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  1. Animal Drug Compounding

Bulk Drug Substances Currently Under Review

List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species

List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals

Bulk Drug Substances Reviewed and Not Listed 


These bulk drug substances are currently being evaluated by FDA. While these evaluations are being completed, the agency generally intends to refrain from taking enforcement action when these bulk drug substances are used to compound a finished drug in a state-licensed pharmacy or federal facility or by a state-licensed veterinarian as described in the initial nomination.

Once the evaluation for a given bulk drug substance has been fully completed, those found to meet the criteria for inclusion on a list will be removed from the “Currently Under Review” status and will be added to the appropriate list for nonfood-producing animals, food-producing animals, or free-ranging wildlife species. Those bulk drug substances that are not found to meet the criteria for inclusion on a list will be designated as “Bulk Drug Substances Reviewed and Not Listed.”

FDA will accept nominations of additional bulk drug substances at any time and will continue to review nominations and update lists. For information on how to submit a bulk drug substance nomination, see the appendix to Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.


DOGS, CATS, HORSES
NONFOOD-PRODUCING MINOR SPECIES
FOOD-PRODUCING ANIMALS (ANTIDOTES)
FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)


DOGS, CATS, HORSES

Bulk Drug Substance (BDS)SpeciesNomination
Acepromazine maleatedog, cat, horseFDA-2018-N-4626-0114
Acetyl-D-glucosaminedog, horseFDA-2018-N-4626-0104
Adenosine monophosphatehorseFDA-2018-N-4626-0825
Aluminum hydroxidedog, catFDA-2018-N-4626-0048
Amantadinedog, horseFDA-2018-N-4626-0136
Aminopentamide sulfatedog, catFDA-2018-N-4626-0017
Aminophyllinedog, catFDA-2018-N-4626-0069
Amitriptyline HCldog, catFDA-2018-N-4626-0018
Ammonium sulfatehorseFDA-2018-N-4626-0822
Apomorphine HCldogFDA-2018-N-4626-0020
FDA-2018-N-4626-0147
Atenololdog, catFDA-2018-N-4626-0041
AtipamezolehorseFDA-2018-N-4626-0054
FDA-2018-N-4626-0801
Atovaquonedog, catFDA-2018-N-4626-0146
AtropinehorseFDA-2018-N-4626-0752
AzaperonehorseFDA-2018-N-4626-0013
Azithromycin/rifampindog, cat, horseFDA-2018-N-4626-0090
Benazepril HCldog, catFDA-2018-N-4626-0091
Benazepril HCl/furosemide/pimobendandog, catFDA-2018-N-4626-0727
Budesonidedog, catFDA-2018-N-4626-0045
FDA-2018-N-4626-0725
Butorphanol tartratedog, horseFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Calcium chloride/magnesium chloride/potassium chloride/sodium acetate/dextrosehorseFDA-2018-N-4626-0823
Chlorambucildog, catFDA-2018-N-4626-0123
FDA-2018-N-4626-0725
Chloramphenicol/betamethasone/ketoconazoledog, catFDA-2018-N-4626-0552
Chlorpheniramine maleatedog, catFDA-2018-N-4626-0139
Cidofovirdog, catFDA-2018-N-4626-0032
FDA-2018-N-4626-0040
Ciprofloxacin HCldog, catFDA-2018-N-4626-0652
Cisapridedog, cat, horseFDA-2018-N-4626-0021
FDA-2018-N-4626-0655
FDA-2018-N-4626-0759
Cisapride/lactulosedog, catFDA-2018-N-4626-0169
CisplatinhorseFDA-2018-N-4626-0112
Clarithromycindog, cat, horseFDA-2018-N-4626-0175
Clarithromycin/rifampindog, cat, horseFDA-2018-N-4626-0100
Clindamycin HCldog, catFDA-2018-N-4626-0042
FDA-2018-N-4626-0583
Clonidine HCldogFDA-2018-N-4626-0977
Cyclophosphamidedog, cat, horseFDA-2018-N-4626-0063
Cyclosporine/tacrolimusdogFDA-2018-N-4626-0108
Cyproheptadine HCldog, cat, horseFDA-2018-N-4626-0102
Dantrolene sodiumdog, cat, horseFDA-2018-N-4626-0095
Decoquinatedog, horseFDA-2018-N-4626-0126
Demecarium bromidedogFDA-2018-N-4626-0028
Desmopressindog, cat, horseFDA-2018-N-4626-0031
Dexamethasonedog, cat, horse

