A-A-51204
27 November 1985
COMMERCIAL ITEM DESCRIPTION
ESTRAMUSTINE PHOSPHATE SODIUM CAPSULES
The General Services Administration has authorized the use of this commercial item description.
The Commercial Item Description covers Estramustine Phosphate Sodium Capsules for use as an antioplastic agent.
Salient characteristics:
Shall be Estramustine Phosphate Sodium Capsules.
Shall contain a quantity of Estramustine Phosphate Sodium equivalent to 140 mg of Estramustine Phosphate per capsule within the applicable assay limits.
Not less than 20 months of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Capsules shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 100 capsules, 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 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 to the maximum extent practical.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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