LA1 - Module 10_Label and Extra-Label Drug Use in Food Animals

Labeling and Record Keeping of Rx

Adequate treatment records must be maintained by the veterinarian for at least two years for all animals treated, to show that the drugs were supplied to clients with whom a VCPR has existed. Such records must include the information set forth under Basic Information for Records, Prescriptions, and Labels Food animal owners must also keep treatment records. Owner treatment records have been developed by several producer organizations and are available in conjunction with quality assurance programs

Vaccines

Always carefully read the manufacturers' label recommendations for disposing of empty or partially empty drug containers. Most can be burned or disposed of in a sanitary landfill. Unused products should not be dumped down a drain or on the ground. Disinfectant should be added to unused portions of live or modified-live vaccines to reduce the accidental exposure to unintended populations. Broken glass vials should be placed in a rigid cardboard box and clearly labeled as "Broken Glass." Unused drugs or vaccines that have become outdated should be disposed of properly. They can often be returned to the manufacturer or to the place of purchase for proper disposal.

Residue:

Any drug or their metabolites that may be present in foods for human consumption.

Warning Statements for Prescription/Restricted Drugs:

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

sharp disposal

Disposal of sharps may be regulated by your state. Contact the agency in your state that is in charge of overseeing the disposal of medical wastes. Alternatively, you may be able to identify a veterinarian, hospital, pharmacy, physician or dentist office that will accept farm or household generated medical wastes. Some states have registered "sharps" collection stations.

Drug Residue Screening Tests

Drug residue tests use milk, urine, meat or serum samples to test for drug residues in dairy and slaughter animals. Basic rules: 1. You must use specific test kits for specific drugs 2. Never use tests to shorten withholding or withdrawal times 3. Do not ship animals or milk which tests positive or eggs from animals which test positive 4. The milk from dairy animals with mastitis may interfere with residue tests designed to test bulk tank milk samples, resulting in false positive samples from these animals.

if sharps are not disposed of properly they can

Injure livestock Injure family members Injure waste handlers Increase the risk of infection Pollute the environment

Withdrawl time example 2

The last time a steer was medicated was at 5 PM on July 1, with a medication with a meat withdrawal time of 6 days. This steer can be slaughtered after 5 PM on July 7. A full 6 days (144 hours) has elapsed between the last treatment and slaughter.

Federal Drug Administration (FDA) "Green Book" Database of Approved Animal Drug Products (DAAD)

available on the internet through the FDA. Information provided will include, but is not limited to trade name(s), sponsor (ex. manufacturer, distributor), ingredient(s), approved species, route(s) of administration, dose form(s), drug form(s), withdrawal/withholding time(s), indications for use, tolerances, and acceptable daily intake. NOTE: The "Green Book" is not a replacement for the product package insert or label.

Dangers of Drug Residues to the Public, Environment & Losses to the Producer

• Allergic reactions (unperceivable to anaphylaxis and death) • Acute toxicities • Antibiotic resistance • Carcinogenicity • Reproductive effect • Teratogenicity • Disruption of normal human flora in the intestine • Environmental concerns • Economic: consumer preference, production loss, legal action

Regulatory Structure for ELDU

• The Food, Drug and Cosmetic Act regulates veterinary use of drugs. • The Food and Drug Administration (FDA) is responsible for administering the Act. FDA's Center for Veterinary Medicine (CVM) regulates the manufacture, classifying and distribution of over the counter, prescription and veterinary feed directive food additives and drugs that will be given to animals. These include animals from which human food is derived, as well as food additives and drugs for companion animals. CVM is responsible for regulated drugs, devices and food additives given to, or used on both companion animals and food animals. • Extra-Label Drug Use is subject to the Animal Medical Use Drug Clarification Act (AMDUCA). • In addition, medication use in dairy cattle is also subject to the Pasteurized Milk Ordinance (P.M.O.) which is written by the FDA and the State in consultation with the dairy industry. • Veterinary biologics are not regulated by the FDA but by the United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS).

