U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Compliance & Enforcement
  4. Unapproved Animal Drugs
  5. Animal Drug Compounding
  6. Bulk Drug Substances Currently Under Review
  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) Species Nomination
Acepromazine maleate dog, cat, horse FDA-2018-N-4626-0114
Acetyl-D-glucosamine dog, horse FDA-2018-N-4626-0104
Adenosine monophosphate horse FDA-2018-N-4626-0825
Aluminum hydroxide dog, cat FDA-2018-N-4626-0048
Amantadine dog, horse FDA-2018-N-4626-0136
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
Ammonium sulfate horse FDA-2018-N-4626-0822
Amitriptyline HCl dog, cat FDA-2018-N-4626-0018
Apomorphine HCl dog FDA-2018-N-4626-0020
FDA-2018-N-4626-0147
Atenolol dog, cat FDA-2018-N-4626-0041
Atipamezole horse FDA-2018-N-4626-0054
FDA-2018-N-4626-0801
Atovaquone dog, cat FDA-2018-N-4626-0146
Atropine horse FDA-2018-N-4626-0752
Azaperone horse FDA-2018-N-4626-0013
Azithromycin/rifampin dog, cat, horse FDA-2018-N-4626-0090
Benazepril HCl dog, cat FDA-2018-N-4626-0091
Benazepril HCl/furosemide/pimobendan dog, cat FDA-2018-N-4626-0727
Budesonide dog, cat FDA-2018-N-4626-0045
FDA-2018-N-4626-0725
Butorphanol tartrate dog, horse FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Calcium chloride/magnesium chloride/potassium chloride/sodium acetate/dextrose horse FDA-2018-N-4626-0823
Cephalexin dog, cat FDA-2018-N-4626-0478
Cetirizine HCl dog, cat, horse FDA-2018-N-4626-0111
Chlorambucil dog, cat FDA-2018-N-4626-0123
FDA-2018-N-4626-0725
Chloramphenicol/betamethasone/ketoconazole dog, cat FDA-2018-N-4626-0552
Chlorpheniramine maleate dog, cat FDA-2018-N-4626-0139
Cidofovir dog, cat FDA-2018-N-4626-0032
FDA-2018-N-4626-0040
Ciprofloxacin HCl dog, cat FDA-2018-N-4626-0652
Cisapride dog, cat, horse FDA-2018-N-4626-0021
FDA-2018-N-4626-0655
FDA-2018-N-4626-0759
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
Clindamycin HCl dog, cat FDA-2018-N-4626-0042
FDA-2018-N-4626-0583
Cyclophosphamide dog, cat, horse FDA-2018-N-4626-0063
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
Demecarium bromide dog FDA-2018-N-4626-0028
Desmopressin dog, cat, horse FDA-2018-N-4626-0031
Dexamethasone dog, cat, horse

