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  1. Animal Drug Compounding

Bulk Drug Substances Reviewed and Not Listed

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

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

Bulk Drug Substances Currently Under Review


FDA reviewed these bulk drug substances and is not including them on either 1) The List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals, or 2) The List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species. Therefore, these bulk drug substances are not covered by the enforcement discretion policy described in Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances. These substances may be nominated again for re-evaluation by FDA using the nomination procedure described in the appendix to GFI #256.

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

Bulk Drug Substance (BDS) Species Dosage form(s) Strength/concentration Reason
Altrenogest
(11/15/2023)
horse any any Altrenogest is not typically needed urgently and FDA- approved altrenogest products can be used as labeled, or in an extralabel manner under 21 CFR Part 530, until a patient-specific prescription can be filled, if needed.
Amikacin
(3/8/2023)
dog, cat






dog, cat, horse
otic ointment

otic solutions




injectable solution
0.67% - 5%

0.67% - 5%




200mg/mL
There are several FDA-approved otic products that could be used as labeled in an urgent situation. If a compounded preparation of amikacin is needed, a patient-specific prescription should suffice. 

If an injectable solution is needed for urgent treatment, Amiglyde-V® (NADA 127-892) or the amikacin injectable solutions FDA-approved for use in humans can be used in an extralabel manner under 21 CFR Part 530.
Amlodipine besylate
(1/19/2023)
dog, cat oral solution

oral suspension

capsule

transdermal gel

oral paste

tablet

soft chewable treat
any concentration other than 1.25 mg/ml
any concentration other than 1.25 mg/ml
any strength other than 0.625 mg
any concentration

any concentration

any strength other than 0.625 mg
any strength 
Insufficient rationale was provided for the need for transdermal gel, oral paste, and soft chewable treat dosage forms on an urgent basis and specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock; insufficient rationale was provided for the needs of strengths other than 0.625 mg for capsules and tablets or for concentrations other than 1.25 mg/mL for oral solutions and oral suspensions as office stock to be used on an urgent basis.  
Amoxicillin
(10/10/23)
dog, cat oral suspension any There are FDA-approved products that can be used as labeled or in an extralabel manner under 21 CFR Part 530 to treat  cats and dogs in an urgent situation, until a patient-specific prescription can be filled, if needed.
Amoxicillin/ clavulanate 
(10/10/23)
dog, cat oral suspension any There are marketed FDA-approved tablets, chewable tablets, and oral suspensions containing the same active ingredient that can be used as labeled or in an extralabel manner under 21 CFR Part 530 for urgent treatment in cats and dogs, until a patient-specific prescription can be obtained, if needed.
Apomorphine hydrochloride
(8/11/2016)
dog subconjunctival solution
subconjunctival tablets

3.125-6.25 mg/mL
6.25 mg

Clevor (ropinirole ophthalmic solution) 30 mg/mL (NADA 141-534) is now FDA-approved for induction of emesis in dogs.
Azithromycin
(4/20/2023)
dog, cat, horse




dog, cat
capsule
liquid
tablet, flavored or unflavored
otic
ointment/solution

oral paste
oral powder
mucoadhesive paste
periodontal gel
soft chew treat
10 – 500 mg
1 – 250 mg/ml
25 – 50 mg
225 mg
0.5 – 5%

20 – 360 mg/ml
1 gm/dose
100 mg/ml
8.5%
25 – 200 mg
There are many FDA-approved and marketed antibiotics that can be used in an urgent situation in dogs, cats, and horses. If a compounded preparation of azithromycin is needed, a patient specific prescription should suffice.
Betamethasone dipropionate
(3/29/2023)
dog, cat, horse otic ointment 
otic suspension
0.05% - 1%
0.05% - 1%
There are several FDA-approved and marketed steroid-containing otic products, with and without antibiotics and/or antifungals, labeled for use in dogs and cats, which can also be used in an extralabel manner in horses. If a compounded preparation of betamethasone is needed, a patient-specific prescription should suffice.
Buprenorphine 
HCl
(4/24/2023)
dog, horse


dog, cat, horse
injectable 
polymeric matrix 
solution

injectable solution

oral solution
any



any

any
FDA-approved injectable solution is available as labeled for administration or for extralabel use under 21 CFR Part 530 for injection or oral administration. Specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock.
Carprofen
(12/19/2023)
dog any any FDA-approved animal drugs (carprofen and other non-steroidal anti-inflammatory drugs) can be used as labeled or in an extralabel manner under 21 CFR Part 530 to treat the same conditions. Specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock.
Chloramphenicol
(2/28/2023)
horse powder for oral administration

topical ointment

ophthalmic solution or ointment
10 g

1%

1%
Oral suspension and paste are listed on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals for use in horses. For topical and ophthalmic use, there are FDA-approved human and animal drug products available for initial empirical treatment, there are human health risks associated with administration of chloramphenicol, and in instances where chloramphenicol may be indicated based on culture and sensitivity results, this preparation can be compounded on an individual patient basis and is not needed for urgent or immediate treatment to prevent animal suffering or death.
Chloramphenicol
(2/28/2023)
dog, cat capsule

