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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.



Bulk Drug Substance (BDS) Species Nomination
Acepromazine maleate dog, cat, horse FDA-2018-N-4626-0114
Acetyl-D-glucosamine dog, horse FDA-2018-N-4626-0104
Actinomycin D dog, cat FDA-2018-N-4626-0106
Altrenogest horse FDA-2018-N-4626-0101
Aluminum hydroxide dog, cat FDA-2018-N-4626-0048
Amantadine dog, horse FDA-2018-N-4626-0136
Amikacin dog, cat, horse FDA-2018-N-4626-0032
Aminocaproic acid dog, horse FDA-2018-N-4626-0107
Aminopentamide sulfate dog, cat FDA-2018-N-4626-0017
Aminophylline dog, cat FDA-2018-N-4626-0069
Amitriptyline HCl dog, cat FDA-2018-N-4626-0018
Amoxicillin/clavulanate potassium dog, cat FDA-2018-N-4626-0177
Apomorphine HCl dog FDA-2018-N-4626-0020
Atenolol dog, cat FDA-2018-N-4626-0041
Atipamezole horse FDA-2018-N-4626-0054
Atovaquone dog, cat FDA-2018-N-4626-0146
Azaperone horse FDA-2018-N-4626-0013
Azithromycin dog, cat, horse FDA-2018-N-4626-0032
Azithromycin/rifampin dog, cat, horse FDA-2018-N-4626-0090
Benazepril HCl dog, cat FDA-2018-N-4626-0091
Betamethasone dipropionate dog, cat, horse FDA-2018-N-4626-0032
Budesonide dog, cat FDA-2018-N-4626-0045
Buprenorphine dog, cat, horse FDA-2018-N-4626-0014
Butorphanol tartrate dog, horse FDA-2018-N-4626-0012
Cetirizine HCl dog, cat, horse FDA-2018-N-4626-0111
Chlorambucil dog, cat FDA-2018-N-4626-0123
Chloramphenicol dog, cat, horse FDA-2018-N-4626-0011
Chlorpheniramine maleate dog, cat FDA-2018-N-4626-0139
Cidofovir dog, cat FDA-2018-N-4626-0032
Cimetidine dog, cat, horse FDA-2018-N-4626-0135
Cisapride dog, cat, horse FDA-2018-N-4626-0021
Cisapride/lactulose dog, cat FDA-2018-N-4626-0169
Cisplatin horse FDA-2018-N-4626-0112
Clarithromycin dog, cat, horse FDA-2018-N-4626-0175
Clarithromycin/rifampin dog, cat, horse FDA-2018-N-4626-0100
Clenbuterol HCl horse FDA-2018-N-4626-0066
Clindamycin HCl dog, cat FDA-2018-N-4626-0042
Clomipramine HCl dog, cat FDA-2018-N-4626-0058
Clopidogrel bisulfate  dog, cat, horse FDA-2018-N-4626-0013
Cyclophosphamide dog, cat, horse FDA-2018-N-4626-0063
Cyclosporine dog, cat, horse FDA-2018-N-4626-0030
Cyclosporine/tacrolimus dog FDA-2018-N-4626-0108
Cyproheptadine HCl dog, cat, horse FDA-2018-N-4626-0102
Dantrolene sodium dog, cat, horse FDA-2018-N-4626-0095
Decoquinate dog, horse FDA-2018-N-4626-0126
Decoquinate/levamisole HCl horse FDA-2018-N-4626-0125
Demecarium bromide dog FDA-2018-N-4626-0028
Desmopressin dog, cat, horse FDA-2018-N-4626-0031
Dexamethasone dog, cat, horse


Diazoxide dog FDA-2018-N-4626-0096
Diclazuril dog, cat, horse FDA-2018-N-4626-0109
Diethylstilbestrol (DES) dog FDA-2018-N-4626-0012
Doxycycline dog, cat, horse FDA-2018-N-4626-0011
Doxycycline/clindamycin dog FDA-2018-N-4626-0116
Edetate disodium dog, cat, horse FDA-2018-N-4626-0170
Enalapril maleate dog, cat FDA-2018-N-4626-0049
Enalapril maleate/furosemide/pimobendan dog, cat FDA-2018-N-4626-0179
