A-A-30017
August 3, 1981
COMMERCIAL ITEM DESCRIPTION
ALUMINUM HYDROXIDE GEL, DRIED, CAPSULES
The General Services Administration has authorized the use of this Commercial Item Description.
This drug is an antacid and demulcent that may be used in the treatment of gastric hyperacidity or nephrolithiasis.
SALIENT CHARACTERISTICS: This commercial item description applies to various capsule strengths, packaged in various quantities according to customary commercial practice, including unit of use and unit dose. Capsules shall contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of Dried Aluminum Hydroxide Gel, USP. Materials used in manufacture shall be of a pharmaceutical grade and finished capsules will have an elegant polish. Expiration dating shall be not less than 18 months remaining at time of delivery to the Government, and may range up to 60 months as deemed appropriate by the contracting officer.
CONTRACTOR CERTIFICATION: The contractor shall certify that the product offered meets the salient characteristics of the description and conforms to the producer’s own drawings, specifications, standards and quality assurance practices, and is the same as the product sold in the commercial marketplace. 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 REUQUIREMENTS. The offeror/contractor shall comply, and be responsible for compliance by their subcontractors/suppliers, with the requirements of the Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder, and the requirements of all other applicable Federal and statutes and regulations.
RECOVERED MATERIALS. The offeror/contractors are encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical.
PRESERVATION, PACKAGING, PACKING AND PACKING. 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 conforms to applicable carrier’s rules and regulations.
For information only- The following product, as of the date of this document is purported by the following company to meet the salient characteristics of the item described herein: Alu-Cap, NDC 0089-0106-10, Riker Laboratories, Inc.
DoD Coordination Activity:
DoD-MB
Agent DLA-DM
Custodians:
Army-MD
Navy-MS
AF-03
Civil Agency Coordinating Activity:
GSA-FSS
FDA-MPQAS (HFO-25)
Preparing Activity:
VA-OSS VAMKC
Agent VA-OSS (93C)
For Parts Inquires submit RFQ to Parts Hangar, Inc.
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