Extra-label drug use revisited

The US Food and Drug Administration (FDA) recently proposed a number of guidance documents aimed at eliminating production uses and over-the-counter (OTC) distribution of “medically important” antimicrobials in livestock feed. This affords us a good opportunity to revisit the regulations governing the extra-label use of antimicrobials in food-producing animals. It is important to note that there is no legal extra-label use of feed-grade antimicrobials. Veterinarians and producers are specifically banned from administering antimicrobials in feed in any manner other than as specifically approved on the label. Simply put, it is illegal to prescribe or use any antimicrobial in livestock feed for any indication, duration, dose, or frequency not listed on the label.

For drugs other than feed-grade antimicrobials, the FDA issued a final rule implementing the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). This rule delineated the guidelines governing the extra-label use of animal and human drugs and applies to both prescription and OTC drugs. Prior to the enactment of AMDUCA, the use of any drug except in a manner specifically outlined on the label rendered the drug “unsafe” in the eyes of the law.

This act allows for drug use under AMDUCA only to treat disease, not for production uses. AMDUCA does not allow for extra-label use if there exists an approved food-animal drug which contains the needed ingredient in the proper dosage form and is labeled for, and effective against, the condition being treated. Extra-label use of a drug is approved if the existing labeled drug is clinically ineffective, provided that the veterinarian has a basis for determining that the approved drug is ineffective in the animals being treated. Drug cost is not an acceptable reason for extra-label use.

According to the FDA, the extra-label use of drugs for reproductive purposes would, in most cases, not be considered treatment and is thus not allowed under AMDUCA. Preventive extra-label use is allowed if the veterinarian can substantiate that the health of the animals is threatened. However, AMDUCA does not allow for the extra-label use of any drugs administered through the feed. Extra-label administration of feed-grade antibiotics is illegal under all circumstances.

The American Veterinary Medical Association has designed a brochure and a flow chart to aid veterinarians with decision making regarding the appropriate use of drugs in an extra-label manner. These reference materials can be accessed at https://www.avma.org/KB/Resources/Reference/Pages/AMDUCA2.aspx. In addition, veterinarians who have questions about AMDUCA or extra-label use of drugs may contact FDA/CVM Division of Compliance, 7519 Standish Place, HFV-230, Rockville, MD 20855; Tel: 240-276-9200.

DEA controlled substances update

This past April, California veterinarians received requests for clarification on their principal places of business when a residential address was used. While this is not illegal, the Drug Enforcement Administration (DEA) does not like to see a residential address used as a place where controlled substances are delivered and stored. That being said, controlled substances cannot be taken outside of a registered location per CFR 1301.12, “A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported or dispensed by a person.” This means that it is illegal for veterinarians to carry controlled substances out of the registered location, be it to a home or clinic, for use on farms, in pet’s homes, or in veterinary mobile units.

The American Veterinary Medical Association (AVMA) sent a letter to the DEA in April following the discussions in California. Since that time, Washington State has also had discussions with their DEA field office in Seattle. The AVMA and other stakeholders, like the United States Animal Health Association, have been involved in ongoing discussions with the DEA on this issue for quite some time. The DEA maintains that a statutory change is required to address this issue.

The AVMA Governmental Relations Division remains engaged with congressional offices, particularly Rep Kurt Schrader (D, Oregon), to address the issues associated with transporting controlled substances. The AVMA’s Council on Biologic and Therapeutic Agents established a subcommittee to provide guidance on this issue. At the same time, numerous allied stakeholders are working with the AVMA to make congressional offices aware of these concerns and garner support for congressional action.

Source: The AVMA Advocate Dr Ashley Morgan, Assistant Director AVMA-GRD

Swine practitioners: Volunteer to mentor a veterinary student

The AASV Foundation is pleased to announce that the National Pork Industry Foundation (NPIF) has renewed funding for the NPIF Internship Stipend for 2013. This program, now in its fifth year, provides internship opportunities to six veterinary students who are interested in swine medicine but have limited means to gain experience early in their education.

