A-A-0053405(DM)
28 March 1988
INTERIM COMMERCIAL ITEM DESCRIPTION
FLECAINIDE ACETATE TABLETS
The General Services Administration has authorized the use of this Interim Commercial Item Description which was developed by the Defense Personnel Support Center, Directorate of Medical Materiel, DPSC-RST, 2800 South 20th Street, Philadelphia, PA 19101, based upon currently available technical information.
Salient characteristics:
Shall be scored Flecainide Acetate Tablets.
All ingredients shall be of pharmaceutical grade.
Shall contain 100 mg of Flecainide Acetate per tablet, within the applicable assay limits for tablets.
Each tablet shall be marked/embossed with a product identification code to identify the active ingredient(s), strength, and manufacturer. The materials used in marking/embossing the dosage forms shall be acceptable to the FDA. The actual code used for the product shall be left to the discretion of the supplier.
Workmanship. The tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit. Bottle shall have a minimum height of 51 mm base to shoulder and shall be supplied with a child-resistant safety closure.
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.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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