horse
FDA-2018-N-4626-0082

FDA-2018-N-4626-0098
Diazoxide dog FDA-2018-N-4626-0096
Diclazuril dog, cat, horse FDA-2018-N-4626-0109
Diclazuril/levamisole HCl/vitamin E acetate horse FDA-2018-N-4626-0849
Diclofenac sodium dog, cat, horse FDA-2018-N-4626-0538
Diethylstilbestrol (DES) dog FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Diltiazem dog, cat FDA-2018-N-4626-0731
Dimercaptosuccinic acid (DMSA) dog, cat FDA-2018-N-4626-0714
Dimethyl sulfoxide (DMSO) dog, horse FDA-2018-N-4626-0618
Doxycycline dog, cat, horse FDA-2018-N-4626-0011
FDA-2018-N-4626-0015
FDA-2018-N-4626-0812
FDA-2018-N-4626-0960
Doxycycline/clindamycin dog FDA-2018-N-4626-0116
Edetate calcium disodium dog, cat, horse FDA-2018-N-4626-0482
Enalapril maleate dog, cat FDA-2018-N-4626-0049
Enalapril maleate/furosemide/pimobendan dog, cat FDA-2018-N-4626-0179
Enrofloxacin/itraconazole/triamcinolone dog, cat FDA-2018-N-4626-0627
Enrofloxacin/miconazole/triamcinolone dog, cat FDA-2018-N-4626-0625
Ertugliflozin horse FDA-2018-N-4626-0737
Erythromycin ethylsuccinate dog, cat, horse FDA-2018-N-4626-0479
Estrone horse FDA-2018-N-4626-0117
Fenbendazole/ponazuril/praziquantel dog, cat FDA-2018-N-4626-0178
Fipronil dog, cat FDA-2018-N-4626-0637
Fluconazole dog, cat, horse FDA-2018-N-4626-0032
FDA-2018-N-4626-0059
Fludrocortisone acetate dog, cat FDA-2018-N-4626-0159
Flurbiprofen horse FDA-2018-N-4626-0654
Fluorouracil dog, horse FDA-2018-N-4626-0171
Flurbiprofen horse FDA-2018-N-4626-0654
Fomepizole dog, cat FDA-2018-N-4626-0656
FDA-2018-N-4626-0725
Furosemide dog, cat, horse FDA-2018-N-4626-0076
Gabapentin dog, cat, horse FDA-2018-N-4626-0032
FDA-2018-N-4626-0051
FDA-2018-N-4626-0084
Gabapentin/trazodone HCl dog, cat FDA-2018-N-4626-0128
FDA-2018-N-4626-0638
GC376 cat FDA-2018-N-4626-0969
Glycopyrrolate dog, cat, horse FDA-2018-N-4626-0584
Gramicidin/neomycin/nystatin/triamcinolone dog, cat, horse FDA-2018-N-4626-0176
Griseofulvin dog, horse FDA-2018-N-4626-0148 
GS-441524  cat FDA-2018-N-4626-0953
FDA-2018-N-4626-0954
FDA-2018-N-4626-0956
Guaifenesin horse FDA-2018-N-4626-0028
Guanabenz acetate horse FDA-2018-N-4626-0742
Hydrocodone bitartrate dog FDA-2018-N-4626-0062
FDA-2018-N-4626-0592
Hydrocodone homatropine dog FDA-2018-N-4626-0593
Idoxuridine cat, horse FDA-2018-N-4626-0024
Imipenem/cilastatin/ketoconazole/triamcinolone dog, cat FDA-2018-N-4626-0555
Iodine horse FDA-2018-N-4626-0824
Isoxsuprine HCl horse FDA-2018-N-4626-0092
Itraconazole with DMSO horse FDA-2018-N-4626-0028
Kanamycin/bismuth subcarbonate/kaolin dog, cat FDA-2018-N-4626-0630
Ketoconazole dog, cat, horse FDA-2018-N-4626-0032
FDA-2018-N-4626-0035
Ketoconazole/amikacin/triamcinolone dog, cat FDA-2018-N-4626-0156
FDA-2018-N-4626-0551
Ketoconazole/enrofloxacin/betamethasone dog, cat FDA-2018-N-4626-0628
Ketoconazole/enrofloxacin/mupirocin/triamcinolone dog, cat FDA-2018-N-4626-0626
Ketoconazole/enrofloxacin/triamcinolone dog, cat FDA-2018-N-4626-0084
FDA-2018-N-4626-0099
FDA-2018-N-4626-0553
Ketoconazole/marbofloxacin/polymyxin B/triamcinolone dog, cat FDA-2018-N-4626-0624
Ketoconazole/marbofloxacin/triamcinolone dog, cat FDA-2018-N-4626-0623
Ketoconazole/mupirocin/silver sulfadiazine/triamcinolone dog, cat, horse FDA-2018-N-4626-0622
Ketoconazole/mupirocin/triamcinolone dog, cat, horse FDA-2018-N-4626-0590
Ketoconazole/ polymyxin B/triamcinolone dog, cat FDA-2018-N-4626-0621
Ketoconazole/triamcinolone dog, cat FDA-2018-N-4626-0589
L-asparaginase dog, cat FDA-2018-N-4626-0028
FDA-2018-N-4626-0032
FDA-2018-N-4626-0725
Lapatinib dog, cat FDA-2018-N-4626-0726
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
Mechlorethamine HCl dog, cat FDA-2018-N-4626-0105
FDA-2018-N-4626-0725
Meclofenamate sodium horse FDA-2018-N-4626-0715
Meloxicam dog, cat


