This document discusses antibiotic use and regulation in animal agriculture. It notes that while antibiotics are an important tool for veterinarians, their overuse and misuse has led to concerns about antibiotic resistance in bacteria. New FDA guidance aims to curb antibiotic overuse by restricting medically important antibiotics to uses overseen by veterinarians, requiring veterinary oversight for all antibiotic use, and improved record keeping. The document advocates for judicious antibiotic use according to principles of using the right drug, at the right time, dose and duration, with proper withdrawal times and record keeping. It outlines programs like PQA Plus that promote responsible antibiotic use and judicious use principles for veterinarians.

1. Antibiotic use, regulation, and
record keeping
Matt S. Anderson, DVM
Suidae Health and Production
Algona, Iowa

2. When Fleming discovered
penicillin, do you think he ever
envisioned such a debate?

3. Tools of the veterinarian
 Vaccine
 Antibiotics
 Host of other medications
 Physicians recognize the value too

4. The Perceived Problem
1. Antibiotics are used in animals
2. Results in the development of resistant
bacteria
3. Resistant bacteria remain on meat through
packing process
4. Resistant bacteria remains on meat through
transport and to the retailer

5. The Perceived Problem
5. Consumer buys meat and resistant bacteria
remains viable through preparation
6. Resistant bacteria is transmitted to
human/human becomes infected
7. Human goes to doctor and is prescribed an
antimicrobial
8. Human does not recover
(Dr. Scott Hurd)

6. Manifestations
 All kinds of groups with specific agendas
and initiatives
 PAMPTA
 GFI 209
 GFI 213
 VFD

7. GFI 209
 Final Guidance for Industry
 Medically important antimicrobial drugs
will be limited to uses assuring animal
health
– Loss of growth promotant claims
– Expanded carbon footprint
– Economically detrimental to producers
 Decreased ADG
 Increased F/G

8. GFI 209
 Medically important antimicrobial drugs
will be limited to uses that include
veterinary oversight and consultation
– Loss of OTC drugs
– Expanded role for veterinarians in oversight
 May be an opportunity but may also cost more

9. GFI 213
 Draft GFI 213
 Implementation of principles espoused in
GFI 209

10. Veterinary Feed Directive
 Draft text
 Marketing status changes

11. Judicious Use of Antibiotics
 The right antimicrobial
 At the right time
 At the right concentration
 With the correct amount of treatment time
 With the correct amount of withdrawal time
observed
 With the proper records completed and
maintained

12. Judicious Use
 Have a herd health management plan
– Supported by current diagnostics
– With a demonstrated VCPR
– Maintain accurate records for the appropriate
amount of time

13. Judicious Use
 Producers
– We care
– PQA Plus
 Veterinarians
– VCPR
– ELDU
– AMDUCA

14. We Care Program
 Produce safe food
 Protect and promote animal well-being
 Ensure practices to protect public health
 Safeguard natural resources in all of our practices
 Provide a work environment that is safe and
consistent with our other ethical principles
 Contribute to a better quality of life in our
communities

15. PQA Plus
 GPP1 Herd health management plan
 GPP2 Appropriate VCPR
 GPP3 Use antibiotics responsibly
 GPP4 ID, track, and maintain medication
and treatment records
 GPP5 Adhere to withdrawal times
 GPP6 Properly store, label, and account for
all drugs

16. PQA Plus
 GPP7 Use proper administration techniques,
etc.
 GPP8-10

17. VCPR
 21 CFR part 530
1. Vet assumes responsibility for making
medical judgments
2. Vet has sufficient knowledge of the
animals in question
3. Vet is readily available for follow up

18. VCPR
 Non-OTC Swine labeled products requiring
a prescription (Baytril or Naxcel)
 Non-swine labeled products
– ELDU

19. ELDU
 ELDU is permitted only by or under the supervision of a veterinarian.
 ELDU is allowed only for FDA approved animal and human drugs.
 A valid Veterinarian/Client/Patient Relationship is a prerequisite for all
ELDU.
 ELDU for therapeutic purposes only (animal's health is suffering or
threatened). Not drugs for production use.
 Rules apply to dosage form drugs and drugs administered in water.
ELDU in feed is prohibited.
 ELDU is not permitted if it results in a violative food residue, or any
residue which may present a risk to public health.
 FDA prohibition of a specific ELDU precludes such use

20. AMDUCA record keeping
 Identify the animals, either as individuals or a group.
 Animal species treated.
 Numbers of animals treated.
 Conditions being treated.
 The established name of the drug and active ingredient.
 Dosage prescribed or used.
 Duration of treatment.
 Specified withdrawal, withholding, or discard time(s), if applicable, for
meat, milk, eggs, or animal-derived food.
 Keep records for 2 years.
 FDA may have access to these records to estimate risk to public health.

21. AMDUCA label requirements
 Name and address of the prescribing veterinarian.
 Established name of the drug.
 Any specified directions for use including the class/species
or identification of the animal or herd, flock, pen, lot, or
other group; the dosage frequency, and route of
administration; and the duration of therapy.
 Any cautionary statements.
 Your specified withdrawal, withholding, or discard time
for meat, milk, eggs, or any other food.

22. FDA Inspection
 Great way to test your knowledge and skill
in the areas of prescription and record
keeping
 These inspectors are
professional, polite, incredibly
thorough, and have a very limited sense of
humor
 FDA inspection can be initiated without any
notice and for not much in the way of a
reason

23. FDA Inspection
 Pre-emptive residue avoidance??????
 Demonstration of VCPR
 Looked at every product in every dark
corner of the farm---2 day effort
 Every label was scrutinized
 Every expiration date was studied
 Many questions were asked
 If you don’t break the rules you’ll be fine

28. The Veterinarian’s Oath
 Being admitted to the profession of veterinary medicine, I solemnly swear to
use my scientific knowledge and skills for the benefit of society through the
protection of animal health, the relief of animal suffering, the conservation of
livestock resources, the promotion of public health, and the advancement of
medical knowledge.
I will practice my profession conscientiously, with dignity, and in keeping with
the principles of veterinary medical ethics.
I accept as a lifelong obligation the continual improvement of my professional
knowledge and competence.
 Adopted by AVMA HOD in 1954
– Revised in 1969 and 1999

29. The Veterinarian’s Oath
 Being admitted to the profession of veterinary medicine, I solemnly swear to
use my scientific knowledge and skills for the benefit of society through the
protection of animal health and welfare, the prevention and relief of animal
suffering, the conservation of animal resources, the promotion of public
health, and the advancement of medical knowledge.
I will practice my profession conscientiously, with dignity, and in keeping with
the principles of veterinary medical ethics.
I accept as a lifelong obligation the continual improvement of my professional
knowledge and competence.
 Revised by the AVMA executive board in late 2010

31. Suidae Health and Production
 Veterinary Clinic
 Research
 Management
 Laboratory Services
 Distribution
 Building
distributorship
 Production