oral suspension

otic ointment/solution/suspension
30 - 1000 mg

125 - 500 mg/mL

1 - 2%
There are FDA-approved animal drug products available for initial empirical treatment. In instances where chloramphenicol may be indicated based on culture and sensitivity results, this preparation can be compounded on an individual patient basis and is not needed for urgent or immediate treatment to prevent animal suffering or death.
Cimetidine
(2/8/2024)
dog, cat, horse any any There are marketed FDA-approved human drugs containing cimetidine in dosage forms that can be used in an extralabel manner under 21 CFR Part 530 to treat dogs, cats and horses in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Clenbuterol
(6/6/2023)
horse oral solution any Ventipulmin Syrup, NADA 140-973, is FDA-approved and can be used as labeled, or in an extralabel manner under 21 CFR Part 530, in horses in an urgent situation, until a patient-specific prescription can be filled, if needed.
Clomipramine HCl
(7/5/2023)
dog, cat capsule
oral suspension
soft chew treat
tablet (flavored or unflavored)
transdermal gel
any Clomipramine should not be needed for urgent treatment to avoid animal suffering or death. There are FDA-approved formulations of clomipramine that can be used as labeled or in an extralabel manner under 21 CFR Part 530. If clomipramine is needed in a formulation that is not FDA-approved, a patient-specific prescription for compounded clomipramine should be sufficient.
Clopidogrel
(11/15/2023)
dog, cat











horse
transdermal gel
soft chewable treat










oral suspension
any
any










any
Oral suspension, tablets, and capsules are on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals and should be sufficient for urgent use. If a specialty formulation such as transdermal gel or soft chewable treat is deemed necessary by a veterinarian, it can be obtained via a patient-specific prescription.

If clopidogrel is needed urgently in horses, tablets FDA-approved for use in humans could be used in an extralabel manner under 21 CFR Part 530 until a patient-specific prescription could be obtained, if needed.
Corticotropin (ACTH)
(1/19/2023)
dog, cat, horse injectable 40 & 80 units/ml There are FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530 in dogs, cats, and horses. There is lack of supporting information that this drug is needed on an urgent basis in these species.
Cyclosporine
(11/30/2023)
dog, cat, horse ophthalmic gel

ophthalmic solution

ophthalmic suspension
any

any concentration other than 1 – 2%
any
Compounded cyclosporine ophthalmic ointment and solution 1-2% for use in dogs, cats, and horses are on the List of Bulk Drug Substances for Compounding Office Stock for Use in Nonfood-Producing Animals. An FDA-approved cyclosporine ophthalmic ointment 0.2% is also available. These should be sufficient for urgent use until a patient-specific prescription for another dosage form or concentration can be filled, if needed.
Decoquinate/ levamisole
(1/31/2024)
horse any any FDA-approved animal drugs can be used as labeled to treat the nominated condition. A compounded formulation of decoquinate/levamisole can be obtained via patient-specific prescription if deemed necessary by the veterinarian.
Dexamethasone
(9/21/2016)
horse oral powder 10 mg/packet FDA-approved human oral tablets can be used to compound 10 mg oral powder doses.
Dipyrone
(10/5/2016)
Shar-Pei and Shar-Pei mixed breed dogs solution for injection 250 and 500 mg/ml The FDA-approved drug product Zimeta (dipyrone 500 mg/mL) (NADA 141-513) can be used in an extralabel manner under 21 CFR part 530.
Edetate disodium
(12/14/2023)
dog, cat, horse any ophthalmic dosage form any Insufficient information was submitted to support the need for urgent use in these species for the conditions nominated. There is a lack of supporting information in the scientific literature that this drug is needed as office stock for urgent or immediate treatment of these species. If a compounded preparation of ophthalmic edetate disodium is needed, a patient-specific prescription should suffice.
Enrofloxacin
(4/11/2024)
dog, cat, horse any any There are marketed FDA-approved animal drugs containing enrofloxacin, in the same or similar dosage forms, that can be used either as labeled or in an extralabel manner under 21 CFR Part 530 in an urgent situation. 
Famciclovir
(6/6/2023)
cat capsules
oral paste
oral powder
soft chew treats
unflavored tablets
flavored quadrisected tablet

