Appendix I: Bulk Drugs List

TABLE OF CONTENTS

This Appendix contains for each of the nominated substances:

1.           The cover sheet provided by the nominator. This includes general information about the substance, including its chemical properties.

2.           Selected abstracts of articles obtained by FDA from the medical literature attesting to the use of the substance. These are a sampling of articles identified through searches of Medline, Toxline, IRIS, and International Pharmaceutical Abstracts.

3.           A summary of the toxicological data for the substance prepared by FDA after review of the literature.

A bibliography prepared by FDA of articles identified through a search of the medical literature concerning the substance. This bibliography is not exhaustive.

NOMINATED SUBSTANCES

1.      4-Aminopyridine

2.      Betahistine Dihydrochloride

3.      Bismuth Citrate

4.      Caffeine Citrate

5.      Cantharidin

6.      Choline Bitartrate

7.      Cyclandelate

8.      Diaminopyridine (3,4)

9.      Diloxanide Furoate

10.    Dimercapto-1-Propanesulfonic Acid

11.    Dinitrochlorobenzene

12.    Ferric Subsulfate

13.    Ferric Sulfate Hydrate

14.    Glutamine

15.    Guaiacol

16.    Hydrazine Sulfate

17.    lodoform

18.    Metronidazole Benzoate

19.    Myrrh Gum Tincture

20.    Pentylene Tetrazole

21.    Phenindamine Tartrate

22.      Phenyltoloxamine Dihydrogen Citrate

23.      Piracetam

24.      Silver Protein Mild

25.      Sodium Butyrate

26.      Sulfadimethoxine

27.      Taurine

28.      Thymol Iodide

29.    Tinidazole

The following additional substances were nominated but are already the subject of a USP/NF monograph and/or components of approved drugs. Under the Federal Food, Drug, and Cosmetic Act as amended by section 127 of the Modernization Act, these may already be used in pharmacy compounding and, therefore, are not included in the documentation or proposed for inclusion on the list:

1.      Clotrimazole

2.        Fluocinonide

3.        Hydrocortisone

4.        Hydroquinone

5.      Pramoxine

6.      Quinacrine Hydrochloride

7.      Salicylic Acid

8.      Tretinoin

9.      Triamcinolone