> CHAPTER: Post-Approval Monitoring of Animal Drugs, Feeds and Devices

+--------------------------------+-----------------+-------------------+
| SUBJECT:                       |                 | IMPLEMENTATION    |
|                                |                 | DATE              |
| **Illegal Residues In Meat,    |                 |                   |
| Poultry, Seafood, and Other    |                 | 08/01/2005        |
| Animal Derived Foods**         |                 |                   |
+--------------------------------+-----------------+-------------------+
|                                |                 | COMPLETION DATE   |
|                                |                 |                   |
|                                |                 | Continuous        |
+--------------------------------+-----------------+-------------------+
| DATA REPORTING                 |                 |                   |
+--------------------------------+-----------------+-------------------+
| PRODUCT CODES                  | PRO             |                   |
|                                | DUCT/ASSIGNMENT |                   |
|                                | CODES           |                   |
+--------------------------------+-----------------+-------------------+
| Industry codes: 16, 17, 67-69  | 71006, 71S006   |                   |
|                                |                 |                   |
|                                | 71004           |                   |
|                                |                 |                   |
|                                | 71003A          |                   |
+--------------------------------+-----------------+-------------------+

**[FIELD REPORTING REQUIREMENTS]{.underline}**

1\. [Hardcopy Reporting]{.underline}

For all Federal and State investigations/inspections submit, Field
Accomplishments Compliance Tracking System (Facts) Coversheet with
endorsement, completed Tissue Residue Evaluation Form(s) (Attachment C),
Drug Inventory Survey Form (Attachment G), to the Compliance Information
Management Team, HFV-235, Attention: Fran Pell.

2\. [FACTS Reporting]{.underline}

a\. Report time for all Federal drug residue follow-ups against Program
Assignment Code (PAC) 71006. For state inspections of residue violations
conducted under contract report time against PAC 71S006. For state
inspections of residue violations conducted under cooperative agreements
report the time under PAC 71006 with a state position class to identify
the work as state-performed. For all inspections include the FSIS sample
number in the description field of FACTS.

b\. Report time for follow-up at medicated feed mills against PAC 71004.

c\. Report time for Contamination Response System (CRS) investigations
of non-drug residues against PAC 71003A.

[**PART I -- BACKGROUND 5**](#part-i-background)

[**PART II -- IMPLEMENTATION** 8](#part-ii-implementation)

[**A. INTRODUCTION** 8](#a.-introduction)

[**B. OBJECTIVES** 8](#b.-objectives)

[**C. PROGRAM MANAGEMENT INSTRUCTIONS**
8](#c.-program-management-instructions)

[1. Inspectional 8](#inspectional)

> [a. On‑Site Inspections by FDA of Meat and Poultry Violations
> 10](#a.-onsite-inspections-by-fda-of-meat-and-poultry-violations)
>
> [b. On‑Site Inspections by FDA of Seafood.
> 11](#b.-onsite-inspections-by-fda-of-seafood.)
>
> [c. Investigation of Food Animal Marketing Firms
> 11](#c.-investigation-of-food-animal-marketing-firms)
>
> [d. Inspections at Aquaculture Farms:
> 11](#d.-inspections-at-aquaculture-farms)
>
> [e. Inspection of other Animal-Derived Products
> 12](#e.-inspection-of-other-animal-derived-products)
>
> [f. Extra-label Use 12](#f.-extra-label-use)
>
> [g. FSIS Special Programs 13](#g.-fsis-special-programs)
>
> [h. FSIS Condemnation Practices 13](#h.-fsis-condemnation-practices)

[2. District Monitor Responsibilities
14](#district-monitor-responsibilities)

[3. Analytical 15](#analytical)

[4. Program Interaction 16](#program-interaction)

[5. Inter‑Agency Agreements 17](#interagency-agreements)

[6. Federal/State Relations 17](#federalstate-relations)

[**PART III ‑ INSPECTIONAL** 18](#part-iii-inspectional)

[**A.** **Inspectional Operations** 18](#a.-inspectional-operations)

[1. Jurisdiction 18](#jurisdiction)

[2. Violation 18](#violation)

> [a. Meat and Poultry Residues 18](#a.-meat-and-poultry-residues)
>
> [b. Seafood and Aquaculture Residues
> 20](#b.-seafood-and-aquaculture-residues)

[3. Responsibility 21](#responsibility)

> [a. Dealer Involvement 21](#a.-dealer-involvement)
>
> [b. Veterinarian Involvement 22](#b.-veterinarian-involvement)

[**B.** **GMP Inspections** 23](#b.-gmp-inspections)

[**C.** **Sampling** 23](#c.-sampling)

[1. Sample Submission 24](#sample-submission)

[2. Collection Report (CR) 24](#collection-report-cr)

[**D. Reporting** 24](#d.-reporting)

[**E. Criminal Activity Investigations**
25](#e.-criminal-activity-investigations)

[**PART IV ‑ ANALYTICAL** 26](#part-iv-analytical)

[**A. Responsibilities** 26](#a.-responsibilities)

[1. Sample Preparation 26](#sample-preparation)

[2. Tissue Sample Storage 26](#tissue-sample-storage)

[**PART V ‑ REGULATORY/ADMINISTRATIVE**
27](#part-v-regulatoryadministrative)

[**A.  GENERAL** 27](#a.-general)

[**B.  INITIAL VIOLATION** 28](#b.-initial-violation)

[**C.  REPEAT/MULTIPLE VIOLATIONS** 29](#c.-repeatmultiple-violations)

[1. Warning Letter 29](#warning-letter)

[2. Injunction 29](#injunction)

[3. Prosecution 30](#prosecution)

[**PART VI - CONTACTS, ATTACHMENTS, AND REFERENCES**
32](#part-vi---contacts-attachments-and-references)

[**A.** **PROGRAM CONTACTS** 32](#a.-program-contacts)

[1. CVM 32](#cvm)

> [a. Program Inquiries 32](#a.-program-inquiries)
>
> [b. Technical Guidance 32](#b.-technical-guidance)
>
> [c. Regulatory Inquiries 32](#c.-regulatory-inquiries)
>
> [d. Policy Questions 32](#d.-policy-questions)

[2. ORA 33](#ora)

> [a. Inspectional Inquiries 33](#a.-inspectional-inquiries)
>
> [b. Analytical Inquiries 33](#b.-analytical-inquiries)
>
> [c. Federal/State Relations Inquiries
> 33](#c.-federalstate-relations-inquiries)

[**B. LIST OF ATTACHMENTS** 33](#b.-list-of-attachments)

[**C.** **APPLICABLE REFERENCES OR AIDS**
34](#c.-applicable-references-or-aids)

[1. INVESTIGATIONS OPERATIONS MANUAL (IOM): Chapters 4 & 5 Sampling and
Inspection.
34](#investigations-operations-manual-iom-chapters-4-5-sampling-and-inspection.)

[2. 21 CFR Parts 500‑599, Animal Drugs, Feeds, and Related Products.
34](#cfr-parts-500599-animal-drugs-feeds-and-related-products.)

[3. Compliance Policy Guides: 34](#compliance-policy-guides)

[4. Compliance Programs 34](#compliance-programs)

[5. Regulatory Procedures Manual. 34](#regulatory-procedures-manual.)

[6. AOAC Official Methods of Analysis, 16th Edition.
34](#aoac-official-methods-of-analysis-16th-edition.)

[**PART VII ‑ CVM RESPONSIBILITIES** 35](#part-vii-cvm-responsibilities)

[**A. Program Evaluation** 35](#a.-program-evaluation)

[**B. Inter‑Center Action** 35](#b.-intercenter-action)

[**C. Compliance Information Management Team**
35](#c.-compliance-information-management-team)

[**D. Enforcement and Regulatory Policy Team**
36](#d.-enforcement-and-regulatory-policy-team)

[**ATTACHMENT A - USDA REPORTING CODES**
37](#attachment-a-usda-reporting-codes)

[**FSIS/USDA Laboratory Reporting Codes**
37](#fsisusda-laboratory-reporting-codes)

> [**USDA TISSUE LOOK-UP TABLE** 46](#usda-tissue-look-up-table)
>
> [**MARCIS SPECIES CODES ON USDA RECORDS**
> 49](#marcis-species-codes-on-usda-records)
>
> [**SPECIES/ANIMAL LOOK-UP TABLE USED BY USDA**
> 50](#speciesanimal-look-up-table-used-by-usda)

[**ATTACHMENT B-1**](#attachment-b-1) - [**SAMPLE PRODUCER WARNING
LETTER** 51](#sample-producer-warning-letter)

[**ATTACHMENT B-2**](#__RefHeading___Toc107891982) - [**SAMPLE WARNING
LETTER**](#sample-warning-letter) [**EXTRA-LABEL DRUG USE by
VETERINARIAN** 54](#extra-label-drug-use-by-veterinarian)

[**ATTACHMENT B-3**](#attachment-b-3) - [**SAMPLE WARNING
LETTER**](#sample-warning-letter-1) [**ILLEGAL DRUG SALE**
57](#illegal-drug-sale)

[**ATTACHMENT B-4**](#attachment-b-4) - [**SAMPLE WARNING
LETTER**](#sample-warning-letter-2) [**BUYER/DEALER** 59](#buyerdealer)

[**ATTACHMENT C - TISSUE RESIDUE EVALUATION FORM**
61](#attachment-c---tissue-residue-evaluation-form)

[**ATTACHMENT D - USDA CONTACTS** 74](#attachment-d-usda-contacts)

> [**FSIS Technical Service Center (TSC)**
> 74](#__RefHeading___Toc107891993)
>
> [**FSIS District Offices** 74](#fsis-district-offices)
>
> [**Office of Program Planning, Evaluation, and Enforcement**
> 77](#office-of-program-planning-evaluation-and-enforcement)
>
> [**Regional Offices** 77](#regional-offices)
>
> [**APHIS Veterinary Services Offices**
> 78](#aphis-veterinary-services-offices)
>
> [**GIPSA** 82](#gipsa)

[**ATTACHMENT E -- GIPSA / TITLE 18 MEMO**
83](#attachment-e-gipsa-title-18-memo)

[**ATTACHMENT F-1**](#attachment-f-1) [**Example of Slaughter House
Affidavit to Document Chain of Custody**
85](#example-of-slaughter-house-affidavit-to-document-chain-of-custody)

[**ATTACHMENT F-2**](#attachment-f-2) [**Example of Slaughter Plant
Inspector Affidavit**
86](#example-of-slaughter-plant-inspector-affidavit)

[**ATTACHMENT G**](#attachment-g) [**DRUG INVENTORY**
87](#drug-inventory)

[**AMDUCA Prohibited Drugs List** 120](#__RefHeading___Toc107892006)

[**ATTACHMENT H - District Monitor Checklist**
121](#attachment-h---district-monitor-checklist)

#####   {#section .unnumbered}

##### 

# **PART I -- BACKGROUND**

This Compliance Program was developed to provide a cohesive framework
for the Field to use that would include inspectional priorities, helpful
technical information, and resources to facilitate the investigation of
residue violations routinely reported to the Food and Drug
Administration (FDA) by the United States Department of Agriculture
(USDA), Food Safety and Inspection Service (FSIS). To protect consumers
from potentially harmful residues in the food that they eat it is
important that inspections are conducted to determine the cause of the
illegal drug residues and to develop data descriptive of on-farm
practices of management and animal drug use for program decision
support, identification of educational needs, and policy development.
This program also provides guidance for enforcement measures.. The
Federal Food, Drug, and Cosmetic Act (the Act)(21 U.S.C. 321(f)) defines
food as "(1) articles used for food or drink for man or other
animals...and (3) articles used for components of any such article."
(Section 201(f)). Food-producing animals and fish, even though not in
their final, edible form, have been held to be food under the statute
[United States v. Tomahara Enterprises Ltd.,]{.underline} Food Drug
Cosm. L. Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live calves intended as veal
are food) and [United States v. Tuente Livestock]{.underline}, 888 F.
Supp. 1416, 1423-26 (S.D. Ohio 1995) (live hogs are food). More
generally, courts have long held that unprocessed or unfinished articles
are or can be food. *See* [Otis McAllister & Co. v. United
States,]{.underline} 194 F.2d 386, 387 (5^th^ Cir. 1952) and cases cited
there (unroasted coffee beans are food). Thus, live animals raised for
food are "food" under the Act.

Tissue residue investigations may reveal:

-   the illegal sale of veterinary prescription drugs

-   the illegal use of bulk drugs

-   the extra-label use of drugs (which includes inadequate
    pre-slaughter withdrawal period)

-   cross-contamination of animal feeds due to poor Good Manufacturing
    Practices (GMPs) (21 CFR Parts 225 or 226)

-   failure to follow good animal husbandry practices

-   the misuse of drugs in medicated animal feeds

-   the marketing of treated/medicated animals intended for rendering
    purposes being diverted to slaughter for human consumption

-   inadequate animal identification

    Protection of the public by assuring a safe meat and poultry supply
    is a responsibility shared by the USDA Food Safety and Inspection
    Service (FSIS), the Grain Inspection, Packers and Stockyards
    Administration (GIPSA), the Animal and Plant Health Inspection
    Service (APHIS), the Food and Drug Administration (FDA) and the
    Environmental Protection Agency (EPA), The FSIS exercises
    supervision over the slaughter and processing of meat and poultry
    products in federally inspected establishments and is responsible
    for the safety of these food products. FSIS reports violative
    residues of drugs, and both violative and non-violative reisidues of
    pesticides, and other contaminants in meat and poultry to FDA for
    follow-up.

    The GIPSA works closely with FSIS in regulating animal marketing
    practices. GIPSA is an enforcement agency within USDA charged with
    enforcing the Packers and Stockyards Act of 1921 (7 U.S.C. §181)
    through economic regulation. GIPSA has also assisted FDA in securing
    producer identification when sales are through auction barns or
    dealers.

    A final rule on swine identification became effective on November
    14, 1988. All swine in interstate commerce must be identified and
    records concerning identification must be maintained. USDA (APHIS
    and FSIS) is responsible for enforcement. (53 FR 40378, October 14,
    1988).

    The EPA establishes the tolerances for pesticide residues in meat
    and poultry. FDA enforces these tolerances.

    FDA is responsible for the approval of new animal drugs, including
    the establishment of tolerances for residues of those drugs in
    edible tissues. FDA conducts investigations of FSIS-reported
    residues to determine the party responsible for causing the tissue
    residue violation and the party responsible for introducing the
    adulterated food into interstate commerce. The results of FDA
    investigations have shown that, in most instances, the animal
    producer is primarily responsible for the illegal drug residues
    because of failure to comply with drug withdrawal times, other label
    warnings, use of contaminated animal feeds, use of drugs for
    unapproved purposes, and employing poor animal husbandry practices.
    Investigations may also lead to other individuals such as a hauler,
    buyer, dealer, auction barn, veterinarian, or slaughter house.

    FDA has the responsibility to ensure the safety of the seafood
    supply. In 1995, FDA published the final HACCP (Hazard Analysis and
    Critical Control Points) regulations for seafood processors (53 FR
    40378, December 18, 1995) (21 CFR Parts 123 and 124). The final rule
    became effective on December 18, 1997. Primary processors of
    aquaculture products are responsible for ensuring that their HACCP
    Plans address systems for drug residue control. The Center for Food
    Safety and Applied Nutrition (CFSAN) issued a Compliance Program
    Guidance Manual (7304.018), Chemotherapeutics in Seafood, in FY 2002
    outlining procedures for sampling aquaculture products to be tested
    for drug residues. This compliance program addresses sampling of
    product from both domestic and imported sources.

    In 1994, Congress passed legislation that would allow veterinarians
    to prescribe drugs in a manner inconsistent with the approved new
    animal or new human drug labeling. This act is called the Animal
    Medicinal Drug Use Clarification Act (AMDUCA)(21 U.S.C. §360b(a))
    and the regulations that implement AMDUCA are published in Title 21
    Code of Federal Regulations Part 530. These regulations describe the
    specific conditions under which extralabel use is permitted.

    Expansion of the Tissue Residue program has paralleled the Agency\'s
    growing concern about consumer exposure to drug residues in the
    edible products of food animals. For example, in 2002, the Agency
    became aware of the use of drugs in the production of honey, to
    treat diseases of honey bees. This Compliance Program has been
    expanded to address this concern.

    In an effort continually to improve the program, CVM develops new
    training courses for Federal and State investigators to address
    identified training needs. CVM also organizes national cooperative
    meetings with officials from FDA, FSIS, GIPSA, APHIS and individual
    states, writes educational articles, and conducts industry outreach
    programs in an effort to provide message-specific information to
    educate firms on sound drug use and residue prevention practices.

    CVM encourages the District Offices to develop cooperative
    agreements (i.e., contracts, partnership agreements, memoranda of
    understanding, and informal arrangements) with their state agencies
    to conduct initial inspections. These inspections are predominantly
    educational in nature and are extremely important in the prevention
    of future residues.

    For residues detected in seafood products the ultimate goal is to
    determine the cause of the residue and pursue regulatory action. The
    current CFSAN sampling program focuses on drugs that are not
    approved for use in aquaculture.

There are currently only two drugs approved for use in honey bees,
oxytetracycline and fumagillin. If a residue is reported of a drug other
than the two approved drugs, then the residue was caused by an
extra-label use, and may be considered a violation of AMDUCA .

# **[PART II -- IMPLEMENTATION]{.underline}**

## **A. INTRODUCTION**

> This program provides a framework from which each District can fashion
> its own drug residue control initiatives. CVM requests that Districts
> receiving reports of violative tissue residues from USDA/FSIS take
> steps to protect the consumer by either conducting Federal or
> assigning State onsite investigations at the farm level and other
> points of responsibility throughout the marketing chain, and to
> initiate actions commensurate with the findings.
>
> CVM will issue FACTS assignments to request Federal investigation of
> repeat violators. CVM will also issue inspectional assignments via
> FACTS for violative residues detected in seafood and other animal
> derived human food. The Districts are encouraged to recommend
> enforcement action for such violations.

## **B. OBJECTIVES**

-   To conduct investigations/inspections to determine the cause of
    illegal drug residues and/or shipment of adulterated food.

-   To develop data descriptive of on‑farm practices of management and
    animal drug use for program decision support, identification of
    educational needs, and policy development.

-   To obtain correction through voluntary and/or enforcement actions.

## **C. PROGRAM MANAGEMENT INSTRUCTIONS**

###  1. Inspectional

> FDA Districts conduct on‑site inspections in the follow‑up of
> violative tissue residue findings of public health concern reported to
> them by FSIS. In association with these assignments the Districts
> should investigate all those in the marketing chain who may have acted
> irresponsibly.
>
> Districts are encouraged to watch for trends or patterns in types of
> residues or involved parties; for example, the same buyer/dealer
> involved in a number of residues or a sudden increase in residue
> reports involving the same drug. The Residue Violation Information
> System (RVIS) is an excellent source for this type of data on
> residues.
>
> The Agency\'s approach to focusing on individual firms for case
> development will be to use a coordinated team approach when
> determining which case(s) to pursue. If the District believes that it
> should develop a case on a specific producer or someone in the
> marketing chain please contact the Compliance Information Management
> Team, HFV-235, Randy Arbaugh or Deborah Cera to discuss
> investigational approach/priority.

Districts should request intensified sampling of egregious firms in an
effort to obtain timely residues to facilitate case development. Please
submit such requests via email to the Compliance Information Management
Team, HFV-235, Deborah Cera, who will handle coordination with the FSIS
Technical Services Center. In order to facilitate successful sample
collection please be sure to provide as much relevant information as
possible regarding the firm's marketing practices, e.g., what slaughter
plant(s) they use, are animals delivered directly to slaughter, or
through a middleman (provide name), and on what day of the week do the
animals generally go to slaughter.

> **NOTE:**
>
> The current CFSAN Compliance Program, 7304.018, Chemotherapeutics in
> Seafood, is a sample collection program designed to test for drugs
> that that are not approved for use in aquaculture. If a domestic
> sample is found to be positive, CVM will issue an assignment for
> follow-up to document the violation. Case development should be
> considered for such residues with all questions directed to the
> Compliance Information Management Team, HFV-235, Fran Pell.
>
> To discuss case development for drug residues in meat and poultry
> contact the Enforcement and Regulatory Policy Team, HFV-232, Reginald
> Walker. For all other residues detected in animal derived foods,
> contact Compliance Information Management Team, HFV-235, Fran Pell, to
> discuss case development.
>
> Pesticide and industrial chemical residues, mycotoxin contamination,
> microbiological residues, and heavy metals reported to the Districts
> by FSIS under its Contamination Response System (CRS) will be covered
> under the Feed Contaminants Program (7371.003). Under unique
> conditions, certain violative drug residues may be reported through
> the CRS. Follow‑up investigational time for CRS drug residues should
> be charged to this program (7371.006). Contact the Enforcement and
> Regulatory Policy Team, HFV-232, Sandra Washington before initiating a
> follow‑up to a CRS report.

#### a. On‑Site Inspections by FDA of Meat and Poultry Violations

#### 

1)  **Repeat Violators:** This is the **top priority** for FDA
    inspections/investigations. Firms or individuals who repeatedly
    present adulterated animals for slaughter may represent a
    significant public health risk. Therefore, CVM will issue an
    assignment to the District in FACTS requesting an FDA on‑site
    investigation for each repeat violator. A repeat violator is an
    individual who sells a slaughter animal whose carcass is found to
    contain a violative concentration of a drug, pesticide, or
    environmental contaminant within a 12‑month period after the first
    violation and after receiving the FSIS Notification Letter.

2)  **First‑time Violators:** As resource allow, conduct an on‑site
    inspection/investigation for first‑time violators when FSIS reports
    violative tissue residues for the following situations:

-   Drugs prohibited from extra-label use in food‑animal use -
    chloramphenicol, diethylstilbestrol (DES), nitrofurans
    (furazolidone, nitrofurazone), or nitroimidazoles (e.g.,
    dimetridazole, ipronidazole), clenbuterol, sulfonamides in lactating
    dairy cattle (except approved use of sulfadimethoxine,
    sulfabromomethazine and sulfaethoxypyridazine), fluoroquinolines,
    glycopeptides, and phenylbutazone in female dairy cattle 20 months
    of age or older.

-   Drugs not approved for food animal use: beta agonists (e.g.,
    fenoterol, salbutamol), tranquilizers, etc.

