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PCAC Continues 2nd Day of Voting Session: IACP Statement on Proceedings

Wednesday, March 9, 2016   (1 Comments)
Posted by: Dagmar Anderson
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The Pharmacy Compounding Advisory Committee (PCAC) began the second day of a two-day session, March 9th, with this morning's vote below.


1) FDA is proposing that metered dose inhalers be placed on the list of drug products that present demonstrable difficulties for compounding in accordance with sections 503A and 503B of the FD&C Act (“the difficult to compound list”). Should Metered dose inhalers be placed on that list?


Yes Votes: 9; No Votes: 0


2) FDA is proposing that dry powder inhalers be placed on the difficult to compound list. Should dry powder inhalers be placed on the list?


Yes Votes: 9; No Votes: 0


PCAC March 8th Voting Recap

Yesterday, the committee discussed six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA discussed the following nominated bulk drug substances: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine.


Please keep in mind this is for the POSITIVE list. PCAC voted whether to add these bulk substances to the positive list and thus allow compounding with these bulk substances.


Should Quinacrine Hydrochloride be placed on the positive list?

Yes votes: 5; No votes: 6

Should Boswellia be placed on the positive list?

Yes votes: 0; No votes: 11 


Should Aloe Vera freeze dried 200:1 be placed on the list?


Yes votes: 1; No votes: 9


Should D-Ribose be placed on the list?


Yes votes: 1;  No votes: 10


Should Chondroitin Sulfate be placed on the list for topical use? This question was changed after a point of clarification from the Committee.


Yes votes: 0;  No votes: 10


Should Acetyl-L-Carnitine be placed on the list?


Yes votes: 1;  No votes: 10


PLEASE NOTE: These votes are NOT final. FDA must release final guidance for this to be FINAL. These are the Committee’s votes on FDA’s recommendations.


IACP Statement on the March 8 & 9 PCAC Proceedings


Patient access to the compounded medications upon which they rely is of paramount importance to the International Academy of Compounding Pharmacists (IACP). For this reason, IACP was very disappointed with the voting trend from yesterday’s PCAC session. From a practicing pharmacist’s perspective, our utmost concern is taking care of our patients. With the inability to use some of these bulk drug substances, patients will be negatively impacted.


While we were encouraged the FDA established the Pharmacy Compounding Advisory Committee (PCAC), IACP never has been confident with the process FDA used to assemble the current panel. IACP continues to have serious concerns about the lack of representation of actual practicing compounding pharmacists.


IACP submitted 24 nominees to the FDA, many with extensive real-life compounding practice experience, and only one was selected. Further the compounding pharmacist we nominated and accepted was not granted the ability to vote by FDA. The FDA deemed this pharmacist a non-voting member of the panel. As a result, we simply are not confident compounding pharmacists have a real seat at the PCAC table, and we have continuing concerns that the Drug Quality and Security Act (DQSA) will not be implemented as Congress intended.


IACP President Gary McCrory, RPh, CCN


Santo Garro says...
Posted Wednesday, March 9, 2016
Kangaroo court!!

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