A-A-54502
For Size 2, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 250 tablets, as specified, constitutes one unit.
For Size 3, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 500 tablets, as specified, constitutes one unit.
For Size 4, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 1000 tablets, as specified, constitutes one unit.
For Size 5, Box (BX). Twenty-five (25) tablets unit dose, shall be supplied in a reverse-numbered continuous roll blister, or strip package or other individually sealed (unit dose) package. One box with tamper evident seal containing 25 tablets, 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.
A-A-54502
For Size 2, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 250 tablets, as specified, constitutes one unit.
For Size 3, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 500 tablets, as specified, constitutes one unit.
For Size 4, Bottle (BT). One bottle with tamper evident seal, either inner or outer seal, containing 1000 tablets, as specified, constitutes one unit.
For Size 5, Box (BX). Twenty-five (25) tablets unit dose, shall be supplied in a reverse-numbered continuous roll blister, or strip package or other individually sealed (unit dose) package. One box with tamper evident seal containing 25 tablets, 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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