Title 21—Food and Drugs--Volume 1
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
§ 558.3   Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved.
(b) The following definitions apply to terms used in this part:
(1) New animal drugs approved for use in animal feed are placed in two categories as follows:
(i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.
(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.
(2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.
(3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.
(4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.
(5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.
(6) A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed pursuant to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian. Use of animal feed bearing or containing a VFD drug must be authorized by a lawful veterinary feed directive.
(7) A “veterinary feed directive” is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client's animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the Food and Drug Administration.
(8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section.
(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.
(10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.
(11) An “acknowledgment letter” is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm:
(i) That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD,
(ii) That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and
(iii) That the distributor has complied with the distributor notification requirements of § 558.6(c)(5).
(12) A “combination veterinary feed directive (VFD) drug” is a combination new animal drug (as defined in § 514.4(c)(1)(i) of this chapter) intended for use in or on animal feed which is limited by an approved application filed under section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed under section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful VFD.
(13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.
(14) “Minor species” means animals, other than humans, that are not major species.
§ 558.4   Requirement of a medicated feed mill license.
(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.
(b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:
(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and
(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.
(c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part.
(d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:
Category I
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
Category II
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
(e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product.
§ 558.5   Requirements for liquid medicated feed.
(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:
(1) Type B feed that is intended for further manufacture of other medicated feeds (§ 558.3(b)(3)) or:
(2) Type C feed that is intended for the following:
(i) Further manufacture of another Type C feed, or
(ii) Top-dressing (adding on top of the usual ration) (§ 558.3(b)(4)).
(b) How is liquid free-choice medicated feed regulated? Liquid free-choice medicated feed is covered by this section and by § 510.455.
(c) What is required for new animal drugs intended for use in liquid feed? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be:
(1) An original NADA,
(2) A supplemental NADA, or
(3) An abbreviated NADA.
(d) What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the following information:
(1) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and
(2) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or
(3) Feed labeling with recirculation or agitation directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(e) How are chemical and physical stability data to be submitted? The data must be submitted as follows:
(1) Directly in the NADA,
(2) By a sponsor, or
(3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.
(f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this subchapter will include the following requirements:
(1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or
(2) A statement that the approval has been granted for a proprietary formula and/or specifications.
(g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:
(1) All liquid medicated feeds that contain a Category II drug, and
(2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.
(h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product containing any form of bacitracin, oxytetracycline, or chlortetracycline, intended for oral administration via animal feed and/or drinking water, and not approved for use in a liquid medicated feed must include in its labeling the following statement: “FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.” The blank may be filled in with the words: “DRY FEEDS”, “DRINKING WATER”, or “DRY FEEDS AND DRINKING WATER”.
(i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (1) The labeling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.
(2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
(3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely.
(j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in § 514.8(c)(3) of this chapter.
§ 558.6   Veterinary feed directive drugs.
(a) General requirements related to veterinary feed directive (VFD) drugs. (1) Animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian.
(2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD.
(3) Use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, conditionally approved, or indexed conditions of use. Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.
(4) All involved parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2 years. The veterinarian must retain the original VFD in its original form (electronic or hardcopy). The distributor and client copies may be kept as an electronic copy or hardcopy.
(5) All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request.
(6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”
(b) Responsibilities of the veterinarian issuing the VFD. (1) In order for a VFD to be lawful, the veterinarian issuing the VFD must:
(i) Be licensed to practice veterinary medicine; and
(ii) Be operating in the course of the veterinarian's professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter.
(2) The veterinarian must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug.
(3) The veterinarian must ensure that the following information is fully and accurately included on the VFD:
(i) The veterinarian's name, address, and telephone number;
(ii) The client's name, business or home address, and telephone number;
(iii) The premises at which the animals specified in the VFD are located;
(iv) The date of VFD issuance;
(v) The expiration date of the VFD. This date must not extend beyond the expiration date specified in the approval, conditional approval, or index listing, if such date is specified. In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expiration date of the VFD must not exceed 6 months after the date of issuance;
(vi) The name of the VFD drug(s);
(vii) The species and production class of animals to be fed the VFD feed;
(viii) The approximate number of animals to be fed the VFD feed by the expiration date of the VFD. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD;
(ix) The indication for which the VFD is issued;
(x) The level of VFD drug in the VFD feed and duration of use;
(xi) The withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;
(xii) The number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the labeling for an approved, conditionally approved, or index listed VFD drug, reorders (refills) are not permitted;
(xiii) The statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.”;
(xiv) An affirmation of intent for combination VFD drugs as described in paragraph (6) of this section; and
(xv) The veterinarian's electronic or written signature.