oral suspension
any






any, other than 25-325 mg/ml
Famciclovir in an oral suspension (25 - 325 mg/ml) for cats is on the List of Bulk Drug 
Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. In 
addition, FDA-approved famciclovir tablets can be used in an extralabel manner under 21 CFR 
Part 530 to treat the same conditions in cats.
Famotidine
(2/8/2024)
dog, cat, horse any any There are marketed FDA-approved human drugs containing famotidine in dosage forms that can be used in an extralabel manner under 21 CFR Part 530 to treat dogs, cats, and horses in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Fenbendazole
(11/20/2023)
dog, cat, horse any any There are a number of FDA-approved fenbendazole products that could be used as labeled or in an extralabel manner under 21 CFR Part 530. Additionally, there are several FDA-approved products with different active ingredients labeled for the same indications that could be used in place of fenbendazole if deemed appropriate by a veterinarian. If a different dosage form and/or strength/concentration of fenbendazole is deemed necessary by a veterinarian, a patient-specific prescription should suffice.
Fenbendazole/praziquantel/pyrantel pamoate
(11/20/2023)
dog, cat any any There are a number of FDA-approved fenbendazole, praziquantel, and pyrantel pamoate products that could be used as labeled or in an extralabel manner under 21 CFR Part 530 for urgent treatment in cats and dogs. Additionally, there are several FDA-approved products with different active ingredients labeled for the same indications that could be used if deemed appropriate by a veterinarian. If a combination fenbendazole/praziquantel/pyrantel pamoate product is deemed necessary by a veterinarian, a patient-specific prescription should suffice.
Flumethasone
(4/18/2023)
horse injectable solution any FDA-approved Bimasone (ANADA 200-612) can be used in horses in an urgent situation until a patient-specific prescription for another dosage form can be filled, if needed.
Flunixin
(10/31/2023)
horse any any FDA-approved flunixin meglumine products can be used as labeled or in an extralabel manner under 21 CFR Part 530 to treat the same conditions in horses in an urgent situation, until a patient-specific prescription can be filled, if needed.
Fluoxetine
(12/21/2022)
dog, cat, horse capsule, tablet, soft chew treat, suspension, paste, transdermal gel all strengths and concentrations Fluoxetine may take several weeks to achieve a therapeutic effect and is not needed for urgent treatment to avoid animal suffering or death. Reconcile® (fluoxetine), NADA 141-272, is approved for use in dogs and there are alternative medications FDA-approved for use in animals that could be used to treat some of the nominated conditions. Additionally, fluoxetine products FDA-approved for use in humans can be used in an extralabel manner if deemed appropriate by a veterinarian as could several other alternative drugs FDA-approved for use in humans. If fluoxetine is needed in a formulation that is not FDA-approved, a patient-specific prescription for compounded fluoxetine should be sufficient.
Flurbiprofen
(3/29/2023)
dog, cat ophthalmic suspension 0.04% FDA-approved flurbiprofen ophthalmic products for humans can be used in an extralabel manner under 21 CFR Part 530 to treat dogs and cats in an urgent situation, until a patient-specific prescription can be filled, if needed.
Gentamicin
(3/29/2023)
dog, cat otic ointment
otic solution
anal sac ointment
topical gel
topical ointment
otic ointment
otic suspension
ophthalmic ointment
0.3-1%
0.3-1%
0.3-1%
0.3%
0.3%
0.3%
0.3%
0.3%
FDA-approved and marketed combination drug products containing gentamicin or other drugs can be used as labeled in an urgent situation in dogs and cats. Drugs containing gentamicin approved for other animal species and humans that be used in an extralabel manner under 21 CFR Part 530. If a compounded preparation of gentamicin is needed, a patient-specific prescription should suffice.
Hydroxyzine HCl
(11/27/2023)
dog, cat, horse any any Hydroxyzine is not typically needed urgently to avoid animal suffering or death. FDA-approved animal drugs can be used as labeled to treat the same conditions, and Hydroxyzine HCl FDA-approved for use in humans can be used in an extralabel manner under 21 CFR Part 530, until a patient-specific prescription can be obtained, if deemed necessary by the veterinarian.
Imatinib
(10/13/2023)
dog, cat any any Imatinib is not typically needed urgently. If treatment with compounded imatinib is deemed necessary by a veterinarian, a patient-specific  prescription should suffice.

The FDA-approved drugs Palladia (NADA 141-295) and Stelfonta (NADA 141-541) can be used as labeled or in an extralabel manner.

FDA-approved imatinib products (for humans) can be used in an extralabel manner under 21 CFR Part 530 in dogs and cats.
Isoflupredone acetate
(12/6/2022)
horse suspension for injection 2 mg/ml FDA-approved drugs are available for urgent use in horses for the same or similar indications.
Itraconazole
(11/27/2023)
cat, dog, horse any oral formulation any Itrafungol (NADA 141-474) is FDA-approved for use in cats. Itraconazole capsules and oral solutions are FDA-approved for use in humans and could be used in an extralabel manner under 21 CFR Part 530 if deemed appropriate by a veterinarian. Peer-reviewed studies indicate that oral itraconazole products compounded from BDS are poorly absorbed and likely to be ineffective, potentially leading to treatment failure and fatality if used in life-threatening infections. If a veterinarian deems a compounded oral itraconazole product necessary, a patient-specific prescription should suffice.
Ketoconazole/chloramphenicol/triamcinolone acetonide
(2/28/2023)

Ketoconazole/gentamicin/triamcinolone acetonide
(2/28/2023)

Ketoconazole/mupirocin/triamcinolone acetonide
(2/28/2023)

Ketoconazole/ofloxacin/triamcinolone acetonide
(2/28/2023)
dog, cat otic gel
otic suspension
otic solution
otic ointment
any There are many FDA-approved and marketed otic combination drug products that can be used as labeled in an urgent situation in dogs and cats. If a compounded preparation of this otic combination is needed, a patient-specific prescription should suffice.
Levamisole
(12/19/2023)
dog, cat




horse
any

 
any

 
Levamisole is not needed urgently for the nominated conditions in dogs and cats and a patient-specific prescription should suffice.

FDA-approved animal drugs can be used to treat the nominated condition in horses in an urgent situation. Levamisole can be obtained via a patient-specific prescription if deemed necessary by the veterinarian.
Marbofloxacin
(11/15/2023)
dog, cat any oral dosage form
any otic dosage form
any
any
There are marketed FDA-approved drugs containing the same active ingredient, in the same or similar dosage form that can be used as labeled for dogs and cats, and FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530. If the veterinarian determines that a different dosage form is needed the FDA-approved formulations can be used until a patient-specific prescription is filled.
Maropitant citrate
(1/20/2023)
dog, cat capsules

oral paste

oral suspension

soft chew treat

tablet, flavored, quadrisected

transdermal gel

nasal solution 

2 – 120 mg

20 – 40 mg/ml

1.8 – 60 mg/ml

2 – 60 mg

8 – 32 mg

25 – 200 mg/ml

0.1%

Cerenia (maropitant citrate) injectable solution 10 mg/mL (NADA 141-263) is FDA-approved for the treatment of vomiting in dogs and cats. Cerenia® is also FDA-approved in tablet form (NADA 141-262) for the treatment of vomiting in dogs and may be used in an extralabel manner in cats. These formulations should be sufficient for urgent use. If longer term treatment is deemed necessary by the veterinarian, compounded formulations may be obtained pursuant to a patient-specific prescription.
Mebendazole
(11/20/2023)
dog any any Mebendazole should not be needed for urgent treatment as there are many FDA-approved medications that could be used as labeled or in an extralabel manner under 21 CFR Part 530 for the same indications. If a veterinarian determines that mebendazole specifically is needed, a patient-specific prescription should suffice.
Mebendazole/praziquantel/pyrantel pamoate
(11/20/2023)
dog any any There are many FDA-approved formulations of praziquantel and pyrantel pamoate that can be used as labeled or in an extralabel manner under 21 CFR Part 530. Mebendazole should not be needed for urgent treatment to prevent animal suffering or death as there are many FDA-approved medications that could be used as labeled or in an extralabel manner under 21 CFR Part 530 for the same indications. If a veterinarian determines that a compounded mebendazole/praziquantel/pyrantel pamoate product is needed, a patient-specific prescription should suffice.
Methimazole
(7/10/2023)
cat capsules
soft chew treat
oral solution
oral suspension
tablets
oral paste
oral suspension
oral solution
transdermal gel
any The nominations did not support the need for compounded methimazole for urgent use in cats. There are FDA-approved methimazole products that can be used as labeled or in an extralabel manner under 21 CFR Part 530 until a patient-specific prescription can be filled, if needed.
Methocarbamol
(3/29/2023)
dog, cat

horse



dog, cat, horse
capsules

oral paste
oral powder
oral suspension

soft chew treat
flavored and quadrisected tablet
15 -250 mg

500 mg/mL
0.5 gm -12 gm/dose
30 – 300 mg/mL

50 -125 mg
500 mg
Methocarbamol in an oral suspension (30-300 mg/ml) for dogs and cats is on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. In addition, there are FDA-approved drugs that can be used as labeled, and FDA-approved methocarbamol products that can be used in an extralabel manner under 21 CFR Part 530 to treat the nominated conditions in dogs, cats, and horses in an urgent situation, until a patient-specific prescription can be filled, if needed.
Metronidazole benzoate
(4/18/2024)
dog, horse









cat
any










any, except oral suspension
any










any, except 80 mg/ml oral suspension
AYRADIA (metronidazole suspension, 125 mg/ml), NADA 141-572, is FDA-approved for use in dogs for treatment of Giardia duodenalis infection
and can be used in an extralabel manner under 21 CFR Part 530 for urgent treatment until a patient-specific prescription can be obtained, if needed.

There are marketed FDA-approved tablets, capsules, and oral suspensions that contain metronidazole that can be used as labeled or in an extralabel manner under 21 CFR Part 530 for urgent treatment in dogs and horses until a patient-specific prescription can be obtained, if needed.

Metronidazole benzoate 80 mg/ml oral suspension appears on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals for use in cats.
Mirtazapine
(12/6/2023)
dog, cat soft chewable treats

oral suspension

oral paste

transdermal gel
1 – 3.75 mg

0.5 – 37.7 mg/ml

1.875 mg/ml

5 – 150 mg/ml
Mirtazapine BDS for compounding tablets (1 – 3.75 mg) and capsules (0.5 – 3.75 mg) is on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. FDA-approved tablets for humans (7.5/15/30/45 mg) can be used in an extralabel manner for dogs. Mirataz (mirtazapine transdermal ointment, 20 mg/g), NADA 141-481, is FDA-approved for use in cats and may be used in an extralabel manner in dogs, although FDA is not aware of evidence of adequate transdermal absorption of mirtazapine in dogs. These dosage forms may be administered to dogs and cats for urgent treatment until a patient-specific prescription for another dosage form can be filled.
Mitotane
(2/28/2023)
dog capsules

oral suspension

soft chew treat
any

any

any
Mitotane should not be needed for urgent treatment to avoid animal suffering or death. If a compounded mitotane product is deemed necessary by a veterinarian, a patient-specific prescription should suffice.
Neomycin sulfate/tetracaine HCl/triamcinolone acetonide
(4/20/2023)
dog, cat, horse otic ointment
topical ointment
topical powder
any
any
any
There are several FDA-approved and marketed drugs that can be used as labeled or in an extralabel manner for dogs, cats, and horses on an urgent basis. If a compounded preparation with neomycin, tetracaine HCl, and triamcinolone acetonide is needed, a patientspecific prescription should suffice.
Nitenpyram
(2/28/2023)
dog, cat oral solution

