FDA proposes banning over-the-counter antibiotics (Shepherd’s Notebook)
(Editor’s note: Susan Schoenian is a sheep and goat specialist with the University of Maryland.)
As a follow-up to the Veterinary Feed Directive which requires antibiotics put in feed or water to be prescribed by a veterinarian, the Food & Drug Administration is proposing banning the sale of over-the-counter antibiotics, as part of its five-year antimicrobial stewardship program, aimed at combating antibiotic resistance.
FDA is proposing banning the over-the-counter sale of more than 100 animal drugs considered to be medically-important for human medicine.
An OTC drug is one that can be purchased at a feed or farm supply store or from a mail order catalog.
It includes injectable and other forms of antibiotics.
An antibiotic is a medicine that kills or prevents the growth of bacteria.
While most of the antibiotics on FDA’s list are “old” drugs, they are still commonly used by sheep and goat producers to treat common disease conditions, such as pneumonia, mastitis, scours, and footrot.
The drug list includes penicillin, cephapirin, sulfas, tetracyclines and spectinomycin.
In addition, it is possible that manufacturers may pull some drugs from the market as a result of the new regulations.
FDA is proposing a two-year implementation period. Once in effect, livestock producers will be required to get a veterinary prescription in order to administer an antibiotic to their livestock.
They will need to have a valid veterinarian-client-patient-relationship to do so.
A VCPR means that the veterinarian has familiarity with the animals being treated, including occasional farm visitations.
The regulations should have minimal effect on most sheep and goat producers, who should already be working with veterinarians to address animal health issues and use drugs extra-label.
With few drugs FDA-approved, extra label drug use is often necessary to treat sick sheep and goats.
For example, of the drugs listed in the paragraph above, only penicillin is FDA-approved and for sheep only.
Only veterinarians have the legal right to use or prescribe drugs extra-label.
It is possible that the regulations will increase the cost of using antibiotics, as producers will need to engage veterinarians in order to use antibiotics and they will need to purchase antibiotics from their veterinarians.
On the other hand, the new regulations may decrease the use of antibiotics, as producers better understand the need to place more emphasis on preventative health care practices, including better facilities, nutrition, and biosecurity and hardier animals.
Easy access to drugs sometimes causes their use to supplant better management practices.
The regulations will pose the greatest challenge to livestock producers who do not have access to local, affordable, knowledgeable veterinary care.
While USDA has identified veterinary shortages in many counties, an even greater challenge can be finding a veterinarian who is willing to treat small ruminants and has specific knowledge about them.
Small ruminant producers who do not currently have a valid veterinarian-client relationship are encouraged to develop such relationships in advance of the probable implementation of the new regulations.
The proposed regulations to ban OTC antibiotic sales were published in the Federal Register on September 24, 2019. Comments are being accepted until December 24, 2019.
Go to https://www.regulations.gov/docket?D=FDA-2019-D-3614 to submit your comments.
Be sure to share how you think the new regulations will affect you, your operation, and your animals.
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