Please note that IACP and other pharmacy organizations previously let Congress know that these meetings should be webcast to the public and you can now watch the PCAC live webcast here. As IACP stated within its comments that you can read here, IACP is still very disappointed that while two PCAC members have been allowed to participate via conference call for this meeting, FDA denied all stakeholder participation via conference calls even during the public meeting sections.

• Produced by fermentation, soluble in water.  Likely to be stable as solid or liquid for oral dosage. 
• Has been used to treat UCDs for 30 years
• Available as a dietary supplement
• Found in many foods, non-essential amino acid, antioxidant and vasodilator.
• Data shows it passes to sheep fetus from placenta
• Little toxicity at high doses
• Adverse Events- 332 reports, 3 deaths but multiple supplements were used so not causality
• Limited safety data, but decades of use shows little in safety concerns
• Compounded and used in dietary supplements and is standard of care in certain UCDs
• Published dosage recommendations.
• Conclusion: It is effective in the treatment of certain UCDs
• Recommendation:  Balance 4 evaluation criteria weighs in favor of adding to bulk drug substances list for 503A.

• Handful of pharmacies specialize in UCDs- relevance for MOU
• Dr. Burn: Question- 500-750mg dosage depending on weight of patient.  (pharmacists provided data on range of dosage to AJ)
• IV vs Oral: AJ not aware of any promotion of or use of IV for L-c
• Q: Subpotent reports.  A: Quality control by wholesaler, previous to pharmacies receiving.  PCCA has process where every ingredient in quarantined and verified.

• Q:  subpotent formulations, were they DS or compounds? A: Bulk substance was not L-c so it was the manufacturer's error.
• Q: How many manufacturing sites for this product.  A: PCCA uses a Japanese co with US office
• Q: Certificate of Analysis for subpotent product did it say it was L-c? A: 99.8% National Compounding Supplier.
• Q: Impurities in fermentation? A: AJ: None other than in FDA presentation.
• Comment: Certificate of Analysis is critical to compounder as they rely on bulk manufacturer.
• With no USP Monograph, where does pharmacist get purity standards?
• Guidance for best practices on compounders dealing with manufacturers.
• AJ: Does independent analysis.
• Q: Qualitative Analysis include identity testing?  A: Yes
• Comment: relationship with Distributor also important to compounder.
• Melting Point studied? Manufacturer chose not to.
• Dietary supplements have been found to be subpotent or totally absent of L-c

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

View FDA Documents and Federal Register Public Meeting Notice