Midazolam_MPID 1_2025-01-31.docx

MEDICAL PROCUREMENT ITEM DESCRIPTION #1 January 31, 2025

NSN 6505-31-019-0519

ITEM IDENTIFICATION: MIDAZOLAM INJECTION CIV, 10MG/0.7ML AUTOINJECTOR

SCOPE. This Medical Procurement Item Description (MPID) covers the Midazolam Injection, which contains Midazolam Injection in a single-dose pre-filled automatic injector (auto-injector) suitable for intramuscular administration. Included in this MPID are salient characteristics of the product, quality assurance provisions, and descriptions of conditions, tests and specifications for initial qualification, release, stability and re-qualification processes. For all MIL-STD testing described in this MPID, MIL-STD-810H will apply.

REGULATORY REQUIREMENTS.

Federal Food, Drug, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/ contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.

Recovered Materials. The offeror/contractor is encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.403 to the maximum extent practical.

SALIENT CHARACTERISTICS.

Indication and Usage. Shall be Midazolam Injection, 10MG/0.7ML benzodiazepine indicated for the treatment of status epilepticus in adults.

MIDAZOLAM Injection, 10MG/0.7ML shall meet the individual requirements for the drug solution as set forth in the NDA. The volume range of the solution shall be 10MG/0.7 per mL. The delivered volume shall be the total drug delivered during the injection process.

Shall be a suitable for intramuscular administration. The formula shall meet the minimum formula for Midazolam Injection as determined by the FDA and Related Biological Products Advisory Committee.

Dose Presentations, Size and Age Indication. Shall be presented in a single-dose, pre-filled autoinjector. Presentation as indicated in the each line item in the Schedule of Supplies. Each, presentation shall include a single 10 mg dose, administered by intramuscular injection using the prefilled autoinjector.

Shall be FDA approved for patients 18 months of age and older.

Perishable Medical Material. Perishable medical material includes both cold chain management and routine temperature-sensitive items. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208, or, as an alternate, in accordance with acceptable commercial practice. When specified in the contract/purchase order and/or SOW, perishable items requiring constant refrigeration shall be properly packaged and marked in accordance with cold chain management protocols. In addition to all applicable regulatory requirements and markings specified in the contract/purchase order and/or SOW, perishable medical material shall be marked as specified in Medical Marking Standard No. 1D.

Packaging and Storage.

Store at 20 ºC to 25 ºC (68 ºF to 77 ºF); excursions permitted between 15 ºC and 30 ºC (59 ºF and 86 ºF) [See USP Controlled Room Temperature]. DO NOT FREEZE.

Expiration Date. Shall be 36 months.

Labeling. The label on each unit of Midazolam Injection shall bear the full prescribing information.

Workmanship. The Midazolam Injection shall be free from defect that detract from its appearance or impair its serviceability.

Unit. Box (BX). One box containing 40 single-dose presentations, as specified, constitutes one (1) unit. Copies of IFU Card and USPI (PI +IFU) are packaged separately.

REGULATORY REQUIREMENTS.

Federal Food, Drug, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/ contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.

Recovered Materials. The offeror/contractor is encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.403 to the maximum extent practical.

QUALITY ASSURANCE PROVISIONS.

Contractor Certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Medical Procurement Item Description, and that the product conforms to the producers' own drawings, specifications, standards, and quality assurance practices, and is the same product offered for sale in the commercial marketplace. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.

Responsibility for Inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.

Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.

Examination and Testing. Examination and testing shall be conducted on the product in accordance with U.S. Army Medical Research and Development Command (USAMRDC) Test Branch. The sampling for examination and testing shall be in accordance with military practice.

Metric Products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units. Dimensions and tolerances specified shall be converted using conversion tables contained in the latest revision of ASTM E 380.

Other Quality Assurance Provisions. Shall be as indicated in the contract/purchase order and/or SOW.

PREPARATION FOR DELIVERY.

Preservation. Preservation shall be commercial, as specified in the contract or purchase order.

Unit. Each unit, as specified in this specification; shall be supplied in a suitable sealed commercial container.

Packing. Packing shall be commercial, as specified in the contract or purchase order.

Commercial. Exterior (shipping) container shall contain one unit.

Unitization. Material shall be unitized on 4-way entry pallets as specified in the contract or purchase order.

Packing list. Packing list shall be supplied as specified in Medical Marking Standard No. 1D.

Labeling and Marking. Marking requirements, Medical material shall be marked in English as specified herein and in the applicable contract or purchase order. Required markings may include identification data, bar codes, destination address, shelf life, lot (control) number, storage legends, markings for items requiring special handling (i.e., perishable items, controlled items, hazardous items, etc.) and shall be supplied as applicable. Markings include, but are not limited to, the following:

Unit Pack. Each unit pack shall be marked in accordance with commercial practice. In addition to the requirements specified in the latest revision of Medical Marking Standard No. 1D (MMS 1D), mark each unit pack with lot number, contractor cage code, manufacturer's cage code and part number. Markings may be supplied by any suitable means, i.e., printed directly on the bag, printed on a pressure-sensitive label permanently affixed to the bag, or printed on a sheet of paper inserted into the bag prior to closing.

Intermediate Package. Each intermediate package shall be marked as specified in Medical Marking Standard No. 1D.

Exterior (shipping) Container. Each exterior (shipping) container shall be marked as specified in Medical Marking Standard No. 1D.

Unitized Load. Each unitized load shall be marked as specified in Medical Marking Standard No. 1D.

Other Required Markings. Other required markings shall be as specified in Medical Marking Standard No. 1D. They shall be supplied as applicable. Markings include, but are not limited to, the following:

Shelf-Life Markings. Shelf-life markings shall be supplied as specified in the contract or purchase order. Shelf-life markings may include the expiration date, date of manufacture, inspection/test date, etc., as applicable.

Material requiring special handling marking and/or storage legends. In addition to applicable commercial markings, and all markings as specified in the contract/purchase order and/or SOW, special handling and/or storage legends shall be supplied on the unit, intermediate package, exterior (shipping) container and unitized load, as applicable, and may consist of printed legends and/or pictorial markings. Placement shall not interfere with or obscure any other markings.

Perishable medical material. Perishable medical material includes both cold chain management and routine temperature-sensitive items. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208, or, as an alternate, in accordance with acceptable commercial practice. When specified in the contract/purchase order and/or SOW, perishable items requiring constant refrigeration shall be properly packaged and marked in accordance with cold chain management protocols. In addition to all applicable regulatory requirements and markings specified in the contract/purchase order and/or SOW, perishable medical material shall be marked as follows:

NOTES.

The following documents are available from the following link:

· Medical Marking Standard No. 1D.

· https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/