Enrofloxacin dog, cat, horse FDA-2018-N-4626-0012
Enrofloxacin/ketoconazole/triamcinolone dog, cat FDA-2018-N-4626-0099
Estrone horse FDA-2018-N-4626-0117
Famciclovir cat FDA-2018-N-4626-0056
Famotidine dog, cat, horse FDA-2018-N-4626-0052
Fenbendazole dog, cat, horse FDA-2018-N-4626-0174
Fenbendazole/ponazuril/praziquantel dog, cat FDA-2018-N-4626-0178
Fenbendazole-praziquantel-pyrantel pamoate dog, cat FDA-2018-N-4626-0182
Fluconazole dog, cat, horse FDA-2018-N-4626-0032
Fludrocortisone acetate dog, cat FDA-2018-N-4626-0159
Flumethasone horse FDA-2018-N-4626-0166
Flunixin horse FDA-2018-N-4626-0025
Fluorouracil dog, horse FDA-2018-N-4626-0171
Flurbiprofen dog, cat FDA-2018-N-4626-0034
Furosemide dog, cat, horse FDA-2018-N-4626-0076
Gabapentin dog, cat, horse FDA-2018-N-4626-0032
Gabapentin/trazodone HCl dog, cat FDA-2018-N-4626-0128
Gentamicin dog, cat FDA-2018-N-4626-0032
Gramicidin/neomycin/nystatin/triamcinolone dog, cat, horse FDA-2018-N-4626-0176
Griseofulvin dog, horse FDA-2018-N-4626-0148 
Guaifenesin horse FDA-2018-N-4626-0028
Hydrocodone bitartrate dog FDA-2018-N-4626-0062
Hydroxyzine HCl dog, cat, horse FDA-2018-N-4626-0115
Idoxuridine cat, horse FDA-2018-N-4626-0024
Isoflupredone acetate horse FDA-2018-N-4626-0012
Isoxsuprine HCl horse FDA-2018-N-4626-0092
Itraconazole horse FDA-2018-N-4626-0011
Itraconazole with DMSO horse FDA-2018-N-4626-0028
Ketoconazole dog, cat, horse FDA-2018-N-4626-0032
Ketoconazole/amikacin sulfate/triamcinolone acetonide dog, cat FDA-2018-N-4626-0156
Ketoconazole/chloramphenicol/triamcinolone dog, cat FDA-2018-N-4626-0131
Ketoconazole/enrofloxacin/triamcinolone cat FDA-2018-N-4626-0084
Ketoconazole/gentamicin/triamcinolone dog, cat FDA-2018-N-4626-0137
Ketoconazole/mupirocin/triamcinolone dog, cat FDA-2018-N-4626-0140
Ketoconazole/ofloxacin/triamcinolone dog, cat FDA-2018-N-4626-0138
L-asparaginase dog, cat FDA-2018-N-4626-0028
Levamisole HCl dog, cat, horse FDA-2018-N-4626-0103
Levetiracetam dog, cat, horse FDA-2018-N-4626-0064
Lomustine dog, cat FDA-2018-N-4626-0067
Magnesium sulfate/tryptophan (L) horse FDA-2018-N-4626-0150
Marbofloxacin dog, cat FDA-2018-N-4626-0070
Mebendazole dog, cat FDA-2018-N-4626-0032
Mebendazole/praziquantel/pyrantel pamoate dog FDA-2018-N-4626-0181
Mechlorethamine HCl dog, cat FDA-2018-N-4626-0105
Meloxicam dog, cat FDA-2018-N-4626-0013
Methazolamide dog, cat FDA-2018-N-4626-0160
Methimazole cat FDA-2018-N-4626-0011
Methocarbamol dog, cat, horse FDA-2018-N-4626-0155
Metoclopramide HCl dog, cat, horse FDA-2018-N-4626-0077
Metronidazole benzoate dog, cat, horse FDA-2018-N-4626-0012
Minocycline HCl dog, cat, horse FDA-2018-N-4626-0124
Mirtazapine dog, cat FDA-2018-N-4626-0013
Misoprostol dog, cat, horse FDA-2018-N-4626-0127
Mitotane dog FDA-2018-N-4626-0144
Mupirocin dog, cat FDA-2018-N-4626-0033
Mycophenolate mofetil dog, cat FDA-2018-N-4626-0153
Neomycin/tetracaine/triamcinolone dog, cat, horse FDA-2018-N-4626-0120
Nitenpyram dog, cat FDA-2018-N-4626-0033