-   Very high level residues, indicating intentional misuse of the drug
    and/or a complete disregard for the withdrawal period.

```{=html}
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```
-   Drug tissue residues reported under the CRS. These assignments will
    be issued from CVM.

> **NOTE:**
>
> **If none of the above criteria is met on an initial residue violation
> then resource constraints do not allow for an FDA investigation.**
> Cooperating State agencies should be assigned inspections of all other
> first‑time violators to determine the cause of the residue and to
> attempt to prevent a repeat violation through education and/or any
> regulatory action deemed appropriate by the State.

#### b. On‑Site Inspections by FDA of Seafood.

The drugs that are being tested for in Seafood are for unapproved drugs.
All violations require an FDA follow-up and a FACTS assignments will be
issued by CVM.

#### c. Investigation of Food Animal Marketing Firms

> Focusing on firms/people responsible for the delivery for introduction
> or the introduction into interstate commerce of adulterated products
> is an important concept under this program. Experience has shown that
> investigations can lead to producers, haulers, dealers, auction barns,
> and buyers, any one of which may be held responsible for the
> violation. Parties throughout the chain of distribution may act
> irresponsibly by not determining if animals they handle are medicated
> or not forwarding this information to the next person or firm in the
> marketing chain. For example, a dealer or auction barn can take
> precautions by determining if animals are medicated and selling them
> as such. Dealers have been found to purchase medicated animals
> supposedly for dog food and then offer them for sale at a
> slaughterhouse for human food. Please relay these incidences to the
> local Grain Inspection Packers and Stockyards Administration. Any
> animal offered for sale at a USDA licensed slaughter facility is for
> human food. Implementation of the marketing chain strategy should be
> coordinated at the local and national levels between FDA, FSIS, APHIS,
> and GIPSA and State agencies. For example, we can request that FSIS
> increase sampling of a producer or dealer\'s animals. The goal is to
> use the expertise and the legal tools possessed by each group. FDA is
> the lead agency in collecting evidence and initiating regulatory
> action.
>
> Districts should work closely with the Enforcement and Regulatory
> Policy Team, HFV-232, Reginald Walker at the onset of selecting a firm
> or individual for possible regulatory action.

#### d. Inspections at Aquaculture Farms

There are six drugs approved for use in aquaculture. They are:
oxytetracycline, sulfadimethoxine/ormetoprim, formalin, chorionic
gonadotropin, tricaine methanesulfonate and sulfamerazine. Sulfamerazine
is not currently marketed. The brand names, species approved for and
conditions of use can be found at:

<http://www.fda.gov/cvm/aqualibtoc.htm#ApprovedDrugs>

> All of the drugs in the current CFSAN testing program are not approved
> for aquaculture use in the United States. The drugs may be labeled for
> non-food fish and later diverted to food fish producers. It is
> important to determine if the drug manufacturer or distributor is
> marketing these drugs for this use. If an FDA approved drug was used
> in an extra label manner determine if a veterinarian was involved. If
> so, follow-up with the veterinarian as appropriate. Determine why the
> producer used the drug and, if not prescribed by a veterinarian, what
> information was used by the producer to determine how to use the drug.

#### e. Inspection of other Animal-Derived Products

During inspections of other animal-derived product producers, the drug
identified by the residue may have been used in an extra-label manner,
so determine if there was a veterinarian involved with the use, and
whether all of the conditions of AMDUCA were met.

#### f. Extra-label Use

The Animal Medicinal Drug Use Clarification Act became law in 1994 and
the regulations implementing this law can be found in Title 21 Code of
Federal Regulations Part 530 (21CFR 530). The regulations describe the
conditions under which FDA approved drugs can be used in a manner
inconsistent with the approved labeling as long as such use is by or on
the lawful written or oral order of a licensed veterinarian within the
context of a Veterinary-Client-Patient Relationship (VCPR). This
regulation only applies to FDA approved drugs and the use must be
therapeutic in that the animal must be sick or might die if not treated,
and there needs to be a valid veterinarian client patient relationship.
For more details refer to the 21CFR 530.

While AMDUCA does not permit the extra-label use of an FDA approved drug
in or on feed, CVM recognizes that for some species of animals this is
not always practical. FDA published a Compliance Policy Guide (CPG Sec.
615.115), 'Extra-Label Use of Medicated Feeds for Minor Species', which
permits the extra-label use of medicated feed for minor species under
specific circumstances. Briefly, this extra-label use can only be done
upon the order of a veterinarian, the feed must be manufactured
according to the approval and there is no reformulating of the feed. For
aquaculture species there are two approved medicated feeds for food
fish. More details can be found at:

<http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-115.html>

#### g. FSIS Special Programs

> \(1\) FAST
>
> FAST (Fast Antimicrobial Screen Test) is a microbial inhibition
> screening test. It was designed to be used by an FSIS veterinarian or
> a designated food inspector in a slaughter plant, for the detection of
> antibiotic and sulfonamide residues in livestock kidney tissue. The
> FAST test reacts with at least 56 different antimicrobials.
>
> The FAST test is based on the principle that if animal tissue contains
> a residue of previously administered antimicrobial, fluid from the
> tissue will inhibit the growth of a sensitive organism on a bacterial
> culture plate. The plates are examined for zones of inhibition around
> the sample, which constitutes a positive test. The significance of the
> FAST test is its high degree of sensitivity over the old CAST (Calf
> Antibiotic Sulfa Test) test and the fact that test results can be
> obtained after a minimum of **6 hours** incubation to a maximum of 24
> hours from the time the plate is incubated.
>
> If the result is negative the carcass is released. If the result is
> positive, tissue samples (muscle, kidney, and liver) are sent to the
> laboratory for bioassay testing and the carcass is retained pending
> laboratory results.
>
> \(2\) STOP
>
> STOP (Swab Test on Premises) is an in‑plant test currently being used
> by FSIS plant inspectors on suspect animals to test for antibiotic
> microbial inhibitors. STOP‑positive carcasses are retained pending the
> receipt of results of confirmatory tests, which are automatically
> conducted in FSIS laboratories.

#### h. FSIS Condemnation Practices

> Where FDA has established a tolerance for a marker residue in a target
> tissue FSIS will condemn the entire carcass when a violative residue
> is confirmed in the target tissue. For other drugs, if the liver or
> kidney is found to contain violative residues, they alone are
> condemned. In all cases if the muscle contains a violative residue
> then the entire carcass is condemned.
>
> An exception to the above is the routine condemnation of the entire
> carcass of any non-ruminating veal calf found to contain a hormonal
> implant.

### 2. District Monitor Responsibilities

Each District should assign an individual to serve as a monitor for this
compliance program. The monitor\'s duties should include the following:

-   Review Weekly Residue Report. CVM, in consultation with the District
    Program Monitor, will issue assignments to the District in FACTS for
    FDA Investigations and enter the appropriate assignment activity
    code in RVIS. The Monitor should enter all activity codes for
    assignments and follow-ups.

-   Once an investigation is completed. The Program Monitor should,
    review the EIR for newly identified sources, name/address, firm‑type
    corrections, and additional middleman information. This information
    should then be entered into RVIS.

-   The Monitor should promptly enter appropriate activity codes
    covering Repeat Violator Status, Completed Investigations,
    Regulatory Reserve Samples, and Regulatory Actions taken. Every
    violation followed up by an FDA or State investigator should have
    the FDA Responsibility Flag entered into RVIS as responsible, not
    responsible, or involved. This information is needed before FSIS can
    post a firm to its Web Report of Repeat Violators.

-   Periodically review RVIS for violator/violation trends, e.g.,
    specific middleman involvement in a number of violations or an
    increase in the number of residues for a specific drug. Notify the
    Compliance Information Management Team, Deborah Cera, Fran Pell, or
    Randy Arbaugh if you believe that an investigation is warranted.
    Keep abreast of RVIS enhancements.

-   Assign State investigations per guidance contained in Part II.C.1.a.
    of this program. Provide the state with computer‑generated
    Attachment C forms for TRIMS data collection and remind them to
    complete the Drug Inventory Survey Form (Attachment G).

-   Review completed EIRs/Attachment C forms and Drug Inventory Survey
    forms to determine if required fields have been completed. Discuss
    any incomplete reports with the appropriate parties to improve the
    quality of future data reported.

-   For all Federal and State investigations/inspections submit a copy
    of the Field Accomplishments Compliance Tracking System (Facts)
    Coversheet with endorsement, completed Tissue Residue Evaluation
    Form(s) (Attachment C), Drug Inventory Survey Form (Attachment G),
    to the Compliance Information Management Team, HFV-235, Attention:
    Fran Pell

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-   Request that the inspectors/investigators contact the District
    Program Monitor before the start of an on‑farm follow‑up so that
    they can get an updated violator history to ensure that additional
    residues have not occurred since the assignment date.

-   Request the Regulatory Reserve Portion of samples for all firms that
    might become the subject of an enforcement action. Requests should
    be timely to ease FSIS's burden of sample retention. All samples not
    requested will be destroyed after 12 months. All requests should be
    directed to Don Gordon, <Donald.Gordon@FSIS.USDA.Gov>, Tel. No.
    314-263-2680 ext. 341.

-   Monitors should maintain a list of samples that they have requested
    to be stored in an FDA laboratory. Periodically review this list and
    request a Sample Destruction Notices (SDNs) be prepared through the
    appropriate channels in your Districts once it becomes clear that
    the District will not be initiating enforcement action against a
    firm.

-   Provide the District Director, and Directors of Compliance and
    Investigations, where appropriate, with a list of local Repeat
    Violators and associated District activities, at least twice
    annually.

-   Serve as a clearinghouse for distribution of information to
    cooperating State officials.

-   Inform District management of all CVM/ORA‑sponsored training
    initiatives. Recommend training of all Federal/State personnel
    conducting residue investigations.

-   Maintain routine communications with local representatives from
    FSIS, APHIS, GIPSA, and the States.

-   Work with CVM to distribute Industry outreach materials appropriate
    to address local residue concerns.

### 3. Analytical

> Ordinarily FSIS will analyze tissues and conduct confirmatory
> analyses. FDA confirmatory analyses of tissue samples collected,
> analyzed, and confirmed by FSIS are not necessary to support
> regulatory action. Other tissue samples **should not** routinely be
> sent to the Denver District Laboratory. FSIS has agreed to run
> confirmatory tests on those samples that the FDA District needs to
> support casework. For example, if during an investigation of a
> neomycin residue it is revealed that a sulfa was used in combination
> with neomycin, a portion of the reserve sample can be sent back to
> FSIS for analysis for sulfas.
>
> One exception to the above would be when FSIS reports finding a
> hormone implant in a veal calf submitted by a "Repeat Violator". The
> District should request that the reserve sample of the actual implant
> be shipped to the Denver District Laboratory where hormones present in
> the implant will be identified.
>
> Please contact the Compliance Information Management Team, HFV-235,
> Deborah Cera, to facilitate requests for additional analyzes.

### 

### 4. Program Interaction

>  
>
> When the investigation implicates a medicated feed produced by either
> a commercial feed mill or an on‑farm mixer/feeder, conduct a
> comprehensive GMP inspection. For example, carbadox residues in swine
> generally result from feed and not dosage form drugs. Charge all time
> expended for GMP inspections to the Feed Manufacturing Program PAC
> 71004, regardless of whether done at the feed mill or the
> mixer‑feeder.  Remember, the regulations in 21 CFR Part 225 sections
> 225.10 to 225.115 apply to facilities manufacturing one or more
> medicated feeds for which an approved medicated feed mill license is
> required. The regulations in 21 CFR Part 225 sections 225.120 to
> 225.202 apply to facilities solely manufacturing medicated feeds for
> which an approved medicated feed mill license is not required.
>
>  
>
> When the tissue residue results from a non‑drug chemical contaminant,
> such as pesticides, metals, mycotoxins, or microbiological
> contaminants, charge the time expended for follow‑up investigations to
> PAC 71003A ‑ Feed Contaminants Program.
>
> The success of the Agency's program to support the prevention of the
> introduction and amplification of BSE in the United States is
> dependent on the ability of investigators to identify violative firms
> and operations. While initial efforts by Federal and State
> investigators have identified and inspected most renderers and
> commercial feed mills, continued efforts are needed to identify and
> continue to inspect all firms subject to the regulation. Ruminant
> feeders are an important obligation that should receive additional
> attention. Unless another BSE inspection has recently been conducted,
> add-on BSE inspections should be conducted for each ruminant feeder
> visited during a tissue residue follow-up. Charge time expended for
> such inspections to PAC 71009 -- BSE/Ruminant Feed Ban Inspections.
>
> Tissue residue monitors should maintain close contact with their
> Regional Milk Specialists and State milk authorities. RVIS reports of
> dairy animal violations are supplied to these individuals on a
> quarterly basis. One long‑term goal is for involved agencies to share
> all available information related to drug residues (milk and meat) in
> dairy animals. This effort can maximize resource utilization in
> targeting enforcement actions and promoting effective residue
> controls.

### 5. Inter‑Agency Agreements

See MOU 225-85-8400 ‑ MOU between FDA, FSIS, and EPA regarding
regulatory activities concerning residues of drugs, pesticides and
environmental contaminants in foods, which went into effect on February
1, 1985.

### 6. Federal/State Relations

States participate in this program under agreements (contract, MOU,
partnership, and informal) to conduct inspections. The emphasis of the
State programs is to determine the cause of the residue and to provide
producer education in an effort to prevent future violations.

> Regions/Districts are urged to develop cooperative work sharing
> agreements with **each of their** states. General guidance for the
> development of work‑sharing agreements is found in RPM Chapter 3‑20.
> Maintain a high level of communication with cooperating States and
> share with them the periodic RVIS reports of State findings and
> results of program evaluations.
>
> For information on the formation of agreements with States, contact
> the Division of Federal‑State Relations, HFC‑150.

# **[PART III ‑ INSPECTIONAL]{.underline}**

## **A. Inspectional Operations**

> The three elements of a case for which evidence should be collected by
> the investigator are: jurisdiction, violation(s), and responsibility.
> The order in which the evidence is gathered is at the District\'s
> discretion. Because of the public health significance, the District
> should be attentive to steps that can be taken to prevent adulterated
> animals from going to market. For example, if an on‑farm investigation
> reveals that veal calves, due to go immediately to market, are still
> being fed a neomycin‑containing milk replacer, steps should be taken
> to prevent their marketing by requesting State assistance (quarantine
> power or other enforcement tools) and by alerting the FSIS Regional
> Office of the potential offering of these animals at USDA licensed
> slaughter facilities.

### 1. Jurisdiction

Establish and document interstate (IS) commerce.

> Obtain affidavits from the involved auction/sales barn or slaughter
> facility or processing plant attesting to the fact that it routinely
> deals in interstate commerce and include the approximate percentage of
> IS business. Examples of recent records of IS sales may also be
> appropriate as part of the documentation with slaughter facilities or
> the processing plant, a current affidavit (desirably no older than 6
> months for injunction or prosecution cases) is acceptable for
> establishing IS commerce. Call the Enforcement and Regulatory Policy
> Team, HFV-232, Reginald Walker for assistance/advice.
>
> Notify the producer or other implicated person that animals or meat
> from animals he/she offers for sale may move in interstate commerce,
> even if the animals are not delivered directly into interstate
> commerce. In those cases in which extra‑label use or other drug
> adulteration or misbranding charges may be appropriate, interstate
> jurisdiction over the drug(s) should be documented.

### 2. Violation

####  a. Meat and Poultry Residues

> FSIS reports violative residues to FDA on a single‑animal basis for
> FDA to follow‑up. FSIS sample results show the amount and type of the
> drug detected. FSIS analysis may be limited to the identification of
> one drug. If investigational evidence supports the presence of another
> drug, call the Compliance Information Management Team (HFV-235),
> Deborah Cera or Fran Pell so that she can request analysis of the
> tissue sample for the additional compound. Animal identity problems
> should be worked out with the FSIS Technical Services Center, Dr.
> Julie Cornett, 402-221-7400, or local APHIS Animal Identification
> Specialist. ID Specialists can be reached by contacting the local
> Veterinary Services Office. (See Attachment D) The identification of
> the responsible party given by FSIS **should** be positively confirmed
> by the FDA investigation. Use ear tag numbers, lot numbers, or other
> means to adequately link the animal to the producer/party responsible
> for the violation. FSIS, APHIS, and GIPSA can assist in responsible
> party identity.
>
> **NOTE:** When doing a follow‑up of a repeat violator that has
> received FDA prior warning, an affidavit should be obtained from all
> FSIS in-plant inspectors associated with each residue. Please notify
> the FSIS Technical Services Center, Dr. Julie Cornett, 402-221-7400 to
> arrange for and authorize a time for you to meet with the appropriate
> inspector(s) to obtain necessary documentation. (See Attachment F for
> an example of the kind of affidavit needed.)
>
> Medication/treatment resulting in illegal residues may be performed by
> the grower/feedlot, veterinarian, or in rare cases, by the dealer,
> hauler, auction barn, buyer, or slaughterhouse. Because of the number
> of people involved in the marketing chain, it is essential that time
> factors and animal identity is well‑documented. For example, if an
> animal is slaughtered within 24 hours of leaving the farm, it is
> unlikely that a middleman treated the animal. Collect affidavits from
> middlemen affirming that whether or not drugs were used on the animal.
>
> Many residues are caused by conditions conducive to potential tissue
> residue violations at the farm, i.e., \"poor husbandry practices.\"
> When doing an investigation at the producer, determine and describe
> the conditions you observe. That should include [at least]{.underline}
> the following:

\(1\) Inventory all drugs on the premises (See Attachment G).

(2) Determine and list other drug‑containing products, such as medicated
    feeds, or other drug sources, that could have been, or are being
    used in food‑producing animals. Although most violative residues
    result from direct misuse of drugs in the animals, tissue residue
    investigations have revealed residues resulting from
    cross‑contamination of withdrawal feeds with medicated feeds in
    feeding bins, or from feeding calves milk from treated cows. If
    possible, physical or documentary samples of drugs or feeds should
    be collected if implicated in the residue.

(3) Describe where the drugs are stored, how they are stored, and who
    has access to the drugs.

(4) Determine who administers medication and try to interview those
    individuals about their medication practices (who determines what
    animals are to be medicated, how are the medications selected, how
    are dosages determined, etc.).

(5) Determine identification systems and segregation/quarantine
    practices, if any, for medicated animals.

(6) Determine if medication records are maintained. Describe the record
    system. Do they include the date of medication, the drug used, the
    dosage administered, milk withholding and slaughter withdrawal
    times, etc.

(7) Determine how the producer has assured that **withdrawal times** are
    met prior to marketing.

> Look for and document fraudulent buying or selling practices
> (violations of Packers and Stockyards Act and regulations) and the
> giving of false certificates or guarantees. GIPSA has been successful
> in levying substantial administrative fines for such violations. All
> swine in interstate commerce must be identified and records concerning
> identification must be maintained (9 CFR Part 71). This rule was
> published by USDA **(APHIS and FSIS) and they will** be responsible
> for its enforcement. If FDA Field offices encounter problems with
> identification of swine, these should be reported to, and worked out
> with your APHIS Animal ID Coordinator. We are also requesting that you
> alert CVM to these problems by reporting them to the Compliance
> Information Management Team, HFV-235, Deborah Cera.
>
> We recommend objectionable conditions be listed on a FDA 483, and
> discussed with management at the conclusion of the inspection. Record
> the applicable information on Attachment C.

#### b. Seafood and Aquaculture Residues

> All drugs that the Agency is currently testing for in seafood are not
> approved for use in aquaculture. The list of approved drugs can be
> found at:
>
> <http://www.fda.gov/cvm/aqualibtoc.htm#ApprovedDrugs>
>
> Some compounds are not traditional drugs but based on their intended
> use, 'to treat or mitigate a disease' they can be considered drugs.
> One example of a compound that falls into this category is malachite
> green. When doing an investigation at the producer, determine and
> describe the conditions that you observe. That should include [at
> least]{.underline} the following:

(1) Inventory all drugs on the premises.

(2) Determine and list other drug‑containing products, such as medicated
    feeds, or other drug sources, that could have been, or are being
    used in fish. Although most violative residues result from direct
    misuse of drugs in the fish, tissue residue investigations have
    revealed residues resulting from cross‑contamination of withdrawal
    feeds with medicated feeds in feed storage bins. If possible,
    physical or documentary samples of drugs or feeds should be
    collected if implicated in the residue.

(3) Describe where the drugs are stored, how they are stored, and who
    has access to the drugs.

(4) Determine who administers medication and try to interview those
    individuals about their medication practices (who determines what
    fish are to be medicated, how are the medications selected, how are
    dosages determined, etc.).

(5) Determine identification systems and segregation/quarantine
    practices, if any, for medicated fish. Keep in mind fish are
    normally medicated in their pond/raceway/net pen. They would
    medicate all the fish in that group. Brood fish may be individually
    medicated.

(6) Determine if medication records are maintained. Describe the record
    system. Do they include the date of medication, the drug used, the
    dosage administered, and slaughter withdrawal times, etc.

(7) Determine how the producer has assured that **withdrawal times**
    have been met prior to marketing.

### 3. Responsibility

> Determine and document who committed the violation, i.e., who did
> what, and when. This would include: misuse of approved drugs, use of
> illegal and unapproved drugs, GMP violations, and poor animal
> husbandry practices that could contribute to causing the violative
> drug residue, and the issuance of false certificates, guarantees, or
> any other statement on the medication status of the animal offered for
> sale. Keep in mind that more than one firm/individual in the marketing
> chain may be held responsible for tissue residue violations.

####  a. Dealer Involvement

> Persons involved in handling, transporting, holding, and marketing
> food‑producing animals should be encouraged to establish systems to
> ensure that if **they administer** drugs to animals in their control
> or care, those drugs are used properly, and to establish systems to
> prevent potentially hazardous drug residues in edible animal products.
>
> Persons who do not administer medications but who acquire animals for
> sale for slaughter (such as livestock dealers) should also establish
> and implement a recordkeeping system. This system should include
> information on the source of the animal and whether the animal has
> been medicated (when, with what drug, and the withdrawal period) to
> preclude marketing of adulterated edible animal tissues.
>
> Specifically, describe the system the dealer has for the following:

(1) Their system to identify the animals they purchase or acquire with
    records to establish traceability to the source of the animal;

(2) Their system to determine from the source of the animal whether the
    animal has been medicated and with what drug(s); and,

(3) If the animal has been medicated, their system to withhold the
    animal from slaughter for an appropriate period of time to deplete
    potentially

> hazardous residues of drugs from edible tissues. If they do not hold
> the medicated animal, then describe how they assure that the animal is
> clearly identified and sold as a medicated animal.
>
> Such persons may be subject to regulatory action if they market
> animals containing illegal residues and have failed to take reasonable
> precautions to prevent the sale of adulterated food \[21 U.S.C.
> 331(a)\].
>
> Seafood does not have dealers like the terrestrial animals. Fish
> haulers are sometimes either associated with the producer or the
> processor. Determine if any drugs or chemicals are put into the fish
> haul truck tanks to reduce stress to fish.

####  b. Veterinarian Involvement

> If the investigation reveals that the drug involved in causing the
> residue was prescribed, administered, or dispensed by a veterinarian
> include the following:
>
> \(a\) Describe the veterinarian/client/patient relationship that
> existed at the time the animals in question were treated. Refer to 21
> CFR Part 530.

-   Does the veterinarian regularly visit the farm premises and examine
    the animals?

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-   Is the veterinarian aware of the husbandry practices utilized by
    this firm?

-   Did the veterinarian examine, prescribe, or administer the drug to
    the animal in question?

-   If the veterinarian administered the drug, report the dosage and
    describe what kind of instructions he/she left for milk withholding
    and/or pre-slaughter withdrawal times. (Did the producer follow
    those instructions?)

-   If the veterinarian did not administer the drug, with whom and what
    kind of instructions did he/she provide for drug administration and
    milk withholding and/or pre‑slaughter withdrawal times? (Did the
    producer follow those instructions?)

(b) Describe how the veterinarian established the recommended withdrawal
    time and how he/she attempted to assure that the producer adhered to
    that time.

(c) Describe how the dispensed product was labeled.

(d) If the drug was one that the veterinarian prepared (by combining 2
    or more products, or other manufacturing methods), list the products
    or ingredients, describe who prepares them, and how they are
    prepared. Use CPG Sec.608.400 - Compounding of Drugs for Use in
    Animals and 21 CFR Part 530.13 for additional guidance.

## **B. GMP Inspections**

## ** **

> Conduct GMP inspections at the feed mill or mixer/feeder when either
> is implicated as causing the residue violation. Use CP 7371.004 for
> guidance and be sure to use Form 2481 when conducting an inspection. 
> See 21 CFR Part 225 sections 225.120 to 225.202 for GMP requirements
> for feed mills that do not require a license.  The GMP regulations at
> 21 CFR Part 226 are for the manufacturers of Type A medicated
> articles.

## **C. Sampling**

> Collect samples (including both documentary samples and/or physical
> samples) to document violative conditions. See IOM Sampling Schedule
> Chart 16 for both potency and drug carryover in feeds.
>
> If illegal or unapproved drugs, such as chloramphenicol or
> nitrofurans, are found on a food‑producing animal farm, collect
> documentary samples of seizable‑sized lots.

### 1. Sample Submission

> Ship all medicated feed and animal drug samples for drug or
> microbiological analyses to the Denver Laboratory. Before shipping
> samples contact the Laboratory Director, Karen Kreuzer, HFR-SW260, at
> 303-236-3060, to discuss inspectional findings and required sample
> analyses.

### 2. Collection Report (CR)

> Prepare a CR for the FSIS‑collected sample [only]{.underline} when
> regulatory action is being considered. CRs need to be prepared for
> each drug being used in an extra‑label manner and for any other sample
> collected during the investigation

## **D. Reporting**

> Submit, Field Accomplishments Compliance Tracking System (Facts)
> Coversheet with endorsement, completed Tissue Residue Evaluation
> Form(s) (Attachment C), Drug Inventory Survey Form (Attachment G) to
> the Compliance Information Management Team, HFV-235, Attention: Fran
> Pell. Photocopy necessary forms for District use. The completion of
> Attachments C and G are essential for the success of the automated
> database, TRIMS (Tissue Residue Information Management System). Upon
> request CVM will provide information for comprehensive District
> reports. TRIMS is extremely useful in identifying trends in causes of
> tissue residues, e.g., illegal use of bulk drugs, extra‑label use of
> dosage form drugs, medicated feeds, etc.
>
> A copy of the fully completed FACTS coversheet, along with pertinent
> parts of the memo of investigation or EIR should be forwarded to the
> FSIS Technical Services Center. Please Fax or email any source
> information changes to FSIS immediately so they can issue a corrected
> notification letter to the appropriate individual and update RVIS. It
> is FDA's responsibility to provide FSIS with updated violator
> information for RVIS. Do not complete an Attachment C for violations
> in Seafood or Honey. Send the EIR with attachments to the Compliance
> Information Management Team, HFV-235, Attention: Fran Pell.

## **E. Criminal Activity Investigations**

> When illegal residue investigations uncover activities of a criminal
> nature, such as using false names, knowingly purchasing medicated
> animals for slaughter, purchasing animals with the understanding that
> they will be sold for rendering or other non‑human food use and then
> offering the animals for slaughter for human food, you should consider
> referring the case to FDA\'s Office of Criminal Investigations (OCI).
> This Office has skills, contacts, and expertise that may be invaluable
> in conducting the investigation and pursuing the appropriate
> enforcement action. The formal procedure for referral is described in
> the Investigations Operations Manual (IOM) Chapter 9, Subchapter 980.
> **If OCI is unable to pursue a specific case, the District should
> still conduct follow‑up inspections in accordance with this program.**
> OCI may be able to assist in certain areas or FDA investigators may
> work jointly with OCI agents in the investigation.

# **[PART IV ‑ ANALYTICAL]{.underline}**

## **A. Responsibilities**

### 1. Sample Preparation

Prepare feed samples for drug analysis as described in the AOAC 16th Ed.

### 2. Tissue Sample Storage

The analyzing FSIS laboratory will retain all FSIS-collected violative
samples for up to 12 months. Once the FDA District Office decides that a
firm may warrant regulatory action they should immediately request that
the pertinent sample(s) be shipped to an FDA laboratory. Please note
that unless a sample shipment request is received, all samples will be
destroyed by FSIS after 12 months. Samples should be retained by FDA
until a compliance action is completed or the firm sufficiently
demonstrates its sustained ability to market animals free of violative
residues.

Districts should devise a sample accountability system for the
FSIS‑collected tissue samples. A suggested system would be to prepare a
sample accountability card for each sample received using the FSIS
laboratory form number as the sample number. By using the form number, a
CR would not be prepared, thereby eliminating the problem of how to
report time for preparing the CR. A CR would, however, need to be
prepared before a case is forwarded for regulatory consideration.

Tissue samples using this system are handled in the same manner as any
FDA sample.

An FSIS Directive establishes a formal system to guarantee sample
integrity. An intact FSIS official seal should be affixed to the sample
container. Contact Compliance Information Management Team, Deborah Cera,
if you find this not to be the case routinely. Although FDA would prefer
all samples from FSIS to be sealed, the lack of a seal should not deter
you from appropriate follow-up.

3\. Problem Area Flags (PAF) for PACs

> PAC 71003A - PAF (PES, NAR)
>
> PAC 71004 - PAF (NAR, KIT, DRT, ANT, DRA)
>
> PAC 71006 - PAF (NAR, DRT, ANT, DRA, KIT)

Note: This only applies to Meat and Poultry samples reported to FDA by
USDA, FSIS. Follow C.P. 7304.018, Chemotherapeutics in Seafood, for
information on seafood samples for drug residues.

# **[PART V ‑ REGULATORY/ADMINISTRATIVE]{.underline}**

 

## **A.  GENERAL**

** **

> Enforcement follow‑up activity is prioritized by the degree of human
> health risk potential involved in the residue violation(s).
> Additionally, enforcement action may be against individual(s)
> responsible for multiple residue violations involving drugs presenting
> a lesser human health risk. The following information covers most
> violative residue situations. Occasionally, however, unique situations
> are encountered which require new or special investigational or
> enforcement procedures. Discuss these new or special situations with
> CVM, Division of Compliance, Enforcement and Regulatory Policy Team,
> Reginald Walker as they occur so that an acceptable investigational or
> enforcement strategy can be developed. Also notify and discuss with
> the Compliance Information Management Team, Deborah Cera proposed
> joint interagency (FDA//FSIS/GIPSA) enforcement actions against
> individuals/firms (other than the producer) at the initial stage of
> development. CVM will contact FSIS, and GIPSA headquarters units and
> the District will contact FSIS, and GIPSA field units to implement
> interagency enforcement actions.

 

> For aquaculture questions contact the Compliance Information
> Management Team, Fran Pell.  For other animal derived human foods
> contact Deborah Cera, or Fran Pell.

 

> Animals are considered food under the Act when offered or intended for
> slaughter for human food at slaughter facilities that ship their
> products into interstate commerce.
>
> The Federal Food, Drug, and Cosmetic Act (the Act)(21 U.S.C. 321(f),
> defines food as "(1) articles used for food or drink for man or other
> animals...and (3) articles used for components of any such article."
> (Section 201(f)). Food-producing animals and fish, even though not in
> their final, edible form, have been held to be food under the statute
> [United States v. Tomahara Enterprises Ltd.,]{.underline} Food Drug
> Cosm. L. Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live calves intended as
> veal are food) and [United States v. Tuente Livestock]{.underline},
> 888 F. Supp. 1416, 1423-26 (S.D. Ohio 1995) (live hogs are food). More
> generally, courts have long held that unprocessed or unfinished
> articles are or can be food. *See* [Otis McAllister & Co. v. United
> States,]{.underline} 194 F.2d 386, 387 (5^th^ Cir. 1952) and cases
> cited there (unroasted coffee beans are food). Thus, live animals
> raised for food are "food" under the Act.
>
> Regulatory action can be taken against a producer or other responsible
> persons when it has been documented that the animals offered for
> slaughter in interstate commerce resulted in illegal residue(s) in
> edible tissue. \[21 U.S.C. 331(a)\] For example, regulatory action can
> be taken against a producer who sells animals containing illegal drug
> residues to an intermediate party, which in turn sells them at an
> auction, where they are purchased by a buyer who in turn sells them to
> a slaughter plant doing an interstate business. In such circumstances
> the producer can be charged with causing the delivery for introduction
> into interstate commerce of adulterated food, even if the producer has
> no specific knowledge of the ultimate destination of the animals.

 

> The other parties involved in the scenario may also be charged with
> causing the delivery for introduction into interstate commerce of
> adulterated food, or they may be charged with offering for
> introduction into interstate commerce. Additionally, \"caused to be
> introduced\" charges may be brought against veterinarians, animal
> dealers, buyers, vendors, auction barns, or other persons who are
> responsible for having caused the residue or having introduced animals
> into interstate commerce without first assuring that the animals were
> free of illegal residues \[21 U.S.C. 331(a)\]

 

> When treated animals remain on the premises, initiate action to
> prevent further processing of the animals, such as requesting that
> USDA/FSIS sample and hold future shipments made by the producer and/or
> requesting State detention/quarantine of the animals. Provide complete
> information (e.g., suspected shipment date, destination, drugs
> involved, etc.) to cooperating agencies and officials.

 

## **B.  INITIAL VIOLATION**

 

> The FSIS Violation Notification Letter includes appropriate language
> to serve as FDA prior warning to the producer shipping animals with
> violative residues. Under the following circumstances it is
> appropriate to issue a Warning Letter to an initial violator (when the
> investigation confirms his culpability):
>
>  

-   Involvement of drugs considered of **high risk to human**
    health/safety whether approved or unapproved.

>  

-   Involvement of apparent extra‑label use. Refer to 21 CFR Part 530.

>  

-   The occurrence of residue levels so high as to indicate intentional
    misuse of the drug

>  

-   Involvement of drugs where no tolerance has been established.

>  
>
> Seafood violations:  All drugs for which seafood is currently tested
> are not approved for any food fish use in the United States.  If the
> violation, jurisdiction, and responsibility can be documented, CVM
> would consider a Warning Letter for the initial violation.
>
>  

## 

## 

## 

## **C.  REPEAT/MULTIPLE VIOLATIONS**

>  
>
> Firms or individuals who repeatedly present adulterated animals for
> slaughter may represent a significant public health risk.
>
>  

### 1. Warning Letter

 

> A Warning Letter should be considered as a follow‑up to a repeat
> violation. See Attachment B for model Warning Letters. Warning Letters
> for tissue residue violations may be issued directly by the District
> Director except those concerning tissue residue violations where no
> tolerance has been established, extra-label use is documented, and/or
> those which involve the use of compounded drugs or other drug
> adulteration. Warning Letters for aquaculture and other animal-derived
> products also require CVM concurrence prior to issuance. The
> exceptions listed above require CVM concurrence prior to issuance. 
>
> Warning Letters must be submitted to CVM no later than 8-10 weeks from
> the date of **last evidence collection** to meet Agency timeframes. In
> the past the regulatory time clock has routinely started on the date
> of investigation/inspection of the animal producer. However, since
> residue investigations frequently require additional time-consuming
> visits to fully document the violation, it is important to include
> dates of visits made to the veterinarian, auction barn, dealer,
> slaughter house, etc. in your recommendation to CVM. Include language
> in the Warning Letter that clearly specifies the beginning and end
> dates of the investigation.
>
>  
>
> Title 18 violations may also be included in the Warning Letter to
> inform the recipient that GIPSA or FSIS may take actions against these
> violations. (See Attachment E). These are circumstances where false
> certificates or guarantees are knowingly provided or when provided
> without any knowledge of the animal\'s medication status. Do not issue
> Warning Letters containing only Title 18 violations.
>
>  
>
> If the state inspection documents residue violation, responsibility,
> and jurisdiction, CVM will consider Warning Letter recommendations
> based on the state inspectional data.
>
>  

### 2. Injunction

 

> If a tissue residue violation(s) **occurs after the** issuance of a
> Warning Letter then injunction should be considered against a producer
> and/or other parties that are responsible for introducing animals into
> interstate commerce that result in illegal residues. As with most
> injunctive actions, we need a history of violations and a good
> description of scope and size of the violator\'s operation to help
> explain the need for court action to achieve compliance. Contact FSIS
> to initiate intensive sampling of the producer\'s animals. The
> injunction will be reviewed concurrently with the effort to obtain any
> additional documented violations. In order to proceed with a
> preliminary injunction a documented violative residue or, if it
> involves a producer, an FDA inspection, no older than 60 days is
> required. If the 60‑day time frame cannot be met, consider proceeding
> with a permanent injunction.  If another residue violation occurs
> after a consent decree has been signed, and the inspection documents a
> violation, responsibility, and jurisdiction, the District should
> contact the Office of General Counsel (OGC) attorney who handled the
> original consent decree to discuss enforcement options.  In the
> absence of the original attorney please contact Eric Blumberg, GCF-1
> for further advice.

### 3. Prosecution

>  
>
> Prosecution may be considered when the residue violations involve one
> or more of the following elements and the individuals knowingly do or
> use:

-   Drugs not permitted for extra-label use in food animals, banned or
    unapproved drugs that present significant human health safety
    concerns.

