A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the application of the Act with respect to alternate uses of new animal drugs and new drugs intended for human use, and for other purposes.
Animal Medicinal Drug Use Clarification Act of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to allow, on order of a veterinarian: (1) a new animal drug approved for one use to be used for a different purpose other than a use in or on animal feed; and (2) a new drug approved for human use to be used in animals.
Specifies that regulations promulgated by the Secretary of Health and Human Services may prohibit particular uses of an animal drug and shall not permit such different use if the labeling of another animal drug that contains the same active ingredient and that is in the same dosage form and concentration provides for such different use.
Permits the Secretary, upon finding that there is a reasonable probability that a use of an animal drug authorized may present a risk to the public health, to establish a safe level for residue of an animal drug for such different authorized use and require the development of a practical, analytical method for the detection of residues of such drug above the safe level established. Directs that the use of an animal drug that results in residues exceeding a safe level so established be considered an unsafe use of such drug. Allows safe levels to be established either by regulation or order.
Authorizes the Secretary by general regulation to provide access to the records of veterinarians to ascertain any use or intended use authorized that the Secretary has determined may present a risk to the public health. Specifies that if the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug so authorized presents such a risk or that an analytical method required has not been developed and submitted, the Secretary may by order prohibit any such use.
Exempts State and local governments from Federal requirements that preempt their authority with respect to nutrition labeling for maple syrup.
See S.340.
Read twice and referred to the Committee on Labor and Human Resources.
Senate Committee on Labor and Human Resources discharged by Unanimous Consent.
Senate Committee on Labor and Human Resources discharged by Unanimous Consent.
Measure laid before Senate. (consideration: CR S14070-14072)
Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.
Passed Senate with an amendment by Voice Vote.
Message on Senate action sent to the House.
Received in the House.
Held at the desk.
Considered by unanimous consent. (consideration: 10/6/94 CR H11172-11173)
Mr. Waxman asked unanimous consent to take from the Speaker's table and consider.
Passed/agreed to in House: On passage Passed without objection.
Enacted as Public Law 103-396
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On passage Passed without objection.
Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 103-396.
Became Public Law No: 103-396.