The Food and Drug Administration concurs with the Academy's finding. FDA proceeded to review all available data relating to the effectiveness of products subject to NADA 46-668 to determine which label claims were supported by the requisite proof of effectiveness. Appropriate oral doses for all the allowable species and claims based on milligrams per pound of body weight are on the current labels. Claims pertaining to bloat in cattle have been deleted from the labels. Claims for growth promotion or stimulation have been removed.
Allowable claims are for increased rate of weight gain and improved feed effieciency.
The NADA 46-668 was originally approved as safe on January 26, 1971. No further safety data are required. FDA's approval of the supplemental application does not involve reevaluation or reaffirmation of the human food safety data in the parent application. The tolerances for residues of penicillin are codified at 21 CFR 556.510. This supplemental NADA satisfies the requirements of section 512 of the Act and demonstrates that Procaine G Penicillin Type A Medicated Article when used under its proposed conditions of use, is safe and effective for the labeled indications.