```{=html}
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```
-   Blatant misuse of toxicologically significant drugs resulting in
    residues substantially above tolerance.

```{=html}
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```
-   Issuing false guarantees that animals with violative residues were
    drug‑free or had been properly withdrawn from the drug(s).

```{=html}
<!-- -->
```
-   Multiple misdemeanor counts and/or one or more felony counts.

> The Office of Criminal Investigations (OCI) is responsible for
> reviewing all matters in FDA for which a criminal investigation is
> recommended, and is the focal point for all criminal matters.
>
> FDA personnel must refer all criminal matters, regardless of their
> complexity or breadth, to OCI. This includes criminal search warrants,
> misdemeanor prosecutions, felony prosecutions, referrals for criminal
> investigation, and Section 305 meetings.
>
> District management must communicate with its local OCI office before
> pursuing any criminal matter. This communication is absolutely
> essential to preclude potential interference with other on-going
> criminal investigations and to prevent confusion among the components
> of the Office of Chief Counsel and the Department of Justice that are
> responsible for handling FDA's criminal cases. During this
> communication, OCI is to be provided with all of the facts of the
> potential case and any additional information that is relevant to, or
> could impact, the case in any way. OCI will decide promptly whether or
> not it is interested in pursuing the case and will communicate its
> decision back to the District Office.

If OCI chooses not to pursue a criminal matter, the District Office is
at liberty to proceed with the case in accordance with the procedures in
Chapter 6 of the Regulatory Procedures Manual.

# **[PART VI - CONTACTS, ATTACHMENTS, AND REFERENCES]{.underline}**

## **A. PROGRAM CONTACTS**

### 1. CVM

#### a. Program Inquiries

Deborah Cera, Program Manager

240-276-9209

> Compliance Information Management Team, HFV-235
>
> CVM/Division of Compliance
>
> Deborah.cera@fda.hhs.gov

#### b. Technical Guidance

> Frances Pell, 240-276-9211 or Deborah Cera, 240-276-9209
>
> Compliance Information Management Team, HFV-235
>
> CVM/Division of Compliance, HFV-235
>
> Deborah.cera@fda.hhs.gov
>
> Frances.pell@fda.hhs.gov

#### c. Regulatory Inquiries

Reginald Walker

240-276-9234

Enforcement and Regulatory Policy Team, HFV-232

CVM/Division of Compliance

Reginald.walker@fda.hhs.gov

#### d. Policy Questions

Gloria Dunnavan, Director

240-276-9200

CVM/Division of Compliance, HFV-230

Gloria.dunnavan@fda.hhs.gov

### 2. ORA

#### a. Inspectional Inquiries

Division of Field Investigations, HFC‑132,

Telephone: Jim Dunnie, 301-827-5652

#### b. Analytical Inquiries

Division of Field Science, HFC‑141,

Telephone: George Salem, 301‑827-1031

#### c. Federal/State Relations Inquiries

Division of Federal‑State Relations, HFC‑152

Telephone: Glenn Johnson, 301‑827-2907

## **B. LIST OF ATTACHMENTS**

> 1\. [Attachment A]{.underline} ‑ FSIS Laboratory Reporting Codes
>
> 2\. [Attachment B]{.underline}‑ Model Letters
>
> 3\. [Attachment C]{.underline}‑ Tissue Residue Evaluation Form
>
> 4\. [Attachment D]{.underline} - USDA Contacts
>
> 5\. [Attachment E]{.underline} ‑ GIPSA/Title 18 Memo
>
> 6\. [Attachment F]{.underline} ‑ Example of Slaughter Plant Affidavits
>
> 7\. [Attachment G]{.underline} - Drug Inventory Survey

8\. [Attachment H]{.underline} -- Program Monitor Checklist

## **C. APPLICABLE REFERENCES OR AIDS**

## 

### 1. INVESTIGATIONS OPERATIONS MANUAL (IOM): Chapters 4 & 5 Sampling and Inspection.

### 2. 21 CFR Parts 500‑599, Animal Drugs, Feeds, and Related Products.

### 3. [Compliance Policy Guides:](http://www.fda.gov/ora/compliance_ref/cpg/default.htm)

> Sec. 608.400 ‑ Compounding of Drugs for Use in Animals. (CPG 7125.40)
>
> Sec. 615.300 ‑ Responsibility for Illegal Drug Residues in Meat, Milk
> and Eggs. (CPG 7125.05)
>
> Sec. 608.100 ‑ Human‑Labeled Drugs Distributed and Used in Animal
> Medicine. (CPG 7125.35)
>
> Sec. 615.200 ‑ Proper Drug Use and Residue Avoidance by
> Non-Veterinarians. (CPG 7125.37)
>
> Sec. 615.115 - Extra-label Use of Medicated Feeds for Minor Species

### 4. Compliance Programs

> 7303.039 National Drug Residue Milk Monitoring Program
>
> 7371.002 Illegal Sales of Veterinary Prescription Drugs
>
> 7371.003 Feed Contaminants
>
> 7371.004 Feed Manufacturing
>
> 7304.018 Chemotherapeutics in Seafood Compliance Program

### 5. [Regulatory Procedures Manual.](http://www.fda.gov/ora/compliance_ref/rpm/)

### 6. AOAC Official Methods of Analysis, 16th Edition.

> 7\. Memorandum of Understanding - MOU 225-85-8400 ‑ Memorandum of
> Understanding between FDA, FSIS and EPA.

# **[PART VII ‑ CVM RESPONSIBILITIES]{.underline}**

## **A. Program Evaluation**

> Information extracted from Attachment C Evaluation Forms will be
> entered into TRIMS (Tissue Residue Information Management System).
> This database will facilitate the management and analysis of
> information related to tissue residue violations.
>
> The Compliance Information Management Team will periodically prepare
> reports of program findings.

## **B. Inter‑Center Action**

> The Compliance Information Management Team will coordinate CVM efforts
> to exchange residue data with the Center for Food Safety and Applied
> Nutrition, especially when the data may indicate a potential for
> residues in seafood, milk, and/or eggs.

## **C. Compliance Information Management Team**

> The Compliance Information Management Team has the primary
> responsibility for managing/coordinating FDA‑related tissue residue
> activities.
>
> Significant functions include the following:

-   To serve as the primary contact between the FDA District Tissue
    Residue Monitors and CVM; the objective is to exchange information
    and provide guidance on residue-related issues and to respond to any
    problems/needs the Field identifies.

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```
-   To identify, recommend, develop, and implement preventive measures
    to reduce the number violative residues.

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```
-   To prioritize work efforts for program-related resources.

```{=html}
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```
-   To identify specific residue/violator trends through the Residue
    Violation Information System (RVIS) and the Tissue Residue
    Information Management System (TRIMS).

```{=html}
<!-- -->
```
-   To provide CVM's Division of Compliance and the Field with relevant
    residue information to support enforcement actions.

```{=html}
<!-- -->
```
-   To coordinate all FDA efforts concerning the RVIS.

```{=html}
<!-- -->
```
-   To serve as the primary contact point between FDA and FSIS in an
    effort to provide meaningful input into the development and
    implementation of the National Residue Program for meat and poultry.

```{=html}
<!-- -->
```
-   To serve as the primary contact point between FDA's CVM and CFSAN to
    provide input into the development and implementation of drug
    residue testing programs.

## **D. Enforcement and Regulatory Policy Team**

> CVM\'s Enforcement and Regulatory Policy Team is responsible for the
> review of all CVM-related enforcement actions and can frequently help
> in determining the responsible parties. It can also provide guidance
> on the proper collection of the analytical, investigational, and other
> evidence needed to support a case. For questions involving case
> development, please contact the Enforcement and Regulatory Policy
> Team, HFV-232, Reginald Walker for assistance.