dog, cat, horse
FDA-2018-N-4626-0013
FDA-2018-N-4626-0029
FDA-2018-N-4626-0046
FDA-2018-N-4626-0585
Melphalan dog, cat FDA-2018-N-4626-0719
FDA-2018-N-4626-0753
Methazolamide dog, cat FDA-2018-N-4626-0160
Methylprednisolone dog, cat, horse FDA-2018-N-4626-0586
Metoclopramide HCl dog, cat, horse FDA-2018-N-4626-0077
Mibolerone dog FDA-2018-N-4626-0725
Minocycline HCl dog, cat, horse FDA-2018-N-4626-0124
Misoprostol dog, cat, horse FDA-2018-N-4626-0127
Mitomycin dog, horse FDA-2018-N-4626-0738
Mupirocin dog, cat FDA-2018-N-4626-0033
Mycophenolate mofetil dog, cat FDA-2018-N-4626-0153
Nalbuphine dog, cat, horse FDA-2018-N-4626-0712
Nalbuphine HCl/azaperone/medetomidine HCl horse FDA-2018-N-4626-0653
Naltrexone HCl horse FDA-2018-N-4626-0733
Nitrofurantoin dog, cat FDA-2018-N-4626-0172
Oseltamivir dog FDA-2018-N-4626-0033
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
Phenobarbital dog. cat FDA-2018-N-4626-0080
FDA-2018-N-4626-0591
Phenoxybenzamine HCl dog, cat FDA-2018-N-4626-0068
FDA-2018-N-4626-0658
Piroxicam dog, cat, horse FDA-2018-N-4626-0060
Ponazuril dog, cat, horse FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
FDA-2018-N-4626-0073
Potassium bromide dog, horse FDA-2018-N-4626-0022
Prednisolone dog, cat, horse FDA-2018-N-4626-0033
FDA-2018-N-4626-0036
FDA-2018-N-4626-0074
Prednisone dog FDA-2018-N-4626-0075
Procarbazine HCl dog, cat FDA-2018-N-4626-0670
FDA-2018-N-4626-0725
Progesterone horse FDA-2018-N-4626-0815
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
Remdesivir cat FDA-2018-N-4626-0966
Riboflavin dog, cat, horse FDA-2018-N-4626-0722
Rifampin dog, cat FDA-2018-N-4626-0061
Romifidine HCl horse FDA-2018-N-4626-0113
Ronidazole dog, cat FDA-2018-N-4626-0142
FDA-2018-N-4626-0582
Secnidazole dog, cat FDA-2018-N-4626-0033
FDA-2018-N-4626-0173
Sildenafil citrate dog, cat FDA-2018-N-4626-0072
Sirolimus dog, cat FDA-2018-N-4626-0674
Sodium carboxymethylcellulose horse FDA-2018-N-4626-0741
Sotalol HCl dog, cat FDA-2018-N-4626-0813
Spironolactone dog, cat FDA-2018-N-4626-0143
Stanozolol dog, cat
dog, cat, horse
FDA-2018-N-4626-0757
FDA-2018-N-4626-0581
Tacrolimus dog FDA-2018-N-4626-0023
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
FDA-2018-N-4626-0037
Ticarcillin disodium/clavulanate potassium horse FDA-2018-N-4626-0756
Tissue plasminogen activator (TPA) dog, cat FDA-2018-N-4626-0701
Tolazoline HCl horse FDA-2018-N-4626-0028
Toltrazuril dog, cat, horse FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Toltrazuril/DMSO horse FDA-2018-N-4626-0157
FDA-2018-N-4626-0847
Tramadol dog, cat, horse FDA-2018-N-4626-0012
FDA-2018-N-4626-0033
FDA-2018-N-4626-0065
Trazodone HCl dog, cat, horse FDA-2018-N-4626-0110
Triamcinolone acetonide dog, cat, horse FDA-2018-N-4626-0033
FDA-2018-N-4626-0094
FDA-2018-N-4626-0657
Trichlormethiazide/dexamethasone horse FDA-2018-N-4626-0149
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
FDA-2018-N-4626-0044
Vitamin A, D, E dog, cat FDA-2018-N-4626-0723
Voriconazole dog, cat, horse

