A-A-0053074 Phenylephrine Hydrochloride Nasal Solution, Usp

Pages 1 - 2 - 3 -

A-A-0053074(DM)

For Size 2- Package (PG). One package containing 1 fl oz (29.5 ml) in a screw-cap dropper bottle or in a screw-cap bottle with separate dropper, as specified, constitutes one unit.

For Size 3- Package (PG). One package containing 0.5 fl oz (15 ml) in a screw-cap dropper bottle or in a screw-cap bottle with separate dropper, as specified, constitutes one unit.

For Size 2 and Size 3, the screw-cap dropper bottle shall have a minimum height of 51 mm base to shoulder or the screw-cap bottle and separate dropper shall be packaged together in a commercially available container with 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.