# **ATTACHMENT A -- USDA REPORTING CODES**

# **FSIS/USDA Laboratory Reporting Codes**

**[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

0 CAST GENERAL

1 RESIDUE-ACTUAL SPIKED AMOUNT

30 AFLATOXIN

50 NITROSAMINES

51 N-NITROSADIMETHYLAMINE

52 N-NITROSADIETHYLAMINE

53 N-NITROSODIPROPYLAMINE

54 N-NITROSODIBUTYLAMINE

55 N-NITROSOPIPERDINE

56 N-NITROSOPYRROLIDINE

57 N-NITROSOMORPHOLINE

59 RECOVERY

60 CYANIDE

61 STYRENE

80 SYNTHETIC PYRETHRINS

81 CYPERMETHRIN

82 DELTAMETHRIN

83 FENVALERATE

84 FLUCYTHRINATE

85 PERMETHRIN

86 NATURAL PYRETHRINS

87 PYRETHRIN I

88 PYRETHRIN II

89 CINERIN I

90 CINERIN II

92 PIPERONYL BUTOXIDE

99 OTHER

100 HALOCARBON PESTICIDES

101 ALDRIN

102 BENZENE HEXACHLORIDE

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

103 CHLORDANE

104 DIELDRIN

105 DDT AND METABOLITES

106 ENDRIN

107 HEPTACHLOR AND METABOLITES

108 LINDANE

109 METHOXYCHLOR

110 TOXAPHENE

111 PCB\'S

112 HEXACHLOROBENZENE

113 MIREX

114 STROBANE

115 NONACHLOR

116 OCTACHLORO DIBENZODIOXIN

117 HEPTACHLORO DIBENZODIOXIN

118 HEXACHLORO DIBENZODIOXON

119 TETRACHLORO DIBENZODIOXIN

120 DICHLOROPHENOL

121 TRICHLOROPHENOL

122 TETRACHLOROPHENOL

123 PENTACHLOROPHENOL

124 P,P-DDT

125 O,P-DDT

126 P,P-DDE

127 O,P-DDE

128 P,P-TDE

129 O,P-TDE

130 UNIDENTIFIED RET REL TO 101

131 UNIDENT PEAK 1 RETN REL TO 101

132 UNIDENT PEAK 2 RETN REL TO 101

133 UNIDENT PEAK 3 RETN REL TO 101

134 UNIDENT PEAK 4 RETN REL TO 101

135 UNIDENT PEAK 5 RETN REL TO 101

136 UNIDENT PEAK 6 RETN REL TO 101

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

137 UNIDENT PEAK 7 RETN REL TO 101

138 UNIDENT PEAK 8 RETN REL TO 101

139 UNIDENT PEAK 9 RETN REL TO 101

140 UNIDENTIFIED RET AMT TO 101

141 UNIDENT PEAK 1 AMT REL TO 101

142 UNIDENT PEAK 2 AMT REL TO 101

143 UNIDENT PEAK 3 AMT REL TO 101

144 UNIDENT PEAK 4 AMT REL TO 101

145 UNIDNET PEAK 5 AMT REL TO 101

146 UNIDENT PEAK 6 AMT REL TO 101

147 UNIDENT PEAK 7 AMT REL TO 101

148 UNIDENT PEAK 8 AMT REL TO 101

149 UNIDENT PEAK 9 AMT REL TO 101

150 KEPONE

161 PARA-DICHLORO-BENZENE

162 TETRACHLOROETHYLENE

163 HEPTACHLOR - CHECK SAMPLE REPORTING

164 HEPTACHLOR EPOXIDE - CHECK SAMPLE REP.

181 HALOWAX

191 PBB

192 ETHYLENEDIBROMIDE

193 METHYLBROMIDE

200 ANTIBIOTICS

201 PENICILLIN

202 STREPTOMYCIN

**[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

203 CHLORAMPHENICOL

204 TETRACYCLINE

205 TYLOSIN

206 ERYTHROMYCIN

207 NEOMYCIN

208 OXYTETRACYCLINE

209 CHLORTETRACYCLINE

210 UNIDENTIFIED MICROBIAL INHIBITOR

211 GENTAMICIN

212 LINCOMYCIN

213 CLOXACILLIN

214 APRAMYCIN

215 AMOXICILLIN

216 NOVOBIOCIN

217 SPECTINOMYCIN

218 VIRGINIAMYCIN

298 TETRACYCLINES (INJECTION SITE)

299 SWAB POSITIVE-BIOASSAY NEGATIVE

300 ORGANIC PHOSPHORUS PESTICIDES

301 COUMAPHOS AND OXYGEN ANALOG

302 DICHLORVOS

303 DIAZINON

304 ETHION AND OXYGEN ANALOG

305 MALATHION

306 PARATHION

307 RONNEL

308 CRUFOMATE

309 TRICHLORFON

310 METHYL PARATHION

311 DIOXATHION

312 DISULFOTON

313 FENETHROTHION

314 STIROFOS (OR TETRACHLORINPHOS)

315 CHLOPYRIFOS

316 FENTHION

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

318 CARBOPHENTHION (TRITHION R)

319 AZINPHOS-METHYL (GUTHION R)

320 CHLORFENVINPHOS

330 UNIDENTIFIED RET REL TO 306

331 UNIDENT PEAK 1 RETN REL TO 306

332 UNIDENT PEAK 2 RETN REL TO 306

333 UNIDENT PEAK 3 RETN REL TO 306

334 UNIDENT PEAK 4 RETN REL TO 306

335 UNIDENT PEAK 5 RETN REL TO 306

336 UNIDENT PEAK 6 RETN REL TO 306

337 UNIDENT PEAK RENT REL TO 306

340 UNIDENTIFIED RET AMT TO 306

341 UNIDENT PEAK 1 AMT REL TO 306

342 UNIDENT PEAK 2 AMT REL TO 306

343 UNIDENT PEAK 3 AMT REL TO 306

344 UNIDENT PEAK 4 AMT REL TO 306

345 UNIDENT PEAK 5 AMT REL TO 306

346 UNIDENT PEAK 6 AMT REL TO 306

347 UNDIENT PEAK 7 AMT REL TO 306

> 360 CHLORINATED ORGANIC PHOSPHORUS 361 ETHION METABOLITE

362 COUMAPHOS METABOLITE

363 CHLORPYRIFOS METABOLITE

370 ORGANIC PHOSPHORUS COMPOUNDS

371 2-ETHYLHEXYLDIPHENYL PHOSPHATE

400 ARSENIC

401 ARSENIC

402 MERCURY

403 COPPER

404 LEAD

405 ZINC

406 CADMIUM

407 ANTIMONY

408 SELENIUM

409 ALUMINUM

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

410 TITANIUM

411 IRON

412 NICKLE

413 COBALT

414 MANGANESE

415 CHROMIUM

416 TIN

417 SODIUM

418 PHOSPHORUS

419 CALCIUM

420 POTASSIUM

421 MAGNESIUM

500 HORMONES

501 DIETHYLSTILBESTROL

502 DIENESTROL DIACETATE

503 ESTRADIOL BENZOATE

504 MELENGESTROL ACETATE

505 PROGESTERONE

506 TESTOSTERONE

508 MEDROXYPROGESTERONE ACETATE

509 CHLOMADINONE ACETATE

510 ZEARALANOL (ZERANOL)

511 ESTRADIOL MONOPALMITATE

512 HEXESTROL

513 ZEARALENONE

514 TALERANOL

600 CARBAMATES

601 CARBARYL

> 602 ALDICARB & METABOLITES SULFOXIDE & SULFO

604 PROPOXUR

605 CARBOFURAN AND 3 HYDROXYCARBOFURAN

> 606 METHIOCARB AND ITS METABOLITE SULFOXIDE

607 BUFENCARB

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

608 METHOMYL

615 THIRAM

620 LARVICIDE

621 CYROMAZINE

622 MELAMINE

650 NITROGEN PESTICIDES

651 CARBOXIN

652 AMITRAZ

700 HERBICIDES

701 2,4,-D

702 2,4,5-T

703 METHNEARSONIC ACID

710 TRIAZINE

711 PROMETON

712 PROPAZINE

713 TERBUTYLAZINE

714 ATRAZINE

715 PROMETRYN

716 TERBUTRYN

717 SIMAZINE

718 AMETRYN

800 SULFAS

801 SULFAETHOXYPYRIDAZINE

802 SULFACHLORPYRIDAZINE

803 SULFADIMETHOXINE

804 SULFANITRAN

805 SULFAMETHAZINE

806 SULFACHLOROPYRAZINE

807 SULFAMETHOXYPYRIDAZINE

808 SULFAMERAZINE

809 SULFATHIAZOLE

810 SULFAQUINOXALINE

811 SULFABROMOMETHAZINE

812 SULFAMETHIZOLE

813 SULFANILAMIDE

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

814 SULFAPYRIDINE

815 SULFADIAZINE

816 SULFADOXENE

830 UNIDENTIFIED RET REL TO 814

831 UNIDENT PEAK 1 RETN REL TO 814

832 UNIDENT PEAK 2 RETN REL TO 814

840 UNIDENTIFIED RET AMT TO 814

841 UNIDENT PEAK 1 AMT REL TO 814

842 UNIDENT PEAK 2 AMT REL TO 814

900 DRUGS, GENERAL

901 CLOPIDOL

902 FURAZOLIDONE

903 NITROFURAZONE

904 DECOQUINATE

905 MONENSIN

906 IPRONIDAZOLE

907 CARBADOX

908 ROBENIDINE

910 LEVAMISOLE

911 DIMETRIDAZOLE

912 GENTIAN VIOLET

913 DIBUTYLTINDILAURATE

914 LYSERGIC ACID DIETHYLAMIDE

915 PHENCYCLIDINE

916 XYLAZINE

917 LASALOCID

918 NARASIN

921 MORANTEL TARTRATE

922 PYRANTEL TARTRATE

923 IVERMECTIN

924 ARSENIC (DRUGS)

926 HALOFUGINONE

927 CLORSULON

931 UNIDENT PEAK 1 RETN REL TO 2

932 UNIDENT PEAK 2 RETN REL TO 2

> **[USDA Residue]{.underline} [USDA Residue Name]{.underline}**

941 UNIDENT PEAK 1 AMT REL TO 29

942 UNIDENT PEAK 2 AMT REL TO 29

950 BENZIMIDAZOLES

951 ALBENDAZOLE

952 FENBENDAZOLE

953 THIABENDAZOLE & METABOLITE

954 MEBENDAZOLE

955 OXFENDAZOLE

##   {#section-9 .unnumbered}

## **USDA TISSUE LOOK-UP TABLE**

> **[Code]{.underline} [Name]{.underline}**
>
> 01 Fat
>
> 02 Liver
>
> 03 Muscle
>
> 04 Kidney
>
> 06 Other
>
> 07 Lung
>
> 08 Lymph Node
>
> 09 Heart
>
> 10 Skin
>
> 11 Spleen
>
> 12 Brain
>
> 13 Eye or Eye Lesion
>
> 14 Peritoneum
>
> 15 Nerve
>
> 16 Bursa Fabricius
>
> 17 Adrenal Gland
>
> 18 Abdomen
>
> 19 Abomasum
>
> 20 Air Sacs
>
> 21 Alveolar Duct
>
> 22 Alveolar Sac
>
> 23 Alveoli
>
> 24 Aorta
>
> 25 Artery
>
> 26 Blood Vessel
>
> 27 Bone
>
> 28 Bronchi
>
> 29 Bronchioles
>
> 30 Cardiac Tissue
>
> 31 Cartilage
>
> 32 Cecum
>
> 33 Cerebellum
>
> 34 Cerebrum
>
> 35 Ceruminous Glands
>
> 36 Cervix
>
> **[Code]{.underline} [Name]{.underline}**
>
> 37 Cheeks
>
> 38 Cloaca
>
> 39 Colon
>
> 40 Comminuted Meat
>
> 41 Corpus Luteum
>
> 42 Crop
>
> 43 Ductus Deferens
>
> 44 Duodenum
>
> 45 Ears
>
> 46 Epididymis
>
> 47 Esophagus
>
> 48 Feather
>
> 49 Feather Follicle
>
> 50 Fur
>
> 51 Gall Bladder
>
> 52 Ganglion
>
> 53 Gizzard
>
> 54 Gray Matter
>
> 55 Hair
>
> 56 Hemal Node
>
> 57 Hock
>
> 58 Hoof
>
> 59 Horn
>
> 60 Intestinal Glands
>
> 61 Joint
>
> 62 Large Intestine
>
> 63 Larynx
>
> 64 Leg
>
> 65 Lips
>
> 66 Lymphatic
>
> 67 Lymph Vessel
>
> 68 Mammary Gland
>
> 69 Mesentery

**USDA TISSUE LOOK-UP TABLE**

> **[Code]{.underline} [Name]{.underline} [Code]{.underline}
> [Name]{.underline}**
>
> 70 Mouth
>
> 71 Neck
>
> 72 Nose
>
> 73 Omasum
>
> 74 Omentum
>
> 75 Ovary
>
> 76 Palate
>
> 77 Pancreas
>
> 78 Parathyroid
>
> 79 Penis
>
> 80 Peripheral Nerve
>
> 81 Phalanges
>
> 82 Pineal Gland
>
> 83 Pituitary Gland
>
> 84 Placenta
>
> 85 Prostate Gland
>
> 86 Proventriculus
>
> 87 Reticulum
>
> 88 Rectum
>
> 89 Rumen
>
> 90 Salivary Gland
>
> 91 Sebaceous Gland
>
> 92 Seminal Vesicle
>
> 93 Small Intestine
>
> 94 Spinal Cord
>
> 95 Stomach
>
> 96 Testis
>
> 97 Tissue Mass
>
> 98 Thigh
>
> 99 Thorax
>
> A1 Thymus
>
> A2 Thyroid Gland
>
> A3 Tongue
>
> A4 Tooth
>
> A5 Trachea
>
> A6 Tumor Mass
>
> A7 Ureter
>
> A8 Urinary Bladder
>
> A9 Uterine Horn
>
> B1 Uterus
>
> B2 Vagina
>
> B3 Vein
>
> B4 Ventriculus
>
> B5 Villi
>
> B6 Vulva
>
> B7 White Matter
>
> B8 Intestine
>
> B9 Blood Smears
>
> C1 Oviduct
>
> C2 Keel Bursa
>
> C3 Blood
>
> C4 Serum
>
> C5 Diaphragm
>
> C6 Parasite
>
> C7 Multiple Specimens
>
> C8 Plant Mat. - Soya

**USDA TISSUE LOOK-UP TABLE**

> **[Code]{.underline} [Name]{.underline} [Code]{.underline}
> [Name]{.underline}**
>
> D1 Secretory Glands
>
> D2 Plant Fiber
>
> D3 Urine
>
> D4 Kidney B
>
> D5 Serum A
>
> D6 Serum B
>
> D7 Bile
>
> D8 Tailhead Fat
>
> D9 Brisket Fat
>
> E1 Hard Bone
>
> E2 Soft Bone
>
> E3 Eggs
>
> E4 Milk
>
> E5 Colostrum
>
> E6 Fatty Tissue
>
> E7 Saliva
>
> E8 Condensate
>
> E9 Feed
>
> F1 Edible Proc. Product
>
> U3 Urine

## **MARCIS SPECIES CODES ON USDA RECORDS**

> **[Code]{.underline} [Name]{.underline} [Code]{.underline}
> [Name]{.underline}**
>
> 00 Non-Species 51 Market Hog
>
> 01 Horse 52 Boar or Stag
>
> 10 Bovine 53 Sow
>
> 11 Bull 59 Other Red Meat
>
> 12 Steer 60 Chicken
>
> 13 Beef Cow 61 Young Chicken
>
> 14 Heifer 63 Mature Chicken
>
> 15 Dairy Cow 70 Turkey
>
> 20 Calf 71 Fry Roast Turkey
>
> 21 Bob Veal 72 Young Turkey
>
> 22 Formula Fed Veal 73 Mature Turkey
>
> 23 Non-formula Fed Veal 81 Duck
>
> 24 Heavy Calves \>400 lbs. 82 Geese
>
> 30 Sheep 91 Rabbit
>
> 31 Mature Sheep 92 Deer
>
> 32 Lamb 97 Blank
>
> 40 Goat 98 Blank
>
> 50 Porcine 99 Other

##  SPECIES/ANIMAL LOOK-UP TABLE USED BY USDA

  ----------- --------------- ---------- ----------------------------------
  **Species   **Species       **Animal   **Animal Name**
  \#**        Name**          \#**       

  1           EQUINE          1          HORSE

  10          CATTLE          10         COWS

                              11         BULLS/STAGS

                              12         STEERS

                              13         COWS - BEEF

                              14         HEIFERS

                              15         COWS - DAIRY

  20          CALVES          20         CALVES

                              21         BOB - VEAL

                              22         FORMULA FED VEAL

                              23         NON FORMULA FED VEAL

                              24         HEAVY CALVES

  30          SHEEP           30         SHEEP

                              31         MATURE SHEEP

                              32         LAMBS & YEARLINGS

  40          GOATS           40         GOATS

  50          SWINE           50         SWINE

                              51         BARROWS & GILTS / MARKET HOGS

                              52         BOARS / STAGS

                              53         SOWS

                              54         ROASTER PIGS

  59          OTHER           58         WATER BUFFALO

                              59         OTHER (BUFFALO, ETC.)

                              99         OTHER ANIMAL

  60          CHICKENS        60         CHICKENS

                              61         YOUNG CHICKENS

                              63         MATURE CHICKENS

  70          TURKEYS         70         TURKEYS

                              71         FRYER ROASTER

                              72         YOUNG TURKEY

                              73         MATURE TURKEY

  80          DUCKS           81         DUCKS

                              82         GEESE

                              84         QUAIL

  90          RATITE          83         OSTRICH

                              85         EMU

                              86         RHEA

  91          RABBITS         91         RABBITS

  92          DEER            92         DEER
  ----------- --------------- ---------- ----------------------------------

# 

# 

# **ATTACHMENT B-1**

# **SAMPLE PRODUCER WARNING LETTER**

**(or for other individual administering medication)**

\[date\]

**[CERTIFIED MAIL]{.underline}**

**[RETURN RECEIPT REQUESTED]{.underline}**

**[OR Federal Express]{.underline}**

RESPONSIBLE INDIVIDUAL(S), TITLE (S)

FIRM NAME

RESPONSIBLE INDIVIDUAL'S COMPLETE MAILING ADDRESS

**[WARNING LETTER]{.underline}**

**(#)**

Dear \[Name\]:

An investigation of your \[dairy, swine raising, etc.\] operation
located at \[inspected facility's physical address (if different from
mailing address)\], conducted by a representative of the U.S. Food and
Drug Administration (FDA) on \[inspection dates (including the last date
of evidence collection)\], confirmed that you offered (an) animal(s) for
sale for slaughter as food that was adulterated under sections
402(a)(2)(C)(ii) \[21 U.S.C. 342 (a)(2)(C)(ii)\] and 402(a)(4) \[21
U.S.C. 342 (a)(4)\] of the Federal Food, Drug, and Cosmetic Act (the
Act). The inspection also revealed that you caused the \[new animal
drug(s)\] \[medicated feed(s)\] \[trade name or generic name of drug(s)
or feed(s)\] to become adulterated within the meaning of section
\[501(a)(5)\]\[21 U.S.C. 351(a)(5)\] \[501(a)(6)\]\[21 U.S.C.
351(a)(6)\] and unsafe under section 512 of the Act \[21 U.S.C 360b\].
You can find the Act and its associated regulations on the Internet
through links on the FDA's web page at
[www.fda.gov](http://www.fda.gov/).

On or about \[date\], you \[sold\] \[consigned\] a \[identify
animal/species\], identified with \[provide some form of man made
identification to appropriately identify the animal\] for slaughter as
food at \[name of slaughterhouse\]. On or about \[date\] this animal was
slaughtered at \[name of slaughterhouse\]. United States Department of
Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of
tissue samples collected from that animal identified the presence of
\[level and name of drug(s) for each tissue(s) in which (an) illegal
residue(s) (was)/(were) reported\]. \[No tolerance\] \[A tolerance of
(level)\] has been established for residues of \[name of drug(s)\] in
the edible tissues of \[type of animal\]\[.\] as codified in Title 21,
[Code of Federal Regulations,]{.underline} Part 556.# (21 C.F.R. 556.#).
The presence of \[this\]/\[these\] drug(s) in edible tissue(s) from this
animal causes the food to be adulterated within the meaning of section
402(a)(2)(C)(ii) \[(21 U.S.C. § 342(a)(2)(C)(ii)\].

\[For three or more residues you may want to develop a table for
clarification\]

Our investigation also found that you hold animals under conditions that
are so inadequate that medicated animals bearing potentially harmful
drug residues are likely to enter the food supply. You lack an adequate
system to ensure that animals medicated by you have been withheld from
slaughter for appropriate periods of time to permit depletion of
potentially hazardous residues of drugs from edible tissues. For
example, \[you failed to maintain treatment records\] \[you failed to
maintain complete treatment records\] \[you failed to segregate treated
animals\] \[you lack an adequate inventory system for determining the
quantities of drugs used to medicate your animal(s)\] **\[etc.\]**. Food
from animals held under such conditions is adulterated within the
meaning of section 402(a)(4) of the Act \[21 U.S.C. 342 (a)(4)\].

In addition, you adulterated \[name of drug(s)\] within the meaning of
section 501(a)(5) \[21 U.S.C. 351 (a)(5)\] of the Act when you failed to
use the drug in conformance with its approved labeling. \"Extralabel
use,\" i.e., the actual or intended use of a drug in an animal in a
manner that is not in accordance with the approved labeling, is only
permitted if the use is by or on the lawful order of a licensed
veterinarian within the context of a valid veterinarian/client/patient
relationship. The extralabel use of approved veterinary or human drugs
must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21
C.F.R. Part 530. Our investigation found that your extralabel use of
\[name of drug(s)\] failed to comply with these requirements.

For example, you administered the \[name of drug(s)\] without following
the \[dosage level\] \[duration of treatment\] \[frequency of
treatment\] \[withdrawal period\] \[in the approved animal class or
species\] **\[other appropriate items\]** set forth in the approved
labeling and you did so without the supervision of a licensed
veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your
extralabel use resulted in an illegal drug residue, in violation of 21
C.F.R. 530.11(c). Because your extralabel use of this drug was not in
compliance with 21 CFR Part 530, the drug was unsafe under section
512(a) of the Act \[21 U.S.C. 360b(a)\] and your use caused it to be
adulterated within the meaning of section 501(a)(5) of the Act \[21
U.S.C. 351(a)(5)\].

In addition, you adulterated \[name of medicated feed(s)\] within the
meaning of section 501(a)(6) of the Act \[21 U.S.C. 351(a)(6)\] when you
failed to use the drug in conformance with its approved labeling. Your
use of this \[medicated feed(s)\] without following the \[dosage level\]
\[duration of treatment\] \[frequency of treatment\] \[withdrawal
period\] \[in the approved animal class or species\] **\[other
appropriate items\]** set forth in the approved labeling causes this
drug to be unsafe within the meaning of section 512 of the Act \[21
U.S.C. 360b\]. Section 512 does not permit the extralabel use of
medicated feeds.

The above is not intended to be an all-inclusive list of violations. As
a producer of animals offered for use as food, you are responsible for
ensuring that your overall operation and the food you distribute is in
compliance with the law.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations do not recur. Failure to do
so may result in regulatory action without further notice such as
seizure and/or injunction.

You should notify this office in writing of the steps you have taken to
bring your firm into compliance with the law within fifteen (15) working
days of receiving this letter. Your response should include each step
that has been taken or will be taken to correct the violations and
prevent their recurrence. If corrective action cannot be completed
within fifteen (15) working days, state the reason for the delay and the
time frame within which the corrections will be completed. Please
include copies of any available documentation demonstrating that
corrections have been made.

Your written response should be sent to \[name\], Compliance Officer,
U.S. Food and Drug Administration, \[mailing address\]. If you have any
questions about this letter, please contact Compliance Officer \[name\]
at \[phone, fax, Email, mailing address\].

> Sincerely yours,
>
> \[name\]
>
> District Director
>
> \[name\] District

cc: Additional Responsible Individual(s)

State Regulatory Authority

Producer's Servicing Veterinarian

bcc: HFA-224

HFC-210

HFC-230

HFV-230

HFV-235

HFV-2\_\_ (Center CSO reviewer)

HFI-35 (purged)

[]{#__RefHeading___Toc107891982 .anchor}**ATTACHMENT B-2**

# **SAMPLE WARNING LETTER**

# **EXTRA-LABEL DRUG USE by VETERINARIAN**

\[Date\]

**[WARNING LETTER]{.underline}**

> Ref:

**[CERTIFIED MAIL]{.underline}**

**[RETURN RECEIPT REQUESTED]{.underline}**

Responsible Individual, Title

Firm Name

Firm's Complete Address

Dear Dr. \_\_\_\_;

On (dates), an investigator from the U.S. Food and Drug Administration
(FDA) conducted an investigation involving the use of drugs in your
veterinary practice. That investigation revealed that you caused animal
drugs to be unsafe under Section 512(a) of the Federal Food, Drug, and
Cosmetic Act (the Act) and adulterated within the meaning of Section
501(a)(5) of the Act because the drugs were used in a manner that did
not conform with their approved uses or the regulations for Extralabel
Drug Use in Animals, Title 21, [Code of Federal Regulations (21
CFR)]{.underline}, Part 530.

The extralabel use of approved veterinary or human drugs in animals is
permitted only if it complies with Sections 512(a)(4) and 512(a)(5) of
the Act and 21 CFR Part 530. Our investigation found that you failed to
comply with 21 CFR Part 530 in that:

> 1\. You used the drug (trade name) brand of (generic name) in an
> extralabel manner by administering the drug intravenously to (type of
> animal). The extralabel use of this drug in this animal is prohibited
> by 21 CFR Part 530.41(a)(9). Approved uses of such drugs are listed in
> 21 CFR Part 520.2220a, copy enclosed.
>
> 2\. You used the drug (trade name) brand of (generic name) in an
> extralabel manner by administering the drug to (type of animal)
> without meeting the requirements of 21 CFR Part 530. For example, in
> the treatment of this animal, milk discard and meat withdrawal periods
> were not established as required by 21 CFR Part 530.20(a)(2)(ii).
>
> 3\. You prescribed the intravenous administration of the injection
> form of the drug (trade name) brand of (generic name) to treat
> pneumonia in lactating dairy cattle. This is an extralabel use.
> Approved uses of (generic name) injection are listed in 21 CFR Part
> 520, copy enclosed. Your prescription for the extralabel use of this
> drug did not meet the requirements of 21 CFR Part 530(a)(2)(i)--(iv),
> which require that you:
>
> \(i\) Make a careful diagnosis and evaluation of the conditions for
> which the drug is to be used;
>
> \(ii\) Establish a substantially extended withdrawal period prior to
> marketing of milk, meat, eggs, or other edible products supported by
> appropriate scientific information, if applicable;
>
> \(iii\) Institute procedures to assure that the identity of the
> treated animal or animals is carefully maintained; and
>
> \(iv\) Take appropriate measures to assure that assigned timeframes
>
> for withdrawal are met and no illegal drug residues occur in any
> food-producing animal subjected to extralabel treatment.

