A-A-0053041A (DM)
vitamins in the formulation (except Vitamin E, Folic Acid, Vitamin D, and Biotin) shall be those specified in the USP in the monograph for “Decavitamin Tablets”. As an alternate, and appropriate, suitable, accurate and reproducible method(s) may be used. Vitamin E, Folic Acid, Vitamin D, and Biotin, shall be assayed by an appropriate, suitable, accurate and reproducible method.
All ingredients entering into the formulation of the tablets shall be of pharmaceutical grade.
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.
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.
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