Advisory Committee Meeting
Event Title
UPDATED INFORMATION: September 12, 2018: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement
September 11, 2018
- Date:
- September 11, 2018
- Time:
- 8:00 PM - 8:00 PM ET
UPDATED INFORMATION (as of 8/14/2018):
The Agenda portion has been changed for the September 12, 2018 meeting of the Pharmacy Compounding Advisory Committee. The choline chloride topic will not be discussed.
The Public Participation information has been updated. Oral presentations from the public will be scheduled between approximately 10:00 a.m. and 10:10 a.m. (alpha lipoic acid), 11:15 a.m. and 11:25 a.m. (coenzyme Q10), 1:15 p.m. and 1:25 p.m. (creatine monohydrate), 2:20 p.m. and 2:30 p.m. (pyridoxal 5 phosphate), and 3:35 p.m. and 3:55 p.m. (quercetin dehydrate) on September 12, 2018. All other information remains the same.
UPDATED INFORMATION (as of 7/25/2018):
The Agenda portion has been changed for the September 12, 2018 meeting of the Pharmacy Compounding Advisory Committee. For choline chloride, the uses reviewed have been updated to include supplementation in long term total parenteral nutrition. In addition, the bulk drug substance quercetin has been updated to quercetin dihydrate. All other information remains the same.
| Drug | Uses Reviewed |
|---|---|
| alpha lipoic acid | Diabetic neuropathy and associated pain, acute liver toxicity from Amanitaspp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain |
| coenzyme Q10 | Mitochondrial disorders |
| creatine monohydrate | Mitochondrial disorders |
| pyridoxal 5 phosphate | Epilepsy and seizure disorders |
| choline chloride | Hepatic steatosis, supplementation in long term total parenteral nutrition, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis |
| quercetin dihydrate | Asthma, allergy, cancer prevention and treatment, and hypertension |
Original Information
| Center | Date | Time | Location |
|---|---|---|---|
| CDER | September 12, 2018 | 8:00 a.m. to 4:30 p.m. | FDA White Oak Campus |
Agenda
The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.
| Drug | Uses Reviewed |
|---|---|
| alpha lipoic acid | Diabetic neuropathy and associated pain, acute liver toxicity from Amanita spp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain |
| coenzyme Q10 | Mitochondrial disorders |
| creatine monohydrate | Mitochondrial disorders |
| pyridoxal 5 phosphate | Epilepsy and seizure disorders |
| choline chloride | Hepatic steatosis, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis |
| quercetin | Asthma, allergy, cancer prevention and treatment, and hypertension |
Meeting Materials
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 web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2018 Meeting Materials, Pharmacy Compounding Advisory Committee.
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-2018-N-2733. The docket will close on September 11, 2018. Submit either electronic or written comments on this public meeting by that date. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 2018. 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 August 28, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows:
Comments received on or before November 3, 2017, will be provided to the committee. Comments received after that date but by November 17, 2017 will be taken into consideration by the Agency.
Interested persons may submit either electronic or written comments regarding this meeting. You may submit comments as follows:
Electronic Submissions
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”).
Written/Paper Submissions
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-2018-N-2733 for “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
- 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.” The Agency 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 Division of Dockets Management. If you do not wish your name and contact information to 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 this 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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 9:40 a.m., 10:45 a.m. and 10:55 a.m., 11:50 a.m. and 12 noon, 1:50 p.m. and 2 p.m., 3:05 p.m. and 3:15 p.m., and 4:10 p.m. and 4:20 p.m. on September 12, 2018. 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 August 20, 2018.
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 August 21, 2018.
Webcast Information
CDER plans to provide a free of charge, live webcast of the September 12, 2018 meeting of the Pharmacy Compounding Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, 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: 2018 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.
Contact Information
- Jay R. Fajiculay, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
Email: PCAC@fda.hhs.gov
- FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).