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Using Antibiotics with Honey Bees

 

Bee Aware of the upcoming changes in obtaining antibiotics for honey bees. The following questions were answered by the Center for Veterinary Medicine this month.  If you have more questions please contact Barb Bloetscher, State Entomologist using the contact information at the bottom of the page.

AskCVM
Center for Veterinary Medicine
U.S. Food and Drug Administration

Thank you for contacting the FDA Center for Veterinary Medicine.  Please see below for the answers to you questions.

1. If beekeepers buy the terramycin or tylosin (for foulbrood diseases) alone instead of mixed in sugar, would they need a prescription vs a VFD?

On January 1, 2017, we expect that certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter (OTC) to Veterinary Feed Directive (VFD) for drugs that are approved to be administered through feed or to prescription (Rx) status for drugs that are approved to be administered through water.  Buying the drug alone does not change whether you will need a prescription or a VFD, the use the drug is approved for (in feed or in water) determines whether you will need a Rx or a VFD to obtain the drug.   

Drugs that have either a prescription or veterinary feed directive marketing status may only be used under the oversight of a veterinarian. We understand that products approved for use in honey bees will be involved in this transition, including oxytetracycline (Type A medicated article) which will transition to VFD. Tylosin (soluble powder) has already transitioned to Rx. CVM has also approved lincomycin (soluble powder) for use in bees.

Below are links to listings of drugs transitioning from OTC to VFD or Rx:

2. Where would beekeepers obtain the products and would they only be available as a feed (premixed with sugar?)

Beekeepers should contact their current distributor to determine whether they plan to continue to distribute the medication after it transitions to Rx or VFD.  VFD drugs may be sold as a Type A medicated article, which would not be premixed with feed.  They may also be sold as a Type B (a concentrated medicated feed that will require further dilution) or Type C medicated feed (a medicated feed that contains a drug concentration that is meant to be fed to the animal).

3. Is January 2017 still targeted as the start date to remove all targeted antibiotics from feed stores, catalogues, etc. so that beekeepers can ONLY obtain them with a prescription/ VFD?

Yes, on January 1, 2017, we expect that certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter (OTC) to Veterinary Feed Directive (VFD) for drugs administered through feed or to prescription (Rx) status for drugs administered through water.  The intent is not to remove these products from stores on January 1, 2017, but rather to have the product remaining in stores labeled and distributed in compliance with the prescription or VFD requirements beginning on January 1, 2017.

4. How quickly will the sources have the antibiotics available to order and purchase?

FDA recently sent a letter to retail establishments to remind them of upcoming changes to the use of antibiotics in food animals. The letter also provides retail establishments with recommendations for addressing current and future inventory of medically important antimicrobials for use in feed or water for food animals.  We hope that the recommendations in this letter allow for the distributors to continue to maintain availability of the drugs that are transitioning throughout the transition period. 

Refer to the link below to view the letter: http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/UCM507354.pdf

As stated in that letter, the prescribing or dispensing of Rx drug products for use in animals must be authorized by a licensed veterinarian under federal law and also under state law in most states. Once the approvals for the affected products are revised to reflect the transition from OTC to Rx marketing status, such products can only be used in compliance with regulations governing the dispensing of Rx drugs, even if the product still has the old OTC labeling.

5. Will the dosage be the same as it is now?

Transitioning of drugs from their present over-the-counter status to prescription and VFD is not expected to modify drug levels – dosages.

6. If a County or a State Inspector writes the Inspection form indicating that an antibiotic is needed, can the beekeeper take that to a vet or a supplier to obtain the antibiotic, thus avoiding the need for the vet to visit the apiary?

No, in order for a veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarians professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter  (21 CFR 558.6(b)(1)).

Refer to the link below to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

The veterinarian may consult with a County or State Inspector in addition to having a VCPR with the beekeeper and bee colony.  However, in order to establish and/or maintain the VCPR the veterinarian will likely need to visit the apiary initially and on a periodic basis.

7. Will the FDA mandate that statements recommending “preventive” use of antibiotics be removed from beekeeping catalogues?

Distributors should not promote or advertise a Type A medicated article, or medicated feed for an extralabel use.   Such promotional activity is not appropriate because extralabel use of medicated feed is not legally permissible under the FD&C Act.

8. Once the beekeeper has a VCPR, would the beekeeper be able to obtain a VFD without the vet re-inspecting the apiary?

As stated previously, depending on your state the state or federal VCPR requirements may apply.  These requirements may vary slightly as to how frequently a veterinarian must see the animals in order to establish and maintain a VCPR.    Your veterinarian will have to determine whether a visit is necessary to  issue a VFD within the context of a VCPR. 

A table identifying whether the state or federal VCPR definition applies to a lawful VFD in each state may be viewed at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

9. Is this document still current? -Requirements for Veterinarians 2015” Guidance for Industry #120, 21 CFR 558.6 (VFD)

Yes, the document is current.

10. Will ODA be able to train vets in Ohio?

There are a number of organizations that provide training for veterinarians.  We recommend you work with your State Board of Veterinary Medicine to discuss any continuing education training opportunities that you may want to provide for vets within your state.   Veterinarians seeking training opportunities may also want to check with the American Veterinary Medical Association or the American Association of Veterinary State Boards to see what training may be available or planned.

We hope you find this information helpful.

Sincerely,AskCVM
Center for Veterinary Medicine
U.S. Food and Drug Administration

 

 

 

Barbara Bloetscher
State Apiarist/Entomologist
Ohio Department of Agriculture
Plant Health Bldg #23
8995 East Main St.
Reynoldsburg, OH 43068
ODA Apiary website: http://www.agri.ohio.gov/divs/plant/apiary/apiary.aspx
614-728-6373
Fax 614-728-6453
BBloetscher@agri.ohio.gov