Compounding should never be performed:

• if there is an appropriate commercial product available, • to simply save money, • if patents are infringed upon, • if the compounding is beyond the ability of the veterinarian or pharmacist to properly prepare the "new" medication

Federal Food, Drug and Cosmetic Act (the Act)

- Anyone who adds drugs to feed is subject to the Federal Food, Drug and Cosmetic Act (the Act). - Just as each label claim for a new animal drug must be approved, a drug must be specifically approved for administration in animal feed. - When the new animal drug application for use of the drug in animal feed is approved, a notice is published in the Federal Register. The medicated feed must be labeled in accordance with the approved labeling. - A drug may only be mixed into feed for uses and at drug levels specifically permitted in the regulations - must be registered with the FDA as a drug manufacturer and hold an approved medicated feed mill license - violation of the Act for drugs to be added for uses or at levels not specified in the regulation, causes seizures - The agency will tolerate off-label use of drugs in the feed of minor species provided certain conditions are met, including the involvement of a licensed veterinarian

Veterinary Feed Directives

- The Animal Drug Availability Act of 1996 (ADAA) amended the Act to establish a new category of drugs, veterinary feed directive (VFD) drugs. - drug approved for use in or on animal feed as a VFD drug is limited to use only under the professional supervision of a licensed veterinarian - A veterinarian, operating within the confines of a valid veterinarian-client-patient relationship, examines and diagnoses animal conditions and determines whether a condition warrants use of a VFD drug. If it does, the veterinarian will issue signed VFD order containing information specified by regulation. Extra-label use of a VFD drug (or any drug) in or on an animal feed is strictly prohibited, i.e., not permitted by anyone, including the veterinarian.

Extra Label Use Drugs (ELUD)

- Use of a medication in an animal other than what is designated on the manufacture's label is considered as off label and subject to the Animal Medical Drug Use Clarification Act (AMDUCA). - It includes use in other species, for different conditions, different amounts or frequencies, other routes of administration, changes in withdrawal or withholding times. - Any OTC or Rx drugs used other than exactly as described on the manufacture's label is considered Extra Label Use of Drugs (ELUD). - The Extra Label Use of Drugs is illegal for everybody except by or on the prescription of a licensed veterinarian.

Sharps should be?

- collected on the farm in a rigid puncture resistant container that has a screw-on or tightly secured lid. purchase or other potential "sharps" containers, while not as satisfactory as special purpose ones, include an empty, thick-walled detergent bottle or an empty 5-gallon drum. Glass bottles, thin walled jugs, such as milk jugs, coffee cans, pop cans or plastic bags are not acceptable for disposing of sharps. Containers should be visibly labeled identifying it as a biohazard waste container. To avoid accidental recycling, clearly label the container as nonrecyclable. When the container is full, it should be sealed and the lid firmly secured. Duct or packaging tape works well to secure the lids.

Extra-Label Use of Medicated Feeds for Minor Species

- defined by exclusion as animals other than cattle, horses, swine, chickens, turkeys, dogs and cats - there are some minor species that cannot be practically medicated in any way other than through the use of medicated feeds. - Furthermore, minor species such as fish and game birds have very few drugs approved for their use. In such situations, a veterinarian may determine that extra-label use of medicated feeds approved for use in other species can prevent suffering and death in these minor species. - extra-label use of medicated feed for treatment of minor species may be considered when the health of animals is threatened and suffering or death would result from failure to treat the affected anima - Agency anticipates that any regulatory action taken based on the extra-label use of a medicated feed for a minor species will be directed at the following: 1.veterinarians who authorize such use in a manner that is inconsistent with this guidance; 2.animal producers who use the feed in a manner that is inconsistent with this guidance; 3.all persons, including veterinarians and animal producers, who promote the feed for extra-label use; and 4.feed mills that manufacture/ distribute the feed in disregard of this guidance.

Prescription/Restricted Drugs

- have the following statement on the label: "CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian". - may only be obtained and used under the supervision of a veterinarian. • A drug restricted by federal law that is prescribed, dispensed and/or administered on the order and general supervision of a veterinarian to insure safe and effective use. • All veterinary prescription drugs are required to bear the statement: "CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian". • Requires a valid Veterinarian/Client/Patient Relationship (VCPR). • Must be used according to manufacture's label. Any other use is extra-label and falls under the requirements for AMDUCA as an Extra Label Use Drug (ELUD). • Prescription drugs should be labeled with specific info

All veterinary prescription drugs must be ?

- must be properly labeled when dispensed. - If that information is included in the manufacturer's drug label, it is unnecessary to repeat it in the veterinarian's label. If there is inadequate space on the label for complete instructions, the veterinarian must provide additional information to accompany the drug dispensed or prescribed. The veterinarian's additional instructions must be kept in the owner's drug storage area . When veterinary prescription drugs are dispensed to companion animal owners, the AVMA recommends that such drugs be placed in child-resistant containers. Such containers are mandated by law in certain states.