Nitrofurantoin dog, cat FDA-2018-N-4626-0172
Omeprazole dog, cat FDA-2018-N-4626-0145
Omeprazole-aluminum hydroxide-magnesium hydroxide horse FDA-2018-N-4626-0183
Omeprazole/cimetidine horse FDA-2018-N-4626-0158
Ondansetron HCl dog, cat FDA-2018-N-4626-0162
Oseltamivir dog FDA-2018-N-4626-0033
Oxantel pamoate dog, cat FDA-2018-N-4626-0033
Oxantel pamoate/praziquantel/pyrantel pamoate dog, cat FDA-2018-N-4626-0130
Paromomycin sulfate dog, cat FDA-2018-N-4626-0184
Penicillamine dog, cat FDA-2018-N-4626-0141
Pentoxifylline dog, cat, horse FDA-2018-N-4626-0119
Pergolide mesylate horse FDA-2018-N-4626-0129
Phenobarbital dog. cat FDA-2018-N-4626-0080
Phenoxybenzamine HCl dog, cat FDA-2018-N-4626-0068
Phenylbutazone horse FDA-2018-N-4626-0028
Phenylpropanolamine dog, cat FDA-2018-N-4626-0087
Pimobendan dog, cat FDA-2018-N-4626-0013
Piroxicam dog, cat, horse FDA-2018-N-4626-0068
Ponazuril dog, cat, horse FDA-2018-N-4626-0012
Potassium bromide dog, horse FDA-2018-N-4626-0073
Potassium chloride dog, cat FDA-2018-N-4626-0118
Praziquantel dog, cat, horse FDA-2018-N-4626-0033
Praziquantel/pyrantel pamoate dog, cat FDA-2018-N-4626-0133
Prazosin dog, cat FDA-2018-N-4626-0033
Prednisolone dog, cat, horse FDA-2018-N-4626-0033
Prednisone dog FDA-2018-N-4626-0075
Pregabalin dog, cat FDA-2018-N-4626-0089
Protirelin acetate (thyrotropin-releasing hormone) horse FDA-2018-N-4626-0047
Pyrantel pamoate dog, cat, horse FDA-2018-N-4626-0033
Pyrimethamine dog, cat, horse FDA-2018-N-4626-0078
Pyrimethamine/sulfadiazine horse FDA-2018-N-4626-0151
Pyrimethamine/sulfadiazine/folic acid horse FDA-2018-N-4626-0180
Reserpine horse FDA-2018-N-4626-0012
Rifampin dog, cat FDA-2018-N-4626-0061
Romifidine HCl horse FDA-2018-N-4626-0113
Ronidazole dog, cat FDA-2018-N-4626-0142
Secnidazole dog, cat FDA-2018-N-4626-0033
Selegiline HCl dog, cat FDA-2018-N-4626-0164
Sildenafil citrate dog, cat FDA-2018-N-4626-0072
Sodium bromide dog FDA-2018-N-4626-0088
Spironolactone dog, cat FDA-2018-N-4626-0143
Stanozolol dog, cat FDA-2018-N-4626-0081
Sucralfate dog, cat, horse FDA-2018-N-4626-0097
Tacrolimus dog FDA-2018-N-4626-0023
Telmisartan dog, cat FDA-2018-N-4626-0167
Terbinafine HCl dog, cat FDA-2018-N-4626-0165
Terbutaline sulfate dog, cat FDA-2018-N-4626-0168
Theophylline dog, cat FDA-2018-N-4626-0033
Thyrotropin releasing hormone horse FDA-2018-N-4626-0084
Toceranib phosphate dog, cat FDA-2018-N-4626-0079
Tolazoline HCl horse FDA-2018-N-4626-0028
Toltrazuril dog, cat, horse FDA-2018-N-4626-0012
Toltrazuril/DMSO horse FDA-2018-N-4626-0157
Tramadol dog, cat, horse FDA-2018-N-4626-0012
Trazodone HCl dog, cat, horse FDA-2018-N-4626-0110
Triamcinolone acetonide dog, cat, horse FDA-2018-N-4626-0033
Trichlormethiazide/dexamethasone horse FDA-2018-N-4626-0149
Trilostane dog, cat FDA-2018-N-4626-0154
Tryptophan (L)/thiamine HCl horse FDA-2018-N-4626-0163
Tryptophan/thiamine HCl/folic acid/niacin horse FDA-2018-N-4626-0161
Tylosin dog, cat FDA-2018-N-4626-0071
