A-A-54364
Unit.
For Size 1 - Bottle (BT). One bottle containing 100 capsules, as specified, constitutes one unit.
For Size 2 - Bottle (BT). One bottle containing 500 capsules, as specified, constitutes one unit.
For Size 3 - Package (PG). One package containing 100 capsules individually sealed in a commercially available blister or strip packaging of 10s for unit dose, as specified, constitutes one unit.
For Size 4 - Package (PG). One package containing 250 capsules individually sealed in a blister or strip packaging of 25s for controlled distribution, 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.
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