Bulk Drug Substances Reviewed and Not Listed
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
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 |
---|---|---|---|---|
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. |
Betamethasone dipropionate | 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. |
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. |
Flurbiprofen | 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 | 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. |
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 |
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. |
Methocarbamol | 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 FDAapproved 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. |
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. |
Xylazine | 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 | 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. |
Xylazine | 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 |
---|---|---|---|---|
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. |
Xylazine | 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.
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