Ursodiol dog, cat, horse FDA-2018-N-4626-0033
Voriconazole dog, cat, horse FDA-2018-N-4626-0122
Xylazine horse FDA-2018-N-4626-0028
Yohimbine HCl dog, cat, horse FDA-2018-N-4626-0013
Zonisamide dog, cat FDA-2018-N-4626-0057


Bulk Drug Substance (BDS) Species Nomination
Aluminum hydroxide rodents, small mammals FDA-2018-N-4626-0048
Amikacin bird, reptile, snake, turtle/tortoise, guinea pig, chinchilla, hamster, rat, mouse, fish FDA-2018-N-4626-0032
Amitriptyline HCl bird FDA-2018-N-4626-0018
Apomorphine HCl ferret FDA-2018-N-4626-0020
Atipamezole African hoof stock, camelids, carnivores, captive zoo species FDA-2018-N-4626-0054
Azaperone African hoof stock, camelids, minor carnivore spp., and small mammals FDA-2018-N-4626-0013
Azithromycin guinea pigs, birds, captive exotic and zoo species FDA-2018-N-4626-0050
Azithromycin/rifampin bird FDA-2018-N-4626-0090
Buprenorphine large cats, bears, small exotic mammal pets, rodents, ferrets, primates, marine mammals, large zoo animals, avian, reptiles, small animals, various exotic and zoo species  FDA-2018-N-4626-0014
Butorphanol/azaperone/medetomidine (BAM) African hoof stock, camelids, carnivores, feral horses, and small mammals FDA-2018-N-4626-0085
Butorphanol tartrate African hoof stock, elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species  FDA-2018-N-4626-0013
Calcium glubionate reptiles, birds FDA-2018-N-4626-0152
Chlorambucil ferret FDA-2018-N-4626-0123
Chloramphenicol avian, small mammals FDA-2018-N-4626-0039
Cisapride rodents, other small mammals and marine mammals FDA-2018-N-4626-0021
Clindamycin HCl avian, ferret, reptiles, assorted exotic and zoo species FDA-2018-N-4626-0042
Clomipramine HCl avian FDA-2018-N-4626-0058
Cyclophosphamide ferret FDA-2018-N-4626-0063
Dexamethasone ferret, rodents

Diazoxide ferret, guinea pig, small mammals FDA-2018-N-4626-0096
Doxycycline rodents, small mammals, birds, reptiles, other exotic and zoo animals FDA-2018-N-4626-0015
Enalapril maleate ferret, bird FDA-2018-N-4626-0049
Enrofloxacin birds (raptors, Psittaciformes, pet birds, etc.), ferrets, rodents, and small mammals, reptiles, assorted exotic and zoo species FDA-2018-N-4626-0016
Famotidine small animal FDA-2018-N-4626-0052
Fenbendazole small mammals, assorted exotic and captive zoo species FDA-2018-N-4626-0174
Fluconazole bird, exotics, small mammal, exotics, captive zoo species, reptile FDA-2018-N-4626-0032
Flunixin ferrets, rodents, chinchillas, small mammals, zoo, exotic, and wildlife species FDA-2018-N-4626-0025
Furosemide ferret, small mammals, bird, reptile FDA-2018-N-4626-0076
Gabapentin avian, exotics, zoo animals FDA-2018-N-4626-0051
Griseofulvin rodents, small mammals, captive exotic and zoo species FDA-2018-N-4626-0148
Hydroxyzine HCl bird, ferret FDA-2018-N-4626-0115
Isoxsuprine HCl bird FDA-2018-N-4626-0092
Ketoconazole bird, exotics, zoo species, rodents, reptiles, small animals FDA-2018-N-4626-0032