(4) The veterinarian may, at his or her discretion, enter the following information on the VFD to more specifically identify the animals authorized to be treated/fed the VFD feed:
(i) A more specific description of the location of animals ( e.g., by site, pen, barn, stall, tank, or other descriptor that the veterinarian deems appropriate);
(ii) The approximate age range of the animals;
(iii) The approximate weight range of the animals; and
(iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD.
(5) For VFDs intended to authorize the use of an approved, conditionally approved, or indexed combination VFD drug that includes more than one VFD drug, the veterinarian must include the drug-specific information required in paragraphs (b)(3)(vi), (ix), (x), and (xi) of this section for each VFD drug in the combination.
(6) The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or may expand such authorization to allow the use of the cited VFD drug(s) along with one or more over-the-counter (OTC) animal drugs in an approved, conditionally approved, or indexed combination VFD drug. The veterinarian must affirm his or her intent regarding combination VFD drugs by including one of the following statements on the VFD:
(i) “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.”
(ii) “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]
(iii) “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”
(7) The veterinarian must issue a written (nonverbal) VFD.
(8) The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy, the veterinarian must send the copy of the VFD to the distributor either directly or through the client.
(9) The veterinarian must provide a copy of the VFD to the client.
(c) Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug. (1) The distributor is permitted to fill a VFD only if the VFD contains all the information required in paragraph (b)(3) of this section.
(2) The distributor is permitted to distribute an animal feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.
(3) The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years.
(4) In addition to other applicable recordkeeping requirements found in this section, if the distributor manufactures the animal feed bearing or containing the VFD drug, the distributor must also keep VFD feed manufacturing records for 1 year in accordance with part 225 of this chapter. Such records must be made available for inspection and copying by FDA upon request.
(5) A distributor of animal feed containing a VFD drug must notify FDA prior to the first time it distributes animal feed containing a VFD drug. The notification is required one time per distributor and must include the following information:
(i) The distributor's complete name and business address;
(ii) The distributor's signature or the signature of the distributor's authorized agent; and
(iii) The date the notification was signed.
(6) A distributor must also notify FDA within 30 days of any change in ownership, business name, or business address.
(7) The notifications cited in paragraphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Food Compliance, 12225 Wilkins Ave., Rockville, MD 20852, or email (via attachment): MedicatedFeedsTeamMail@fda.hhs.gov.
(8) A distributor is permitted to distribute a VFD feed to another distributor only if the originating distributor (consignor) first obtains a written (nonverbal) acknowledgment letter, as defined in § 558.3(b)(11), from the receiving distributor (consignee) before the feed is shipped. Consignor distributors must retain a copy of each consignee distributor's acknowledgment letter for 2 years.
§ 558.55   Amprolium.
(a) Specifications. Type A medicated article containing 25 percent amprolium.
(b) Sponsor. No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.50 of this chapter.
(d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use —(1) Cattle. It is used as follows:
(2) Chickens. It is used as follows:
(3) Turkeys. It is used as follows:
(4) Pheasants. It is used as follows:
(5) Permitted combinations. Amprolium may also be used in combination with:
(i) Virginiamycin as in § 558.635.
(ii) [Reserved]
§ 558.58   Amprolium and ethopabate.
(a) Specifications. Type A medicated articles containing:
(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;
(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.50 and 556.260 of this chapter.
(d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use. It is used in chicken feed as follows:
(f) Amprolium and ethopabate may also be used in combination with:
(1)-(2) [Reserved]
(3) Chlortetracycline as in § 558.128.
§ 558.59   Apramycin.
(a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.52 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for apramycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for apramycin shall not be refilled.
(e) Conditions of use in swine —
§ 558.68   Avilamycin.
(a) Specifications. Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.60 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.
(e) Conditions of use. Administer in feed as follows:
(1) Chickens —
(2) Swine —
§ 558.76   Bacitracin methylenedisalicylate.
(a) Specifications. (1) Type A medicated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound.
(2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraph (d) of this section.
(2) No. 069254 for use of product in paragraph (a)(2) of this section as in paragraph (d) of this section.
(c) Related tolerances. See § 556.70 of this chapter.
(d) Conditions of use —(1) Chickens —
(2) Turkeys —
(3) Swine —
(4) Cattle —
(5) Game birds —
(6) Bacitracin methylenedisalicylate may also be used in combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in § 558.58.
(iii) Chlortetracycline as in § 558.128.
(iv) Clopidol as in § 558.175.
