Animal & Veterinary
Regulatory Activities - November/December 2004
FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 6
The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:
• Jeremy M. Clayson, Manager, Cedar Arch-North, Firth, ID
• Jeffrey D. Wendler, DVM, Partner; Ron Aardema, Partner; Donald -Aardema, Jr., Partner; and Michael -Aardema, Partner; St. Bridget Dairy, LOP, Wendell, ID
• Chris J. Parker, Co-Owner, Parker & Sons, LLC, Silver Lake, IN
• Dean E. Zimmer, Owner, Zimmer View Dairy, Marietta, OH
• Gene A. Martin, Sauk Centre, MN
• Bernard Choutchourrou, Owner, Choutchourrou Dairy, Caldwell, ID
• Bernardus P. Goedhart, Owner, -Vermeer & Goedhart Dairy, Shafter, CA
• Ray Albers, Owner, Heritage Dairy, Ontario, CA
The above violations involved penicillin, sulfadimethoxine, oxyte-tracycline, gentamicin, and flunixin in cows.
A Warning Letter was issued to Mr. Lowell J. Ahl, President, Lowlyn Pharmacies, Inc., doing business as Red Cross Drug, Blanchard, OK, after inspection of the veterinary drug compounding operation disclosed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection confirmed the company compounded and distributed veterinary drugs using bulk active pharmaceutical ingredients (APIs). The compounded veterinary drugs were found to be unsafe within the meaning of section 512 of the Act because they are not the subject of approved New Animal Drug Applications, and, as such, are adulterated under section 501(a)(5) of the Act. Sections 512(a)(4) and (5) of the Act, and their implementing regulations, allow some extralabel use of approved animal and human drugs, including compounding from such approved drugs, but these provisions apply only to approved drugs and do not permit compounding from bulk APIs. A significant number of the firm’s compounded veterinary drugs appear to be compounded outside the context of a valid veterinarian-client-patient relationship for administration by an end user. Instead, they appear to be sales to veterinarians for use as office stock in their professional practice and/or for further distribution. Another concern is the drugs being compounded could be used in food-producing animals, and therefore could result in unsafe drug residues in edible tissues. Moreover, at least two of the drugs being compounded, nitrofurazone and diethylstilbestrol, are not permitted for extralabel use in food-producing animals because they present a risk to public health.
A Warning Letter was issued to Jerry D. Suther, President, Suther Feeds, Inc., Frankfort, KS, for significant deviations from current Good Manufacturing Practice (cGMP) regulations for medicated feeds. The deviations include equipment that comes in contact with active drug components and feeds in process is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed; sequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs; failure to investigate and implement corrective action when assay results show medicated feeds are not within permissible assay limits; failure to consistently and adequately control the receipt, storage, and inventory of drug products; failure to maintain master records and batch production records as required; failure to maintain distribution records for each shipment of medicated feed; and failure of the firm’s mixer/blender study to demonstrate equipments’ capability to produce a medicated feed of intended potency.
A Warning Letter was issued to Gary Henry, Co-Owner, West Union, OH, after inspection of the farm found serious violations of the Act. The investigation found that the farm’s use of the medicated premixes Bovatec 68 (Lasalocid) and Terramycin 50 (Oxytetracycline) in making the medicated feed for their sheep does not conform to the drug’s approved New Animal Drug Applications (NADAs). The combination of the drugs is not approved for use in feed for sheep or at the levels found in a sample of the bulk medicated feed collected at the farm. Thus, the feeds are adulterated under 501(a)(6) of the Act. The medicated feed is further adulterated under section 501(a)(2)(B) because of failure to comply with the current Good Manufacturing Practice (cGMP) regulations for medicated feeds.
Examples of the farm’s failures to follow cGMPs include not having a measuring device that is adequate to measure the amounts of medicated premix added to their feed, and not having records identifying the formula and date of mixing.
Warning Letters were issued to -David L. McMahan, Owner, Redfield Feed Service, Redfield, SD, and to -Dayton H. Kloss, Owner, -Hitchcock Feed Serv-ice, Hitchcock, SD, for selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian, which caused the products to be misbranded within the meaning of Section 503(f)(1)(C) of the Act. Examples of veterinary prescription drugs dispensed by the Redfield Feed Service without the order from a licensed veterinarian include sulfamethoxazole/trimethoprim, florfenicol, tilmicosin, enrofloxacin, dinoprost tromethamine, and dexamethasone. Examples of veterinary prescription drugs dispensed by Hitchcock Feed Service without an order from a licensed veterinarian include flunixin and florfenicol.
Warning Letters were issued to John H. Newman, DVM, Dublin, TX, and to Neal L. Womack, DVM, and Curtis A. Leyk, DVM, Co-Owners, Lake Country Veterinary Service, P.S., Albany, WI, because investigations revealed serious deviations from extralabel drug use in animals. The extralabel use of approved animal drugs by veterinarians is allowed under the Act provided that the regulations contained in 21 CFR Part 530 are followed. Extralabel use of an approved animal drug that is not in compliance with the regulations renders the drug unsafe under Section 512 and thus adulterated under Section 501(a)(5) of the Act.