horse
FDA-2018-N-4626-0082

FDA-2018-N-4626-0098
DiazoxidedogFDA-2018-N-4626-0096
Diclazurildog, cat, horseFDA-2018-N-4626-0109
Diclazuril/levamisole HCl/vitamin E acetatehorseFDA-2018-N-4626-0849
Diclofenac sodiumdog, cat, horseFDA-2018-N-4626-0538
Diethylstilbestrol (DES)dogFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Diltiazemdog, catFDA-2018-N-4626-0731
Dimercaptosuccinic acid (DMSA)dog, catFDA-2018-N-4626-0714
Dimethyl sulfoxide (DMSO)dog, horseFDA-2018-N-4626-0618
DipyronedogFDA-2018-N-4626-0992
DomperidonehorseFDA-2018-N-4626-1036
Doxycyclinedog, cat, horseFDA-2018-N-4626-0011
FDA-2018-N-4626-0015
FDA-2018-N-4626-0812
FDA-2018-N-4626-0960
Doxycycline/clindamycindogFDA-2018-N-4626-0116
Edetate calcium disodiumdog, cat, horseFDA-2018-N-4626-0482
Enalapril maleatedog, catFDA-2018-N-4626-0049
Enalapril maleate/furosemide/pimobendandog, catFDA-2018-N-4626-0179
Enrofloxacin/itraconazole/triamcinolonedog, catFDA-2018-N-4626-0627
Enrofloxacin/miconazole/triamcinolonedog, catFDA-2018-N-4626-0625
ErtugliflozinhorseFDA-2018-N-4626-0737
Erythromycin ethylsuccinatedog, cat, horseFDA-2018-N-4626-0479
EstronehorseFDA-2018-N-4626-0117
Fenbendazole/ponazuril/praziquanteldog, catFDA-2018-N-4626-0178
Fipronildog, catFDA-2018-N-4626-0637
Fluconazoledog, cat, horseFDA-2018-N-4626-0032
FDA-2018-N-4626-0059
Fludrocortisone acetatedog, catFDA-2018-N-4626-0159
FlurbiprofenhorseFDA-2018-N-4626-0654
Fluorouracildog, horseFDA-2018-N-4626-0171
FlurbiprofenhorseFDA-2018-N-4626-0654
Fomepizoledog, catFDA-2018-N-4626-0656
FDA-2018-N-4626-0725
Furosemidedog, cat, horseFDA-2018-N-4626-0076
Gabapentindog, cat, horseFDA-2018-N-4626-0032
FDA-2018-N-4626-0051
FDA-2018-N-4626-0084
Gabapentin/trazodone HCldog, catFDA-2018-N-4626-0128
FDA-2018-N-4626-0638
GC376catFDA-2018-N-4626-0969
Glycopyrrolatedog, cat, horseFDA-2018-N-4626-0584
Gramicidin/neomycin/nystatin/triamcinolonedog, cat, horseFDA-2018-N-4626-0176
Griseofulvindog, horseFDA-2018-N-4626-0148 