(v) Decoquinate as in § 558.195.
(vi) Diclazuril as in § 558.198.
(vii) Fenbendazole as in § 558.258.
(viii) Halofuginone as in § 558.265.
(ix) Ivermectin as in § 558.300.
(x) Lasalocid as in § 558.311.
(xi) Monensin as in § 558.355.
(xii) Narasin as in § 558.363.
(xiii) Narasin and nicarbazin as in § 558.364.
(xiv) Nicarbazin as in § 558.366.
(xv) Robenidine as in § 558.515.
(xvi) Salinomycin as in § 558.550.
(xvii) Semduramicin as in § 558.555.
(xviii) Zoalene as in § 558.680.
§ 558.78   Bacitracin zinc.
(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.70 of this chapter.
(d) Conditions of use. (1) It is used as follows:
(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:
(i) To aid in stimulating growth and improving feed efficiency.
(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 054771.
(3) Bacitracin zinc may also be used in combination with:
(i) Amprolium and ethopabate as in § 558.58.
(ii) Clopidol as in § 558.175.
(iii) Decoquinate as in § 558.195.
(iv) Lasalocid as in § 558.311.
(v) Monensin as in § 558.355.
(vi) Naracin as in § 558.363.
(vii) Nicarbazin as in § 558.366.
(viii) Robenidine as in § 558.515.
(ix) Salinomycin as in § 558.550.
§ 558.95   Bambermycins.
(a) Specifications. Type A medicated articles containing 2, 4, or 10 grams bambermycins per pound.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.75 of this chapter.
(d) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.
(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.
(e) Conditions of use —(1) Chickens. Use in medicated feed as follows:
(2) Turkeys. Use in medicated feed as follows:
(3) Swine. Use in medicated feed as follows:
(4) Cattle.
(iii) Used as a free-choice Type C medicated loose-mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:
( a ) Specifications.
*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
( b ) Amount per ton. 120 grams.
( c ) Indications for use. For increased rate of weight gain.
( d ) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:
( a ) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.
( b ) Indications for use. For increased rate of weight gain.
( c ) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
(v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows:
(A) Specifications.
* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams.
(C) Indications for use. For increased rate of weight gain.
(D) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
(5) Combinations. Bambermycins may also be used in combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in § 558.58.
(iii) Clopidol as in § 558.175.
(iv) Diclazuril as in § 558.198.
(v) Halofuginone as in § 558.265.
(vi) Lasalocid as in § 558.311.
(vii) Monensin as in § 558.355.
(viii) Narasin as in § 558.363.
(ix) Narasin and nicarbazin as in § 558.364.
(x) Nicarbazin as in § 558.366.
(xi) Salinomycin as in § 558.550.
(xii) Zoalene as in § 558.680.
§ 558.115   Carbadox.
(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in § 510.600(c) of this chapter.
(b) Related tolerances. See § 556.100 of this chapter.
(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.
(d) Conditions of use. It is used for swine as follows:
(1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).
(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.
(2) Amount per ton. 50 grams (0.0055 percent).
(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.
(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).
(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm ( Oesophagostomum ) infections.
(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.
(4) Carbadox may also be used in combination with oxytetracycline as in § 558.450.
§ 558.128   Chlortetracycline.
(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A medicated article.
(2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.
(3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
(c) Related tolerances. See § 556.150 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.
(3) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”
(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this section must conform to § 510.455 of this chapter.
(5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”
(e) Conditions of use —(1) Chickens. It is used as follows:
(2) Turkeys. It is used as follows:
(3) Swine. It is used as follows:
(4) Cattle. It is used as follows:
(5) Minor species. It is used as follows:
(6) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(ii) Amount. 6,000 grams per ton.
(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.
(v) Sponsors. See Nos. 054771 and 069254 in § 510.600(c) of this chapter.
§ 558.140   Chlortetracycline and sulfamethazine.
(a) Specifications. Type A medicated articles containing:
(1) 35 grams (g) per pound (/lb) each, chlortetracycline and sulfamethazine.
(2) 40 g/lb each, chlortetracycline and sulfamethazine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.
(2) No. 069254 for use of product described in paragraph (a)(1) as in paragraph (e)(1)(i) of this section.
(3) Nos. 054771 and 069254 for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section.
(c) Related tolerances. See §§ 556.150 and 556.670 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.
(e) Conditions of use —(1) Cattle —
(2) Swine —
§ 558.175   Clopidol.
(a) Specifications. Type A medicated article containing 25 percent clopidol.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.160 of this chapter.
