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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Newman, John H., DVM 29-Sep-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


September 29, 2004

Ref: 2004-DAL-WL-32

WARNING LETTER

Certified Mail
Return Receipt Requested

John H. Newman, DVM
101 CR 438
Dublin, Texas 76446

Dear Dr. Newman:

An investigator from the US Food and Drug Administration (FDA) conducted an inspection at your veterinary practice on April 9, May 13, and June 4, 2004. The investigation confirmed that you prescribed on two occasions Flunixin Meglumine injection 50 mg/mL in an extralabel manner for dairy cattle owned by [redacted]

Our investigation revealed that on May 12, 2003 and December 2, 2003, you signed a prescription form which allowed the dispensing of, among other drugs, flunixin meglumine 50 mg/mL 250 ml bottles to [redacted] for his use at [redacted] The prescription dated May 12, 2003, does not indicate a quantity and the December 2, 2003 prescription indicates “PRN,” or as needed. Both prescriptions were renewable for 180 days. The prescriptions ordered the dispensing of Flunixin Meglumine for use as an anti-endotoxin, anti-inflammatory administered either intramuscularly (IM) or intravenously (IV), 1 mL per 100 pounds of body weight twice a day for not more than 3 days. The prescription further ordered a milk withhold of 96 hours and a meat withdrawal of 4 days.

On September 17, 2003, [redacted] dba [redacted] offered a cow, back tag number [redacted] for slaughter as human food at [redacted] USDA analysis (Laboratory Report #436141) of tissue samples collected from that animal identified the presence of flunixin at 0.777 ppm in the liver.

In addition, on February 20, 2004, [redacted] offered a cow, back tag number [redacted] for slaughter as human food at [redacted] USDA analysis (Laboratory Report # 440588) of tissue samples collected from that animal identified the presence of flunixin at 0.2870 ppm in the liver.

Flunixin meglumine is not approved for intramuscular administration in non-lactating dairy cows. Extralabel use of approved animal drugs is permitted under section 512(a)(r))(A) of the Act if the drug is used (i) by or on the order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship; and (ii) in compliance with regulations at 21 CFR Part 530.

Our investigation revealed the following deviations from 21 CFR Part 530:

- Prior to prescribing flunixin for an extralabel use in food animals, you did not make a careful diagnosis and evaluation of the conditions for which the drug was to be used in violation of 21 CFR 530.20(a)(2)(i).

- Prior to prescribing flunixin for an extralabel use in food animals, you did not establish a substantially extended withdrawal period supported by appropriate scientific information in violation of 21 CFR 530.20(a)(2)(ii),

- Prior to prescribing flunixin for an extralabel use in food animals, you did not institute procedures to assure that the identity of the treated animals was carefully maintained in violation of 21 CFR 530.20(a)(2)(iii).

- Prior to prescribing flunixin for an extralabel use in food animals, you did not take appropriate measures to assure that assigned timeframes for withdrawal were met and no illegal drug residues occurred in any food-producing animal subjected to extralabel treatment in violation of 21 CFR 530.20(a)(2)(iv).

Because you did not prescribe flunixin in conformance with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the Act and therefore adulterated under section 501(a)(5) of the Act.

In addition to the above, it was noted that your use of the blanket prescription form provided by [redacted] allowed [redacted] dba [redacted] unlimited access to prescriptions drugs for indiscriminate extralabel use. Some of the drugs made available for extralabel use include an antimicrobial (fluoroquinolone) prohibited from extralabel use in food-producing animals (see 21 CFR 530.41(a)(10)) and a hormone drug ((ECP, estradiol cypionate) unapproved for use in animals.

Again, extralabel use of approved drugs is only permitted when the requirements of 21 CFR 530 are met. For example, you must prescribe the drugs within the context of a valid veterinarian-client-patient relationship (VCPR). A copy of 21 CFR 530, which includes the definition of a valid VCPR, is enclosed.

The above is not intended to be an all-inclusive list of violations. You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. This may include injunction. You should notify this office, in writing, within fifteen (15) working days, of the steps you have taken to prevent a recurrence of similar violations. Your response should be directed to Sherrie L. Krolczyk, Recall and Emergency Coordinator, at the above letterhead address.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

Enclosure