Section ATCP 42.46 - Good manufacturing practices(1) GENERAL. Medicated commercial feed, and dog and cat food shall be manufactured, processed, packaged, stored, and distributed in a manner which prevents adulteration and misbranding.(2) BUILDINGS. Buildings and facilities used in manufacturing medicated commercial feed or dog or cat food shall be all of the following: (a) Adequate for the purpose used.(b) Capable of being kept clean and in good repair.(c) Constructed to allow convenient access for routine cleaning and maintenance.(d) Kept clean and in good repair.(e) Kept free of unhealthful or unsanitary conditions.(3) EQUIPMENT. Equipment used to manufacture medicated commercial feed or dog or cat food shall be all of the following: (a) Adequate for the purpose used. Scales and measuring devices shall be accurate.(b) Designed, constructed and installed to facilitate routine cleaning, inspection and maintenance.(c) Capable of being kept clean and in good repair.(d) Kept clean and in good repair.(4) CROSS-UTILIZATION. Areas and equipment used to manufacture, handle, or store medicated commercial feeds, dog food, or cat food may not be used to manufacture, handle, or store fertilizers or pesticides, unless the fertilizers or pesticides are approved for use in the manufacture of the medicated commercial feeds, dog food, or cat food.(5) MEDICATED FEEDS; MANUFACTURING. (a) Type A medicated articles shall be manufactured according to 21 CFR 226.(b) Type B and type C medicated feeds shall be manufactured according to 21 CFR 225.(6) MEDICATED FEED INGREDIENTS. (a) The operator of a medicated feed manufacturing facility shall establish and maintain procedures for identifying, storing, and controlling inventories of Type A medicated articles and Type B medicated feeds used in manufacturing medicated feeds. The procedures shall preserve the identity, strength, quality and purity of the drug sources.(b) Packaged Type A medicated articles and Type B medicated feeds shall be stored in designated areas in their original closed containers. Bulk Type A medicated articles and bulk Type, B medicated feeds shall be identified and stored in a manner which preserves their identity, strength, quality, and purity.(c) Type A medicated articles and Type B medicated feeds shall be used according to label directions.(7) INGREDIENT LABELING. All packaged and bulk ingredients received or held for use in the manufacture of medicated commercial feed or dog or cat food shall be accurately labeled to facilitate proper use.(8) RECORDS. A manufacturer of medicated commercial feed or dog or cat food shall keep records of all manufactured products, including product formulas, manufacturing dates, batch numbers, and shipment dates. The records shall be adequate to facilitate the recall of specific batches of medicated commercial feed or dog or cat food, should that become necessary. Records for each batch of manufactured product shall be retained for at least one year after the last product from that batch has been distributed.Wis. Admin. Code Department of Agriculture, Trade and Consumer Protection § ATCP 42.46
Cr. Register, September, 1996, No. 489, eff. 10-1-97.Amended by, CR14-047: am. (3) (c) Register, Register May 2015 No. 713, eff.6/1/2015