GS-441524 catFDA-2018-N-4626-0953
FDA-2018-N-4626-0954
FDA-2018-N-4626-0956
FDA-2018-N-4626-0976
FDA-2018-N-4626-0993
GuaifenesinhorseFDA-2018-N-4626-0028
Guanabenz acetatehorseFDA-2018-N-4626-0742
Hydrocodone bitartratedogFDA-2018-N-4626-0062
FDA-2018-N-4626-0592
Hydrocodone homatropinedogFDA-2018-N-4626-0593
Idoxuridinecat, horseFDA-2018-N-4626-0024
Imipenem/cilastatin/ketoconazole/triamcinolonedog, catFDA-2018-N-4626-0555
IodinehorseFDA-2018-N-4626-0824
Isoxsuprine HClhorseFDA-2018-N-4626-0092
Itraconazole with DMSOhorseFDA-2018-N-4626-0028
Kanamycin/bismuth subcarbonate/kaolindog, catFDA-2018-N-4626-0630
Ketoconazoledog, cat, horseFDA-2018-N-4626-0032
FDA-2018-N-4626-0035
Ketoconazole/amikacin/triamcinolonedog, catFDA-2018-N-4626-0156
FDA-2018-N-4626-0551
Ketoconazole/enrofloxacin/betamethasonedog, catFDA-2018-N-4626-0628
Ketoconazole/enrofloxacin/mupirocin/triamcinolonedog, catFDA-2018-N-4626-0626
Ketoconazole/enrofloxacin/triamcinolonedog, catFDA-2018-N-4626-0084
FDA-2018-N-4626-0099
FDA-2018-N-4626-0553
Ketoconazole/marbofloxacin/polymyxin B/triamcinolonedog, catFDA-2018-N-4626-0624
Ketoconazole/marbofloxacin/triamcinolonedog, catFDA-2018-N-4626-0623
Ketoconazole/mupirocin/silver sulfadiazine/triamcinolonedog, cat, horseFDA-2018-N-4626-0622
Ketoconazole/mupirocin/triamcinolonedog, cat, horseFDA-2018-N-4626-0590
Ketoconazole/ polymyxin B/triamcinolonedog, catFDA-2018-N-4626-0621
Ketoconazole/triamcinolonedog, catFDA-2018-N-4626-0589
L-asparaginasedog, catFDA-2018-N-4626-0028
FDA-2018-N-4626-0032
FDA-2018-N-4626-0725
Lapatinibdog, catFDA-2018-N-4626-0726
Levetiracetamdog, cat, horseFDA-2018-N-4626-0064
Lomustinedog, catFDA-2018-N-4626-0067
Magnesium sulfate/tryptophan (L)horseFDA-2018-N-4626-0150
Mechlorethamine HCldog, catFDA-2018-N-4626-0105
FDA-2018-N-4626-0725
Meclofenamate sodiumhorseFDA-2018-N-4626-0715
Medroxyprogesterone acetatehorseFDA-2018-N-4626-0982
Meloxicamdog, cat