(d) Conditions of use —(1) Chickens —
(2) Turkeys —
(3) Combinations. Clopidol may also be used in combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Lincomycin as in § 558.325.
§ 558.185   Coumaphos.
(a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.168 of this chapter.
(d) Special considerations. (1) Labeling shall bear the following warning: The active ingredient coumaphos is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals.
(2) See § 500.25 of this chapter.
(e) Conditions of use in laying chickens.
§ 558.195   Decoquinate.
(a) Specifications. Type A medicated article containing 6 percent decoquinate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.170 of this chapter.
(d) Special considerations. (1) Bentonite should not be used in decoquinate feeds.
(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.
(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.
(e) Conditions of use. It is used as follows:
(1) Chickens —
(2) Cattle —
(3) Minor species —
(4) Decoquinate may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128.
(iv) Lincomycin as in § 558.325.
§ 558.198   Dichlorvos.
(a) Specifications. Each pound of Type A medicated article containing 3.1 or 9.6 percent dichlorvos.
(b) Sponsor. See No. 054628 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.180 of this chapter.
(d) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or administer as wet mash. Feed must be dry when administered. Do not use in animals other than swine. Do not allow fowl access to feed containing this preparation or to feces from treated animals.
(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal.
(3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used.
(e) Conditions of use. It is used in swine feed as follows:
§ 558.205   Diclazuril.
(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.185 of this chapter.
(d) Conditions of use —(1) Chickens. For chickens it is used as follows:
(2) Turkeys. For turkeys it is used as follows:
(3) Diclazuril may also be used in combination with virginiamycin as in § 558.635.
§ 558.235   Efrotomycin.
(a) Specifications. Type A medicated articles containing 14.5 grams efrotomycin per pound.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.224 of this chapter.
(d) Conditions of use in swine —
§ 558.248   Erythromycin.
(a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt).
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.230 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled.
(e) Conditions of use —(1) Chickens —
(2) Turkeys —
§ 558.254   Famphur.
(a) Specifications. Type A medicated articles containing 13.2 or 33.3 percent famphur.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.273 of this chapter.
(d) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
(e) Conditions of use. It is used in cattle feed as follows:
§ 558.258   Fenbendazole.
(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.275 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use —(1) Turkeys.
(2) Swine.
(3) Cattle.
(iii) Top dress medicated feed —(A) Proprietary formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:
(B) [Reserved]
(iv) Free-choice medicated feeds —(A) Proprietary formulas (21 CFR 510.455(e)(2)). The following feeds can be manufactured only per an approved proprietary formula and specifications:
(B) Published formulas (§ 510.455(e)(1) of this chapter). The following feeds can be manufactured only per one of the formulas and specifications published below:
( 1 ) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:
1 Formulation modifications require FDA approval prior to marketing. Selenium is not approved for use in the liquid, free-choice formulations described in paragraph (e)(3)(iv)(B) of this section. Free-choice cattle feeds containing selenium must comply with published regulations ( see 21 CFR 573.920).
2 The labeling for the liquid free-choice Type C medicated feed must bear an expiration date of 12 weeks after the date of manufacture.
3 The percentage of cane molasses and water in the formulation may be adjusted as needed to bring the brix value of the molasses to the industry standard of 79.5 brix.
4 The contents of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds.
( 2 ) Indications for use. As in paragraph (e)(3)(i) of this section.
( 3 ) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
(4) Horses.
(5) Zoo and wildlife animals.
(6) Fenbendazole may also be used in combination with:
(i) [Reserved]
(ii) Lincomycin as in § 558.325.
§ 558.261   Florfenicol.
(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:
(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.
(2) 500 grams per kilogram for use as in paragraph (e)(2) of this section.
(b) Sponsors. See sponsor numbers as in § 510.600(c) of this chapter.
(1) No. 000061 for use of products described in paragraph (a) of this section as in paragraph (e) of this section.
(2) No. 066104 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
(c) Related tolerances. See § 556.283 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for florfenicol medicated feeds:
(i) For swine must not exceed 90 days from the date of issuance.
(ii) For fish must not exceed 6 months from the date of issuance.
(3) VFDs for florfenicol shall not be refilled.
(4) Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.”
(e) Conditions of use —(1) Swine —
(2) Fish —
§ 558.265   Halofuginone.
(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.308 of this chapter.
(d) Conditions of use. It is used in feed as follows:
(1) Chickens —
(2) Turkeys —
(3) Halofuginone may also be used in combination with:
(i) Lincomycin as in § 558.325.
(ii) [Reserved]
§ 558.274   Hygromycin B.
(a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb).
