Meeting of the Pharmacy Compounding Advisory Committee Meeting June 9, 2021 FDA will host a June 9, 2021 meeting of the Pharmacy Compounding Advisory Committee (PCAC) to discuss four bulk drug substances nominated for inclusion on FDA's list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug and Cosmetic Act (503A bulks list) and a potential addition to the withdrawn or removed list. The bulk drug substances being considered for inclusion on the 503A bulks list are choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. Anyone interested may present data, information, or views, in writing on issues pending before the committee. FDA established a docket (FDA-2021-N-0357) for public comment on this meeting. The electronic filing system will accept comments until 11:59 p.m. Eastern Time on June 8, 2021. CDER is providing a free, live webcast of the June 9, 2021 Pharmacy Compounding Advisory Committee meeting. Further information regarding the webcast is available on the PCAC page. FDA's evaluation of the bulk drug substances under consideration (included in briefing information made available prior to the meeting) and the Pharmacy Compounding Advisory Committee's recommendations regarding these substances (which are made during the meeting) are not final determinations. FDA's consideration of a bulk drug substance for use in human drug compounding does not impact the availability of dietary supplements. While compounded drugs do not undergo premarket review for safety, effectiveness, and quality, we recognize they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. FDA will continue to evaluate additional bulk drug substances for use in compounding as part of continuing efforts to help ensure compounded drugs are available for patients who have a medical need for them. | 
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