dog, cat, horse
FDA-2018-N-4626-0013
FDA-2018-N-4626-0029
FDA-2018-N-4626-0046
FDA-2018-N-4626-0585
Melphalandog, catFDA-2018-N-4626-0719
FDA-2018-N-4626-0753
Methazolamidedog, catFDA-2018-N-4626-0160
MethocarbamolhorseFDA-2018-N-4626-1035
Methylprednisolonedog, cat, horseFDA-2018-N-4626-0586
Metoclopramide HCldog, cat, horseFDA-2018-N-4626-0077
MiboleronedogFDA-2018-N-4626-0725
Minocycline HCldog, cat, horseFDA-2018-N-4626-0124
Misoprostoldog, cat, horseFDA-2018-N-4626-0127
Mitomycindog, horseFDA-2018-N-4626-0738
MolnupiravircatFDA-2018-N-4626-0981
Mupirocindog, catFDA-2018-N-4626-0033
Mycophenolate mofetildog, catFDA-2018-N-4626-0153
Nalbuphinedog, cat, horseFDA-2018-N-4626-0712
Nalbuphine HCl/azaperone/medetomidine HClhorseFDA-2018-N-4626-0653
Naltrexone HClhorseFDA-2018-N-4626-0733
Nitrofurantoindog, catFDA-2018-N-4626-0172
OseltamivirdogFDA-2018-N-4626-0033
Paromomycin sulfatedog, catFDA-2018-N-4626-0184
Penicillaminedog, catFDA-2018-N-4626-0141
Pentoxifyllinedog, cat, horseFDA-2018-N-4626-0119
Phenobarbitaldog. catFDA-2018-N-4626-0080
FDA-2018-N-4626-0591
Phenoxybenzamine HCldog, catFDA-2018-N-4626-0068
FDA-2018-N-4626-0658
Piroxicamdog, cat, horseFDA-2018-N-4626-0060
Ponazurildog, cat, horseFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
FDA-2018-N-4626-0073
Potassium bromidedog, horseFDA-2018-N-4626-0022
Povidone iodinehorseFDA-2018-N-4626-0979
Prednisolonedog, cat, horseFDA-2018-N-4626-0033
FDA-2018-N-4626-0036
FDA-2018-N-4626-0074
PrednisonedogFDA-2018-N-4626-0075
Procarbazine HCldog, catFDA-2018-N-4626-0670
FDA-2018-N-4626-0725
ProgesteronehorseFDA-2018-N-4626-0815
Pyrimethaminedog, cat, horseFDA-2018-N-4626-0078
Pyrimethamine/sulfadiazinehorseFDA-2018-N-4626-0151
Pyrimethamine/sulfadiazine/folic acidhorseFDA-2018-N-4626-0180
RemdesivircatFDA-2018-N-4626-0966
Riboflavindog, cat, horseFDA-2018-N-4626-0722
Rifampindog, catFDA-2018-N-4626-0061
Romifidine HClhorseFDA-2018-N-4626-0113
Ronidazoledog, catFDA-2018-N-4626-0142
FDA-2018-N-4626-0582
Sildenafil citratedog, catFDA-2018-N-4626-0072
Sirolimusdog, catFDA-2018-N-4626-0674
Sodium carboxymethylcellulosehorseFDA-2018-N-4626-0741
Sotalol HCldog, catFDA-2018-N-4626-0813
Spironolactonedog, catFDA-2018-N-4626-0143
Stanozololdog, cat
dog, cat, horse
FDA-2018-N-4626-0757
FDA-2018-N-4626-0581
TacrolimusdogFDA-2018-N-4626-0023
Terbinafine HCldog, catFDA-2018-N-4626-0165
Terbutaline sulfatedog, catFDA-2018-N-4626-0168
Theophyllinedog, catFDA-2018-N-4626-0033
FDA-2018-N-4626-0037
Ticarcillin disodium/clavulanate potassiumhorseFDA-2018-N-4626-0756
Tissue plasminogen activator (TPA)dog, catFDA-2018-N-4626-0701
Tolazoline HClhorseFDA-2018-N-4626-0028
Toltrazurildog, cat, horseFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Toltrazuril/DMSOhorseFDA-2018-N-4626-0157
FDA-2018-N-4626-0847
Tramadoldog, cat, horseFDA-2018-N-4626-0012
FDA-2018-N-4626-0033
FDA-2018-N-4626-0065
Trazodone HCldog, cat, horseFDA-2018-N-4626-0110
Triamcinolone acetonidedog, cat, horseFDA-2018-N-4626-0033
FDA-2018-N-4626-0094
FDA-2018-N-4626-0657
Trichlormethiazide/dexamethasonehorseFDA-2018-N-4626-0149
Tryptophan (L)/thiamine HClhorseFDA-2018-N-4626-0163
Tryptophan/thiamine HCl/folic acid/niacinhorseFDA-2018-N-4626-0161
Tylosindog, catFDA-2018-N-4626-0071
Ursodioldog, cat, horseFDA-2018-N-4626-0033
FDA-2018-N-4626-0044
Vitamin A, D, Edog, catFDA-2018-N-4626-0723
Voriconazoledog, cat, horse

