Inspections, Compliance, Enforcement, and Criminal Investigations
Prime Veal Feed, Ltd. 15-Dec-04
Department of Health and Human Services
Public Health Service
Cincinnati District Office
WARNING LETTER CIN-0523397
via federal Express
December 15, 2004
Joseph A. Gingerich, Co-Owner
Prime Veal Feed, Ltd
27781 State Route 30
Kensington, OH 44427
Dear Mr. Gingerich:
From August 16 to September 3, 2004, an investigator from our office conducted an inspection of your feed mill located at 27781 State Route 30, Kensington, Ohio. That inspection revealed that your firm is selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian. Because your firm dispensed prescription new animal drugs without a lawful written or oral order from a licensed veterinarian while held for sale, they are misbranded within the meaning of Section 503(f)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of prescription veterinary drugs your firm dispensed without an order from a licensed veterinarian include: Banamine (flunixin meglumine), Micotil (tilmicosin), and Nuflor (florfenicol).
In addition, these prescription veterinary drugs are misbranded within the meaning of Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) because they do not bear adequate directions for use, and they do not fall into an exception to that requirement. FDA has defined "adequate directions for use" as "directions under which the layman can use a drug safely and for the purposes for which it is intended." 21 CFR 201.5. Directions under which a layperson can safely use prescription animal drugs cannot be written because such drugs can only be used safely under the professional supervision of a licensed veterinarian. Thus, adequate directions for lay use cannot be written for these prescription new animal drugs. These drugs are not exempt from Section 502(f)(1) because they fail to comply with the conditions set forth in Section 503(f)(2)(A) and 21 CFR 201.105 in that they were not sold by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice.
You also dispensed Flunixin Meglumine Injection bearing a Dexamethasone label and Selenium-Vitamin E Injection (Mu-Se) bearing an Amoxicillin label. These drugs are misbranded under section 502(a) of the Act because the labeling is false or misleading, specifically and 502(i)(3) in that they were offered for sale under the name of another drug.
Our inspection also found that you may be dispensing human prescription drugs, such as Sulfamethoxazole and Trimethoprim tablets, Cephalexin capsules, and Amoxicillin capsules, for extralabel use in animals. Please note that extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with Sections 512(a)(4) and (5) of the Act and 21 CFR Part 530. Among other requirements, the drugs must be dispensed by or on the order of a licensed veterinarian and must bear or be accompanied by certain labeling information to assure the safe and proper use of the product. 21 CFR 530.10(a) and 530.12. We have enclosed a copy of 21 CFR Part 530 for your reference.
The above is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the Act, including the extra-label use regulations promulgated under the Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice including, but not limited to, seizure and/or injunction.
Please notify this office in writing within 15 working days of your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of steps being taken to prevent the recurrence of similar violations. Also, include copies of any available documentation demonstrating that corrections have been made. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time period within which the corrections will be completed. You should address your reply to this letter to Deborah A. Grelle, Director of Compliance, U. S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237.
Carol A. Heppe