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

FDA-2018-N-4626-0701
Yohimbine HCl dog, cat, horse FDA-2018-N-4626-0013
Zonisamide dog, cat FDA-2018-N-4626-0057

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS) Species Nomination
Aluminum hydroxide rodents, small mammals FDA-2018-N-4626-0048
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
FDA-2018-N-4626-0801
Azaperone African hoof stock, camelids, minor carnivore spp., and small mammals FDA-2018-N-4626-0013
Azithromycin/rifampin bird FDA-2018-N-4626-0090
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
Carprofen non-human primates FDA-2018-N-4626-0477
Cephalexin non-human primates FDA-2018-N-4626-0478
Chlorambucil ferret FDA-2018-N-4626-0123
Cisapride rodents, other small mammals, and captive marine mammals FDA-2018-N-4626-0021
FDA-2018-N-4626-0655
FDA-2018-N-4626-0759
Clindamycin HCl avian, ferret, reptiles, assorted exotic and zoo species


avian
FDA-2018-N-4626-0042

FDA-2018-N-4626-0583
Cyclophosphamide ferret FDA-2018-N-4626-0063
Dexamethasone ferret, rodents

camelids
FDA-2018-N-4626-0082
FDA-2018-N-4626-0098
Diazoxide ferret, guinea pig, small mammals FDA-2018-N-4626-0096
Dimercaptosuccinic acid (DMSA) avian FDA-2018-N-4626-0714
Doxycycline rodents, 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 maleate ferret, bird FDA-2018-N-4626-0049
FDA-2018-N-4626-0084
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
FDA-2018-N-4626-0059
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
Isoxsuprine HCl bird FDA-2018-N-4626-0092
Ketoconazole bird, exotics, zoo species, rodents, reptiles, small animals FDA-2018-N-4626-0032
FDA-2018-N-4626-0035
Ketoconazole/mupirocin/triamcinolone avian, ferrets, small mammals FDA-2018-N-4626-0590
L-asparaginase ferrets FDA-2018-N-4626-0725
Marbofloxacin avian, reptiles, assorted captive exotic and zoo species FDA-2018-N-4626-0070
Medetomidine/ketamine African hoof stock, camelids, carnivores, feral horses, and small mammals FDA-2018-N-4626-0189
Meloxicam birds, 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 HCl small mammals FDA-2018-N-4626-0077
Nalbuphine HCl/ azaperone/medetomidine HCl African hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammals FDA-2018-N-4626-0653
Naltrexone African hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammals FDA-2018-N-4626-0733
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-4626-0060
Ponazuril small mammals, reptiles, assorted exotic species FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
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
Pyrimethamine avian, exotics FDA-2018-N-4626-0078
Sildenafil citrate assorted exotic and captive zoo species FDA-2018-N-4626-0072
Stanozolol small mammals


avian
FDA-2018-N-4626-0081

FDA-2018-N-4626-0581
Terbinafine HCl avian


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

FDA-2018-N-4626-0662
Toltrazuril small mammals, reptiles, camelids, assorted large and small exotic/zoo species FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
Tramadol HCl avian, sea turtle, ungulates, small mammals, reptiles, captive zoo and exotic species FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
FDA-2018-N-4626-0033
FDA-2018-N-4626-0065
Tylosin ferrets, exotic and captive zoo species FDA-2018-N-4626-0071
Ursodiol bird FDA-2018-N-4626-0044
Vitamin A, D, E bird, gecko FDA-2018-N-4626-0723
Voriconazole bird FDA-2018-N-4626-0122
Yohimbine HCl small mammals, zoo/captive bird species, pet birds, llama, large and small exotic/zoo species FDA-2018-N-4626-0013

FOOD-PRODUCING ANIMALS (ANTIDOTES)

Bulk Drug Substance (BDS) Species Nomination
Methylene blue cattle, sheep, goats FDA-2018-N-4626-0730

FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)

Bulk Drug Substance (BDS) Species Nomination
Atipamezole North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife FDA-2018-N-4626-0054
FDA-2018-N-4626-0801
Azaperone North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat species FDA-2018-N-4626-0013
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
Medetomidine HCl/ketamine HCl North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0189
Nalbuphine HCl/ azaperone/medetomidine HCl North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0653
Naltrexone HCl North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0733
 
Back to Top