You caused the aforementioned animal drug to be unsafe under Section
512(a) of the Act and adulterated within the meaning of Section
501(a)(5) of the Act because the drugs were prescribed and used in a
manner that did not conform with their approved uses or the regulations
for Extralabel Drug Use in Animals, 21 CFR Part 530.

The above is not intended to be an all-inclusive list of violations. As
licensed veterinarians, you are responsible for complying with the
requirements of the Act, including the extralabel use regulations
promulgated under the Act. You should take prompt action to correct the
above violations and to establish procedures whereby such violations do
not recur. Failure to do so may result in regulatory action without
further notice, such as seizure and/or injunction.

We have enclosed a copy of 21 CFR Part 530 for your reference. We
strongly suggest that you review 21 CFR Part 530 and become familiar
with all of its requirements so that you can prevent future violations
of the Act.

You should notify this office in writing within 15 working days of
receiving this letter of the specific steps you have taken to correct
the noted violations, including an explanation of each step being taken
to prevent the recurrence of similar violations. If corrective action
cannot be completed within 15 working days, state the reason for the
delay and the time within which the corrections will be completed. Also,
include copies of any available documentation demonstrating that your
corrections have been made.

Your reply should be directed to Compliance Officer (name) at the
address indicated on the letterhead.

> Sincerely,
>
> District Director

cc: State Board of Veterinary Medicine, FSIS TSC, State, HFV-232, etc.

# **ATTACHMENT B-3**

# **SAMPLE WARNING LETTER**

# **ILLEGAL DRUG SALE**

\[Date\]

**[WARNING LETTER]{.underline}**

> Ref:

**[CERTIFIED MAIL]{.underline}**

**[RETURN RECEIPT REQUESTED]{.underline}**

FIRM NAME

RESPONSIBLE INDIVIDUAL, TITLE

FIRM'S COMPLETE ADDRESS

Dear \_\_\_\_,

Recently an inspection was made of your veterinary drug distribution
facility located at (address). This inspection was conducted on (dates),
by a Food and Drug Administration (FDA) investigator from this office,
who documented the sales of prescription veterinary drugs, such as (name
of drug(s)), without requiring a written prescription or oral order from
a licensed veterinarian. Under Section 503(f)(1)(C) of the Federal Food,
Drug and Cosmetic Act, the dispensing of a prescription drug other than
by or upon the lawful written or oral order of a licensed veterinarian
results in the drug being misbranded.

In addition, the prescription drugs dispensed by your firm are
misbranded within the meaning of section 502(f)(1) because they lack
adequate directions for use. Pursuant to Title 21, Code of Federal
Regulations, section 201.5, "adequate directions for use" means adequate
directions under which the layman can use a drug safely and for the
purposes for which it was intended. Such adequate directions for use by
laypersons cannot be written for prescription drugs because the drugs
can only be used safely at the direction of, and under the supervision
of, a licensed veterinarian.

The corrective action of posting a sign with a list of prescription
veterinary drugs that require a veterinarian\'s prescription does not
appear to be adequate. During the inspection of your firm, the FDA
Investigator observed your employee selling prescription animal drugs
without requiring a written prescription or oral order from a licensed
veterinarian. In addition, photographs of your firm's product inventory
showed that prescription animal drugs where being held for sale that do
not appear on the sign posted by your firm.

You should take prompt action to correct these violations and to
establish procedures to prevent their recurrence. Failure to promptly
correct these violations may result in regulatory action without further
notice, such as seizure and/or injunction.

The violations listed above are not intented to be an all-inclusive
list. As a corporate official of this firm, you have a responsibility to
ensure that all drugs sold by you or other employees of your firm comply
with all state and federal laws.

It is necessary that you take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date
you receive this letter of the steps you are taking to correct the
problems and bring your firm into compliance with the law. Your response
should include each step being taken, or that will be taken to correct
the violations and prevent their recurrence. If corrective action cannot
be completed within fifteen (15) working days, please state the reason
for delay and the time frame within which the corrections will be
completed. Please include copies of any available documentation
demostrating that corrections have been made.

Your reply should be directed to the Food and Drug Administration
(Attention: Compliance Officer) at the above address. If you have any
questions concerning the deficiencies noted, you may contact Compliance
Officer (name).

> Sincerely,
>
> District Director

#  **ATTACHMENT B-4**

# **SAMPLE WARNING LETTER**

# **BUYER/DEALER**

\[Date\]

**[WARNING LETTER]{.underline}**

> Ref:

**[CERTIFIED MAIL]{.underline}**

**[RETURN RECEIPT REQUESTED]{.underline}**

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

Dear \_\_\_\_\_\_\_\_**:**

An inspection of your operation located in (City, State), by a Food and
Drug Administration investigator on (dates), confirmed a (cow/calf/hog)
purchased and sold by you on or about (date), for slaughter for human
food to (slaughter house), was in violation of Section 402 (a)(2)(C)(ii)
of the Federal Food, Drug, and Cosmetic Act.

USDA/FSIS analyses of tissues collected from that animal disclosed the
presence of the drug (level and name of drug for each tissue in which
illegal residue was reported). A tolerance of ( ) level ppm has been
established for residues of (name of drug) in the edible tissues of
(type of animal) Title 21 Code of Federal Regulations Section 556. The
presence of this drug in edible tissue from this animal causes the food
to be adulterated under Section 402(a)(2)(C)(ii) of the Act.

‑ If appropriate, include the following:

In addition, USDA has reported the finding of illegal residues in
(number) other (type of animals) sold by you and offered for slaughter
for human food (list animal. drug, date). Copies of letters from
USDA/FSIS notifying you of these residues are attached.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations do not recur. Failure to do
so may result in regulatory action without further notice such as
seizure and/or injunction.

The violations listed above are not intended to be an all-inclusive
list. It is your responsibility to assure that your operations are in
compliance with the law. As a dealer of animals, you are frequently the
individual who introduces or offers for introduction into interstate
commerce, the adulterated animal. As such, you share the responsibility
for violating the Federal Food, Drug and Cosmetic Act. To avoid future
illegal residue violations you should take precautions such as:

1\. Implementing a system to identify the animals you purchase with
records to establish traceability to the source of the animal;

2\. Implementing a system to determine from the source of the animal
whether the animal has been medicated and with what drug(s); and

3\. If the animal has been medicated**,** implementing a system to
withhold the animal from slaughter for an appropriate period of time to
deplete potentially hazardous residues of drugs from edible tissue. If
you do not want to hold the medicated animal then it should not be
offered for human food, and it should be clearly identified and sold as
a medicated animal.

If appropriate, include the following:

You should be aware that it is not necessary for you to have personally
shipped an animal in interstate commerce to be responsible for a
violation of the Act. The fact that you offered an animal for sale to a
slaughterhouse that ships in interstate commerce is sufficient to hold
you responsible for a violation of the Act.

You should notify this office in writing within 15 working days of the
steps you have taken to bring your firm into compliance with the law.
Your response should include each step being taken, that has been taken,
or will be taken to correct the violations and prevent their recurrence.
If corrective action cannot be completed within 15 working days, state
the reason for the delay and the time frame within which the corrections
will be completed. Please include copies of any available documentation
demonstrating that corrections have been made.

Your reply should be directed to the Food and Drug Administration
Attention Compliance Officer.

Sincerely,

District Director

cc: FSIS TSC, State, HFV-232, etc.

#  **ATTACHMENT C - TISSUE RESIDUE EVALUATION FORM** 

# 

Complete one attachment C for each sample and source investigated. The
intent of this document is to compile data for statistical reasons on
the drugs causing residues. The document is not a substitute for the
Official report. The information for this data collection form should be
obtained from your inspection report.

All the information on the Attachment has to be related to the source
identified in the section, AName and Address of Owner of Animal from
FSIS Warning Letter. If you determine during your inspection that 1) the
owner wasn=t correctly identified, or 2) the residue can=t be properly
traced back or 3) the investigated source ownership changed, then
terminate the inspection per Question #2. You should complete a new
Attachment C for each new source investigated.

When completing Attachment C, Question #2, select only **one** answer
for either an FDA investigation (A) or a State investigation (B). If B
is selected fill in the appropriate 2-letter state code.

Complete questions 9-13 for each residue reported for each sample.

Make sure that you properly relate the source to the sample in RVIS

Send to HFV-235, ATT: Fran Pell

\- A complete Attachment C for each source/sample investigated,

\- A summary of findings for each investigation

> \- If the Attachment C (at least the first two pages) is not printed
> from the system please write the Source ID on the front page of the
> Attachment

**Section 1**

**[BACKGROUND INFORMATION]{.underline}**

Automatically obtained from RVIS, appropriate entries will be printed

  ----------------- ----------------- ----------------- -----------------
  FSIS Sample       FSIS Sample       FSIS Warning      FSIS Case Number:
  Number Initiating Collection Date   Letter Date:      
  Investigation:    of Report                           
                    Initiating                          
                    Investigation:                      

                                                        
  ----------------- ----------------- ----------------- -----------------

**CONCENTRATION OF RESIDUE(S) IN TISSUES AS REPORTED BY FSIS:**

(**Note**:For the case of multiple animals per source the option to
select and print more than one animal\'s sample data will be programmed)

**ANIMAL:** **FSIS SAMPLE FORM NO. \_ \_ \_ \_ \_ \_ \_ \_**

> **ANIMAL SPECIES \_ \_ \_ \_ \_ \_ \_**

  ----------------------- ----------------------- -----------------------
  **RESIDUE**             **TISSUE**              **CONCENTRATION**

                                                  

                                                  

                                                  
  ----------------------- ----------------------- -----------------------

**NAME AND ADDRESS OF OWNER OF ANIMAL FROM FSIS WARNING LETTER:**

  ----------- ------------- ----------- ------------ ----------- -----------
  **Name**    **Address**   **City**    **County**   **State**   **Zip**

                                                                 
  ----------- ------------- ----------- ------------ ----------- -----------

**SOURCE ALSO KNOWN AS:**

  ----------- ----------- ----------- ----------- ----------- -----------
  Name        Address     City        County      State       Zip

                                                              
  ----------- ----------- ----------- ----------- ----------- -----------

**INSPECTIONS ATTRIBUTED TO THIS SOURCE:**

  ----------- ----------- ------------ ----------- ----------- ---------------
              FSIS sample Collection   Residue     FSIS Letter Investigation
              \#          Date                     Date        Date

  A                                                            

  B                                                            

  C                                                            
  ----------- ----------- ------------ ----------- ----------- ---------------

**Section 2**

**Please answer the following as completely as possible:**

**1. WERE THE NAME AND ADDRESS OF THE ANIMAL OWNER IDENTIFIED ABOVE BY
USDA SPELLED AND LISTED CORRECTLY?**

> YES (go to 2)/ NO *(if No, ask District Program Monitor to make
> corrections in RVIS and to notify appropriate FSIS personnel.)*

**[THE INVESTIGATION]{.underline}**

(Questions 2-8)

**2. TYPE OF INVESTIGATION CONDUCTED IN RESPONSE TO CURRENT FSIS RESIDUE
REPORT** ***(circle one letter)*:**

**A. FDA INVESTIGATION (complete 1 or 2 below)**

**B. STATE (enter 2-letter state code) or:**

**(circle one number for either A or B):**

1\. On-Site Inspection (Complete Remainder of Report).

2\. Inspection Terminated Due to:

a\. Unable to locate source or traceback

b\. Investigated sources ownership changed

c\. Incorrect source identified by USDA

d\. Other

**3. DATE INVESTIGATION/INSPECTION COMPLETED:**

\_ \_ / \_ \_ / \_ \_

m m d d y y

**4**. **DID THE OWNER IDENTIFIED AT SLAUGHTER ADMIT TO *TREATING* OR
*AUTHORIZING* THE TREATMENT OF THIS ANIMAL/HERD/FLOCK\...?**

**YES / NO**

5.  **LIST THE FOLLOWING INFORMATION FOR ALL INDIVIDUALS / ORGANIZATIONS
    WHO HANDLED THE ANIMAL / HERD / FLOCK\...WITHIN THREE MONTHS PRIOR
    TO THE SLAUGHTER DATE ?**

Date Animal Date Animal

[Name]{.underline} [Address]{.underline} [Acquired]{.underline}
[Disposed of]{.underline}

**A**. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_ \_ / \_ \_ / \_
\_ \_ \_ / \_ \_ / \_ \_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ m m d d y y m m d d
y y

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

firm type(i.e. dealer, hauler)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reason for Acquisition
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Reason for Disposition
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

**B**. \_\_\_\_\_\_\_\_\_\_\_\_\_\_­­­­\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_ \_/\_ \_ /
\_ \_ \_ \_ / \_ \_ / \_ \_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ m m d d y y m m
d d y y

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

firm type(i.e. dealer, hauler)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reason for Acquisition
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Reason for
Disposition \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**C**. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_ \_/\_ \_ / \_ \_
\_ \_ / \_ \_ / \_ \_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ m m d d y y m m d d
y y \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

firm type(i.e. dealer, hauler)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reason for Acquisition
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Reason for Disposition
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**D**. \_\_\_\_\_\_\_\_\_\_\_\_\_\_­­\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_ \_ / \_ \_ / \_
\_ \_ \_ / \_ \_ / \_ \_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ m m d d y y m m d d
y y \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

firm type(i.e. dealer, hauler)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reason for Acquisition
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reason for Disposition
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**E**. None of these

**Which source listed in \# 5 is responsible for the violation?**

**(Write the letter, A - E ) \_\_\_\_**

**6. IS THE SLAUGHTER CLASS OF (printed from RVIS as on the lab form)
REPRESENTATIVE OF THIS PRODUCER\'S PRIMARY BUSINESS?**

***(circle one)***

***YES [(go to question 7]{.underline}) / NO (if NO, circle one
below)***

The general description of this production unit is (circle one):

A. Dairy Farm D. Poultry Flock

B. Swine Operation E. Beef Ranch (other than Feedlot)

C. Feedlot (Beef) F. Veal Operation

G. Other (Select one number)

1\. Sales/Auction Barn 4. Hobby herd/flock 2. Buyer/Dealer 5.
Multi-species unit

3\. Slaughter Facility 6. Other

**7. APPROXIMATE SIZE OF BUSINESS *(circle one letter below)*:**

[No. of Animals]{.underline} (On the premises at the date of
inspection/investigation)

A. l - 20

B. 2l - l00

C. 101 - 500

D. 50l - 2000

E. Over 2000

> **Note:** For dairies use total animals on contiguous production unit.
> Do not include calves/replacement animals reared by a contractor at
> remote locations.

***8. GENERAL ANIMAL HUSBANDRY PRACTICES OF BUSINESS (provide an answer
for each letter):***

A. *One individual* or *multiple individuals* are authorized to treat
animals:
\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....
**(1) One / (M) Multiple**

B. Utilizes services of
veterinarian)\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....***YES
/ NO***

**(*If yes, please circle one number below)***

1\. On as-needed basis (not routine)

2\. For herd health programs only, including pregnancy check

3\. For all veterinary medical needs (herd health and as needed)

4\. As a member of staff

C. Mixes own feed
:*\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....**YES
/ NO***

**(*If yes, please circle all numbers that apply)***

1\. Grinder/mixer/mill routinely cleaned/flushed after processing of
medicated feeds

2\. Uses sequencing to control unsafe contamination

3\. Conforms to cGMPs for mills

4\. Mixes non-medicated feed only

> D. Buys commercial feed (a complete feed)
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....Y***ES
> / NO***

E. Uses medicated milk replacer
\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....Y***ES
/ NO***

F. Feeds, or allows the young to suckle milk from treated dams
\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....Y***ES
/ NO***

G. Observes the directions of products used during the dry cow
period\...\...\...\...\...\...\...\...\...\...\...\...\...***YES / NO***

H. Water for animals comes from a private water source (wells, etc.)
*\...\...\...\...\...\...\...\...\...\...\...\...\.....Y**ES / NO***

I. Has system for separating treated and non-treated animals
\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....***YES
/ NO***

J. Keeps medical records
\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....***YES
/ NO***

**Circle all numbers below that are included in medical recordkeeping:**

> 1- Animal ID 5- Route of administration
>
> 2- Treatment date 6- Withdrawal time for meat and milk
>
> 3- Drug(s)/medicated feed used 7- Individual who administered drug
>
> 4- Dosage(s) given 8- If treatment recommended by veterinarian
>
> 9-Date animal can be slaughter and/or milk can be used

K. Keeps records on the sale and/or purchase of
animals\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....***YES
/ NO***

L. Keeps records on the inventory and accountability of drugs and
medicated feeds\.....***YES / NO***

**Section 3**

**[THE COMPOUND]{.underline}**

(Questions 9-15)

**THE FOLLOWING QUESTIONS ARE ABOUT THE DRUG(S) WHOSE USE RESULTED IN
THE CURRENT TISSUE RESIDUE VIOLATION:** (IF MULTIPLE ANIMALS ARE
INVOLVED AND USES/CAUSES/TREATMENTS VARY AMONG ANIMALS PLEASE COMPLETE A
SET OF THE FOLLOWING QUESTIONS (questions 9-13) FOR EACH ANIMAL. Also if
multiple residues are reported for a single sample complete questions
9-13 for each residue reported)

**9. NAME OF DRUG USED ON THE ANIMAL WHICH CAUSED THE RESIDUE of
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**(Obtain from the product label if available) If unknown write
*UNKNOWN***

**DRUG NAME**

> Trade/Proprietary name preferred

**NADA \#** or **NDC#**

***[Is the prescription label present]{.underline}***? ***YES / NO***
(i.e., Caution: Federal Law restricts this drug to use by or on the
order of a licensed veterinarian.)

***10. DRUG WAS ADMINISTERED AS FOLLOWS :***

**DOSE**~(i.e.\ \#\ cc=s/\ \#\ sites)~ **ROUTE** **FREQUENCY**
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

(FOR ***[ROUTE]{.underline}***, WRITE IN LETTER USING LIST BELOW):

> A. Intravenous D. Intramammary G. Drinking Water
>
> B. Intramuscular E. Oral Bolus, Liquid, Tablet H. Milk Replacer
>
> C. Subcutaneous F. Feed I. Intra-Uterine

J. Topical

> (FOR ***[FREQUENCY]{.underline}*** WRITE IN LETTER USING LIST BELOW):
>
> A. Once D. TID(Three times daily) G. PRN(As Needed)
>
> B. SID(Once a day) E. QID(Four times daily) H. Other
>
> C. BID(Twice a day) F. EOD(Every other day)

**11. REASON THE DRUG WAS ADMINISTERED TO THE ANIMAL/HERD/FLOCK\...**

***(circle one letter below)*:**

A. If used because of illness; specify ailment(s) treated :

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

B. If used as a preventive measure ***(circle all numbers that
apply)*:**

> 1\. Prior to transportation
>
> 2\. Prior to addition to an established herd/flock
>
> 3\. Prior to or during introduction to a farm, ranch, or region with
> endemic disease
>
> 4\. To aid animal or flock\'s adjustment to changes in weather
> conditions
>
> 5\. Other:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

C. If used as a growth promotant/production aid.

D.
Other:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**12. IS DRUG LABELED FOR THE USE INDICATED IN QUESTION 11:**

> **YES / NO/ CANNOT BE DETERMINED**
>
> A. Product was purchased from? Indicate name, address, and firm type:

Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

***(circle one number below)***

1\. Feed/Supply Store 4. Mobile Peddler/Salesperson 2. Mail Order 5.
Veterinarian

3\. Feed From A Commercial Feed Mill 6.
Other:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

B. Did a veterinarian, through a valid veterinarian-client-patient
relationship (VCPR), prescribe the use of the drug in
#9?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...**YES
/ NO**

**(If yes, verify and answer 12C and 12D)**

Is there a [veterinarian's label]{.underline} on the
product?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....**YES
/ NO**

Does the [veterinarian\'s label]{.underline} on the product specify the
following:

1\. Indications for
Use?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....**YES
/ NO** 2.
Dosage?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....**YES
/ NO** 3. Duration of
Therapy?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...**YES
/ NO** 4. Expiration
Date?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....**YES
/ NO** 5. Name and address of
practitioner?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....**YES
/ NO**

6\.
Contraindications?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....**YES
/ NO**

7\. Route of
Administration?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...**YES
/ NO**

8\. Withdrawal
Period?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....**YES
/ NO**

9\. Active
Ingredients\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....**YES
/ NO**

**COMPLETE BELOW IF A FOLLOW-UP AT THE VETERINARIAN\'S** **IS
CONDUCTED** (CP 7371.006, Part III, pp. 4-5)

C. Do the veterinarian\'s records substantiate a valid VCPR?
**\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....YES/NO/CANNOT
BE DETERMINED**

D. Was the prescribed use;

> 1\. Consistent with an approved product\'s
> label?**\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...YES/NO**
>
> 2 Modification of indications, dose, or precautions of an approved
> product?**\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....YES/NO**
>
> 3\. Compounded from one or more (approved/unapproved)
> ingredients?**\.......\...\...\...\...\...\...\...YES/NO**
>
> If #3 is yes, circle one answer for each letter below:

a\. For a **(T) *therapeutic*** or ***(P) production***
use?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....**T
/ P**

b\. Based on **(C)** ***clinical needs*** or ***(A) anticipation of
sale***?\...\...\...\...\...\...\...\...\...\...\...\...\...\....**C /
A**

c\. Product ***(I) is*** or ***(N) is not*** promoted for
sale?\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...**I
/ N**

If compounded by a veterinarian, list all the components of the product:

> Product 1. Product 2.

Name \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_: Name
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_:

Components: Components:

> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Prescribed withdrawal time days Prescribed withdrawal time days

13\. WHAT WAS THE PRIMARY FACTOR CAUSING THIS VIOLATION ?

***(circle one letter below)*:**

> A. Production Management causes

**(If production management is the cause, circle ONE number below:)**

> 1\. Animal(s) fed colostrum or milk containing drug residue
>
> 2\. Animal(s) fed medicated feed by mistake
>
> 3\. Drug administered to animal(s) by mistake
>
> 4\. Failure to keep proper animal identity and treatment records
>
> 5\. Inadequate segregation of treated animal(s)

6\. Failure to follow labeled withdrawal time

> 7\. Feed manufacturing cGMP deviations
>
> B. Extra-Label Use

**(If extra-label use is the cause, circle ONE below)**

> 1\. Veterinarian's prescribed withdrawal period not observed
>
> 2\. Withdrawal period verbally recommended by veterinarian not
> observed
>
> 3\. Animal treated with higher than the recommended/labeled dosage of
> drug
>
> 4\. Labelled route of administration not observed

5\. No withdrawal period prescribed

6\. Drug not approved for species

7\. Frequency of treatment different than on label

8\. Duration of treatment longer than on label

> C. Unable to Determine
>
> D. Interviewee stated drug used was not the same as residue reported
> by FSIS.
>
> E. Interviewee told purchaser/hauler animal was medicated -animal
> later diverted for human food.
>
> F. All label/ prescription directions followed and documented, residue
> still occurred.
>
> G. Other

14\. WHAT ARE **ADDITIONAL** FACTORS CONTRIBUTING TO THIS VIOLATION ?