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as follows:
(c) Related tolerances. See § 556.330 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled.
(e) Conditions of use. It is used in feed as follows:
(1) Chickens —
(2) Swine —
§ 558.295   Iodinated casein.
(a) Specifications. Type A medicated article containing iodinated casein.
(b) Sponsor. See No. 017762 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Ducks —
(2) Dairy cows —
§ 558.300   Ivermectin.
(a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb).
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.344 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use in swine. It is used in feed as follows:
§ 558.305   Laidlomycin.
(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.346 of this chapter.
(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.
(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:
(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.
(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.
(iii) Not for use in animals intended for breeding.
(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:
(f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128.
§ 558.311   Lasalocid.
(a) Specifications. Each pound of Type A medicated article contains 68 grams (15 percent), 90.7 grams (20 percent), or 150 grams (33.1 percent) lasalocid as lasalocid sodium activity. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.347 of this chapter.
(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.
(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:
(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and
(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.
(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.
(5) Required label statements:
(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.
(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(3)(vi) through (e)(3)(viii) of this section must be the subject of an approved NADA or supplemental NADA as provided in § 510.455 of this chapter.
(e) Conditions of use. It is used as follows:
(1) The conditions of use for chickens are:
(2) The conditions of use for turkeys are:
(3) The conditions of use for cattle are—
(4) The conditions of use for minor species are:
(5) It is used as a free-choice mineral Type C feed as follows:
(i) Specifications.
1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
2 To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses.
(ii) Amount. 1,440 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(6) It is used as a ruminant free-choice liquid Type C feed as follows:
(i) Specifications.
1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses.
(ii) Amount. 150 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(7) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
2 To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses.
(ii) Amount. 1,088 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.
(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(8) Lasalocid may also be used in combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Chlortetracycline and sulfamethazine as in § 558.140.
(iii) Lincomycin as in § 558.325.
(iv) Melengestrol as in § 558.342.
(v) Oxytetracycline as in § 558.450.
(vi) Tylosin alone or in combination with melengestrol acetate as in § 558.625.
(vii) Virginiamycin as in § 558.635.
2. At 79 FR 13545, Mar. 11, 2014, § 558.311 was amended; however, the amendment could not be incorporated because of the inaccurate amendatory instruction.
§ 558.325   Lincomycin.
(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.360 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.
(3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:
(i) “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”
(ii) [Reserved]
(4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:
(i) “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”
(ii) “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”
(e) Conditions of use —(1) Chickens —
(2) Swine —
§ 558.330   Lubabegron.
(a) Specifications. Each pound of Type A medicated article contains 4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per kilogram) of lubabegron as lubabegron fumarate.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.370 of this chapter.
(d) Special considerations. Labeling shall bear the following caution statements:
(1) Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals.
(2) Do not allow horses or other equines access to feed containing lubabegron.
(3) A decrease in dry matter intake may be noticed in some animals receiving lubabegron.
(e) Conditions of use. (1) It is used in cattle feed as follows:
(2) Lubabegron may also be used in combination with:
(i) [Reserved]
(ii) Tylosin as in § 558.625.
§ 558.340   Maduramicin.
(a) Specifications. Type A medicated articles containing 4.54 grams maduramicin per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.375 of this chapter.
(d) Conditions of use in chickens —
§ 558.342   Melengestrol.
(a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound.
(2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound.
(b) Sponsor. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) No. 054771 for use of products described in paragraph (a)(1) of this section:
(2) Nos. 016592, 051311, 054771, and 058198 for use of product described in paragraph (a)(2) of this section.
(c) Related tolerances. See § 556.380 of this chapter.
(d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.
(3) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be labeled in accordance with § 558.311(d).
(4) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and monensin must be labeled in accordance with § 558.355(d).
(5) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with § 558.625(d).
(6) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement.
(e) Conditions of use —(1) Cattle.
(2) Melengestrol may also be used in combination with:
(i) Oxytetracycline as in § 558.450.
(ii) Ractopamine as in § 558.500.
(iii) Tylosin as in § 558.625.
(iv) Zilpaterol as in § 558.665.
§ 558.348   Mibolerone.
(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms (µg) of mibolerone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 30 µg for animals weighing up to 25 pounds; 60 µg for animals weighing 26 to 50 pounds; 120 µg for animals weighing 51 to 100 pounds; 180 µg for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months.
(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.
(3) Limitations. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 558.355   Monensin.
(a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 058198 for use as in paragraph (e) of this section.
(2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(2)(i), (e)(3), (e)(4)(v), and (e)(5) of this section.
