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  1. Animal Drug Compounding

Bulk Drug Substances Nominated Without Sufficient Supporting Evidence

Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
Nominated Bulk Drug Substances That May NOT Be Used to Compound Office Stock Drugs or Antidotes for Use in Animals
Nominated Bulk Drug Substances Currently Under Review


These bulk drug substances were nominated without sufficient supporting information for FDA to evaluate them. These substances cannot be used in compounding office stock drugs or antidotes, and FDA will not consider them for inclusion on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals unless they are nominated again with complete information, using the nomination procedure described in the appendix of draft GFI #256.

For information on how to submit a bulk drug substance nomination, see the appendix of draft Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.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