A-A-30028
October 28, 1981
COMMERCIAL ITEM DESCRIPTION
METHENAMINE HIPPURATE TABLETS
The General Services Administration has authorized the use of this Commercial Item Description.
This drug is a urinary antiseptic that may used in the long-term treatment of recurring urinary tract infections.
SALIENT CHARACTERISTICS: This Commercial Item Description applies to 1 gram tablets, packaged in various quantities according to customary commercial practice, including unit of use and unit dose. The tablets shall contain the required amount of Methenamine Hippurate within the applicable assay limits. Materials used in manufacture shall be of a pharmaceutical grade and finished tablets will be uncoated and scored. Expiration dating shall be not less than 18 months remaining at time of delivery to the Government, and may range up to 60 months, as deemed appropriate by the contracting officer.
CONTRACTOR CERTIFICATION: The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producer’s own drawings, specifications, standards, and quality assurance practices, and is the same as the product sold 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.
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 ordinances, statutes, and regulations.
Recovered Materials - The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical.
PRESERVATION, PACKAGING, PACKING, LABELING, AND MARKING: Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carrier’s rules and regulations. Intermediate and exterior packaging quantities and labeling and marking shall be as specified in the contract and/or order.
For Information Only – The following products, at of the date of this document, are purported by the following companies to meet the salient characteristics of the item described herein: Urex Tablets, 1 gram, NDC 0089-0371-50, Riker Laboratories, Inc.: Hiprex Tablets 1 gram NDC 0068-0277-65, Merrell-National Laboratories.
MILITARY INTERESTS:
Military Coordinating Activity
DoD-MB
Agent
DLA-DM
Custodians
Army – MD
Navy – MS
Air Force – 03
Review Activities
DMSSO – SD
PREPARING ACTIVITY:
VA – OSS VAMKC (904E)
AGENT:
VA – OSS VACO (93C)
For Parts Inquires submit RFQ to Parts Hangar, Inc.
© Copyright 2015 Integrated Publishing, Inc.
A Service Disabled Veteran Owned Small Business