A-A-30023
October 28, 1981
COMMERCIAL ITEM DESCRIPTION
DYPHYLLINE TABLETS
The General Services Administration has authorized the use of this Commercial Item Description.
This drug is a bronchodilator that may be used in the treatment of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema.
SALIENT CHARACTERISTICS: This Commercial Item Description applies to tablets packaged in various quantities according to customary commercial practice, including unit of use and unit dose. Tablets shall contain not less than 94.0 percent and not more than 106.0 percent of the labeled amount of 7-(2, 3-Dihydroxypropyl) theophylline. Materials used in manufacture shall be of a pharmaceutical grade and finished tablets will be smooth and intact. 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 this 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 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 the 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 ordinances, statutes, and regulations.
Recovered Materials - The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical.
PRESERVATION, PACKAGING, PACKING, LABELING, AND MARKING: 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 shall conform to applicable carrier’s rules and regulations. Intermediate and exterior packaging quantities and labeling and marking shall be as specified in the contract and/or order.
For Information Only - The following products, as of the date of this document, are purported by the following companies to meet the salient characteristics of the item described herein: Neothylline Tablets, 200 reg., NDC 0093-0030-10, Lemon Company; Lufylline Tablets, 200 reg., NDC 0037-0521-97, Wallace Laboratories.
MILITARY INTERESTS:
Military Coordinating Activity
DoD-MB
Agent
DLA-DM
Custodians
Army – MD
Navy – MS
Air Force – 03
Review Activities
DMSSO – SD
PREPARING ACTIVITY:
VA – OSS VAMKC (904E)
AGENT:
VA – OSS VACO (93C)
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