503B Bulk Drug Substances List
Updated August 21, 2023
FDA is evaluating bulk drug substances that were nominated for inclusion on the 503B bulks list, proceeding case by case, under the standard provided by the statute.
FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:
|
Bulk Drug Substances Included on the 503B Bulks List |
Federal Register Citation |
Date of Publication |
|---|---|---|
|
Diphenylcyclopropenone (for topical use only) |
87 FR 4240 |
1/27/2022 |
|
Glycolic acid (for topical use in concentrations up to 70% only) |
87 FR 4240 |
1/27/2022 |
|
Quinacrine HCl (for oral use only) |
88 FR 20531 |
4/6/2023 |
|
Squaric acid dibutyl ester (for topical use only) |
87 FR 4240 |
1/27/2022 |
|
Trichloroacetic acid (for topical use only) |
87 FR 4240 |
1/27/2022 |
FDA has evaluated the following bulk drug substances and determined that there is not a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:
|
Bulk Drug Substances Not Included on the 503B Bulks List |
Federal Register Citation |
Date of Publication |
|---|---|---|
|
Diazepam |
87 FR 4240 |
1/27/2022 |
|
Dipyridamole |
87 FR 4240 |
1/27/2022 |
|
Dobutamine hydrochloride |
87 FR 4240 |
1/27/2022 |
|
Dopamine hydrochloride |
87 FR 4240 |
1/27/2022 |
|
Edetate calcium disodium |
87 FR 4240 |
1/27/2022 |
|
Ephedrine sulfate |
88 FR 56837 |
8/21/2023 |
|
Folic acid |
87 FR 4240 |
1/27/2022 |
|
Glycopyrrolate |
87 FR 4240 |
1/27/2022 |
|
Hydroxychloroquine sulfate |
88 FR 56837 |
8/21/2023 |
|
Hydroxyzine hydrochloride |
88 FR 20531 |
4/6/2023 |
|
Mannitol |
88 FR 20531 |
4/6/2023 |
|
Methacholine chloride |
88 FR 20531 |
4/6/2023 |
|
Metoclopramide hydrochloride |
88 FR 20531 |
4/6/2023 |
|
Nalbuphine hydrochloride |
88 FR 20531 |
4/6/2023 |
|
Nicardipine hydrochloride |
84 FR 7383 |
3/4/2019 |
|
Potassium acetate |
88 FR 20531 |
4/6/2023 |
|
Procainamide hydrochloride |
88 FR 20531 |
4/6/2023 |
|
Sodium bicarbonate |
88 FR 20531 |
4/6/2023 |
|
Sodium nitroprusside |
88 FR 20531 |
4/6/2023 |
|
Sodium thiosulfate (except for topical administration which will be evaluated in a future Federal Register notice) |
87 FR 4240 |
1/27/2022 |
|
Vasopressin |
84 FR 7383 |
3/4/2019 |
|
Verapamil hydrochloride |
88 FR 20531 |
4/6/2023 |