rectal gel
22.7 mg/mL

11.4 and 57 mg
FDA-approved Capstar (nitenpyram), NADA 141-175, can be used as labeled, or in an extralabel manner under 21 CFR Part 530, to treat the same conditions in dogs or cats in an urgent situation, until a patient-specific prescription can be filled, if needed.
Omeprazole
(2/8/2024)
dog, cat











horse
any











any
any











any
There are marketed FDA-approved human drugs containing omeprazole in dosage forms that can be used in an extralabel manner under 21 CFR Part 530 to treat dogs and cats in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.

GastroGard oral paste (NADA 141-123) and UlcerGard oral paste (NADA 141-227) are FDA-approved omeprazole products for horses that can be used in an urgent situation.
Omeprazole/ aluminum hydroxide/ magnesium hydroxide
(2/8/2024)
horse any any GastroGard oral paste (NADA 141-123) and UlcerGard oral paste (NADA 141-227) are FDA-approved omeprazole products for horses that can be used in an urgent situation. 

There are marketed FDA-approved human drugs containing aluminum hydroxide and magnesium hydroxide (either singularly or in combination) in dosage forms that can be used in an extralabel manner under 21 CFR Part 530 to treat horses in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Omeprazole/
cimetidine
(2/8/2024)
horse any any GastroGard oral paste (NADA 141-123) and UlcerGard oral paste (NADA 141-227) are FDA-approved omeprazole products for horses that can be used in an urgent situation.

There are marketed FDA-approved human drugs containing cimetidine, in the same or similar dosage forms, that can be used in an extralabel manner under 21 CFR Part 530 to treat horses in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Ondansetron
(2/8/2023)
dog, cat capsules 
oral solution soft chew treat transdermal gel
0.5 - 24 mg
0.7 - 40 mg/ml
2 mg
20 – 70 mg/ml
There are FDA-approved products that can be used as labeled, or in an extralabel manner under 21 CFR Part 530, to treat the nominated conditions in dogs and cats in an urgent situation, until a patient-specific prescription can be filled, if needed.
Oxantel pamoate
(11/20/2023)
dog any any Oxantel pamoate should not be needed for urgent treatment to prevent animal suffering or death as there are many FDA-approved medications that could be used as labeled or in an extralabel manner under 21 CFR Part 530 for the same indications. If a veterinarian determines that oxantel pamoate specifically is needed, a patient-specific prescription should suffice.
Oxantel pamoate/praziquantel/pyrantel pamoate
(11/20/2023)
dog, cat any any There are many FDA-approved formulations of praziquantel and pyrantel pamoate that can be used as labeled or in an extralabel manner under 21 CFR Part 530. Oxantel pamoate should not be needed for urgent treatment to prevent animal suffering or death as there are many FDA-approved medications that could be used as labeled or in an extralabel manner under 21 CFR Part 530 for the same indications. If a veterinarian determines that a compounded oxantel pamoate/praziquantel/pyrantel pamoate product is needed, a patient-specific prescription should suffice.
Pentosan polysulfate sodium
(12/20/2022)
dog, cat, horse capsules

oral suspension

injectable solution
10-800 mg

75-400 mg/ml

100-250 mg/ml
Zycosan (NADA 141-599) (pentosan polysulfate sodium 250 mg/ml) solution for injection is FDA-approved for use in horses for the control of clinical signs associated with osteoarthritis. There are numerous FDA-approved products that can be used as labeled or in an extralabel manner under 21 CFR part 530 in dogs, cats, and horses.
Pergolide mesylate
(4/21/2023)
horse capsule
oral granules 
oral suspension 
oral paste
oral powder packet
tablets, flavored
transdermal gel 
any There is a marketed FDA-approved animal drug containing the same active ingredient, in the same or similar dosage form, that can be used as labeled in horses, and the drug is not typically needed urgently. If the veterinarian determines a different drug formulation is needed, a patient-specific prescription can be filled.
Phenylbutazone
(11/3/2023)
horse any any There are marketed FDA-approved drugs containing the same active ingredient, in the same or similar dosage forms that can be used as labeled in horses, and FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530. If the veterinarian determines that a different dosage form is needed the FDA-approved formulations can be used until a patient-specific prescription is filled.
Phenylpropanolamine
(11/27/2023)
dog, cat any any Phenylpropanolamine should not be needed urgently to prevent animal suffering or death. FDA-approved phenylpropanolamine products can be used as labeled or in an extralabel manner under 21 CFR Part 530. If an alternative formulation is needed, this could be achieved with a patient-specific prescription.
Pimobendan
(2/14/2024)
dog, cat any any FDA-approved VETMEDIN (NADA 141- 273) and VETMEDIN Solution (NADA 141-575) can be used as labeled in dogs, or in an extralabel manner under 21 CFR Part 530 in cats in an urgent situation until a patient-specific prescription for another dosage form can be filled, if needed.
Praziquantel
(11/20/2023)
dog, cat, horse any any Praziquantel is FDA-approved as an injectable solution (NADA 111-607) and as oral tablets (NADA 111-798) for use in cats and dogs. Praziquantel is FDA-approved for use in horses as part of a combination product with ivermectin (NADA 141-214 and NADA 141-215) and with moxidectin (NADA 141-216). These FDA-approved formulations should provide sufficient options for urgent use in cats, dogs, and horses. If a veterinarian deems an alternative formulation of praziquantel is necessary, a patient-specific prescription should suffice.
Praziquantel/pyrantel pamoate
(11/20/2023)
dog, cat any any There are several FDA-approved formulations of praziquantel and pyrantel pamoate that can be used as labeled or in an extralabel manner under 21 CFR Part 530 for urgent treatment. If a veterinarian deems an alternative formulation of this combination is necessary, a patient-specific prescription should suffice.
Prazosin
(2/28/2023)
dog, cat soft chewable treat

