Midazolam_MPID 1_2025-01-31_FINAL.pdf

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. Do NOT administer the 10mg/0.7mL Midazolam prefilled autoinjector to pediatric patients. Dose adjustment is not possible with the autoinjector. Midazolam injection is not indicated for types of seizures other than status epilepticus.

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 mL.

The delivered volume shall be the total drug delivered during the injection process.

Shall be suitable for intramuscular administration. Inject in the mid-outer thigh (vastus lateralis muscle) using the prefilled autoinjector. The Midazolam autoinjector can inject through clothing. Move all objects from in and around the patient’s clothing that may interfere with the injection. For people who do not have a lot of fat at the mid-outer thigh, bunch up the thigh at the injection site to provide a thicker area for administration. The formula shall meet the minimum formula for Midazolam Injection as determined by the

FDA.

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 adults.

Perishable Medical Material. The Controlled Room Temperature Protocols of Cold Chain Packaging may be applicable. These protocols are designed to keep temperature sensitive products requiring controlled temperature between 15 degrees C and 30 degrees C during transportation, for a minimum of 72 hours. These protocols can be located on the Pharmaceuticals Division’s page of DLA Troop Support Medical Supply Chain DMMonline’s website: https://www.medical.dla.mil/Portal/.

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.

Delivery. Not less than 30 months of the expiration dating period shall remain at time of delivery to the Government.

Labeling. The label on each unit of Midazolam Injection shall bear the FDA approved text.

The FDA approved full prescribing information is available separately (IFU).

Workmanship. The Midazolam Injection shall be in line with the product’s approved release specifications.

https://www.medical.dla.mil/Portal/

Unit. Box (BX). One box containing 40 single-dose presentations or fewer, 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 expected under current GMP requirements. 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 the FDA approved NDA.

Metric Products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units.

Other Quality Assurance Provisions. Shall be in accordance with the FDA approved NDA.

PREPARATION FOR DELIVERY.

Preservation. Preservation shall be commercial, as specified in the latest version of the Medical Marking Standard (MMS 1D).

Unit. Each single unit, as specified in this specification; shall be supplied in a suitable sealed plastic bag.

Packing. Packing shall be commercial, as specified in the approved NDA.

Commercial. Exterior (shipping) container shall be aligned with shipping requirements as set forth in the NDA.

Unitization. Material shall be unitized on 4-way entry pallets as specified in the latest version of MIL-STD-147.

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 in the FDA approved NDA. In addition, a separate label shall be created for the required markings as specified in the latest version of the Medical Marking Standard (MMS 1D). The Medical Marking Standard is a DLA regulation which is the standard for identification of material. It requires pertinent labeling and marking for receipt by the Distribution center and the Armed Forces. Markings include, but are not limited to, the following:

Unit Pack. Each unit shall be labeled in accordance with the FDA approved NDA. In addition to the requirements specified in the latest revision of Medical Marking Standard (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 (carton) shall be labeled in accordance with the FDA approved NDA. In addition, each intermediate package shall be marked as specified in Medical Marking Standard No. 1D.

Exterior (shipping) Container. Each exterior (shipping) container shall be labeled in accordance with the FDA approved NDA. In addition, 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 FDA approved NDA. 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.

NOTES.

The following documents are available from the following link:

- Medical Marking Standard No. 1D dated 23 Feb 2024 https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/

- MIL-STD-147E, Change 3 dated 5 September 2024 can be found on the ASSIST website, search by Document ID and enter “MIL-STD-147” https://quicksearch.dla.mil/qsSearch.aspx https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/ https://quicksearch.dla.mil/qsSearch.aspx