dog, cat
FDA-2018-N-4626-0122

FDA-2018-N-4626-0701
Yohimbine HCldog, cat, horseFDA-2018-N-4626-0013
Zonisamidedog, catFDA-2018-N-4626-0057

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS)SpeciesNomination
Aluminum hydroxiderodents, small mammalsFDA-2018-N-4626-0048
Amitriptyline HClbirdFDA-2018-N-4626-0018
Apomorphine HClferretFDA-2018-N-4626-0020
AtipamezoleAfrican hoof stock, camelids, carnivores, captive zoo speciesFDA-2018-N-4626-0054
FDA-2018-N-4626-0801
AzaperoneAfrican hoof stock, camelids, minor carnivore spp., and small mammalsFDA-2018-N-4626-0013
Azithromycin/rifampinbirdFDA-2018-N-4626-0090
Butorphanol/azaperone/medetomidine (BAM)African hoof stock, camelids, carnivores, feral horses, and small mammalsFDA-2018-N-4626-0085
Butorphanol tartrateAfrican hoof stock, elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species FDA-2018-N-4626-0013
ChlorambucilferretFDA-2018-N-4626-0123
Cisapriderodents, other small mammals, and captive marine mammalsFDA-2018-N-4626-0021
FDA-2018-N-4626-0655
FDA-2018-N-4626-0759
Clindamycin HClavian, ferret, reptiles, assorted exotic and zoo species


avian
FDA-2018-N-4626-0042

FDA-2018-N-4626-0583
CyclophosphamideferretFDA-2018-N-4626-0063
Dexamethasoneferret, rodents

camelids
FDA-2018-N-4626-0082
FDA-2018-N-4626-0098
Diazoxideferret, guinea pig, small mammalsFDA-2018-N-4626-0096
Dimercaptosuccinic acid (DMSA)avianFDA-2018-N-4626-0714
Doxycyclinerodents, small mammals, birds, reptiles, other exotic and zoo animals

whales, dolphins, porpoises
FDA-2018-N-4626-0015

FDA-2018-N-4626-0673
Edetate calcium disodium (calcium disodium edetate) birds


captive eagles, California condors, other raptors
FDA-2018-N-4626-0482

FDA-2018-N-4626-0523
FDA-2018-N-4626-0558
Enalapril maleateferret, birdFDA-2018-N-4626-0049
FDA-2018-N-4626-0084
Fenbendazolesmall mammals, assorted exotic and captive zoo speciesFDA-2018-N-4626-0174
Fluconazolebird, exotics, small mammal, exotics, captive zoo species, reptileFDA-2018-N-4626-0032
FDA-2018-N-4626-0059
Furosemideferret, small mammals, bird, reptileFDA-2018-N-4626-0076
Gabapentinavian, exotics, zoo animalsFDA-2018-N-4626-0051
Griseofulvinrodents, small mammals, captive exotic and zoo speciesFDA-2018-N-4626-0148
Isoxsuprine HClbirdFDA-2018-N-4626-0092
Ketoconazolebird, exotics, zoo species, rodents, reptiles, small animalsFDA-2018-N-4626-0032
FDA-2018-N-4626-0035
Ketoconazole/mupirocin/triamcinoloneavian, ferrets, small mammalsFDA-2018-N-4626-0590
L-asparaginaseferretsFDA-2018-N-4626-0725
Marbofloxacinavian, reptiles, assorted captive exotic and zoo speciesFDA-2018-N-4626-0070
Medetomidine/ketamineAfrican hoof stock, camelids, carnivores, feral horses, and small mammalsFDA-2018-N-4626-0189
Medroxyprogesterone acetatecaptive deerFDA-2018-N-4626-0982
Meloxicambirds, rats, mice, gerbils, hamsters, other small mammals, marine mammals, large zoo animals and captive wildlife, ferrets, reptiles, assorted exotic and zoo animals