(c) Related tolerances. See § 556.420 of this chapter.
(d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expiration date of 90 days after its date of manufacture.
(2)-(3) [Reserved]
(4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture.
(5) All Type A medicated articles containing monensin shall bear the following warning statement: When mixing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.
(6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.
(7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements:
(i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions.
(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats.
(iii) Must be thoroughly mixed in feeds before use.
(iv) Do not feed undiluted.
(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.
(vi) Do not feed to lactating goats.
(vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).
(viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
(ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows.
(x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats.
(8) Type A medicated articles containing monensin intended for use in chickens, turkeys, and quail shall bear the following statements:
(i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.
(ii) Must be thoroughly mixed in feeds before use.
(iii) Do not feed undiluted.
(iv) Do not feed to laying chickens.
(v) Do not feed to chickens over 16 weeks of age.
(vi) Not for broiler breeder replacement chickens.
(vii) Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.
(viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain.
(9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i) through (v), (vii), and (viii) of this section.
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i) through (iv), (vii), (viii), and (ix) of this section.
(iii) Goats : See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this section.
(iv) Chickens : See paragraphs (d)(8)(i) through (d)(8)(vi), and (d)(8)(viii) of this section.
(v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this section.
(vi) Quail : See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of this section.
(10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i), (v), (vii), and (viii) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i), (vii), (viii), and (ix) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.
(iii) Goats : See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section.
(iv) Chickens : See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(8)(viii) of this section.
(v) Turkeys : See paragraphs (d)(8)(i) and (d)(8)(vii) of this section.
(vi) Quail : See paragraph (d)(8)(i) of this section.
(11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section.
(12) Mixing directions for liquid feeds requiring recirculation or agitation:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(e) Conditions of use. It is used as follows:
(1) Chickens —
(2) Turkeys —
(3) Cattle —
(4) Free-choice cattle feeds —
(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:
1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).
(B) [Reserved]
(5) Minor species —
(6) Monensin may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) Chlortetracycline as in § 558.128.
(iii) Decoquinate as in § 558.195.
(iv) Lubabegron as in § 558.330.
(v) Lincomycin as in § 558.325.
(vi) Melengestrol acetate as in § 558.342.
(vii) Oxytetracycline as in § 558.450.
(viii) Ractopamine as in § 558.500.
(ix) Tilmicosin as in § 558.618.
(x) Tylosin as in § 558.625.
(xi) Virginiamycin as in § 558.635.
(xii) Zilpaterol alone or in combination as in § 558.665.
§ 558.360   Morantel.
(a) Specifications. Each pound of Type A medicated article contains 88 grams morantel tartrate.
(b) Sponsor. See No. 066104 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.425 of this chapter.
(d) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite.
(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(e) Conditions of use. It is used in feed as follows:
§ 558.363   Narasin.
(a) Specifications. Type A medicated articles containing 36, 45, 54, 72, or 90 grams narasin per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.428 of this chapter.
(d) Special considerations. An expiration date of 2 months (8 weeks) is required for narasin Type C medicated swine feeds.
(e) Conditions of use. It is used as follows:
(1) Chickens —
(2) Swine —
(3) Narasin single-ingredient Type A medicated articles may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) [Reserved]
§ 558.364   Narasin and nicarbazin.
(a) Specifications. A fixed-ratio, combination drug Type A medicated article containing 36 grams narasin and 36 grams nicarbazin per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Tolerances. See §§ 556.428 and 556.445 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Chickens —
(2) Narasin and nicarbazin fixed-ratio, combination drug Type A medicated articles may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) Virginiamycin as in § 558.635.
§ 558.365   Neomycin sulfate.
(a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.430 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled.
(e) Conditions of use. Neomycin sulfate is used as follows:
§ 558.366   Nicarbazin.
(a) Specifications. Type A medicated articles containing 25 percent nicarbazin.
(b) Sponsors. See Nos. 060728, 066104, and 069254 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.445 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Chickens —
(2) Nicarbazin single-ingredient Type A medicated articles may also be used in combination with:
(i) [Reserved]
(ii) Virginiamycin as in § 558.635.
§ 558.415   Novobiocin.
(a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.460 of this chapter.
(d) Conditions of use. It is used in animal feeds as follows:
(1) Chickens —
(2) Turkeys —
(3) Minor species —
§ 558.430   Nystatin.
(a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.470 of this chapter.
(d) Conditions of use —
§ 558.450   Oxytetracycline.
(a) Specifications. Each pound of Type A medicated article contains:
(1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.
