TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Subpart A - General Provisions
§ 516.1 - Scope.
§ 516.2 - Purpose.
§ 516.3 - Definitions.
Subpart B - Designation of a Minor Use or Minor Species New Animal Drug
§ 516.11 - Scope of this subpart.
§ 516.12 - Purpose.
§ 516.13 - Definitions.
§ 516.14 - Submission of requests for designation.
§ 516.16 - Eligibility to request designation.
§ 516.20 - Content and format of a request for MUMS-drug designation.
§ 516.21 - Documentation of minor use status.
§ 516.22 - Permanent-resident U.S. agent for foreign sponsor.
§ 516.23 - Timing of requests for MUMS-drug designation.
§ 516.24 - Granting MUMS-drug designation.
§ 516.25 - Refusal to grant MUMS-drug designation.
§ 516.26 - Amendment to MUMS-drug designation.
§ 516.27 - Change in sponsorship.
§ 516.28 - Publication of MUMS-drug designations.
§ 516.29 - Termination of MUMS-drug designation.
§ 516.30 - Annual reports for a MUMS-designated drug.
§ 516.31 - Scope of MUMS-drug exclusive marketing rights.
§ 516.34 - FDA recognition of exclusive marketing rights.
§ 516.36 - Insufficient quantities of MUMS-designated drugs.
§ 516.52 - Availability for public disclosure of data and information in requests.
Subpart C - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
§ 516.111 - Scope of this subpart.
§ 516.115 - Definitions.
§ 516.117 - Submission of correspondence under this subpart.
§ 516.119 - Permanent-resident U.S. agent for foreign requestors and holders.
§ 516.121 - Meetings.
§ 516.123 - Informal conferences regarding agency administrative actions.
§ 516.125 - Investigational use of minor species new animal drugs to support indexing.
§ 516.129 - Content and format of a request for determination of eligibility for indexing.
§ 516.131 - Refuse to file a request for determination of eligibility for indexing.
§ 516.133 - Denying a request for determination of eligibility for indexing.
§ 516.135 - Granting a request for determination of eligibility for indexing.
§ 516.137 - Notification of decision regarding eligibility for indexing.
§ 516.141 - Qualified expert panels.
§ 516.143 - Written report.
§ 516.145 - Content and format of a request for addition to the index.
§ 516.147 - Refuse to file a request for addition to the index.
§ 516.149 - Denying a request for addition to the index.
§ 516.151 - Granting a request for addition to the index.
§ 516.153 - Notification of decision regarding index listing.
§ 516.155 - Labeling of indexed drugs.
§ 516.157 - Publication of the index and content of an index listing.
§ 516.161 - Modifications to indexed drugs.
§ 516.163 - Change in ownership of an index file.
§ 516.165 - Records and reports.
§ 516.167 - Removal from the index.
§ 516.171 - Confidentiality of data and information in an index file.
Subpart D [Reserved]
Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species
Fluocinolone Topical and Otic Dosage Forms
§ 524.981 - [Reserved]
§ 524.981a - Fluocinolone cream.
§ 524.981b - Fluocinolone solution.
§ 524.981c - Fluocinolone and neomycin cream.
§ 524.981d - Fluocinolone and dimethyl sulfoxide solution.
§ 524.981e - Fluocinolone and dimethyl sulfoxide otic solution.
§ 524.998 - Fluralaner.
§ 524.1001 - Fluralaner and moxidectin.
§ 524.1005 - Furazolidone powder.
§ 524.1044 - Gentamicin ophthalmic and topical dosage forms.
§ 524.1044a - Gentamicin ophthalmic solution.
§ 524.1044b - Gentamicin and betamethasone otic solution.
§ 524.1044c - Gentamicin ophthalmic ointment.
§ 524.1044d - Gentamicin and betamethasone ointment.
§ 524.1044e - Gentamicin spray.
§ 524.1044f - Gentamicin and betamethasone spray.
§ 524.1044g - Gentamicin, betamethasone, and clotrimazole ointment.
§ 524.1044h - Gentamicin, mometasone, and clotrimazole otic suspension.
§ 524.1044i - Gentamicin and betamethasone ophthalmic solution.
§ 524.1132 - Hydrocortisone, miconazole, and gentamicin otic suspension.
§ 524.1140 - Imidacloprid and ivermectin.
§ 524.1146 - Imidacloprid and moxidectin.
§ 524.1193 - Ivermectin topical solution.
§ 524.1195 - Ivermectin otic suspension.
§ 524.1200 - Kanamycin ophthalmic and topical dosage forms.
§ 524.1200a - Kanamycin ophthalmic ointment.
§ 524.1200b - Kanamycin ophthalmic solution.
§ 524.1204 - Kanamycin, amphomycin, and hydrocortisone ointment.
§ 524.1240 - Levamisole.
§ 524.1376 - 2-Mercaptobenzothiazole solution.
§ 524.1443 - Miconazole.
§ 524.1445 - Miconazole, polymixin B, and prednisolone suspension.
§ 524.1446 - Milbemycin otic solution.
§ 524.1448 - Mirtazapine transdermal ointment.
§ 524.1450 - Moxidectin.
§ 524.1465 - Mupirocin.
§ 524.1484 - Neomycin ophthalmic and topical dosage forms.
§ 524.1484b - Neomycin, isoflupredone, and tetracaine powder.
§ 524.1484c - Neomycin, isoflupredone, and tetracaine ointment.
§ 524.1484d - Neomycin, hydrocortisone, and tetracaine otic ointment.
§ 524.1484e - Neomycin and polymyxin B ophthalmic solution.
§ 524.1484f - Neomycin, prednisolone, and tetracaine otic suspension.
§ 524.1484g - Neomycin, thiabendazole, and dexamethasone solution.
§ 524.1484h - Neomycin, penicillin, polymyxin B, and hydrocortisone suspension.
§ 524.1484i - Neomycin and hydrocortisone ointment.
§ 524.1484k - Neomycin and prednisolone suspension.
§ 524.1580 - Nitrofurazone topical dosage forms.
§ 524.1580a - Nitrofurazone ointment.
§ 524.1580b - Nitrofurazone soluble powder.
§ 524.1580c - Nitrofurazone and butacaine ointment.
§ 524.1600 - Nystatin ophthalmic and topical dosage forms.
§ 524.1600a - Nystatin, neomycin, thiostrepton, and triamcinolone ointment.
§ 524.1600b - Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment.
§ 524.1610 - Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.
§ 524.1662 - Oxytetracycline ophthalmic and topical dosage forms.
§ 524.1662a - Oxytetracycline and hydrocortisone spray.
§ 524.1662b - Oxytetracycline and polymyxin B ophthalmic ointment.
§ 524.1742 - Phosmet emulsifiable liquid.
§ 524.1982 - Proparacaine ophthalmic solution.
§ 524.2080 - Ropinirole.
§ 524.2098 - Selamectin.
§ 524.2099 - Selamectin and sarolaner.
§ 524.2101 - Selenium disulfide suspension.
§ 524.2350 - Tolnaftate cream.
§ 524.2482 - Triamcinolone spray.
§ 524.2620 - Liquid crystalline trypsin, Peru balsam, castor oil.
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Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Source: 72 FR 41017, July 26, 2007, unless otherwise noted.
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