A-A-51047
4 October 1985
COMMERCIAL ITEM DESCRIPTION
GUANABENZ ACETATE TABLETS
The General Services Administration has authorized the use of this commercial item description.
This Commercial Item Description covers Guanabenz Acetate Tablets for use as a hypotensive agent.
Salient characteristics:
Shall be Guanabenz Acetate Tablets.
Shall contain Guanabenz Acetate equivalent to 4 mg of Guanabenz per tablet within the applicable assay limits for the tablets.
Not less than 32 of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Tablets shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. 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 statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.
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