***(Circle all letters and numbers that apply below)*:**

> A. Production Management causes
>
> 1\. Animal(s) fed colostrum or milk containing drug residue
>
> 2\. Animal(s) fed medicated feed by mistake
>
> 3\. Drug administered to animal(s) by mistake
>
> 4\. Failure to keep proper animal identity and treatment records
>
> 5\. Inadequate segregation of treated animal(s)

6\. Failure to follow labeled withdrawal time

> 7\. Feed manufacturing cGMP deviations
>
> B. Extra-Label Use
>
> 1\. Veterinarian's prescribed withdrawal period not observed
>
> 2\. Withdrawal period verbally recommended by veterinarian not
> observed
>
> 3\. Animal treated with higher than the recommended/labeled dosage of
> drug
>
> 4\. Labelled route of administration not observed

5\. No withdrawal period prescribed

6\. Drug not approved for species

7\. Frequency of treatment different than on label

8\. Duration of treatment longer than on label

> C. Unable to Determine
>
> D. Interviewee stated drug used was not the same as residue reported
> by FSIS.
>
> E. Interviewee told purchaser/hauler animal was medicated - animal
> later diverted for human food.
>
> F. All label/prescription directions followed and documented, residue
> still occurred.
>
> G. Other

15\. ACTION(S) TAKEN TO EDUCATE INDIVIDUAL/ORGANIZATION(S) RESPONSIBLE
FOR CURRENT VIOLATION ON HOW TO PREVENT THE OCCURRENCE OF TISSUE RESIDUE
VIOLATIONS IN THE FUTURE ***(circle all that apply)*:**

> A. Discussed the need to adhere to drug-label instructions with
> special emphasis on dosage, withdrawal time, route of administration,
> and approved species
>
> B. Discussed the need to properly identify animals
>
> C. Discussed the need to keep good medical and sale/purchase records
> on treated animals
>
> D. Discussed the need to maintain a cull pen for treated/sick animals,
> especially the need to separate treated dams (or their products) from
> sucklings
>
> E. Discussed availability of husbandry information and consultation
> services provided by Federal/State/County Extension Services

F. Discussed inventory and accountability of all drugs and medicated
feeds

G. Other:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> **i.e. Consult vets, QA programs, Training of persons involved w/
> drugs, control of access to drugs**

# **ATTACHMENT D -- USDA CONTACTS**

[]{#__RefHeading___Toc107891993 .anchor}**FSIS Technical Service Center
(TSC)** The TSC serves as the Agency\'s center for technical assistance,
advice and guidance.Telephone (402) 221-7400 FAX (402) 221-7438

## **FSIS District Offices**

**Alameda, CA**

**District 05**

**State: California**

Dr. Neal Westgerdes, District Manager

620 Central Avenue

Building 2c

Alameda, CA 94501

Phone: (510)337-5000

Ext. 1 for DM or DDM

FAX: (510)337-5081

Emergency 24-Hour: 1-866-729-9307

**Albany, NY**

**District 65**

**States: Connecticut, Maine, Massachusetts, New Hampshire, New York,
Rhode Island, Vermont**

Mr. Louis Leny, district Manager

230 Washington Ave. Extension

Albany, NY 12203-5369

Phone: (518)452-6870

FAX: (518)452-6870

Emergency 24-Hour: 518-452-6870, Ext. 250

**Atlanta, GA**

**District 85\
States: Florida, Georgia, Puerto Rico, Virgin Islands\
**Dr. Larry Smith, District Manager\
100 Alabama St., SW; Bldg 1924\
Suite 3R90\
Atlanta, GA 30303\
Phone: (404) 562-5900\
FAX: (404) 562-5877\
Emergency 24-Hour: 1-800-282-7005

**Beltsville, MD\
District 75\
States: Delaware, District of Columbia, Maryland, Virginia, West
Virginia**\
Dr. Mohamed Ibraheim, District Manager\
5601 Sunnyside Ave.\
Suite 1-2288 B\
Beltsville, MD 20705-5200\
Phone: (301) 504-2136\
FAX: (301) 504-2140\
Emergency 24-Hour: 1-800-289-4116

**Boulder, CO\
District 15\
States: Alaska, American Samoa, Arizona, Colorado, Guam, Hawaii, Idaho,
New Mexico, Nevada, Northern Mariana Islands, Oregon, Utah, Washington**

**Boulder Office\
**Dr. Ronald K. Jones, District Manager

Boulder Office\
665 South Broadway\
Suite B\
Boulder, CO 80303\
Phone: (303) 497-5411\
FAX: (303) 497-7306\
24-Hour Emergency: (303) 497-5411

**Salem Office**\
530 Center Street, NE\
Mezzanine\
Salem, Oregon 97301\
Phone: (503) 399-5831\
FAX: (503) 399-5636\
24-Hour Emergency: (303) 497-5411

**Chicago, IL**

**District 50**

**States: Illinois, Indiana, Ohio**

Mr. Richard Mackey, District Director

**Chicago Office**\
1919 South Highland Avenue\
Suite 115C\
Lombard, IL 60148\
Phone: (630) 620-7474\
FAX: (630) 620-7599\
24-Hour Emergency: 1-888-874-6503

**Pickerington Office**\
155 East Columbus Street\
Pickerington, OH 43147\
Phone: (614) 833-1405\
FAX: (614) 833-1067\
24-Hour Emergency: 1-888-874-6503

**Dallas, TX\
District 40\
State: Texas**\
Mr. Alfred Almanza, District Manager\
1100 Commerce Street\
Room 516\
Dallas, TX 75242-0598\
Phone: (214) 767-9116\
FAX: (214) 767-8230\
24-Hour Emergency: (214) 767-9116, Ext. 250

**Des Moines, IA\
District 25\
States: Iowa, Nebraska**\
Mr. Dennis Greening, District Manager\
Room 985, Federal Building\
210 Walnut Street\
Des Moines, IA 50309\
Phone: (515) 727-8960\
or 1-800-990-9834\
FAX: (515) 727-8991\
24-Hour Emergency: (515) 710-1829 or (515) 240-0181

**Jackson, MS\
District 90\
States: Alabama, Mississippi, Tennessee**\
Dr. Paul Resweber, District Manager\
715 S. Pear Orchard Road, Suite 101\
Ridgeland, MS 39157\
Phone: (601) 965-4312\
FAX: (601) 965-5901\
24-Hour Emergency: (601) 662-3407

**Lawrence, KS\
District 30\
States: Kansas, Missouri**\
Dr. William M. Walker, District Manager\
4920 Bob Billings Parkway\
Lawrence, KS 66049-3855\
Phone: (785) 841-5600\
FAX: (785) 841-5623\
24-Hour Emergency: (785) 840-0020

**Madison, WI\
District 45\
States: Michigan, Wisconsin**\
Dr. Linda Madson, District Manager\
2810 Crossroads Dr.\
Suite 3500\
Madison, WI 53718-7969\
Phone: (608) 240-4080\
FAX: (608) 240-4092\
24-Hour Emergency: 1-888-724-3212 Pin #300267

**Minneapolis, MN\
District 20\
States: Minnesota, Montana, North Dakota, South Dakota, Wyoming**\
Dr. Nathaniel Clark, District Manager\
Butler Square West, Suite 989-C\
100 N. 6th Street\
Minneapolis, MN 55403\
Phone: (612) 370-2400\
FAX: (612) 370-2411\
24-Hour Emergency: 1-800-923-9535

**Philadelphia, PA**

**District 60\
States: New Jersey, Pennsylvania**\
Mr. Jan T. Behney, District Manager\
Mellon Independence Center\
701 Market Street -- Suite 4100-A\
Philadelphia, PA 19106-1576\
Phone: (215) 597-4219, Ext. 101\
or 1-800-637-6681\
FAX: (215) 597-4217\
24-Hour Emergency: 1-800-637-6681, Ext. 101 or Ext. 113

**Raleigh, NC\
District 80\
States: Kentucky, North Carolina, South Carolina**\
Dr. Lewis Burgman, District Manager\
6020 Six Forks Road\
Raleigh, NC 27609\
Phone: (919) 844-8400\
or 1-800-662-7608\
FAX: (919) 844-8411\
24-Hour Emergency: (919) 844-8400

**Springdale, AR\
District 35\
States: Arkansas, Louisiana, Oklahoma**\
Dr. Marcia Endersby, District Manager\
Country Club Center\
Bldg. B, Suite 201\
4700 South Thompson

Springdale, AR 72764\
Phone: (479) 751-8412\
FAX: (479) 751-9049\
24-Hour Emergency: (479) 751-8412

##   {#section-13 .unnumbered}

## **Office of Program Planning, Evaluation, and Enforcement** 

## **Regional Offices**

**Western Region\
States: Alaska, American Samoa, Arizona, California, Colorado, Guam,
Hawaii, Idaho, Mariana Islands, Nevada, New Mexico, Oregon, Utah,
Washington**\
Regional Manager\
620 Central Avenue, Building 2B\
Alameda, CA 94501\
Phone: (510) 337-5000, Ext. 249\
FAX: (510) 337-5080\
Emergency: (202) 276-1610

**Southwest Region\
States: Arkansas, Louisiana, Oklahoma, Texas**\
Regional Manager\
1100 Commerce Street, Room 516\
Dallas, TX 75242\
Phone: (214) 767-9116, Ext. 400\
FAX: (214) 767-8230\
Emergency: (214) 763-1853

**Great Plains Region\
States: Iowa, Kansas, Minnesota, Missouri, Montana, Nebraska, North
Dakota, South Dakota, Wyoming**\
Regional Manager\
4920 West 15th Street, Suite B\
Lawrence, KS 66049\
Phone: (785) 840-9026\
FAX: (785) 843-0548\
Emergency: (785) 423-5402

**Midwest Region\
States: Illinois, Indiana, Ohio, Michigan, Wisconsin**\
Regional Manager\
1919 South Highland Avenue, Suite 120C\
Lombard, IL 60148\
Phone: (630) 916-6226, Ext. 264\
FAX: (630) 620-7876\
Emergency: (630) 768-8418 (Alert 1)

**Southeast Region\
States: Alabama, Delaware, District of Columbia, Florida, Georgia,
Kentucky, Maryland, Mississippi, North Carolina, Puerto Rico, South
Carolina, Tennessee, Virginia, Virgin Islands, West Virginia**\
Regional Manager\
100 Alabama Street SW\
1924 Building, Suite 3R90\
Atlanta, GA 30303\
Phone: (404) 562-5962\
FAX: (404) 562-5935\
Emergency: (404) 569-3060

## **APHIS Veterinary Services Offices**

**(Call Veterinary Services Office to contact current Animal ID
Coordinator)**

**Alabama**

Dr. O. W. Hester\
USDA, APHIS, VS\
P.O. Box 70429\
Montgomery, AL 36107\
(334) 223-7141\
Fax (334) 223-7352\
<Owen.Hester@usda.gov>\
\
**Alaska**\
Dr. Gary L. Brickler\
USDA, APHIS, VS\
2604 12th Court, SW, Suite B\
Olympia, WA 98502\
(360) 753-9430\
Fax (360) 753-9585\
<Gary.L.Brickler@usda.gov>\
\
**Arizona**\
Dr. Hortentia Harris\
USDA, APHIS, VS\
1400 E. Southern Ave., Suite 245\
Tempe, AZ 85282\
(480) 491-1002\
Fax (480) 491-1895\
<Hortentia.D.Harris@usda.gov>\
\
**Arkansas**\
Dr. Ronnie Blair\
USDA, APHIS, VS\
1200 Cherry Brook Dr., Suite 300\
Little Rock, AR 72211\
(501) 224-9515\
Fax (501) 225-5823\
<Ronnie.E.Blair@usda.gov>\
\
**California**\
Dr. Paul Ugstad\
USDA, APHIS, VS\
9580 Micron Ave., Suite E\
Sacramento, CA 95827\
(916) 857-6170\
Fax (916) 857-6196\
<Paul.O.Ugstad@usda.gov>

**Colorado**\
Dr. Jerry W. Diemer\
USDA, APHIS, VS\
755 Parfet Street, Suite 136\
Lakewood, CO 80215\
(303) 231-5385\
Fax (303) 231-5390\
<Jerry.W.Diemer@usda.gov>

**Florida**\
Dr. Robert E. Southall\
USDA, APHIS, VS\
7022 NW 10th Place\
Gainesville, FL 32605-3147\
(352) 333-3120\
Fax (352) 333-6849\
<Robert.E.Southall@usda.gov>\
\
**Georgia**\
Dr. Edgardo Arza\
USDA, APHIS, VS\
1498 Klondike Rd., Suite 200\
Conyers, GA 30094\
(770) 922-7860\
Fax (770) 483-9000\
<Edgardo.Arza@usda.gov>\
\
**Hawaii**\
Dr. Gary L. Brickler\
USDA, APHIS, VS\
2604 12th Court, SW., Suite B\
Olympia, WA 98502\
(360) 753-9430\
Fax (360) 753-9585\
<Gary.L.Brickler@usda.gov>\
\
**Idaho**\
Dr. Cynthia Gaborick\
USDA, APHIS, VS\
9158 West Black Eagle Drive\
Boise, ID 83709\
(208) 378-5631\
Fax (208) 378-5637\
<Cynthia.M.Gaborick@usda.gov>

**Illinois**\
Lennis Knight\
USDA, APHIS, VS\
2815 Old Jacksonville Rd., Suite 104\
Springfield, IL 62704\
(217) 241-6689\
Fax (217) 241-6695\
<Lennis.C.Knight@usda.gov>\
\
**Indiana**\
Dr. Francisco Collazo Mattei\
USDA, APHIS, VS\
5685 Lafayette Road, Suite 400\
Indianapolis, IN 46254-6158\
(317) 290-3300

Fax (317) 290-3311\
<Francisco.Collazo-Mattei@usda.gov>

**Iowa**\
Dr. Kevin L. Petersburg\
USDA, APHIS, VS\
Federal Bldg., Rm. 891\
210 Walnut Street\
Des Moines, IA 50309\
(515) 284-4140\
Fax (515)284-4156\
<Kevin.L.Petersburg@usda.gov>\
\
**Kansas**\
Dr. Kevin P. Varner\
USDA, APHIS, VS\
1947 NW Topeka Blvd., Suite F\
Topeka, KS 66608\
(785) 235- 2365\
Fax (785) 235-1464\
<Kevin.P.Varner@usda.gov>\
\
**Kentucky**\
Dr. Roger J. Odenweller\
USDA, APHIS, VS\
P.O. Box 399\
Frankfort, KY 40602\
(502) 227-9651\
Fax (502) 223-7121\
<Roger.Odenweller@usda.gov>

**Louisiana**\
Dr. Joel Goldman\
USDA, APHIS, VS\
5825 Florida Blvd., Rm 1140\
Baton Rouge, LA 70806-9985\
(225) 389-0436\
Fax (225) 389-0524\
<Joel.Goldman@usda.gov>

**Maryland** (**DE**, **DC**)\
Dr. David F. Vogt\
USDA, APHIS, VS\
1598 Whitehall Road, Suite A\
Annapolis, MD 21401\
(410) 349-9708\
Fax (301) 261-8113\
[David.F.Vogt@usda.gov[\
]{.underline}](mailto:David.F.Vogt@usda.gov)

**Massachusetts** (**CT**, **ME**, **NH**, **RI**, **VT**)\
Dr. William G. Smith\
USDA, APHIS, VS\
160 Worcester-Providence Road\
Sutton Square Plaza, Suite 20\
Sutton, MA 01590-9998

\(508\) 865-1421, 22\
Fax (508) 865-9317\
<William.G.Smith@usda.gov>\
\
**Michigan**\
Dr. Reed Macarty\
USDA, APHIS, VS\
3001 Coolidge Road, Suite 325\
East Lansing, MI 48823\
(517) 324-5290\
Fax (517) 324-5289\
<Reed.E.Macarty@usda.gov>

**Minnesota**\
Dr. Michael L. Stine\
USDA, APHIS, VS\
251 Starkey Street\
Bolander Bldg., Suite 229\
St. Paul, MN 55107\
(651) 290-3691\
Fax (651) 228-0654\
<Michael.L.Stine@usda.gov>\
\
**Mississippi**\
Dr. Charles P. Nettles\
USDA, APHIS, VS\
345 Keyway Street\
Flowood, MS 39232\
(601) 965-4307\
Fax (601) 965-5535\
<Charles.Nettles@usda.gov>\
\
**Missouri**\
Dr. Robert L. Fischer\
USDA, APHIS, VS\
P.O. Box 104418\
Jefferson City, MO 65110-4418\
(573) 636-3116\
Fax (573) 636-4384\
<Robert.L.Fischer@usda.gov>\
\
**Montana**\
Area Veterinarian-in-Charge - Vacant\
USDA, APHIS, VS\
208 North Montana Ave., Suite 101\
Helena, MT 59601-3837\
(406) 449-5407\
Fax (406) 449-5439

**Nebraska**\
Dr. Kathleen Akin\
USDA, APHIS, VS\
P.O. Box 81866\
Lincoln, NE 68501\
(402) 434-2300

Fax (402) 434-2330\
<Kathleen.J.Akin@usda.gov>

**Nevada**\
Dr. Paul Ugstad\
USDA, APHIS, VS\
9580 Micron Ave., Suite E\
Sacramento, CA 95827\
(916) 857-6170\
Fax (916) 857-6196\
<Paul.O.Ugstad@usda.gov>\
\
**New Jersey**\
Jonathan Zack\
USDA, APHIS, VS\
Mercer Corporate Park\
320 Corporate Blvd.\
Robbinsville, NJ 08691-1598\
(609) 259-8387\
Fax (609) 259-2477\
<Jonathan.T.Zack@usda.gov>\
\
**New Mexico**\
Dr. Michael T. Greenlee\
USDA, APHIS, VS\
6200 Jefferson Street, NE, Suite 117\
Albuquerque, NM 87109\
(505) 761-3160\
Fax (505) 761-3176\
<Michael.T.Greenlee@usda.gov>\
\
**New York**\
Roxanne Mullaney\
USDA, APHIS, VS\
One Winners Circle, Suite 100\
Export/Area Office\
Albany, NY 12205\
(518) 453-0187\
Fax (518) 453-0213\
<Roxanne.C.Mullaney@usda.gov>

**North Carolina**\
Eric Coleman\
USDA, APHIS, VS\
930 Main Campus Drive, Suite 200\
Raleigh, NC 27606\
(919) 855-7700\
Fax (919) 855-7720\
Export Line (919) 855-7701\
<Eric.S.Coleman@usda.gov>

**North Dakota**\
Area Veterinarian-in-Charge - Vacant\
USDA, APHIS, VS\
3509 Miriam Ave., Suite B

Bismarck, ND 58501\
(701) 250-4210\
Fax (701) 250-4471\
\
**Ohio**\
Dr. Susan Skorupski\
USDA, APHIS, VS\
12927 Stonecreek Drive\
Pickerington, OH 43147\
(614) 469-5602\
Fax (614) 866-1086\
<Susan.Skorupski@usda.gov>\
\
**Oklahoma**\
Dr. Brian H. Espe\
USDA, APHIS, VS\
4020 North Lincoln Blvd., Suite 101\
Oklahoma City, OK 73105\
(405) 427-9413\
Fax (405) 427-9451\
<Brian.H.Espe@usda.gov>\
\
**Oregon**\
Dr. Don Herriot\
USDA, APHIS, VS\
530 Center St., NE, Suite 335\
Salem, OR 97301\
(503) 399-5871\
Fax (503) 399-5607\
<Don.E.Herriott@usda.gov>\
\
**Pennsylvania**\
Dr. Enzo R. Campagnolo\
USDA, APHIS, VS\
2301 N. Cameron St., Rm. 412\
Harrisburg, PA 17110\
(717) 782-3442\
Fax (717) 782-4098\
<Enzo.R.Campagnolo@usda.gov>

**Puerto Rico**\
Dr. Miguel A. Borri-Diaz\
USDA, APHIS, VS\
IBM Building\
654 Munoz Rivera Avenue, Suite 700\
Hato Rey, PR 00918\
(787) 766-6050\
Fax (787) 766-5159\
<Miguel.A.Borri-Diaz@usda.gov>\
\
**South Carolina**\
Dr. Delorias Lenard\
USDA, APHIS, VS\
9600 Two Notch Road, Suite 10\
Columbia, SC 29229

\(803\) 788-1919\
Fax (803) 788-2102\
<Delorias.M.Lenard@usda.gov>\
\
**South Dakota**\
Dr. Lynn. A. Tesar\
USDA, APHIS, VS\
314 S. Henry, Suite 100\
Pierre, SD 57501-0640\
(605) 224-6186\
Fax (605) 224-8451\
<Lynn.A.Tesar@usda.gov>\
\
**Tennessee**\
Dr. Mark Davidson\
USDA, APHIS, VS\
P.O. Box 110950\
Nashville, TN 37222\
(615) 781-5310\
Fax (615) 781-5309\
<Mark.L.Davidson@usda.gov>

**Texas**\
Area Veterinarian-in-Charge - Vacant\
USDA, APHIS, VS\
Thornberry Bldg., Rm. 220\
903 San Jacinto Blvd.\
Austin, TX 78701\
(512) 916-5551\
Fax (512) 916-5197\
\
**Utah**\
Dr. Robert A. DeCarolis\
USDA, APHIS, VS\
176 N. 2200 West, Suite 230\
Airport Park, Bldg. #4\
Salt Lake City, UT 84116\
(801) 524-5010\
Fax (801) 524-6898\
<Robert.A.DeCarolis@usda.gov>

**Virginia**\
Dr. Terry L. Taylor\
USDA, APHIS, VS\
Washington Bldg., 6th Floor\
1100 Bank Street\
Richmond, VA 23219\
(804) 771-2774\
Fax (804) 771-2030\
<Terry.L.Taylor@usda.gov>

**Washington**\
Dr. Gary L. Brickler\
USDA, APHIS, VS\
2604 12th Court, SW., Suite B

Olympia, WA 98502\
(360) 753-9430\
Fax (360) 753-9585\
<Gary.L.Brickler@usda.gov>\
\
**West Virginia**\
Dr. Susan Skorupski\
USDA, APHIS, VS\
12927 Stonecreek Drive\
Pickerington, OH 43147\
(614) 469-5602\
Fax (614) 866-1086\
<Susan.Skorupski@usda.gov>\
\
**Wisconsin**\
Dr. Linn Wilbur\
USDA, APHIS, VS\
6510 Schroeder Road, Suite 2\
Madison, WI 53711\
(608) 270-4000\
Fax (608) 270-4001\
<Linn.A.Wilbur@usda.gov>\
\
**Wyoming**\
Dr. Bret A. Combs\
USDA, APHIS, VS\
5353 Yellowstone Road, Room 209\
Cheyenne, WY 82009\
(307) 772-2186\
Fax (307) 772-2592\
<Bret.A.Combs@usda.gov>

## **GIPSA**

**Headquarters**

GIPSA

1400 Independence Ave., SW

Room 1641

South Bldg

Washington, DC 20250

\(202\) 720-7051

**Regional Offices States Covered**

P&SP AL, AK, CT, DC, DE, FL, GA, LA, MA, MD, ME,

75 Spring Street MS, NC, NH, NJ, NY, PA, RI, SC, TN, VA, VT,

Suite 230 WV

Atlanta, GA 30303

\(404\) 562-5840

P&SP AK, AZ, CA, CO, HI, ID, KS, MT, NE, NM, OK,

1 Gateway Centre OR, TX, VT, WA, WY

3950 Lewiston

Suite 200

Aurora, CO 80011

\(303\) 375-4240

PS&P IA, IL, IN, KY, OH, MI, MO, MN, ND, SD, WI

Federal Bldg

Room 317

210 Walnut Street

Des Moines, IA 50309

\(515\) 323-2590

# **ATTACHMENT E -- GIPSA / TITLE 18 MEMO**

DEPARTMENT OF HEALTH & HUMAN SERVICES

Date JUN 2 3 1987

From Acting Associate Director for

Surveillance and Compliance, HFV‑200

**Subject** 403(a), Packers and Stockyards Act, and Title 18,

Chapter 100 References in Regulatory Letters: Illegal Residues

All District offices

We have recently had occasion to review a number of issues regarding
Regulatory Letters issued on illegal tissue residue violations in cases
where false certificates were identified under the *USDA* Voluntary Veal
Certification Program.