(2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.
(2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.
(c) Related tolerances. See § 556.500 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.
(3) In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”
(e) Conditions of use —(1) Chickens —
(2) Turkeys —
(3) Swine —
(4) Cattle —
(5) Minor species —
§ 558.455   Oxytetracycline and neomycin.
(a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.
(b) Sponsors. See Nos. 066104 and 069254 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.430 and 556.500 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline and neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled.
(3) Cattle feeds shall bear the following warning statement: “Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”
(e) Indications for use —(1) Chickens. It is used in feed as follows:
(2) Turkeys. It is used in feed as follows:
(3) Swine. It is used in feed as follows:
(4) Cattle. It is used in feed as follows:
(5) Sheep. It is used in feed as follows:
(ii) [Reserved]
§ 558.464   Poloxalene.
(a) Specifications. Dry Type A medicated articles containing 53 percent poloxalene or liquid Type A medicated articles containing 99.5 percent poloxalene.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.517 of this chapter.
(d) Conditions of use. (1) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle.
(2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.
§ 558.470   Polyoxyethylene.
(a) Specifications. Each molasses-based block contains 2.2 percent polyoxyethylene (23) lauryl ether.
(b) Sponsor. See No. 067949 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Amount. 2 grams of polyoxyethylene (23) lauryl ether per 100 kilograms of body weight per day (1 pound of block per 500 kilogram (1,100 pound) animal per day). Initially, provide one block per five head of cattle. Start treatment 10 to 14 days before exposure to bloat-producing pastures.
(2) Indications for use. For reduction of the incidence of bloat (alfalfa and clover) in pastured cattle.
(3) Limitations. Administer free-choice to beef cattle and nonlactating dairy cattle only. Do not allow cattle access to other sources of salt while being fed this product. Do not feed this product to animals without adequate forage/roughage consumption.
§ 558.485   Pyrantel.
(a) Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as follows:
(1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section.
(2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section.
(c) Related tolerances. See § 556.560 of this chapter.
(d) Special considerations. (1) See § 500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use —(1) Swine —
(2) Horses —
(ii) Top dress medicated feed —(A) Proprietary Formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:
(B) [Reserved]
(3) Pyrantel may also be used in combination with:
(i) Carbadox as in § 558.115.
(ii) Lincomycin as in § 558.325.
(iii) Tylosin as in § 558.625.
§ 558.500   Ractopamine.
(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.
(2) Nos. 051311 and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.
(c) Related tolerances. See § 556.570 of this chapter.
(d) Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”
(2) Labeling of Type B and Type C swine feeds shall bear the following:
(i) “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”
(ii) “Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”
(3) Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”
(4) Tylosin in combinations as tylosin phosphate.
(5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(e) Conditions of use —(1) Swine —
(2) Cattle.
(3) Turkeys —
(4) Ractopamine may also be used in combination with tylosin in as in § 558.625.
§ 558.515   Robenidine.
(a) Specifications. Type A medicated articles containing 30 grams per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.580 of this chapter.
(d) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use. It is used in feed for chickens as follows:
(f) Robenidine may also be used in combination with:
(1) Chlortetracycline as in § 558.128.
(2) Lincomycin as in § 558.325.
(3) Oxytetracycline as in § 558.450.
§ 558.550   Salinomycin.
(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(c) Related tolerances. See § 556.592 of this chapter.
(d) Special considerations. Not approved for use with pellet binders.
(e) Conditions of use. It is used as follows:
(1) Chickens —
(2) Game birds —
(3) Combinations. Salinomycin may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) Chlortetracycline as in § 558.128.
(iii) Lincomycin as in § 558.325.
(iv) Oxytetracycline as in § 558.450.
(v) Virginiamycin as in § 558.635.
§ 558.555   Semduramicin.
(a) Specifications. Type A medicated article containing:
(1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin (as semduramicin sodium).
(2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass).
(b) Sponsor. See No. 066104 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section; for use of product described in paragraph (a)(2) of this section as in paragraph (e) of this section.
(c) Related tolerances. See § 556.597 of this chapter.
(d) Conditions of use in chickens. It is used in chicken feed as follows:
(e) Conditions of use in chickens. It is used in chicken feed as follows:
(f) Semduramicin may also be used in combination with virginiamycin as in § 558.635.
§ 558.575   Sulfadimethoxine and ormetoprim.
(a) Specifications. Type A medicated articles containing either:
(1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this section.
(2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(3)(iv) and (v) of this section.
(c) Related tolerances. See §§ 556.490 and 556.640 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled.