Extra-label drug use

- not approved for use in food animal but necessary in certain situations -withdrawal times not printed - FARAD (Food Animal Residue Avoidance and Depletion program) is primary resource for recommendations for withdrawal times after ELDU in food animals - use form to record client communication: summary, date, time, method of communication, signature

Regulatory Guidance

- warning letter to animal producer & vet The feed mill also may be considered for regulatory action if there is sufficient evidence to show that it knew that the feed was intended for extra-label use in other than a minor species. If there is a tissue residue violation, the District should establish the responsible individuals. This would ordinarily be the animal producer and/or veterinarian if not covered under the circumstances of this policy. However, in rare situations such as documented misformulation or no approval in 21 CFR part 558, the feed mill may be considered responsible for the violation.

Compounding

-manipulation of drugs to obtain products that differ from the starting materials in their approved dosage form. -considered extra-label use. - Human or animal drugs can be used for compounding -illegal if an approved animal drug is available that would satisfy the need for the compounded preparation. -must be performed by a licensed pharmacist or veterinarian and should be based on acceptable standards of practice. -example:mixing of two different pharmaceutical in the same syringe for administration. Administrating the same two pharmaceutical independently would not constitute compounding.

Compounding should only be performed:

-when the best medication for the patient is not commercially available - the active medication ingredient is not commercially available in the desired concentration or dosage form - the commercial product is on extended backorder and the continuity of the therapy would be in jeopardy, - the commercial product is no longer manufactured for reasons other than non-safety or non-efficacy - compliance on the part of the client and patient will be enhanced by the use of a friendly (ex. flavor, size) dosage form - a cutting edge preparation has been reported in the veterinary literature but is currently not commercially available -if the patient is allergenically sensitive to a non-active portion of the commercially available product

ELUD Client (Owner or Caretaker) Responsibilities

1. Read and follow labeled directions carefully. Labeled directions may change frequently 2. Use the drugs only in the patient(s) listed on the label. Drugs used in other animals and/or species may cause adverse reactions or illegal residues. 3. Store all medications in the labeled manner 4. Keep stored medications separated for lactating and non-lactating dairy animals 5. Administer all drugs properly (dose, frequency, route of administration, asepsis). Variations may cause harm to the patient, illegal residues and/or render the treatment ineffective 6. Select proper instruments (size, types) appropriate for the patient and product to be administered to avoid injury to the patient, reduced effectiveness of the medication and/or illegal residues 7. Follow labeled-calculated-prescribed withdrawal and withholding times. Withholding and discard times are calculated from the last time of administration of the medication, vaccine or other product 8. Do not "double dose" or use other non-prescribed medication(s) concurrent with the existing prescribed treatment scheme. Use of excessive or other products by the same or different routes may cause harm to the patient, unpredictable effects or ineffectiveness of one or both of the products or cause illegal residues 9. Identify all treated animals 10. Maintain proper treatment records (date, time, animal ID, drug, dosage, route of administration, withdrawal / withholding time, and person who administered) 11. Use drug residue screening tests 12. All storage bins and bunks and watering devices used for feeds containing drugs/additives or Veterinary Feed Directive Drugs should be cleaned after use for these products to avoid contamination of water or subsequent non-additive products being stored in the bins thus causing the potential for drug residues and adverse effects in the animals 13. Educate all individuals who medicate animals on the proper procedures 14. Educate employees on farm regarding disposal of medical wastes 15. A signed statement of understanding, agreement and acceptance of the ELUD plan.

Prohibited Drugs

1. The use of human drugs in food animals is not normally permitted. Exceptions may be made for insulin and anesthetic agents. 2. The FDA has stated it has no regulatory interest in the extra-label use of human or animal drugs in companion animals. 3. The extra label use of drugs in animal feeds is illegal. A drug may not be mixed into a feed except as permitted on the label, even if ordered by a veterinarian. 4. The following drugs are a few examples of drugs that under AMDUCA are currently illegal and prohibited (including by ELUD) from use in food producing animals: •Chloramphenicol • Clenbuterol • Diethylstilbestrol (DES) • Dimetidazole • Ipronidazole • Dipyrone • Enrofloxacin • Baytril in poultry • Nitrofurazone (except for approved topical use) • Monensin in lactating dairy cattle Lasalocid in lactating dairy cattle • Generally sulfonamide drugs in lactating dairy cattle • Furazolidone (except for approved topical use)

