UPDATE: FDA Releases PCAC Briefing Documents Ahead of November 20-21 Meeting Detailing FDA's Recommendations on API & Compound Nominations
The November 20-21, 2017
Pharmacy Compounding Advisory Committee (PCAC)
meeting briefing document has been uploaded to the FDA website.
In addition, FDA has made updates to the PCAC meeting agenda and public participation details which can be found
here.
These updates include: The Agenda portion has been changed for the November 20-21, 2017 meeting of the Pharmacy Compounding Advisory Committee. For L-citrulline, the uses reviewed have been updated from "Hyperammonaemia due to cycle disorders" to "Hyperammonaemia due to urea cycle disorders". In addition, "The committee also intends to discuss liposome drug products and drug products produced using hot melt extrusion technology" has been updated to "The committee also intends to discuss liposome drug products and drug products produced using hot melt extrusion."
The public participation information has been updated. The deadline for making formal oral presentation requests has been changed from Thursday, October 26, 2017 to
Wednesday, November 8, 2017 and the contact person will now notify interested persons regarding their request to speak
by Thursday, November 9, 2017. All other information remains the same.
Background - What you Need to Know!
The
Food & Drug Administration (FDA) announced on October 25th that a
Pharmacy Compounding Advisory Committee (PCAC) meeting would occur on
November 20-21, 2017 during the week of the Thanksgiving holiday.
PLEASE NOTE: The PCAC meeting will be open to the public, and you are encouraged to submit comments and attend the meeting.
The meeting will be held from 8:30 am to 5:00 pm on Monday, November 20th, and from 8:30 am to 11:30 am on Tuesday, November 21st at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.
In the Agenda portion of the notice, the FDA announced that the nominators of the following substances and products will be invited to make a short presentation supporting the nomination:
astragalus, L-citrulline, pregnenolone, 7-keto dehydroepiandrosterone (DHEA), epigallocatechin gallate (EGCg), and
resveratrol.
There are Three Ways YOU Can Participate and Help:
(1) Submit Comments: Please note while the meeting is November 20-21, comments are due November 17th. Specifically, the invite states that all comments received on or before November 3, 2017 will be provided to the Committee for the meeting. The docket number is FDA-2017-N-5818. The docket will close on November 17, 2017. Submit either electronic or written comments on this public meeting by November 17, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 17, 2017. 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.
(2) Help the Nominators Speak on these Compounds:
a. Do Not Compound List - The committee also intends to discuss liposome drug products and drug products produced using hot melt extrusion for inclusion on the Do Not Compound (Difficult to Compound) List.
b. APIs Positive List - FDA invited those that nominated and we need your help! We are looking for folks that will speak on the drugs nominated and for the uses nominated. Please note that the below APIs have been nominated and the FDA recommendation is out beside the bulk ingredient name
a.
L-citrulline for oral administration - Yes - to add to the Positive List
b.
Astragalus - No - to keep off the Positive List
c.
Pregnenolone - No - to keep off the Positive List
d.
7-keto dehydroepiandrosterone - No - to keep off the Positive List
e.
Epigallocatechin gallate - No - to keep off the Positive List
f.
Resveratrol - No - to keep off the Positive List
|
Drug
|
Uses Reviewed
|
Astragalus
|
Allergic rhinitis, asthma, diabetes, herpes simplex keratitis, wound healing
|
| L-citrulline |
"Hyperammonaemia due to urea cycle disorders
|
| Pregnenolone |
Rheumatoid arthritis, hypercholesterolemia, manic and depressive symptoms of bipolar disorder and bipolar disorder with substance abuse (dual diagnosis), positive and negative symptoms of schizophrenia
|
| 7-keto dehydroepiandrosterone |
Weight loss, Raynaud's phenomena
|
| Epigallocatechin gallate |
Treatment of obesity, wound healing, corneal neovascularization, nonalcoholic fatty liver disease, cardiac hypertrophy, diabetes (type 1 & 2),
Parkinson's disease
|
| Resveratrol |
Treatment of older adults with impaired glucose tolerance, pain
|
(3)
You can Speak at the PCAC Meeting During the Public Session!
Members may speak during the Public Portion of the PCAC Meeting: As a reminder, anyone can speak during the public portion of the meeting. There are designated public sections during every PCAC and sadly hardly anyone speaks due to the lack of knowledge by the public that they may speak during this section. The deadline for making formal oral presentation requests has been changed from Thursday, October 26, 2017 to Wednesday, November 8, 2017 and the contact person will now notify interested persons regarding their request to speak by Thursday, November 9, 2017. The public may speak at the following times:
a. November 20th
i. 9:35 am - 9:45 am
ii. 10:55 am - 11:05 am
iii. 12:00 pm - 12:10 pm
iv. 2:05 pm - 2:15 pm
v. 3:25 pm - 3:35 pm
vi. 4:30 pm - 4:40 pm
b. November 21st
i. 9:40 am - 9:50 am
ii. 11:10 am - 11:20 am
|
