Bulk Drug Substances Reviewed and Not Listed

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
Amikacin	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	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.
Apomorphine hydrochloride	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.
Chloramphenicol	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	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.
Corticotropin (ACTH)	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.
Dexamethasone	horse	oral powder	10 mg/packet	FDA-approved human oral tablets can be used to compound 10 mg oral powder doses.
Dipyrone	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.
Enrofloxacin	horse	oral paste and suspension	100-200 mg/ml	There are FDA-approved enrofloxacin products that can be used in an extralabel manner or used to compound enrofloxacin paste and suspension.
Fluoxetine	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.
Isoflupredone acetate	horse	suspension for injection	2 mg/ml	FDA-approved drugs are available for urgent use in horses for the same or similar indications.
Ketoconazole/amikacin sulfate/triamcinolone acetonide Ketoconazole/chloramphenicol/triamcinolone acetonide Ketoconazole/enrofloxacin/triamcinolone acetonide Ketoconazole/gentamicin/triamcinolone acetonide Ketoconazole/mupirocin/triamcinolone acetonide Ketoconazole/ofloxacin/triamcinolone acetonide	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.
maropitant citrate	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.
Mirtazapine	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	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.
Nitenpyram	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.
Ondansetron	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.
Pentosan polysulfate sodium	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.
Prazosin	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	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.
Sucralfate	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	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	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.

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration	Reason
amikacin	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.
Butorphanol-Azaperone-Medetomidine (BAM)	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.
Chloramphenicol	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.
Corticotropin (ACTH)	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.
Haloperidol	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.
Naloxone hydrochloride	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.

FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration	Reason
Naloxone hydrochloride	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.

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.

To view information that was previously submitted for these nominations, click on the hyperlinked Docket ID for each of these nominations, below.

Docket ID: FDA-2015-N-1196-0005
Substance(s): Prednisolone and prednisone 2.5mg, 5mg, 10mg, 20mg, 50mg, doxycycline 50mg, 100mg, 200mg, ketoconazole 200mg, cyclosporin 2% ophthalmic suspension

Docket ID: FDA-2015-N-1196-0006
Substance(s): Lanolin, enrofloxacin, triamcinolone, and neomycin in combination

Docket ID: FDA-2015-N-1196-0007
Substance(s): Doxycycline, metronidazole, methimazole, ponazuril

Docket ID: FDA-2015-N-1196-0009
Substance(s): List of 85 bulk drug substances

Docket ID: FDA-2015-N-1196-0017
Substance(s): Copper peptide, Superoxide dismutase

Docket ID: FDA-2015-N-1196-0018
Substance(s): Ophthalmic: idoxuridine, cidofivir, cyclosporine 2%, tacrolimus 2%, fluconazole, voriconazole

Docket ID: FDA-2015-N-1196-0019
Substance(s): List of 23 bulk drug substances

Docket ID: FDA-2015-N-1196-0020
Substance(s): Methimazole, amlodipine, ondansetron, prednisolone, prednisone, metronidazole, griseofulvin, cyproheptadine, mirtazapine, doxycycline

Docket ID: FDA-2015-N-1196-0021
Substance(s): Apomorphine, methocarbamol, buprenorphine, antibiotics, fentanyl, morphine

Docket ID: FDA-2015-N-1196-0024
Substance(s): Metronidazole, baytril, buprenorphine, morphine, prazosin, prednisone, methocarbamol, omeprazole

Docket ID: FDA-2015-N-1196-0036
Substance(s): Tylan soluble powder

Docket ID: FDA-2015-D-1176-0113
Substance(s): Diclofenac