Veterinarians may prescribe drugs extra label as long as the following conditions are met:

1. Valid Veterinarian/Client/Patient Relationship (VCPR) exists. 2. For therapeutic purposes only. 3. A careful diagnosis is made by an attending veterinarian within the context of a valid veterinarian client-patient relationship. May require additional laboratory and/or diagnostic procedures. 4. No labeled drug alternatives is available. That is, a determination is made that: a. There is no marketable drug specifically labeled to treat the condition diagnosed, or b. Treatment at the dosage recommended by the labeling was found clinically ineffective. 5. Procedures are instituted to assure that the identity of the treated patient is carefully maintained. 6. Adequate records are kept by the veterinarian and client 7. Significantly prolonged withdrawal times. That is, a significantly extended period of time is assigned for drug withdrawal prior to marketing the treated patient or the patients milk or eggs, and steps are taken to assure the assigned time frames are met and no "violative" residues occur. The ELUD withdrawal/withholding time is usually calculated at >2 to 3X's longer than the manufacturer's labeled withdrawal time. This ELUD withdrawal/withholding time is prescribed by the veterinarian based on the best available information. 8. Drug is properly labeled by the veterinarian or as designated by the veterinarian with adequate information to assure proper use of the product 9. Extra-Label Drug Use is permitted as an additive to the drinking water. 10. Extra-Label Drug Use of feed additives is not permitted under any circumstances. 11. Compounding is considered an extra label use.

the Agency ordinarily will not consider regulatory action for Extra-Label Use of Medicated Feeds for Minor Species if:

1.The medicated feed is used in an extra-label manner only for treatment of minor species Extra-label use includes, but is not limited to: use in minor species not listed in the labeling, use for indications (diseases or other conditions) not listed in the labeling, and deviation from the labeled withdrawal time; 2.The medicated feed is approved for use in a major species animal and is formulated and labeled according to its approved labeling as described in the Code of Federal Regulations. The nutrient content and formulation are in accordance with use in the approved major species. The labeling reflects the approved use in dosage, formulation, and nutrient content 3.The medicated feed is to be used in a food-producing minor species and the feed is approved in a major food-producing species; 4.Extra-label use of medicated feed in aquaculture is limited to medicated feed products approved for use inaquatic species; 5.Extra-label use of medicated feed is limited to farmed or confined minor species. Use for the treatment of unconfined wildlife is not appropriate under this policy; 6.The medicated feed is used in an extra-label manner only with the express prior written recommendation(see part 8.h. of this guidance) and oversight of an attending licensed veterinarian within the context of a valid veterinarian-client-patient relationship. 7.Extra-label use is limited to therapeutic treatments when the health of an animal is threatened and suffering or death may result from failure to treat. It is inappropriate under any circumstances to use a medicated feed in an extra-label manner for improving rate of weight gain, feed efficiency, or other production purposes 8.The veterinarian has determined it neccessary 9.The animal producer has: kept records, followed rules, etc, safety

Withdrawal time example 1

A lactating dairy cow has been medicated on Monday at noon, with a drug with a 48-hour discard time. The cows are milked twice a day 6 AM and 6 PM. Therefore the milk must be discarded for four milkings. The Wednesday evening milk may be marketed. A full 48 hours has elapsed between the last treatment and the last time the milk must be discarded. If this cow was on a three times a day milking schedule, 6 "milkings" would have been discarded in the same time period.

Blue Bird Labels

A new animal drug application (NADA) for a Type A medicated article is required to include, among other things, representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug The Center for Veterinary Medicine (CVM) uses the term Blue Bird labels to refer to such representative labeling One is the specimens of labeling to be used for such new animal drug which must include adequate directions for the manufacture and use of finished feeds for all conditions for which the new animal drug is intended, recommended, or suggested in any of the labeling, including advertising, sponsored by the applicant. The other labeling component required for such drugs is the representative labeling proposed for use in Type B and Type C medicated feeds containing the new animal drug.

Precaution Statements and Symbols

Contraindication, Adverse Reaction, Safety, Precaution, Caution, Residue Precaution and Warning statements and/or symbols may be required by law, suggested, prudent and/or necessary due to the nature of the specific product.