transdermal gel

capsule
0.5 - 1 mg

2.5 - 10 mg/ml

1 - 20 mg
FDA-approved prazosin drug products for humans can be used in an extralabel manner under 21 CFR Part 530 in most dogs and cats. Prazosin is on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals in several concentrations and dosage forms that can be used in small dogs and cats. The need for specialized drug formulations beyond these can be addressed using patient-specific prescriptions.
Pregabalin
(2/8/2023)
dog, cat capsules 10 - 55 mg There are FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530 to treat the same conditions in dogs and cats in an urgent situation, until a patient-specific prescription can be filled, if needed.
Pyrantel pamoate
(11/20/2023)
dog, cat, horse any any There are several FDA-approved formulations of pyrantel pamoate that can be used as labeled or in an extralabel manner under 21 CFR Part 530 for urgent treatment. Additionally, there are several FDA-approved medications containing different active ingredients that could be used as alternatives to pyrantel pamoate for the same indications if deemed appropriate by the veterinarian. If a veterinarian deems an alternative formulation of pyrantel pamoate is necessary, a patient-specific prescription should suffice.
Reserpine
(10/11/23)
horse any any FDA-approved drugs could be used as labeled or in an extralabel manner under 21 CFR Part 530 in the short-term, until a patient-specific prescription for reserpine can be filled for longer-term use, if needed.
Selegiline 
(10/26/2023)
dog, cat any any There are FDA-approved animal and human drug products containing selegiline that can be used as labeled, or in an extralabel manner under 21 CFR Part 530, to treat the nominated conditions in dogs and cats. Selegiline is not typically needed urgently; a patient-specific prescription can be filled, if needed.
Sodium bromide
(7/6/2023)
dog capsules
oral solution
any
any
KBroVet-CA1 (potassium bromide, NADA 141-544) is conditionally approved for use in dogs. If a compounded preparation of sodium bromide is needed, a patient-specific prescription should suffice.
Sucralfate
(2/28/2023)
dog, cat, horse

dog, horse

horse
capsules
oral paste
oral suspension

oral powder


oral powder (packet)
500 - 1,100 mg
250 - 500 mg/mL
2.5 - 500 mg/mL

250 mg/dose to 12 g/dose

10 g/packet
There are marketed FDA-approved human drugs containing sucralfate, in the same or similar dosage forms, that can be used in an extralabel manner under 21 CFR Part 530 to treat the same conditions in dogs, cats, and horses in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Telmisartan
(2/22/2023)
dog, cat capsules
oral suspension
soft chew treats
flavored tablets
0.5-47 mg
1-180 mg/mL
2-20 mg
10 mg
There are FDA-approved products that can be used as labeled, or in an extralabel manner under 21 CFR Part 530, to treat the same conditions in dogs and cats in an urgent situation, until a patient-specific prescription can be filled, if needed.
Toceranib phosphate
(2/8/2023)
dog, cat capsules
oral suspension 
soft chew treat 
2 - 180 mg
5 - 115 mg/ml
7 - 65 mg
Toceranib phosphate is FDA-approved for dogs (Palladia®, NADA 141-295) and can be used in an extralabel manner under 21 CFR Part 530 in cats. If a different dosage form is needed for longer term treatment of a specific patient, a patient-specific prescription can be filled.
Trilostane
(7/6/2023)
dog, cat any any Trilostane should not be needed for urgent treatment to avoid animal suffering or death. Additionally, FDA-approved products can be used as labeled, or in an extralabel manner under 21 CFR Part 530, in an urgent situation, until a patient-specific prescription can be filled, if needed.
Vinblastine
(11/15/2023)
dog, cat any any Vinblastine is not typically needed urgently, and FDA-approved products can be used as labeled, or in an extralabel manner under 21 CFR Part 530 until a patient-specific prescription can be filled, if needed.
Xylazine
(3/28/2023)
any any any FDA-approved xylazine products, can be used as labeled, or in an extralabel manner under 21 CFR Part 530, as a single agent or in combined drug protocols for sedation or immobilization of the nominated species.

