under those statutes. This product labeling is required for hazardous materials delivered to the Government.
3. Finally, suppliers must train their employees on the new safety data sheets, hazardous communication labels, and requirements of 29 C.F.R. 1910.1200.
For more information on SDS, refer to OSHAs website, available at:
https://www.osha.gov/law-regs.html
For information on 29 C.F.R. 1910.1200, refer to the below link:
https://www.osha.gov/dsg/hazcom/index.html
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS 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 fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
.
SHALL BE MARKED IAW THE LATEST EDITION OF
THE MEDICAL MARKING STANDARD NO. 1.
MMS NO. 1 IS AVAILABLE ONLINE AT:
https://www.dla.mil/Logistics-Operations/Packaging/
TEVA PHARMACEUTICALS USA, INC. 3V8D7 P/N NDC00093-3174-31 PERRIGO DIRECT INC 9DDF3 P/N NDC45802-0088-01
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.
SPE2DP-26-T-4353
SECTION B
PR: 7017656180 PRLI: 0001 CONT’D
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 7017656180 0001 EA 3.000
NSN/MATERIAL:6505015436562
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: 6505-01-543-6562 Quantity: 3 EA Purchase Request: 7017656180QTY: 3 Delivery: 20 days ADO

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