Used Drug Containers

Empty or partially empty drug containers should be properly disposed of to reduce the risk of environmental contamination with chemicals or infectious agents. Injectable medications Antibiotics Vitamins and minerals Mastitis tubes Oral medications Dewormers Antibiotics Vitamins and minerals Topical Medications Sprays Dewormers Ointments

Withdrawl time example 4

If the drug administered to the steer in example #2 was administered in an extra label manner, the withdrawal time would be usually 2-3 times the labeled withdrawal time. The veterinarian will make the decision based on the best current knowledge available what the actual extended time will be. Therefore in this case, the withdrawal time would be 12-18 days, or 288 to 432 hours

Withdrawl time example 3

If the drug in example #1 was administered in an extra label manner, the withholding time would be usually 2-3 times the labeled withholding time. The veterinarian will make the decision based on the best current knowledge available what the actual extended time will be. Therefore in this case the withholding would be 96-144 hours, or 8-12 milking for twice a day milked cows or 12-18 milkings for three time a day milked cows.

Example of Drug Specific Warnings and Precautions:

MAST - X® (amoxicillin) Lactating Cow Formula Intra-mammary Infusion: Rx XYC Pharmaceutical Company CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. WARNING: Milk taken from animals during treatment and for 60 hours (5 twice a day or 8 three time a day "milkings") after the last treatment must not be used for food. Treated animals must not be slaughtered for food purposes within 12 days after the last treatment. PRECAUTION: Because Mast - X® is derived from amino-penicillanic acid, it has the potential for producing allergic reactions. Such reactions are uncommon; however, if they occur, the subject should be treated with standard therapeutic agents for amino-penicillanic acid allergic reactions (antihistamines, pressor amines).

Veterinary Prescription Orders

Orders issued by licensed veterinarians authorize drug distributors to deliver veterinary prescription drugs to a specific client, or authorize pharmacists to dispense such drugs to a specific client. Veterinarians should assure compliance with relevant regulations of their State Board of Pharmacy and State Board of Veterinary Medici

Miscellaneous Medical Waste

Other medical waste that may be generated on livestock farms include: Bandages Medical gloves These items should be placed in securely fastened leak proof bags before putting them in with the rest of your trash.

ELDU label

Patient ID should include unique individual and/or group ID, species, and number of animals treated if a group

Veterinary and Producer Non-Compliance:

Penalties for not following laws and/or label directives are commensurate with the severity and consequences of the infraction and the number of times the infraction has been committed

two classes of legal drugs:

Prescription/Restricted (Rx) Drugs Over-the-Counter (OTC).

prohibited drugs

Prohibited therapy in food animals: chloramphenicol, clenbuterol, diethylstilbestrol, dimetridazole, ipronidazole, other nitromidazoles, furazolidone, nitrofurazone, other nitrofurans, glycopeptides. • Prohibited therapy in food animals except approved uses: fluoroquinolone class of antibiotics. • Prohibited therapy in lactating dairy cows: any sulfonamide except for those specifically approved (sulfadimethoxine, sulfabromethazine and sulfaethoxypyridazine). • Prohibited therapy in female dairy cattle 20 months of age or older: phenylbutazone.

Livestock producers can potentially generate medical waste on a daily basis. These wastes include:

Sharps: Needles, syringes, scalpels Drug containers: Empty drug or vaccine vials, Outdated drugs As stewards of the environment, livestock producers should take precautions to assure that medical wastes do not become hazards to themselves, their families, their operations or the community.

Auxiliary Labels:

Since it is the responsibility of the veterinary health care team to inform, caution or warn the client, auxiliary cautionary or warning labels may be necessary regarding administration, handling or storage, such as: • keep refrigerated • protect from freezing • protect from sunlight • store in a dark cool place • shake well • do not use after (date) • poison • for topical use only • for veterinary use only • keep out of the reach of children

"T.A.L.K. before you treat."

