A-A-0051959(DM)
For Size 2, shall be supplied as a dry mixture, equivalent to 5 grams of Ampicillin (250 mg per 5 ml when reconstituted to 100 ml), in a bottle (minimum height 51 mm base to shoulder) with child-resistant safety closure and sufficient capacity to hold 100 ml with adequate space. One bottle, as specified, constitutes one unit.
For Size 3, shall be supplied as a dry mixture, equivalent to 10 grams of Ampicillin (250 mg per 5 ml when reconstituted to 200 ml), in a bottle (minimum height 51 mm base to shoulder) with child-resistant safety closure and sufficient capacity to hold 200 ml with adequate space. One bottle, 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 materials in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 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 package quantities and labeling and marking shall be as specified in the contract and/or order.
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