avian, ferrets, rats, guinea pigs
FDA-2018-N-4626-0029
FDA-2018-N-4626-0046

FDA-2018-N-4626-0585
Metoclopramide HClsmall mammalsFDA-2018-N-4626-0077
Nalbuphine HCl/ azaperone/medetomidine HClAfrican hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammalsFDA-2018-N-4626-0653
NaltrexoneAfrican hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammalsFDA-2018-N-4626-0733
Oxantel pamoate/praziquantel/pyrantel pamoateferret, reptileFDA-2018-N-4626-0130
Paromomycin sulfateelephant, reptileFDA-2018-N-4626-0184
PenicillamineavianFDA-2018-N-4626-0141
Piroxicamsmall mammalsFDA-2018-N-4626-0060
Ponazurilsmall mammals, reptiles, assorted exotic speciesFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Prednisoloneavian, rodents, small mammals, reptiles, other exotic and zoo speciesFDA-2018-N-4626-0074
Prednisoneavian, rodents, small mammalsFDA-2018-N-4626-0075
Pyrimethamineavian, exoticsFDA-2018-N-4626-0078
Sildenafil citrateassorted exotic and captive zoo speciesFDA-2018-N-4626-0072
Stanozololsmall mammals


avian
FDA-2018-N-4626-0081

FDA-2018-N-4626-0581
Terbinafine HClavian


bottlenose dolphins, California sea lions
FDA-2018-N-4626-0165

FDA-2018-N-4626-0662
Toltrazurilsmall mammals, reptiles, camelids, assorted large and small exotic/zoo speciesFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Tramadol HClavian, sea turtle, ungulates, small mammals, reptiles, captive zoo and exotic speciesFDA-2018-N-4626-0012
FDA-2018-N-4626-0019
FDA-2018-N-4626-0033
FDA-2018-N-4626-0065
Tylosinferrets, exotic and captive zoo speciesFDA-2018-N-4626-0071
UrsodiolbirdFDA-2018-N-4626-0044
Vitamin A, D, Ebird, geckoFDA-2018-N-4626-0723
VoriconazolebirdFDA-2018-N-4626-0122
Yohimbine HClsmall mammals, zoo/captive bird species, pet birds, llama, large and small exotic/zoo speciesFDA-2018-N-4626-0013

FOOD-PRODUCING ANIMALS (ANTIDOTES)

Bulk Drug Substance (BDS)SpeciesNomination
Methylene bluecattle, sheep, goatsFDA-2018-N-4626-0730

FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)

Bulk Drug Substance (BDS)SpeciesNomination
Alpha-chloralosecommon ravens, pigeons (rock doves), wild and feral turkeys, and non-native and feral geese, ducks, chickens, and swans FDA-2018-N-4626-0978
AtipamezoleNorth American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlifeFDA-2018-N-4626-0054
FDA-2018-N-4626-0801
AzaperoneNorth American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat speciesFDA-2018-N-4626-0013
Butorphanol/azaperone/medetomidine (BAM)North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and small mammalsFDA-2018-N-4626-0085
Butorphanol tartrateNorth American hoof stock; large ungulates including deer, elk, moose, bighorn sheepFDA-2018-N-4626-0013
Medetomidine HCl/ketamine HClNorth American hoof stock; large ungulates including deer, elk, moose, bighorn sheepFDA-2018-N-4626-0189
Nalbuphine HCl/ azaperone/medetomidine HClNorth American hoof stock, large ungulates including deer, elk, moose, bighorn sheepFDA-2018-N-4626-0653
Naltrexone HClNorth American hoof stock, large ungulates including deer, elk, moose, bighorn sheepFDA-2018-N-4626-0733
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