T - Talk to your veterinarian. Always check with your veterinarian before giving any drug to your animals. A - Ask if the drug is approved by FDA for use in your animals. FDA's approval means the drug is safe and effective when it is used according to the label. FDA's approval also ensures that the drug's strength, quality, and purity are consistent from batch to batch, and that the drug's labeling is appropriate and truthful. L - Look at the label. Know what drug you are giving and the dosage regimen. Be aware of the withdrawal time for the dosage regimen you are using. The dosage regimen includes: How much of the drug to give (the dose); How often to give it (the frequency); How long to give it (the duration); and How to give it (the route of administration). Various routes of administration include injecting the drug Under the skin, into muscle, or into a vein; giving the drug by mouth; or applying the drug topically to the skin. K - Keep complete treatment records. Good record-keeping will help you avoid illegal chemical residues because you will know: Which animals were treated; What drug they were treated with; How they were treated (the dosage regimen used); Why they were treated; and When it is safe for food products made from treated animals to enter the food supply.

Valid Veterinarian/Client/Patient Relationship (VCPR)

Therefore the Veterinarian/Client/Patient Relationship (VCPR) is required when any prescription drug is given to a patient. As defined by the American Veterinary Medical Association (AVMA): • "A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian; • There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the patient(s) by virtue of an examination of the patient(s) or by medically appropriate and timely visits to the premises where the patient(s) is (are) keep; and • The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regime of therapy. Such a relationship can only exist when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

Over-the-Counter Drugs

can be purchased and used following the label directions by livestock producers without establishing a relationship with a veterinarian • May be purchased by anyone, and used without the supervision of a veterinarian • The label of the OTC must bear adequate directions for use by the producer • The label must be written so that it is understandable by the producer • Must be used in accordance with label directions. Any other use is extra-label and falls under AMDUCA thus requiring veterinary supervision as an Extra Label Use Drug (ELUD).

Food Animal Residue Avoidance Databank (FARAD)

computer-web-based decision support system designated to provide livestock producers, extension specialists, and veterinarians with practical information on how to avoid drug, pesticide and environmental contamination residue problems. Among other things FARAD provides information on meat and milk withdrawal times for drugs given in an extra-label manner. (withdrawal times of approved drugs, database of scientific articles with data on drug residues and pharmacokinetics of non approved drugs, tolerances of drugs in meat/milk/eggs)

Veterinary Prescription Drugs

drugs are those drugs restricted by federal law to use by or on the order of a licensed veterinarian The law requires that the drug sponsor label such drugs with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

residue contaminated milk or meat: consequences

economic and legal on farmer and the farmer may see the vet team as responsible (fail to follow procedures or give inaccurate advice)

To avoid illegal residues and to keep food products safe, CVM reminds veterinarians and animal producers to ?

follow the withdrawal time for every drug they use in food-producing animals. CVM also asks animal producers to "T.A.L.K. before you treat."

Symbols: arrows

indicate residue warnings, and would contain withdrawal/withholding/discard times between them

Prescription drugs should be labeled with:

o Veterinarian's name and address (clinic name is not sufficient), telephone number. o Client's name, address and telephone number o Date of treatment, prescription or dispensing of drug o ID of patient(s) treated, species, number treated if possible o Active ingredient(s) and quantity of drug to be dispensed (number of dosage unite or volume dispensed) o Dosage, route of administration and duration of treatment o Withdrawal time, even if zero (0) o Cautionary statement o Expiration Date o Number of refills o Signature o Language the client can understand, use words instead of numbers, do not use abbreviations For example, say or write: "Administer two boluses by mouth every twelve hours for four days" Do not say or write: "Administer 120 grains, p.o., q12h for 4 days," as the owner may not know the meaning of grains, per os, or the abbreviation q12h. o Since the information is extensive and the physical label is small, a supplemental information sheet is commonly warranted.

withdrawal, withholding or discard times

set to make sure that drug residues are no longer present in the animal product (meat or milk) at the time of slaughter or collection. They are calculated using full 24 hour time periods starting with the last time an animal receives the drug. The time may be expressed in hours, days, number of milkings, or dates and times. CAUTION: When using dates and times, the assumption is that the individual administering the medication or vaccine administered at a specific time, each and every time. This may be difficult to insure. apply to all drugs, vaccines and anything applied, fed or otherwise administered to the animal that is raised for human consumption, and is not limited to antibiotics, vaccines, analgesics, anesthetics, or anti-parasitic agents. Even herbs and other additives require withholding or withdrawal times, as they may leave residues in the meat or milk.

