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Drug and Product Labeling

Drug and Product Labeling. FDA requires that livestock producers use drugs only in accordance with the label instructions Uses that are contrary to label directions include: – Ignoring labeled withdrawal times – Using the product for a species not indicated on the label

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Drug and Product Labeling

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  1. Drug and Product Labeling • FDA requires that livestock producers use drugs only in accordance with the label instructions • Uses that are contrary to label directions include: – Ignoring labeled withdrawal times – Using the product for a species not indicated on the label – Using the product at a different dosage or route of injection than stated on the label – Using the product to treat a condition not listed on the label

  2. Extra Label Drug Use • The use of a product in a manner that is different from what is specified on the label or using any product that is not approved and labeled for use in goats constitutes “extra label drug use” • FDA allows extra-label drug use under certain circumstances when there is a valid veterinarian/client/patient (VCP) relationship. The prescribing veterinarian must be familiar with the herd, the problem being treated, and that the owner is willing to follow instructions regarding treatment. An extended withdrawal time may be necessary to prevent drug residues in food products.

  3. Drug Withdrawal Times • The withdrawal time of a drug (the time from the last treatment to the time when products from the animal can safely be consumed) is based on the recommended dosage, duration of treatment, and any extra label concerns. • Products that are fed have withdrawal times as well, but the extra-label use of feed additives is not allowed by FDA. Label instructions must be followed for a feed additive to be used in a legal manner.

  4. Drug Use in Dairy Goats • Health care is the second greatest cost of production in raising goats. • There are few drugs approved by FDA for use in dairy goats. This means “everything is extra label”. • Milk producers and their veterinarians should develop a written treatment plan for disease prevention and control.

  5. The Drug Label • Read the label before treatment to ensure the appropriate medication is used in the proper strength to avoid over or under dosing. • The label should include: dosing information, precautions, indications, and withdrawal times. • Determine if the product requires special storage (‘refrigerate’ or ‘store away from direct sunlight’). • Determine if the age of the animal is appropriate for this product. • Check any expiration dates.

  6. Drug Labels Comply With LabelingRequirements • All over-the-counter and prescription drugs must contain: – Name of drug – Active ingredients e.g., Penicillin – Instructions for use – Withholding times – Quantity of contents – Name of manufacturer, distributor, veterinarian+ address

  7. Drug Labels • Drugs used “extra label” must include: – the veterinarian’s name, address – dosage and route of administration instructions – disease/condition to be treated – restrictions/ withdrawal period

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