Скачать с ютуб October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee (PCAC) в хорошем качестве

October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)

Meeting Topics: The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: ibutamoren mesylate, L-theanine, ipamorelin-related bulk drug substances (ipamorelin acetate and ipamorelin (free base)), and kisspeptin-10. The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the nominators of these substances will be invited to make a short presentation supporting the nomination. The Committee will also discuss a revision FDA is considering to the Withdrawn or Removed List. Specifically, FDA is considering whether to amend § 216.24 to add an entry to the list: hydroxyprogesterone caproate: all drug products containing hydroxyprogesterone caproate to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous birth. As previously explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 through 37690), the list entry may specify that a drug may not be compounded in any form. Alternatively, the list entry may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list, or a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms. FDA plans to seek the Committee’s advice concerning the inclusion of this entry on the list. Link to Meeting Information and Materials: https://www.fda.gov/advisory-committe...