Marbofloxacin avian, reptiles, assorted captive exotic and zoo species FDA-2018-N-4626-0070
Meloxicam birds, rats, mice, gerbils, hamsters, other small mammals, marine mammals, large zoo animals and captive wildlife, ferrets, reptiles, assorted exotic and zoo animals FDA-2018-N-4626-0029
Metoclopramide HCl small mammals FDA-2018-N-4626-0077
Metronidazole benzoate small mammals, exotic species FDA-2018-N-4626-0012
Metronidazole minor species: avian or other wildlife species FDA-2018-N-4626-0084
Oxantel pamoate/praziquantel/pyrantel pamoate ferret, reptile FDA-2018-N-4626-0130
Paromomycin sulfate elephant, reptile FDA-2018-N-4626-0184
Penicillamine avian FDA-2018-N-4626-0141
Piroxicam small mammals FDA-2018-N-4626-0068
Ponazuril small mammals, reptiles, assorted exotic species FDA-2018-N-4626-0012
Praziquantel camelids, avian, rodents, small mammals, ferrets, snakes, amphibians, tortoises

captive exotic and zoo species, small mammals, avian, rodents

Praziquantel/pyrantel pamoate ferret, reptile FDA-2018-N-4626-0133
Prednisolone avian, rodents, small mammals, reptiles, other exotic and zoo species FDA-2018-N-4626-0074
Prednisone avian, rodents, small mammals FDA-2018-N-4626-0075
Pyrantel pamoate donkeys, llama, avian, rodents, small mammals, reptiles FDA-2018-N-4626-0033
Pyrimethamine avian, exotics FDA-2018-N-4626-0078
Sildenafil citrate assorted exotic and captive zoo species FDA-2018-N-4626-0072
Sodium chloride/edetate disodium captive marine mammals FDA-2018-N-4626-0028
Stanozolol small mammals FDA-2018-N-4626-0081
Terbinafine HCl avian FDA-2018-N-4626-0165
Toltrazuril small mammals, reptiles, camelids, assorted large and small exotic/zoo species FDA-2018-N-4626-0012
Tramadol HCl avian, sea turtle, ungulates, small mammals, reptiles, captive zoo and exotic species FDA-2018-N-4626-0012
Trilostane small mammals FDA-2018-N-4626-0154
Tylosin ferrets, exotic and captive zoo species FDA-2018-N-4626-0071
Ursodiol bird FDA-2018-N-4626-0044
Voriconazole bird FDA-2018-N-4626-0122
Xylazine African hoof stock, zoo species including camelids, minor carnivore spp., goats, and small mammals FDA-2018-N-4626-0028
Yohimbine HCl small mammals, zoo/captive bird species, pet birds, captive swine species, llama, large and small exotic/zoo species FDA-2018-N-4626-0013


Bulk Drug Substance (BDS) Species Nomination
Alpha-chloralose Sandhill Cranes CVM-initiated internal review
Atipamezole North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife FDA-2018-N-4626-0054
Azaperone North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat species FDA-2018-N-4626-0013
Buprenorphine wildlife species FDA-2018-N-4626-0014
Butorphanol/azaperone/medetomidine (BAM) North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and small mammals FDA-2018-N-4626-0085
Butorphanol tartrate North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0013
Xylazine North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0028
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