- June 9, 2021
UPDATED INFORMATION (as of 6/4/2021):
The meeting time has changed to 9:45 a.m. to 5:05 p.m. Eastern Time for the June 9, 2021 Pharmacy Compounding Advisory Committee meeting.
Public Participation Information:
Oral presentations from the public are scheduled between approximately 10:45 a.m. to 11 a.m., 12:25 p.m. to 12:40 p.m., 2:15 p.m. to 2:30 p.m., 3:35 p.m. to 3:50 p.m., and 4:40 p.m. to 4:55 p.m. Eastern Time.
UPDATED INFORMATION (as of 5/21/2021):
The Agenda portion has been changed for the June 9, 2021 meeting of the Pharmacy Compounding Advisory Committee. For choline chloride, one of the uses reviewed has been updated from “Liver diseases (including hepatic steatosis and non-alcoholic fatty liver disease)” to “Liver diseases (including non-alcoholic fatty liver disease) and hepatic steatosis”.
All other information remains the same.
|CDER||June 9, 2021||9:45 a.m. to 5:05 p.m.||Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.|
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
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.
|Bulk Drug Substance||Uses Evaluated|
|Choline Chloride||Liver diseases (including hepatic steatosis and non-alcoholic fatty liver disease).|
|Fetal alcohol spectrum disorder.|
|Supplementation in long term total parenteral nutrition.|
|Melatonin||Treatment of sleep disorders in patients with autism spectrum disorder (specifically children and adolescents).|
|Methylcobalamin||Amyotrophic lateral sclerosis (also known as ALS).|
|Peripheral neuropathy (including diabetic neuropathy).|
|Inborn errors of metabolism (also known as genetic metabolic disorders) (including methylenetetrahydrofolate reductase deficiency (also known as MTHFR)).|
|Hyperhomocysteinemia (including conjunctive therapy in hemodialysis patients).|
|Vitamin B12 deficiency.|
|Autism spectrum disorder.|
|Oxitriptan (5-HTP)||Treatment for patients with tetrahydrobiopterin (BH4) deficiency.|
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.
FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at 2021 Meeting Materials, Pharmacy Compounding Advisory Committee. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-0357. The docket will close on June 8, 2021. Submit either electronic or written comments on this public meeting by June 8, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 8, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Comments received on or before May 26, 2021, will be provided to the committee. Comments received after that date but by June 8, 2021 will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows:
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2021-N-0357 for “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
- Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:15 a.m., 12:25 p.m. to 12:40 p.m., 2:15 p.m. to 2:30 p.m., 3:35 p.m. to 3:50 p.m., and 4:40 p.m. to 4:55 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 17, 2021.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 18, 2021.
CDER plans to provide a free of charge, live webcast of the June 9, 2021 Pharmacy Compounding Advisory Committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2021 Meeting Materials, Pharmacy Compounding Advisory Committee
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- Takyiah Stevenson, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
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