(e) Conditions of use. It is used in animal feeds as follows:
(1) Chickens —
(2) Turkeys —
(3) Minor species —
§ 558.582   Sulfamerazine.
(a) Specifications. Type A medicated articles containing 99 percent sulfamerazine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.660 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled.
(e) Conditions of use. It is used in fish feed for as follows:
§ 558.586   Sulfaquinoxaline.
(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.685 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled.
(e) Conditions of use —(1) Chickens —
(2) Turkeys —
(3) Rabbits —
§ 558.612   Tiamulin.
(a) Specifications. Type A article containing 363.2 grams of tiamulin hydrogen fumarate per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.732 of this chapter.
(d) Special considerations. (1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.
(2) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.
(3) Use as sole source of tiamulin.
(e) Conditions of use —(1) Swine. It is used as follows:
(2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128.
§ 558.618   Tilmicosin.
(a) Specifications. Type A medicated article containing 90.7 grams (g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
(b) Sponsor. See Nos. 016592 and 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.735 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) VFDs for tilmicosin phosphate shall not be refilled.
(3) Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings:
(i) Do not allow horses or other equines access to feeds containing tilmicosin.
(ii) [Reserved]
(4) Special considerations for use of tilmicosin medicated swine feeds include the following:
(i) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for swine must bear the following warning: “Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.”
(iii) Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial.
(5) Special consideration for use of tilmicosin medicated cattle feeds include the following:
(i) The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for cattle must bear the following warning: “Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin.”
(iii) To assure both food safety and responsible use in cattle, administration of feed containing tilmicosin to cattle experiencing an outbreak of BRD must be initiated during the first 45 days of the production period, shall not exceed a single 14-consecutive-day treatment, should not occur concurrent with or following administration of an injectable macrolide, and should not occur within 3 days following administration of a nonmacrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy.
(e) Conditions of use. It is used in feed as follows:
(1) Swine —
(2) Cattle —
§ 558.625   Tylosin.
(a) Specifications. Type A medicated articles containing tylosin phosphate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 016592: Type A medicated articles containing 40 or 100 grams per pound (g/lb).
(2) No. 054771: Type A medicated article containing 40 g/lb.
(3) No. 058198: Type A medicated articles containing 10, 40, or 100 g/lb.
(4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
(c) Related tolerances. See § 556.746 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for tylosin medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin shall not be refilled.
(3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(4) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture.
(5) Do not use tylosin liquid Type B medicated feeds in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate, or complete feed) containing in excess of 2 percent bentonite.
(e) Conditions of use —(1) Swine —
(2) Cattle —
§ 558.630   Tylosin and sulfamethazine.
(a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 058198 for use as in paragraph (e)(1) of this section.
(2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section.
(c) Related tolerances. See §§ 556.670 and 556.746 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled.
(3) Labeling shall bear the statement: “Do not use in medicated feeds containing in excess of 2% bentonite.”
(e) Conditions of use. It is used in feed for swine as follows:
§ 558.633   Tylvalosin.
(a) Specifications. Type A medicated articles containing 77.12 grams tylvalosin per pound as tylvalosin tartrate.
(b) Sponsor. See No. 066916 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.748 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) VFDs for tylvalosin shall not be refilled.
(3) Crumbled Type C medicated feeds must bear an expiration date of 7 days after the date of manufacture.
(e) Conditions of use.
§ 558.635   Virginiamycin.
(a) Specifications. Type A medicated articles containing 10, 20, 50, or 227 grams virginiamycin per pound.
(b) Sponsors. See No. 066104 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.750 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for virginiamycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for virginiamycin shall not be refilled.
(3) Not for use in breeding swine over 120 pounds.
(4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.
(e) Conditions of use —(1) Chickens —
(2) Swine —
(3) Cattle —
§ 558.665   Zilpaterol.
(a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound.
(b) Approvals. See No. 000061 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.765 of this chapter.
(d) Special considerations. (1) Labeling shall bear the following caution statements: “Zilpaterol hydrochloride is not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.”
(2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statement in paragraph (d)(3) of this section.
(3) Labeling of complete Type C medicated feeds shall bear the following caution statements: “Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.”
(4) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(e) Conditions of use in cattle. It is administered in feed as follows:
(f) Zilpaterol may also be used in combination with tylosin as in § 558.625.
§ 558.680   Zoalene.
(a) Specifications. Type A medicated article containing 25 percent zoalene.
(b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.770 of this chapter.
(d) Conditions of use —(1) Chickens —
(2) Turkeys —
(3) Zoalene may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Lincomycin as in § 558.325.