FDA Proposes Ending Over-the-counter Antibiotic Sales

Milk splash. ( Farm Journal, Inc. )

In just a few years, you will no longer be able to buy over-the-counter (OTC) antibiotics from your local farm supply store or mail order catalogue.

In a draft guidance issued in late September, the Food and Drug Administration is proposing to end the OTC sale of more than 100 animal drugs. Some of the more common OTC drugs on FDA’s list are formulations that include cephapirin, penicillin G procaine, sulfamethazine and tetracycline. The change will take at least two years to implement—if not longer.

In effect, FDA’s proposal would require livestock producers to obtain veterinary prescriptions for these medications if they want to continue their use. Note: Some of these drugs might become unavailable if their manufacturers opt to pull them the market.

The purpose of the FDA action is to reduce the use of medically-important antimicrobials in animal agriculture and ensure that they are only used when necessary for the treatment, control or prevention of specific diseases. By moving these drugs to prescription-only, it assures the drugs will be administered to animals under the supervision of a licensed veterinarian.

The proposal sounds more ominous than it really is, say veterinarians and pharmaceutical companies. “Moving these drugs from over-the-counter to prescription will have a minor impact on dairy farmers,” says Ron Erskine, a veterinary and mastitis specialist with Michigan State University.

To start with, most of the antibiotics sold OTC are old drugs. Most, if not all, of the drugs on the list are decades old formulations approved prior to the mid-1990s.

Under the FARM (Farmers Assuring Responsible Management) program, dairy farmers are already required to have a valid, signed veterinary/client/patient relationship with their local veterinarian and have established written protocols for the use of antibiotics, he notes. “Everybody wants protocols in place for FARM audits,” Erskine says.  

Drug residues in milk has become almost a non-issue, with residue rates dropping steadily over the past decade. In fiscal year 2018, just 364 tanker loads of milk tested positive antibiotic residues out of the 3,598,188 tankers tested. That’s a positive rate of 0.01%, reports the National Milk Drug Residue Data Base. A pilot project looking for tetracycline residues in raw milk conducted in 2017 and 2018 found just six positives in the 304,289 tankers tested, for a positive rate of 0.002%.

The bigger problem is antibiotic residues in cull dairy cows. When USDA veterinarians conduct follow-up investigations of carcass residues, they find the majority of farms investigated have not had veterinarian involvement or direction in the use of antibiotics to treat sick animals nor do the farms have appropriate treatment and drug withdrawal records, says Mike Lormore, Director, Dairy Cattle Technical Services at Zoetis.

Bringing all antibiotic use under the umbrella of the veterinary/client/patient relationship is simply prudent, responsible use, he says.

FDA is accepting comments on the proposal until December 24, 2019. The agency will then issue a final guidance followed by a two-year implementation period.

 For more on FDA’s efforts to combat antimicrobial resistance, see these articles from BovineVetOnline:

FDA Releases Draft GFI to End OTC Sales of Most Animal Antibiotics

FDA Funds Duration of Use Studies

FDA Plans Next Moves on Antimicrobials

 

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