The AASV Student Recruitment Committee (AASV-SRC) developed the program to link each selected first- or second-year veterinary student with a practitioner mentor for 1 year. During the summer, the student is required to spend 1 month under the practitioner’s guidance in the field. The $3300 stipend provided to each student is meant to defer costs of travel, lodging, and compensation for the 1-month period. In addition, the student is encouraged to attend both the AASV Annual Meeting and the Leman Conference.

The AASV-SRC is seeking six US swine practitioners to be mentors for the students. Commitments include answering one student’s questions regarding the industry throughout the year and hosting the student for a minimum of 1 month in the summer. If you are interested in being a practitioner mentor, please contact Dr Nathan Winkelman at 320-393-7447 (office), 320-760-0318 (cell), or nwink@jetup.net.

Applicants sought for alternate student delegate on AASV Board of Directors

The AASV Student Recruitment Committee is accepting applications for veterinary students interested in serving as the alternate student delegate on the AASV Board of Directors. This student will represent student interests and serve as a non-voting member of the AASV board. This experience will provide the student with a unique perspective of the inner workings of the AASV. The term of service is 2 years: the first year as alternate student delegate and the second year as the student delegate.

The alternate student delegate and student delegate are required to attend the AASV board’s two meetings each year: the spring meeting held during the AASV Annual Meeting and the fall meeting, which is usually held in October. The student delegate presents a summary of board activities to the student membership at the student breakfast during the AASV Annual Meeting and outlines student opportunities in AASV to the AASV student members at that time. In addition, the delegate and alternate delegate are voting members of the AASV Student Recruitment Committee and are invited to participate in committee conference calls and meetings. The delegates receive reimbursement to cover travel and lodging expenses for the fall board meeting and transportation expenses for the spring meeting.

Interested students must be members of AASV in their freshman or sophomore year. Applicants are required to submit the following documentation to the AASV (830 26th Street, Perry, IA 50220-2328; E-mail: aasv@aasv.org):

1. An introductory letter, not to exceed one page, explaining why they want to serve as the alternate student delegate for AASV and their level of interest and background in swine medicine.

2. A one- or two-page resume featuring the student’s interest and experience in production medicine, particularly swine medicine.

3. A statement of recommendation from a faculty member.

The deadline for submission of necessary documentation is November 12, 2012. The delegate will be chosen by members of the AASV Student Recruitment Committee following review of the submitted materials. Applicants will be notified of the committee’s decision by December 15.

The term of service is 2 years, beginning at the AASV Annual Meeting. During the first year, the student will serve as the alternate student delegate. The alternate delegate will automatically succeed as student delegate, beginning at the annual meeting the following year. The alternate delegate will serve in the capacity of delegate if the selected student delegate is unable to carry out his or her duties. Each year, a new alternate delegate is selected by the AASV Student Recruitment Committee.

Questions may be directed to the chair of the AASV Student Recruitment Committee, Dr Clayton Johnson, clayton.johnson@pigsrus.net.

AASV awards nominations due December 14

Do you know an AASV member whose dedication to the association and the swine industry is worthy of recognition? The AASV Awards Committee requests nominations for the following five awards to be presented at the upcoming AASV Annual Meeting in San Diego.

Howard Dunne Memorial Award – Given annually to an AASV member who has made a significant contribution and rendered outstanding service to the AASV and the swine industry.

Meritorious Service Award – Given annually to an individual who has consistently given time and effort to the association in the area of service to the AASV members, AASV officers, and the AASV staff.

Swine Practitioner of the Year – Given annually to the swine practitioner (AASV member) who has demonstrated an unusual degree of proficiency in the delivery of veterinary service to his or her clients.

Technical Services/Allied Industry Veterinarian of the Year – Given annually to the technical services or allied industry veterinarian who has demonstrated an unusual degree of proficiency and effectiveness in the delivery of veterinary service to his or her company and its clients as well as given tirelessly in service to the AASV and the swine industry.

Young Swine Veterinarian of the Year – Given annually to a swine veterinarian who is an AASV member, 5 years or less post graduation, who has demonstrated the ideals of exemplary service and proficiency early in his or her career.

Nominations are due December 14. The nomination letter should specify the award and cite the qualifications of the candidate for the award. Submit to AASV, 830 26th Street, Perry, IA 50220-2328; Fax: 515-465-3832; E-mail: aasv@aasv.org.