Our considerations in this [memorandum]{.underline} are based on the
presumption that you have other supportable Title 21 charges to include
in your Regulatory Letter. We are not prepared to issue Regulatory
Letters addressing Title 18 alone. In addition, *FDA* is not committing
itself to take regulatory action under Title 18, or the PSA Act for
false drug residue certificates, which are in fact, presented to another
Federal agency, i.e. FSIS, as it would be their prerogative and
responsibility to bring such action our intent in addressing Title 18,
in these circumstances, is to inform the violator that another agency
(PSA or FSIS*)* may be interested in taking action under their Acts (7
U.S.C. 181 et. seq, 15 U.S.C. 50) or under 18 U.S.C. 1001, for false
information presented to that agency. This is the result of an agreement
with those agencies that we will convey the message concerning Title 18
violations in letters we issue.

1\. [Title 18 (18 U.S.C. 1001)]{.underline}

\(a\) When an illegal tissue residue violation occurs and the offering
of a false certificate is well documented, demonstrating a willful,
intentional act, we recommend the District consider referral of the case
to the Packers and Stockyards Administration (PSA) and the Food Safety
Inspection Service (FSIS) (see attached lists for referral), since a
felony prosecution may be appropriate. A Title 18 reference in a
Regulatory Letter would not be appropriate in these circumstances.

\(b\) When evidence of false certificates exists, without a well
documented, willful, intentional act, we recommend the following
cautionary statement:

We caution you that it is a violation of United States Code, Title 18,
Section 1001 (18 U.S.C. 1001) (copy enclosed) to make intentional or
willful, false, fictitious or fraudulent statements or representations
in any matter within the jurisdiction of any department or agency of the
United States, and that you may be subject to severe penalties under the
criminal provisions of 18 U.S.C. 1001.

2\. Likewise in all cases where evidence of false certificates exist,
with documentation of an intentional act, *the* District should refer,
in the information portion of the Regulatory Letter, to
[possible]{.underline} action by the Packers and Stockyards
Administration, under the Packers and Stockyards Act (7 U.S.C. 181 et.
seq. and 15 U.S.C. 50), in addition to referral of the case to the
Packers and Stockyards Administration.

[Example]{.underline}: We note that you have provided (a) false drug
residue certificate(s) on the calf (calves) identified with Back Tag
\_\_\_, which may subject you to possible action under the Packers mid
Stockyards Act (7) U.S.C. 181 et. seq. and 15 U.S.C. 50 by the Packers
and Stockyards Administration.

3\. In addition, a copy of the Regulatory Letter should be sent to the
local/regional office of the Packers and Stockyards Administration, in
all cases where false certificates exist. A copy should also be sent to
the local compliance office of the Food Safety and Inspection Service.
(Use attached lists for mailing copies)

4\. [403(a) Charge]{.underline}

A 403(a) charge has been proposed in at Ieast one tissue residue case,
for the offering of a false drug residue certificate, considering the
certificate as labeling, and the \"labeling\" as false and misleading.

We currently are unable to support a 403(a) misbranding charge for the
offering of a false certificate by the seller of an animal. We do not
believe a 403(a) charge is appropriate in such circumstances.

# **ATTACHMENT F-1**

# **Example of Slaughter House Affidavit to Document Chain of Custody**

AFFIDAVIT Sample No. [\_ (Doc. Sample No.)]{.underline}

STATE OF\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ COUNTY
OF\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Before me, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, an employee of the Department
of Health and Human Services, Food and Drug Administration, designated
by the Secretary, under authority of the Act of January 31, 1925, 43
Statutes at Large 803: Reorganization Plan No. IV, Secs. 12-15,
effective June 30, 1940; Reorganization Plan No. I of 1953, Secs.1-9,
effective April 11. 1953; and P.L. 96-88, Sec. 509. 93 Statutes at Large
965 (20 U.S.C. 3508), effective May 4, 1980; to administer or take
oaths. Affirmations and affidavits, personally appeared
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ in the county and State aforesaid,
who, being duly sworn, deposes and says:

I am the Accounts Payable Livestock employee at firm [name, address,
city, state,]{.underline}

[Zip,]{.underline} and I am responsible for all record keeping practices
regarding the consignment, slaughter, identification, distribution, and
compensation for dairy cows and other types of animals.

On 5/1/04, \_\_\_\_\_\_Dairy, located at \_\_\_\_\_\_\_\_, consigned
three cows at this slaughter facility, as shown by Consignment Record
dated \_\_\_\_. This record shows that the cows were identified by back
tag #'s \_\_\_, \_\_\_, and \_\_\_. It also shows that [insert dealer
name and address]{.underline} picked up these cows, identified them, and
transported them to us in his truck and trailer for slaughter into food
for human consumption.

Kill Sheet dated \_\_\_\_ shows that we slaughtered the cow identified
by back tag #\_\_\_ as part of lot #\_\_\_. It also shows that she was
identified by several numbers, i.e., House Tag #\_\_\_, and USDA Retain
Tag #\_\_\_\_ (last four digits).

While in our possession, we did not medicate this cow in any manner.

All records have been identified by me and supplied to Investigator
\_\_\_\_\_\_\_\_\_\_\_\_.

AFFIANT'S SIGNATURE AND TITLE

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

FIRMS NAME AND ADDRESS (Include ZIP Code)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Subscribed and sworn to before me at \_\_\_\_\_\_\_\_ (City /State) this
day of \_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

(Employee\'s Signature)

Employee of the Department of Health and Human Services designated under
Act of January 31, 1925. Reorganization Plan IV effective June 30, 1940.
Reorganization Plan No, I of 1953, effective April 11, 1953; and PL
96-88 effective May 4, 1980.

# **ATTACHMENT F-2** 

# **Example of Slaughter Plant Inspector Affidavit**

AFFIDAVIT Sample No. \_\_\_\_\_\_

STATE OF\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ COUNTY
OF\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Before me, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, an employee of the Department
of Health and Human Services, Food and Drug Administration, designated
by the Secretary, under authority of the Act of January 31, 1925, 43
Statutes at Large 803: Reorganization Plan No. IV, Secs. 12-15,
effective June 30, 1940; Reorganization Plan No. I of 1953, Secs.1-9,
effective April 11. 1953; and P.L. 96-88, Sec. 509. 93 Statutes at Large
965 (20 U.S.C. 3508), effective May 4, 1980; to administer or take
oaths. Affirmations and affidavits, personally appeared
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ in the county and State aforesaid,
who, being duly sworn, deposes and says:

On September \_\_\_, 200\_, a F.A.S.T. test that I ran yielded a
positive result.

Whenever a tissue sample is collected for laboratory analysis an FSIS
Form 10, Q-02-2 is prepared by filling in items one (1) through
seventeen (17). The tissue and the forms are then sent directly to the
USDA laboratory in \_\_\_\_\_\_\_\_ for identification and
quantification of the drug residue. The samples are packed in specially
constructed shipping ice boxes which contain bottles of frozen water to
refrigerate the samples which are shipped by overnight delivery. I or my
staff collected the sample and performed the F.A.S.T. screening test on
the following animal:

Sample Form No.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Collection Location
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Collection Date
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Retain Tag
Number\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Animal ID
Tag(s)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

AFFIANT'S SIGNATURE AND TITLE

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

FIRMS NAME AND ADDRESS (Include ZIP Code)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Subscribed and sworn to before me at \_\_\_\_\_\_\_\_ (City /State) this
day of \_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

(Employee\'s Signature)

Employee of the Department of Health and Human Services designated under
Act of January 31, 1925. Reorganization Plan IV effective June 30, 1940.
Reorganization Plan No, I of 1953, effective April 11, 1953; and PL
96-88 effective May 4, 1980.

# **ATTACHMENT G**

# **DRUG INVENTORY**

**TISSUE RESIDUE INSPECTIONS**

Drug inventory to be completed by all Federal and State investigators
conducting tissue residue inspections.

FSIS Sample Number:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Fiscal Year:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

State:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

FDA
District:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Type of Animal:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please circle the drug tradename of **all** drugs found at the firm
(drugs are listed alphabetically by active ingredient, and under each
active ingredient by dosage form and trade name.) The information
collected via this inventory will be used to develop future sampling
strategies. While completing this document please look for and document
the use of any illegally compounded products, Animal Medicinal Drug Use
Clarification Act (AMDUCA)-prohibited drugs, or unapproved drugs (a
further description of these products can be found at the end of this
inventory). Space has been allotted at the end of the list for
additional drugs you may find on the premises. Return this drug
inventory survey to your local FDA district Tissue Residue Coordinator.
If you have any questions on this inventory please contact Deborah Cera
at (301)827-0181.

**Acepromazine Maleate (tranquilizer)**

-   Injection

> PromAce^®^ Injectable
>
> Acepromazine Maleate Injection

-   Oral

> PromAce^®^ Tablets
>
> Acepromazine Maleate Tablets

**Albendazole: (antiparasitic, benzimidazole family)**

-   Oral: Valbazen^®^

**Albuterol**: **(bronchodilator**, **Beta-agonist) Approved for use in
horses only. Not approved in cattle or swine.**

-   Intranasal: Torpex ™

**Amikacin (antimicrobial, aminoglycoside {AGS})**

-   Injection

Amiglyde-V

Amikacin Sulfate Injection

**Amoxicillin Trihydrate (antimicrobial, penicillin family beta
lactam)**

-   Oral:

Amoxi-Doser

Amoxi-Bol

Amoxi-Sol

Amoxi-Tabs

Amoxi-Drop^®^ Oral Suspension

Clavamox^®^ Tablets

Clavamox^®^ Drops

Robamox^®^-V Tablets

-   Injectable

Amoxi-Inject 25 Grams

Amoxi-Inject 3 Grams

Robamox^®^-V

-   Intramammary: Amoxi-Mast

**Ampicillin Anhydrous: (antimicrobial, penicillin family beta lactam)**

-   Injectable: Omnipen 250 mg

**Ampicillin Sodium: (antimicrobial, penicillin family beta lactam)**

-   Injectable: Amp-Equine

**Ampicillin Trihydrate (antimicrobial, penicillin family beta lactam)**

-   Injectable:

Polyflex^®^

Princillin Injection

Ampicillin Trihydrate

Princillin Injection 200 mg

Ampi-Ject

-   Oral:

Princillin Bolus

Ampi-Bol

Princillin Capsules 125 mg

Princillin Capsules 250 mg

Princillin Capsules 500 mg

Princillin \"125\" For Oral Suspension

-   Water: Princillin Soluble Powder

**Amprolium:** **(anticoccidial)**

-   Water:

Amprovine 9.6% Solution

Amprovine 20% Soluble Powder

Corid 20% Soluble Powder

-   Medicated Feed:

Broiler PMX No.1620,

Amprol HI-E^®^ Plus

Amp Ethopabate CTC^®^ Sodium Sulfate

Erythro^®^ (Low Lev) / Amp plus Etho

Swisher Super Broiler 300-108;

Swisher Super Broiler 400-112

Chick Grower-Developer Fortified

Amprol Plus / Lincomix^®^ / Roxarsone

Lincomix^®^ / Amprol Plus

Amprol HI-E^®^ / Roxarsone

Amprol HI-E^®^ / BMD^®^ / Roxarsone

Rainbrook Broiler Premix No.1

Rainbow Broiler Base Concentrate

Rainbow Broiler Base Concentrate

Amprol HI-E^®^ & Bambermycins

Amprol HI-E^®^ / Flavomycin^®^

3-Nitro^®^ / Amprol HI-E^®^ / Flavomycin^®^

3-Nitro^®^ / Amprol / Flavomycin

3-Nitro^®^ / Amprol / Flavomycin^®^

Zinc Bacitracin & Amprol HI-E^®^

Baciferm^®^ / Amprol HI-E^®^ Premix

Amprol / Carb-O-Sep^®^

Amprol HI-E^®^ / Stafac^®^

Flavomycin^®^ / Amprolium

3-Nitro^®^ / Amprol^®^ / BMD^®^

Amprol^®^ / BMD^®^

Albac^®^ / Amprol Hi-E^®^

3-Nitro^®^ / Albac^®^ / Amprol Hi-E^®^

3-Nitro^®^ / Albac^®^ / Amprol Hi-E^®^

-   Oral: Purina^®^ Liquid Amprol

**Aspirin: (Non Steroidal Anti Inflammatory {NSAID})**

-   Oral: boluses

**Boldenone Undecylenate (anabolic steroid) Controlled Drug (DEA)**

-   Injectable: Equipoise^®^

**Bovine Somatotropin (growth hormone)**

 

-   Injectable: Sometribove Zinc)Posilac 1 Step®

**Butorphanol (analgesic, opioid) Controlled Drug (DEA)**

-   Injectable:

Torbutrol® Injection

Torbugesic®

Torbugesic-SA ®

Dolorex®

-   Oral: Torbutrol® Tablets

**Carbadox (anticoccidial)**

-   Medicated Feed:

Mecadox^®^ Premix 10

Banminth^®^ / Mecadox^®^

**Ceftiofur**: **(antimicrobial, cephalosporin family beta lactam)**

-   Injectables:

Excenel®

Naxcel®

**Cephapirin** **(antimicrobial, cephalosporin family beta lactam)**

-   Intramammary:

Cefa-Dry®

Tomorrow® Infusion

Cefa-Lak®

Today® Intramammary Infusion

**Chloramphenicol (antimicrobial) Extra label use prohibited in Food
Animals**

*(chloramphenicol drugs below are small animal approvals )*

-   Injection: Mychel-Vet Injection

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-   Oral:

Chlorasol

Chloromycetin Tablets 100 mg

Chloromycetin Tablets 250 mg

Chloromycetin Tablets 500 mg

Chlora-Tabs 100

Tevcocin Tablets

Amphicol-V

Chloromycetin Ophthalmic Ointment

Chloramphenicol Capsules

Chloricol

Mychel-Vet Capsules (50 mg)

Chloramphenicol Capsules

Anacetin Tablets

Mychel-Vet Tabs

Medichol Tablets

-   Topical chloramphenicol:

Chlorasone Ophthalmic Ointment

Chloramphenicol 1% Ophthalmic

Vetrocloricin Opthalmic Ointment

**Chlortetracycline: (antimicrobial, tetracycline family)**

-   Medicated feed

Aureomix S 700-A

Aureomix S 700-E

Aureomix S 700 Crumbles

Aureomix S 700 g

Chlorachel ™ 10

Chlorachel ™ 20

Chlorachel ™ 35

ChlorMax ™ 10 Type A Medicated Article

CLTC-10

CLTC-20

CLTC-30

CLTC-50

CLTC-50 MR

Pennchlor ™ 64

-   Milk replacer: Pfichlor 100S Milk Replacer Type A Medicated Article

-   Oral

> Aureomycin® Tablets 25 mg

Calf Scour Boluses,

-   Water

Soluble powder

Aureomycin® Soluble Powder

**Chlorothiazide: (diuretic)**

-   Oral: Diuril® bolus

**Clenbuterol: (beta agonist) Extra label use prohibited in food
animals**

-   Oral : Ventipulmin®

**Clindamycin (antimicrobial, lincosamide family)**

-   Oral:

Antirobe® Capsules,

Antirobe® Aquadrops Liquid

Clindamycin Hydrochloride Oral Liquid

Clinsol®

Clindamycin Hydrochloride Capsules

Clintabs®

**Cloxacillin** **(antimicrobial, penicillin family beta lactam)**

-   Intramammary

Boviclox

Dry-Clox®

Dry-Clox® Intramammary Infusion

Orbenin DC, Dariclox®

**Danofloxacin (antimicrobial, fluoroquinolone family) Extra label use
prohibited in food animals**

-   Injection: A180® (beef cattle)

**Dihydrostreptomycin** **(antimicrobial, aminoglycoside family)**

-   Intramammary:

Quartermaster® Dry Cow Treatment

Dry-Mast

-   Injection:

Dihydrostreptomycin

Pfizer-Strep

-   Bulk drug[^1]:

Dihydrostreptomycin Sulfate

**Dexamethazone: (anti-inflammatory long acting glucocorticoid
\[steroid\])**

-   Injectable

> Azium® Aqueous Suspension Veterinary
>
> Voren® Suspension, generics

-   Oral

> Azium® Boluses
>
> Azium® Powder 10 mg
>
> Naquasone® Bolus,

**Decoquinate (anticoccidial, quinolone)**

-   Medicated feed:

> Deccox® Type A Medicated Article
>
> Deccox® / Lincomycin
>
> Decoquinate & Lincomycin
>
> 3-Nitro® / Deccox®
>
> Albac® / Deccox®; Broiler Finisher Medicated
>
> ChlorMax ™ / Deccox®
>
> Decoquinate & Chlortetracycline
>
> Lincomix® / Deccox®
>
> Deccox® / Lincomycin
>
> Decoquinate & Lincomycin
>
> 3-Nitro® / Deccox® / Albac®
>
> Deccox® - M Medicated Powder for Whole Milk
>
> 3-Nitro® / BMD® / Deccox®
>
> BMD® / Deccox®
>
> Chloromax® / Deccox®
>
> Decox ® / Rumensin ®
>
> Deccox® / Rumensin® / Tylan®
>
> Aureomycin® / Deccox®
>
> 3-Nitro® / Albac® / Deccox®
>
> Albac® / Deccox®

**Detomidine (sedative, nonopioid)**

-   Injectable: Dormosedan ™

**Dimethyl sulfoxide (DMSO): (NSAID, solvent)**

-   Topical: Domoso® Solution, Domoso® Gel

**Dinoprost Tromethamine**: **(hormone, synthetic prostaglandin
analog)**

-   Injectable: Lutalyse® Sterile Solution

**Dipyrone: (NSAID) Not approved in the US!**

-   injectable

**Enrofloxacin: (antimicrobial-fluoroquinolone family)** **Extra label
use prohibited in food animals**

-   Injection: Baytril® 100 Injectable Solution (beef cattle), Baytril®
    Antibacterial Injectable Solution (dogs)

-   Oral: Baytril® Antibacterial Tablets (dogs); Baytril® Taste Tabs ™
    Antibacterial Tablets (dogs); Baytril® 3.23% Concentrate
    Antimicrobial Solution (chickens)

-   Topical: Baytril® Otic (dogs)

**Eprinomectin (antiparasitic-ivermectin family)**

-   Topical Pour-On

Ivomec® Eprinex ™ Pour-On for Beef and Dairy Cattle

Ivomec® Eprinex ™ Pour-On for Cattle

**Erythromycin (antimicrobial-macrolide family)**

-   Injectable: Erythro® - 100, 200; Gallimycin® Injectable,
    Erythro®-100 Injection

-   Intramammary: Erythro®-36 Dry; Gallimycin®-36 Dry, Erythromast 36,
    Gallimycin®-36 Sterile

-   Medicated feed: Gallimycin® 50

**Estradiol (hormone, nonsynthetic)**

-   Implants:

Compudose 200

Compudose 400

Revalor^®^-200

Revalor^®^-H

Revalor^®^-IH

Synovex^®^ Plus

**Estradiol Benzoate (hormone, synthetic)**

-   Implant:

Component^®^ TE-G with Tylan^®^

Component^®^ TE-S with Tylan^®^

Synovex^®^-C

Synovex^®^-S

Synovex^®^-H

**Estradiol Cypionate (hormone, synthetic) Not approved in US**

-   Injection: Estradiol Cypionate

**Fenbendazole**: **(antiparasitic, benzimidazole family)**

-   Oral:

Panacur® Suspension 10% (Rx label)

Panacur® Granules 22.2%

Panacure®-C, Panacur® Paste

Safeguard® (OTC label) --paste

Safe-Guard® Suspension 10%

Purina® Worm-A-Rest Litter Pack

-   Medicated feed:

Safeguard® Type A medicated article

BMD® / Safe-Guard®

-   Medicated feedblocks: Safe-Guard® Enproal Feedblocks

**Florfenicol (antimicrobial, chloramphenicol family)**

-   Injection: Nuflor® Injection

-   Oral: Nuflor® Concentrate Solution

**Flunixin meglumine:** (**NSAID)**

-   Injection:

Banamine® injectable Solution

Flunixin Meglumine Injection

Flunixin Meglumine Solution

-   Oral:

Banamine® paste

Banamine granules

**Furazolidone \[see nitrofurazone\]: (antimicrobial-nitrofuran family)
Extra label use prohibited in food animals**

-   Topical:

Furox® Aerosol Powder

Topazone Aerosol Powder

 

**Furosemide: (diuretic)**

-   Injection: Lasix®

**Gentamicin:** **(antimicrobial, aminoglycoside)**

-   Dip (turkey eggs):

Garasol® Solution

Gentasol

-   Injectables: ***No approvals in Cattle, very long preslaughter
    withdrawal***

Gentocin®

Garasin®

Garasol®

Gentamicin Sulfate Inj. Sol.

