The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. The chart below identifies the use(s) FDA reviewed for each of the four bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances or another interested party will be invited to make a short presentation supporting the nomination.
The committee will also discuss revisions FDA is considering to the Withdrawn or Removed List. FDA now is considering whether to amend the rule to add one more entry to the list: Neomycin Sulfate: All parenteral drug products containing neomycin sulfate (except for ophthalmic or otic use, or when combined with polymyxin B sulfate for irrigation of the intact bladder). As previously explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 through 37690), the list may specify that a drug may not be compounded in any form, or, alternatively, may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list. Moreover, a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms because it has been found to be unsafe or not effective in those particular formulations, indications, routes of administration, or dosage forms. FDA plans to seek the committee’s advice concerning the inclusion of this drug product on the list.
Advisory Committee Meeting information: