A-A-51113
26 November 1985
COMMERCIAL ITEM DESCRIPTION
PEMOLINE TABLETS
The General Services Administration has authorized the use of this commercial item description.
The Commercial Item Description covers Pemoline Tablets for use as a central nervous system agent.
Salient characteristics:
Shall be Pemolnie Tablets.
Shall contain 37.5 Pemoline per tablet within the applicable assay limits for the tablets.
Type I tablets shall be oral tablets which are suitable to be swallowed without being chewed (not suitable for chewing).
Type II tablets shall be oral tablets which are suitable for chewing.
Not less than 32 months of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 100 tablets of one type only, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product 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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