Gentamicin Sulfate Solution

Legacy Sterile Solution

Gentaglyde ™ Solution

Gentamex ™ 100

Gentamicin Sulfate Solution

-   Intramammary: *none approved* (may dilute in saline, or
    reconstitute)

-   Ophthalmic:

Gentocin® Durafilm Ophthalmic Solution

Gentocin® Ophthalmic Ointment

Gentocin® Pink Eye Spray

-   Oral:

Garacin Oral Solution

Gentocin® Oral Solution

Gentocin® (Garacin) Pig Pump Oral Solution

Gentocin® (Garacin) Soluble Powder

Gentamicin Sulfate Pig Pump Oral Solution

Gentoral®

-   Topical:

Gentocin® Otic Solution

Topagen® Ointment

Gentocin® Topical Spray

Otomax®

Mometamax ™ Otic Suspension

Betagen ™ Topical Spray

Tri-Otic Ointment

Gentavet® Otic Solution

-   Water: Gen-Gard ™ Soluble Powder

**Hetacillin** **(antimicrobial, penicillin family beta lactam)**

-   Intramammary:

Hetacin® K

Hetacin® K Intramammary Infusion

**Isoflupredone**: **(anti-inflammatory, glucorticoid)**

-   Injectable: Predef® 2x Sterile Aqueous Suspension

-   Topical: Neo Predef® Sterile Ointment

**Ivermectin:** **(antiparasitic, ivermectin family)**

-   Injection:

Eqvalan® Injection

Ivomec® F Injection For Cattle

Ivomec® Plus Injection For Cattle

Ivomec® .27% Injection Grower And Feeder Pigs

Ivomec® 1% Injection

Ivomec® 1% Injection Cattle And Swine

Ivomec® Injection

-   Oral:

Eqvalan® Oral Liquid For Horses

Eqvalan® Oral Liquid

Ivomec® Liquid

Eqvalan®; Eqvalan® Paste For Horses

Ivomec® Cattle Paste 0.153%

> Ivomec® Sustained-Release Bolus for Cattle

Phoenectin ™ Injection for Cattle and Swine

Phoenectin ™ Paste 1.87%

Iversol Liquid for Horses

Equell ™

Primectin ™ Equine Oral Liquid

> Primectin ™ Drench for Sheep
>
> Ivercide ™ Liquid for Horses
>
> Ivermectin Liquid for Horses
>
> Phoenectin ™ Liquid for Horses

-   Topical Pour On:

> Ivomec® Pour-On For Cattle
>
> Ivomec® Premix for Swine
>
> Ivomec® Premix for Swine and Lincomix® Premix
>
> BMD® / Ivomec® Premix for Swine
>
> Ivermectin Pour-On for Cattle
>
> Phoenectin ™
>
> Phoenectin ™ Pour-On for Cattle
>
> Iver-On ™
>
> Virbamec ™ Pour-On
>
> Privermectin ™
>
> Ecomectin

-   Medicated Feed: Ivomec^®^ Premix plus BMD^®^

**Kanamycin: (antimicrobial)**

-   Injectable: Kantrim® 200

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-   Oral: Amforol® Suspension

**Ketamine: (anesthetic) Controlled Drug (DEA). Should not be on the
farm unless in the Vet's truck**

-   Injectable: Ketaset®

**Ketoprofen**: **(NSAID)**

-   Injectable: Ketofen®

**Lasalocid:** **(anticoccidial-ionophore family)**

-   Medicated feeds:

Avatec® Premix

Bovatec® Premix

Bovatec® Type A Medicated Article)

> Moorman\'s® Cattle Minerals BT

**Levamisol: (antiparasitic, imidiathiazole family)**

-   Oral:

Ripercol L Bolus

Tramisol® Cattle Wormer Bolus

Ripercol L Soluble Drench Powder

Ripercol L Wormer Oblets

Tramisol® Sheep Wormer Oblets

Levasole® Soluble Drench Powder

Tramisol® Soluble Drench Powder

**Lincomycin**: **(antimicrobial, lincosamide family)**

-   Injectable:

Lincomix® Injectable -- 25

Lincomix® Injectable -- 50

Lincomix® Injectable -- 100

Lincomix® Injectable -- 300

Lincocin® Sterile Solution (Rx)

Lincomycin Injectable 30%

-   Topical: Lincocin® Aquadrops 

-   Oral: Lincocin® Tablets

-   Medicated feed:

> Lincomix® Feed Medication Types A, B
>
> Lincomix^®^ / Amprol Plus / Roxarsone
>
> Lincomix^®^ & Amprol Plus
>
> Lincomix®, Lincomix® / Deccox®
>
> Coyden® / Lincomix®
>
> Lincomix® / Bonaid
>
> Lincomycin & Buquinolate,
>
> Deccox® / Lincomycin
>
> Decoquinate & Lincomycin,
>
> Lincomix® / Zoamix®, Coban® / Lincomix®
>
> Coban® / Lincomix®
>
> Coban® / Lincomix® / Roxarsone, Nicarbazin Lincomycin Premix
>
> 3-Nitro® / Avatec® / Lincomycin
>
> Banminth® / Lincomix®
>
> Purina® Check-R-Ton Li
>
> Linco-8
>
> Linco-20
>
> Cadco Li-8
>
> Cadco Li-20
>
> Link-8
>
> Link-20
>
> Swine L-4
>
> Swine L-8
>
> Swine L-20
>
> Linco 8
>
> Linco 20
>
> Lincomycin 4 Antibiotic Premix
>
> Lincomycin 5 Antibiotic Premix
>
> Lincomycin 10 Antibiotic Premix
>
> Lincomycin 20 Antibiotic Premix
>
> Linco 8
>
> Linco 20
>
> Nutra-Mix Linco 4
>
> Master Mix Linco Option 5
>
> Master Mix Linco Option 10
>
> Micro-Pak LX
>
> Linco 4
>
> Linco 20
>
> Bio-Cox® / Lincomix®
>
> Banminth® / Lincomix®
>
> Banminth® / Lincomix® 20
>
> Lincomix® / Stenorol®
>
> 3-Nitro® / Bio-Cox® / Lincomix®
>
> Lincomix® / Maxiban®
>
> Lincomix® Type A Medicated Article/ Safe-Guard® Type A Medicated
> Article
>
> Ivomec® Premix for Swine and Lincomix® Premix
>
> 3-Nitro® / Lincomix® / Sacox®
>
> Sacox® / Lincomix®
>
> 3-Nitro® / Lincomix® / Nicarmix 25®
>
> Lincomix® / Nicarmix 25®

-   Water:

> Lincomix® Soluble Powder
>
> L-S 50 Water Soluble® Powder
>
> Lincomycin Hydrochloride Soluble Powder
>
> Lincomycin Soluble
>
> Linco Soluble
>
> Lincosol Soluble Powder

**Melengestrol Acetate (MGA): (hormone, synthetic)**

-   Medicated Feed Ingredient:

> MGA® 100 / Rumensin® / Tylan®
>
> MGA® 200 / Rumensin® / Tylan®, MGA® 100 Premix
>
> MGA® 200 Premix
>
> MGA® 500 Liquid Premix

**Metronidazole**: **(antiprotozoal, nitroimidazole family) Extra label
use prohibited in food animals**

-   Oral: Flagyl® (human approval only, no animal approval)

**Monensin: (anticoccidial-ionophore family)**

-   Medicated Feed:

> Rumensin®
>
> Rumensin® 80
>
> Coban® - 45
>
> Coban® - 60
>
> Coban® - 110
>
> Elancoban-100

**Neomycin sulfate: (antimicrobial, aminoglycoside family)**

-   Oral:

Biosol® Sterile Solution

Biosol® Sterile Solution 50 mg

Neo-Sol 50®

NEORAL Oral Solution

-   Water:

Neomix® 325 Soluble Powder

Neomix® AG 325 Soluble Powder

Neomycin 325 Soluble Powder

**Nitrofurazone: (antimicrobial, nitrofuran family) Extra label use
prohibited in food animals**

-   Topical:

Furacin®

NFZ® Puffer

Nitrofurazone Solution

> Furacin Dusting Powder
>
> Furacin Ear Solution
>
> Furacin Solution Veterinary
>
> Furacin-Microfur
>
> Sulfamylon-N
>
> Fura Ointment
>
> Furaderm
>
> Fura-Solution
>
> Fura-Septin Soluble Dressing
>
> Nitrofurazone Dressing
>
> Fura-Vet
>
> Nitrofurazone Anesthetic Dress.
>
> Furacol Solution
>
> Nitrozone Solution
>
> Fura-Zone
>
> Fura-Zone Solution
>
> NFZ® Wound Dressing
>
> Nitrofurazone Soluble Dressing

-   Water: Furacin Soluble Powder

**Novobiocin:** **(antimicrobial)**

-   Intrammary: Albamast® Suspension

**Orbifloxacin: (antimicrobial-fluoroquinolone family) Extra label use
prohibited in food animals**

-   Oral: Orbax ™ Tablets

**Oxytetracycline: (antimicrobial, tetracycline family)**

-   Injectable:

LA 200®

Liquamycin® Injectable

Terramycin® Injectable

-   Oral

Terramycin® Animal Formula

Terramycin® Soluble Powder

Terramycin® Scour Tablets

MGA® (liquid) / Terramycin®

**Penicillin: (antimicrobial-penicillin family beta lactam)**

-   Penicillin benzathine injectable:

Combicillin® AG

Dura-biotic

Longicil Fortified

Benza-Pen

Pen BP-48

Bicillin Fortified

-   Procaine Penicillin G Injectable

Flo-cillin®

Agricillin Pen Aqueous

Aqua-Cillin; Penicillin G Co-op

Crystalline Pro Penicillin G

Crysticillin

Penicillin G Procaine

-   Intrammammary:

Albadry Plus® Suspension

Quartermaster® Dry Cow Treatment

Aqua-Mast

Hanfords Four-Pen

Formula A-34

Uni Biotic 4 Dose

Dry-Mast

**Phenylbutazone:** (**NSAID) Prohibited in female dairy cows over 20
months of age**

-   Injection:

Butazolidin Injectable 20%

EquiBute Injection

Robizone-V Injection

-   Oral:

Butazolidin Bolus

Butazolidin Tablets

Tevcodyne tablets

Bizolin®-100 tablets

Bizolin®-200 tablets

Robizone-V tablets

**Pirlimycin: (antimicrobial, lincosamide family)**

-   Intramammary:

Pirsue® Aqueous Gel

Pirsue® Sterile Solution

**Progesterone: (hormone, nonsynthetic)**

-   Implants:

Synovex^®^-C

Synovex^®^-S

Component® E-C with Tylan®

Component® E-S with Tylan®

 

-   Intravaginal: EAZI-Breed™ CIDR® Cattle Insert

**Ractopamine: (growth promotant, beta agonist) Approved for use in
growing swine only. Not approved in cattle.**

-   Medicated Feed:

Paylean®; Paylean® 45

Paylean® / Tylan®

**Salicylic Acid: (NSAID, aspirin)**

-   Bougie[^2]: Shurjets

-   Oral: None approved at this time

**Spectinomycin**: **(antimicrobial, aminoglycoside family)**

-   Injectable:

Adspec® Sterile Solution

Spectam® Injectable

PROSPEC® Injectable

Spectinomycin Injectable

Spectinomycin Injection

-   Oral:

Spectinomycin Tablet

Spectam® Scour Halt

Spectinomycin Oral Liquid

Spectam® Tablets

-   Water

Spectam® Water Soluble Concentrate

L-S 50 Water Soluble® Powder

**Streptomycin: (antimicrobial, aminoglycoside family)**

-   Bulk Drug: *Under AMDUCA, compounded drugs made from bulk illegal
    for use in Animal Drugs*

Dihydrostreptomycin Sulfate

Streptomycin Sulfate Bulk (Veterinary)

-   Medicated Feed:

Rainbrook Broiler Premix No.1

-   Oral:

Entromycin Powder

Entromycin Tablets No.1

Entromycin Tablets No.2

Streptomycin Oral Solution

Strep-Sol

**Sulfadimethoxine:** **(antimicrobial, Sulfonamide)**

-   Injectable:

Albon®

Agribon Injection 40%

-   Oral:

Albon®

Agribon Boluses - 2.5

Agribon Boluses - 5.0

Agribon Boluses - 15.0

Albon® S.R. (Sustained Release)

-   Water:

Agribon 12.5% Drinking Water Solution

Di-Methox Antibacterial Soluble Powder

Sulfasol® Soluble Powder

**Sulfabromomethazine: (antimicrobial, Sulfonamide)**

-   Oral: Sulfabrom 2.5 g

**Sulfaethoxypyridazine**: **(antimicrobial, Sulfonamide)**

-   Injectable: S.E.Z. Intravenous Solution

-   Oral: S.E.Z. Oblets 15 G

-   Water: S.E.Z. Drinking Water Solution

 

**Sulfamethazine: (antimicrobial, Sulfonamide) Extra label use
prohibited in lactating dairy cows**

-   Injectable:

Sulmet® Solution Injectable

-   Oral:

Tylocine Sulfa Tablets 50

HavaSpan Prolonged Release Bolus;

SulfaSpan Prolonged Release Bolus

Sulka-S ™ Bolus

Sulfa Sustained Release Bolus

Calfspan ™

> Purina® Sulfa

Sulfamethazine Spanbolet II

Sustain III® Bolus

Sulmet® Oblets

> Veta-Meth ™

-   Medicated Feed

> Aureo SP-250; Aureomix 500
>
> Aureomix S 700 Crumbles; Aureomix S 700 g
>
> Tylan® 10 Sulfa-G Premix; Tylan® 40 Sulfa-G Premix
>
> Aureomix S 700-A
>
> Aureomix S 700-D
>
> Aureomix S 700-G
>
> Aureomix S 700-E
>
> Aureomix S 700-F
>
> Aureomix S 700-C-2
>
> Aureomix S 700-B
>
> Aureomix S 700-H
>
> Purina® Pork-Plus Medicated
>
> Chlorachel ™ 250 Swine / Pficlor SP 250
>
> ChlorMax ™-SP 250; ChlorMax ™-SP 500
>
> ChlorMax ™-SP 1000
>
> CO-OP Tylosin 40 Plus Sulfamethazine
>
> Tylan® 40 Plus Sulfa-G
>
> Hubbard Tylan® Plus Sulfa Premix
>
> Swine Med-A-Mix TS 8000 Premix
>
> Tylan® 40 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Quali-Tech Tylan®-Sulfa Premix 10 -10
>
> Tylan® 5 Sulfa-G; Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G; Tylan® 40 Sulfa-G
>
> Medi-Flex T:S
>
> Tylan® Sulfa 10-10 Premix
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® Sulfa 5 G
>
> Tylan® Sulfa 10 G
>
> Tylan® Sulfa 20 G
>
> Tylan® Sulfa 40 G
>
> Purina® Tylan® 40 Plus Sulfamethazine
>
> Mill Co Medicator TS-40 Premix
>
> Seeco Tylan®-Sulfa 10 Premix Med.
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> HFA Tylosin-10 Plus Sulfa
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Nutra-Mix Tylan®-Sulfa Premixes
>
> Heinold Tylan® 5 Sulfa Premix
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® Sulfa
>
> Tylan® 5 Sulfa Premix
>
> Tylan® 10 Sulfa Premix
>
> Tylan® 5 Sulfa Premix
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Nutra-Blend Tylan® 5 Sulfa Premix
>
> Tylan® 5 Sulfa Premix
>
> Tylan® 10 Sulfa Premix
>
> Tylan® 20 Sulfa Premix
>
> Tylan® 40 Sulfa Premix
>
> Tylan® 5 Sulfa-G
>
> Tylan® 5 Sulfa Premix
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G

Tylan® 40 Sulfa-G

> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G
>
> Tylan® Sulfa-G
>
> Tylan® Sulfa-G
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan® Sulfa-G
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan 5 Sulfa-G
>
> Tylan 10 Sulfa-G
>
> Tylan 20 Sulfa-G
>
> Tylan 40 Sulfa-G
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix
>
> Tylan® 5 Sulfa-G Premix
>
> Tylan® 10 Sulfa-G Premix
>
> Tylan® 20 Sulfa-G Premix
>
> Tylan® 40 Sulfa-G Premix

-   Water

Sulmet® Drinking Water Solution

Aureomycin® Sulmet Soluble Powder

Aureo Sulfa Soluble Powder

Sulmet® Soluble Powder

**Sulfachlorpyridazine: (antimicrobial, sulfonamide) Extra label use
prohibited in lactating dairy cows**

-   Oral:

Prinzone Bolus

Pyradan Bolus

Vetisulid® Bolus

Vetisulid® Tablets

Prinzone Oral Suspension

Pyradan Oral Suspension

Vetisulid® Oral Suspension

-   Injection:

> Prinzone Injection
>
> Pyradan Injection
>
> Vetisulid® Injection

-   Water:

Prinzone Powder

Pyradan Powder

Vetisulid® Powder

**Sulfamethoxazole: (antimicrobial, sulfonamide-no current approvals)
Extra label use prohibited in lactating dairy cows**

**Sulfadiazine/trimethoprim: (antimicrobial, potentiated sulfonamide)
Extra label use prohibited in lactating dairy cows**

-   Injectable: Tribrissen® 48% Injection

-   Oral:

Tribrissen® 30 Tablets

Tribrissen® 120 Tablets

Tribrissen® 480 Tablets

Tribrissen® 960 Tablets

Tribrissen® 400 Oral Paste

Tucoprim® Powder

Sulfa Di-Trim® Tablets

**Testosterone Propionate: (hormone)**

-   Implant: Synovex^®^-H

**Tetracycline:** **(antimicrobial, tetracycline family)**

-   Oral

> Panmycin® 500 Bolus
>
> Polyotic® Oblets®
>
> Tet-Sol 10
>
> Tet-Sol 324 ™

**Tilmicosin:** **(antimicrobial, macrolide family)**

-   Injectable: Micotil® 300

-   Medicated Feed: Pulmotil®

**Trenbolone Acetate: (hormone, synthetic "androgenic" anabolic
steroid)**

-   Implant:

> Finaplix^®^-H
>
> Finaplix^®^-S
>
> Revalor^®^-G
>
> Revalor^®^-S
>
> Revalor^®^-200
>
> Revalor^®^-H
>
> Revalor^®^-IH, Synovex^®^ Plus
>
> Component^®^ TE-G with Tylan^®^
>
> Component^®^ TE-S with Tylan

**Trichlormethiazide**: **(diuretic)**

-   Oral: Naquasone® Bolus (also contains dexamethasone)

**Tripelennamine Hydrochloride (antihistamine) Human approved drug is
called PBZ®**

-   Injectable: Recovr® Injectable

**Tylosin: (antimicrobial, macrolide family)**

-   Injectable: Tylan®, Tylosin® Injection

-   Medicated Feed: ***See Sulfamethazine under Feeds***

> Tylan® 40 CAL Type A Medicated Article
>
> Tylan® 100 CAL Type A Medicated Article
>
> Tylan® Soluble, Tylan® 100 Premix
>
> CO-OP Tylan® 10 Mix

Tylosin® 5 Type A Medicated Article

> Tylosin® 10 Type A Medicated Article
>
> Tylosin® 20 Type A Medicated Article
>
> Tylosin® 40 Type A
>
> Quali-Tech Tylan®-10 Premix
>
> Tylan® 5 Sulfa-G
>
> Tylan® 10 Sulfa-G
>
> Tylan® 20 Sulfa-G
>
> Tylan® 40 Sulfa-G

**Xylazine (sedative, nonopioid)**

-   Injectable:

Rompun® Injectable (20 mg)

Rompun® Injectable (100 mg)

Anased®; Anased® Injectable

Xylazine HCl Injection

Sedazine ™

Chanazine®

Chanazine®

**Zeranol (hormone, synthetic "estrogenic" anabolic steroid)**

-   Implants:

Ralgro^®^ Implants

Ralgro^®^ Magnum

Additional Drugs:

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Explanation of terms used in entries and footnotes:**

**Example:**

**Gentamicin:** **(antimicrobial)**

-   Dip (turkey eggs): Garasol® Solution, Gentasol

> **Antimicrobial** is a broad term that includes drugs that kill or
> inhibit bacteria. Gentamicin is "cidal", i.e. kills bacteria
> susceptible to it.
>
> Garasol® is the drug "**trade name**" : designated by the "®". **An
> approved new animal drug always has an NADA (new animal drug
> application) number on the labeling!** Note that the approved use
> should also be on the labeling.
>
> Gentamicin is the "**established name**" for this drug. Sometimes
> "established name" is used interchangeably with the term "generic",
> and they are not necessarily the same thing.

**Generic**: This term is used 2 ways-

> 1\. used interchangeably with term "established name" for a drug.
>
> 2\. a "**Generic Drug**": an FDA approved generic drug . Requirements
> for approval of an ANADA (abbreviated new animal drug application)
> include: the "pioneer" drug has to be off patent and still considered
> safe and effective; generic has to be an *exact* copy of the "pioneer"
> including its manufacturing, claims, etc. Generic copies generally do
> not have "®" after the name, and sometimes the drug established name
> is the only name given on the bottle, i.e. gentamicin sulfate. **An
> approved Generic Drug always has an ANADA number on the labeling!**
>
> **Pioneer Drug:** These drugs are from the sponsor's original
> approval, often the first trade name to come on the market for a
> particular drug entity. The "pioneer", or first, drug approved for a
> particular drug entity has patents and other protections so that
> "generic copies" cannot be made for several years following the
> original approval. **In the case of gentamicin,** Schering-Plough has
> the original approvals-the "pioneer products" with tradenames
> **Garasol®, Garacin®, Gentocin®**.
>
> []{#__RefHeading___Toc107892006 .anchor}**AMDUCA Prohibited Drugs
> List** <http://www.fda.gov/cvm/Documents/530_41.txt>
>
> **The following drugs (both animal and human), families of drugs, and
> substances are prohibited for extra-label uses in all food-producing
> animals:**

-   **Chloramphenicol;**

-   **Clenbuterol;**

-   **Diethylstilbestrol (DES);**

-   **Dimetridazole;**

-   **Ipronidazole;**

-   **Other nitroimidazoles (i.e. metronidazole);**

-   **Furazolidone, Nitrofurazone, other nitrofurans;**

-   **Sulfonamide drugs in lactating dairy cattle (except approved use
    of**

> **sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);**

-   **Fluoroquinolones (enrofloxacin, danofloxacin, orbifloxacin)**

-   **Glycopeptides (vancomycin, teicoplanin, oritavancin)**

-   **Phenylbutazone (in female dairy cattle 20 months of age or
    older)**

**Compounded Drugs:**

-   FDA defines compounding as the manipulation of drugs to obtain
    products that differ from the starting materials in an approved
    dosage form drug. **[Under AMDUCA, compounding is considered to be
    extra-label drug use, and must be done from approved finished dosage
    form drugs only]{.underline}.**

-   It is illegal for veterinarians, or pharmacists, to compound
    unapproved finished new animal drug products from *bulk* drugs.

-   **Non-commercial labels may serve as a cue for identifying
    compounded products.**

#  {#section-14 .unnumbered}

# **ATTACHMENT H - District Monitor Checklist**

**RVIS Activities**

Review Weekly Report for assignment

Check RVIS for addl. residues prior to insp.

Provide State with computer-generated

Attachment C forms prior to inspection

Enter appropriate follow-up activity codes

Each Fed/State inspec. must have an FDA

responsibility code entered (R, I, N)

Enter activity codes for Enforcement Actions

Periodically run reports to identify specific

violation/violator trends/patterns

Twice per year provide District mgmt.

with list of Repeat Violators

Review the "Not Investigated Repeat

Violator Report" to make sure none of

your DO's firms are on the report.

Review the "Investigated w/No

Responsibility Code Entered Report"

to make sure none of your DO's

firms are on the report.

**Administrative Activities**

Promptly issue assignments for Fed/State inspections per CP guidelines

Remind all to complete the Drug Inventory Survey

Review completed EIR's for changes to firm info.

Enter firm change information into RVIS.

Review Attachment C's for compleeteness (IF not complete, contact FDA
investigator or State Coordinator and explain what should have been
completed in effort to improve quality of future rpts.

Request Regulatory Reserve Samples for firms possibly subject of an
enforcement action.

Monitors should maintain a list of samples that they have requested to
be stored in an FDA laboratory. Periodically review this list and
request a Sample Destruction Notices (SDNs) be prepared through the
appropriate channels in your District once it becomes clear that the
District will not be initiating enforcement action against a firm.

For all Federal and State investigations/inspections submit to HFV-235 a
copy of the FACTS coversheet w/ endorsement, and Attachments C & G.

Work with CVM to distribute industry outreach materials to address local
residue concerns.

Serve as a clearinghouse for distribution of pertinent information to
cooperating State Officials and District Mgmt.

Recommend training of al Fed/State personnel conducting residue
investigations.

Maintain routine communications with local reps. Form FSIS, APHIS, GIPSA
and the States.

[^1]: Bulks drugs prohibited from use in compounded drugs for Animals,
    under AMDUCA!

[^2]: Device for delivery of the drug-stays in teat canal till next
    milking