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS) Species Dosage form(s) Strength/concentration Reason
Amikacin
(2/8/2023)
birds, guinea pigs, chinchillas, hamsters, rats, mice, fish, and reptiles (including snakes, turtles, tortoises) injectable solution 200 mg/ml If an injectable solution is needed for urgent treatment, Amiglyde-V (NADA 127-892) or the amikacin injectable solutions FDA-approved for use in humans can be used in an extralabel manner under 21 CFR Part 530.
Amoxicillin
(10/11/23)
non-human primates in a research setting oral suspension any There are FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530 to treat non-human primates in a research setting in an urgent situation, until a patient-specific prescription can be filled, if needed.
Azithromycin
(4/20/2023)
guinea pigs, birds (nonfood-producing), assorted captive exotic and zoo species

rabbits
any






any
any






any
Insufficient information was submitted to support the need for urgent use in these species.




Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Buprenorphine HCl
(4/24/2023)
captive non-human primates, captive marine mammals



large cats, bears, small exotic mammal pets, rodents (e.g., mice and rats), ferrets, large zoo animals

rabbits
injectable polymeric matrix solution

injectable solution

oral solution


injectable polymeric matrix solution

injectable solution

oral solution
any, except for 5.0-10 mg/ml


any

any


any


any

any



any
FDA-approved injectable solution is available as labeled for administration or for extralabel use under 21 CFR Part 530 for injection or oral administration. Specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock.

Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Butorphanol-Azaperone-Medetomidine (BAM)
(2/1/2022)
laboratory animals (mice, rats, and rabbits) fixed-combination injectable solution butorphanol (27.3 mg/ml)-azaperone (9.1 mg/ml)-medetomidine (10.9 mg/ml) Butorphanol and medetomidine are FDA-approved animal drugs available in concentrations that can be used in an extralabel manner under 21 CFR part 530 for sedation and anesthesia in laboratory animals. While FDA-approved azaperone is not marketed in the United States, azaperone tartrate is included on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals and can be used to compound office stock for use in laboratory animals.
Calcium glubionate
(3/7/2024)
captive reptile and avian species oral suspension

oral syrup
any

any
Insufficient information was submitted to support the need for urgent use in these species for the conditions nominated. There is a lack of supporting information in the scientific literature that this drug is needed as office stock for urgent or immediate treatment of these species. If a compounded preparation of calcium glubionate oral suspension/syrup is needed, a patient-specific prescription should suffice.
Carprofen
(12/19/2023)
non-human primates any any FDA-approved animal drugs (carprofen and other non-steroidal anti-inflammatory drugs) can be used in an extralabel manner under 21 CFR Part 530 to treat the nominated conditions. Specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock.
Chloramphenicol
(2/28/2023)
small mammal, birds oral capsule

oral suspension

otic ointment/solution/suspension
30 - 1000 mg

125 - 500 mg/mL

1 - 2%
Insufficient information was submitted to support the need for urgent use in birds and small mammals.
Clomipramine
(7/5/2023)
birds oral suspension any Clomipramine should not be needed for urgent treatment to avoid animal suffering or death. There are FDA-approved formulations of clomipramine that could be used in an extralabel manner under 21 CFR Part 530. If clomipramine is needed in a formulation that is not FDA-approved, a patient-specific prescription for compounded clomipramine should be sufficient.
Corticotropin (ACTH)
(1/19/2023)
birds injectable 40 & 80 units/ml There are FDA-approved products that can be used in an extralabel manner under 21 CFR Part 530 in birds. There is lack of supporting information that this drug is needed on an urgent basis in these species.
Enrofloxacin
(4/11/2924)
captive psittacine birds, hedgehogs, reptiles






rabbits
any oral dosage form










any
any Insufficient information was provided regarding why other FDA-approved fluoroquinolone antimicrobials available as oral suspensions cannot be used in an urgent situation. The nominated animal groups were overly broad and non-specific.

Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Famotidine
(2/8/2024)
small animals any any There are marketed FDA-approved human drugs containing famotidine in dosage forms that can be used in an extralabel manner under 21 CFR Part 530 to treat small animals in an urgent situation. The FDA-approved human drugs can be used until a patient-specific prescription for a different dosage form is filled, if needed.
Fenbendazole
(11/20/2023)
small mammals, large mammals, assorted exotic and captive zoo species any any Nominator did not explain why FDA-approved drugs would not be suitable for use in these species and did not provide sufficient information to support the urgent use of fenbendazole in these species.
Flunixin
(10/31/2023)
ferrets, rodents, chinchillas, small mammals, zoo, exotic spp.



rabbits
any









any
any









any
Insufficient supporting information was submitted for CVM to adequately review the use of flunixin meglumine in the broad categories of minor species nominated, in multiple dosage forms, for urgent use.

Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Haloperidol
(2/1/2022)
large herbivores (zoo hoofed stock), exotic pet birds Injectable (lactate, aqueous)

capsules

oral solution

oral suspension
20 mg/ml

60 mg

0.1 mg/ml to 2 mg/ml

2 mg/ml
Haloperidol is available as FDA-approved human drug products that can be used as formulated or used to compound a different concentration or to add flavor if needed.
Hydroxyzine HCL
(11/27/2023)
ferrets, nonfood-producing avian spp.






rabbits
any









any
any









any
Hydroxyzine HCl is not typically needed urgently to avoid animal suffering or death. Specialty formulations can be obtained via patient-specific prescription and are not generally needed as office stock.

Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Itraconazole
(11/27/2023)
birds, reptiles, rodents, and other small mammals



rabbits
any oral formulation






any oral formulation
any






any
The nominator did not provide sufficient information to support the need for itraconazole compounded from BDS for urgent use in these species.

Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Marbofloxacin
(11/15/2023)
assorted captive exotic and zoo species, birds (nonfood-producing), reptiles

rabbits
any







any
any







any
The nominated animal groups are overly broad and non-specific and insufficient information was submitted to support the need for urgent use in these animals.


Rabbits (except laboratory rabbits) are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Metronidazole benzoate
(4/18/2024)
small mammals, exotic species suspension (oral)
powder (oral)
paste
chewable treat
capsule
tablet, flavored and unflavored
any Insufficient information was submitted to support the need for urgent use in these species for the conditions nominated.
Naloxone hydrochloride
(2/1/2022)
bears, birds, camelids, canids, pocket pets, cervids, otters, primates, rabbits, lab rodents, ratites, sheep, and free-ranging wild animals injectable solution 1 mg/ml There are FDA-approved naloxone 1 mg/ml injection products that can be used in animals in an extralabel manner under 21 CFR part 530.
Oxantel pamoate/praziquantel/pyrantel pamoate
(11/20/2023) 
ferret, reptiles any any Nominator did not explain why FDA-approved drugs would not be suitable for use in these species and did not provide sufficient information to support the urgent use of this drug combination in these species.
Praziquantel
(11/20/2023)
captive exotic and zoo species, small mammals, birds, rodents, chinchilla, ferret, snakes, tortoises, camelids, amphibians, fish

rabbits
any











any
any











any
Nominator did not explain why FDA-approved drugs would not be suitable for use in these species and did not provide sufficient information to support the urgent use of praziquantel in these species. 




Rabbits (except laboratory rabbits), sheep, and goats are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife.
Praziquantel/pyrantel pamoate
(11/20/2023)
ferret, reptiles









rabbit, sheep, goat
any









any
any









any
Nominator did not explain why FDA-approved drugs would not be suitable for use in these species and did not provide sufficient information to support the urgent use of this drug combination in these species.

Rabbits (except laboratory rabbits), sheep, and goats, are considered food-producing animals. Review of BDS nominations for food-producing animals is limited to antidotes for food-producing animals and sedatives and anesthetics for free-ranging wildlife. 
Pyrantel pamoate
(11/20/2023)
birds, reptiles, small mammals, donkeys, camelids, rodents any any Nominator did not explain why FDA-approved drugs would not be suitable for use in these species and did not provide sufficient information to support the urgent use of pyrantel pamoate in these species.
Sodium chloride/edetate disodium
(12/5/2023)
captive marine mammals any any The BDS nomination did not include information to support the urgent use of this drug in marine mammals, and there is a lack of supporting information in the scientific literature about the use of this drug in these species or that it would be needed on an urgent basis as office stock. If a compounded preparation of ophthalmic sodium chloride/edetate disodium is needed, a patient-specific prescription should suffice.
Trilostane
(7/6/2023)
small mammals any any No information was submitted regarding the use of trilostane in small mammals.
Xylazine
(3/28/2023)
any any any FDA-approved xylazine products, can be used as labeled, or in an extralabel manner under 21 CFR Part 530, as a single agent or in combined drug protocols for sedation or immobilization of the nominated species.

FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES

Bulk Drug Substance (BDS) Species Dosage form(s) Strength/concentration Reason
Azithromycin
(4/20/2023)
rabbits any any Azithromycin is not an antidote, sedative, or anesthetic.
Buprenorphine
HCl (4/24/2023)
rabbits, free-ranging wildlife any any Buprenorphine is not an antidote, sedative, or anesthetic.
Enrofloxacin
(4/11/2024)
rabbits any any Enrofloxacin is not an antidote, sedative, or anesthetic.
Flunixin
(10/31/2023)
rabbits, free-ranging wildlife any any Flunixin meglumine is not an antidote, anesthetic or sedative.
Hydroxyzine HCl
(11/27/2023)
rabbits any any Hydroxyzine HCl is not an antidote, sedative, or anesthetic.
Itraconazole
(11/27/2023)
rabbits any any Itraconazole is not an antidote, sedative, or anesthetic.
Marbofloxacin
(11/15/2023)
rabbits any any Marbofloxacin is not an antidote, sedative, or anesthetic.
Naloxone hydrochloride
(2/1/2022)
sheep and free-ranging wild animals injectable solution 1 mg/ml There are FDA-approved naloxone 1 mg/ml injection products that can be used in animals in an extralabel manner under 21 CFR part 530.
Praziquantel
(11/20/2023)
rabbit, sheep, goat, fish any any Praziquantel is not an antidote, sedative, or anesthetic.
Pyrantel pamoate
(11/20/2023)
rabbit any any Pyrantel pamoate is not an antidote, sedative, or anesthetic.
Xylazine
(3/28/2023)
any any any FDA-approved xylazine products, can be used as labeled, or in an extralabel manner under 21 CFR Part 530, as a single agent or in combined drug protocols for sedation or immobilization of the nominated species.

These bulk drug substances are not covered by FDA’s enforcement discretion policy described in GFI #256. FDA will consider them for inclusion on any List if they are nominated again with new information, using the nomination procedure described in the appendix to GFI #256.

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.

 
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