"acceptable daily intake" (ADI)

the largest amount of the drug that will not harm people if they ingest that amount every day. CVM residue chemists set the tolerance for the drug, which is the level of chemical residues allowed to be in or on food products made from treated animals. Eating food that contains even the full amount of chemical residues allowed by the tolerance will not exceed the ADI. Based on the tolerance, the residue chemists set the withdrawal time If a drug is used in an extra-label ("off-label") manner in a food-producing animal, a veterinarian must be involved and is responsible for establishing an appropriate withdrawal time.

withdrawal times

time between admin of known dose of a drug/chem to animal and time that the animals meat, eggs, or milk are presumed safe for human consumption US FDA is responsible for drug approval and establishing withdrawal times based on scientific evidence times are printed on labels of approved substances

ELUD Responsibilities and Record Requirements for Veterinarians and Other Members Veterinary Health Care Team

veterinarian must keep the following records for a minimum of two years after treatment with an ELUD and present them to any person designated by the FDA: 1. Identification of the drug or ingredients 2. Condition treated 3. Identification of the animal(s), including species 4. Dosage administered 5. Duration of treatment 6. Number of animals treated 7. Specific withdrawal, withholding or discard time for food animals The veterinary health care team is responsible for the education of the client regarding their responsibilities and to be reasonably certain the client has the ability to and will comply within the parameters of the veterinarian-client-patient relationship.

Handling and Storage

veterinarian should inform clients to whom prescription drugs are delivered or dispensed about appropriate drug handling and storage. drugs should be stored separately from over-the-counter drugs, and be easily distinguishable by the professional and paraprofessional staff. Drugs should be stored under conditions recommended by the manufacturer. All drugs should be examined periodically to ensure cleanliness and current dating.

Common Reasons (not justifications) for Residues

• Accidentally milked treated patient (dry and in-milk) into the bulk tank • Milked treated patient last, but pipeline not diverted from the bulk tank • Put milk in bulk tank or shipped milk from treated patient too soon - before end of withholding time • Not following label directions for correct treatment • Not following the label directions for the appropriate withdrawal period • Treatment not recorded as a written record resulting in shipping patient too soon • Poor or no patient identification • Inappropriate extra label drug use • Person in charge of treating patients are not working closely with the veterinary health care team to maintain current plan of treatment • Lack of an initial, continuing, routine training program for new and experienced employees • Erroneous medication or amount of medication administered • Erroneous patient treated • Inappropriate medication storage • Inappropriate medication prescribed

For ELDU, the FDA specifies that the following criteria must be met:

• Make a careful diagnosis and evaluation of the conditions for which the drug is to be used. • There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration. Alternatively, an approved animal drug exists, but a veterinarian finds, within the context of a veterinarian/client/ patient relationship, that the approved drug is clinically ineffective for its intended use. • Assure that the identity of the treated animal(s) is carefully maintained. • Establish a substantially extended withdrawal period supported by appropriate scientific information prior to marketing milk, meat, eggs, or other edible products from the treated animal(s).

Basic Information for Records (R), Prescriptions (P), and Labels (L)

• Name, address, and telephone number of veterinarians. (RPL) • Name (L), address, and telephone number of clients (RP) • Identification of animal(s) treated, species and numbers of animals treated, when possible (RPL) • Date of treatment, prescribing, or dispensing of drug (RPL) • Name and quantity of the drug (or drug preparation) to be prescribed or dispensed (RPL) • Dosage and duration directions for use (RPL) • Number of refills authorized (RP) • Cautionary statements, as needed (RPL) • Expiration date (L) • Slaughter withdrawal and/or milk withholding times, if applicable (RPL) • Signature or equivalent (P)

Warning Statements for All Drugs (Rx and OTC):

• Precaution: Administration of this product in any manner other than described under Dosage and Administration may result in drug residues. • Veterinary Use Only • For Animal Use Only • Not for Human Use • Keep Out of Reach of Children • Discard Empty Container—Do Not Reuse • Do Not Store Above _ _°C (_ _°F) • Protect From Freezing

Rx drugs

• Veterinary prescription drugs are labeled for use only by or on the order of a licensed veterinarian. • Veterinary prescription drugs are to be used or prescribed only within the context of a veterinarian-client-patient relationship (VCPR). • Veterinary prescription drugs must be properly labeled before being dispensed. • Appropriate dispensing and treatment records must be maintained, and drugs should be dispensed only in quantities required for the treatment of the animal(s) for which the drugs are dispensed. • Any drug used in a manner not in accordance with its labeling (extra-label use) should be subjected to the same supervisory precautions that apply to veterinary prescription drugs