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Administrator
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Registered: ‎02-22-2010
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Webinar on the Current State of Compounding Standards: What Happens Next?

[ Edited ]

Thanks for joining our webinar, "The Current State of Compounding Standards: What Happens Next?" with Eric S. Kastango, M.B.A., B.S.Pharm., FASHP. 

 

Have a question for Eric regarding only content covered by the webinar? Please ask it here.

Administrator
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Re: Webinar on the Current State of Compounding Standards: What Happens Next?

Some questions from our live presentation that we did not have time for:

 

Q: FDA guidelines have shorter BUD then the defaults in USP 797. Do you anticipate that the FDA will lengthen or will USP shorten theirs?

 

Q: Do you think/feel that justification of scientifically based decisions being used by some 503b facilities will come to be accepted by the FDA? i.e. validation of the processes that ensure sterility and stability in lieu of sampling every batch

 

Q: Has FDA changed the exemption of GMP for Phase 1 trials?

 

Q: Are 503B pharmacies allowed to provide non-sterile office use compounds if their state allows office use compounding?

Expert
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Registered: ‎02-23-2010
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Re: Webinar on the Current State of Compounding Standards: What Happens Next?

Thank you for your patience and these thought-provoking questions.  See my responses below.

 

Q: FDA guidelines have shorter BUD then the defaults in USP 797. Do you anticipate that the FDA will lengthen or will USP shorten theirs? 

 

A: I believe that there is no reason that pharmacy prepared CSPs need an extended BUD past 45-60 days.  We have become so accustomed to maximizing BUD with minimal regard to the impact when microbiological contamination is present.  I expect that the shorten BUDs will be carried over to the next revision of USP 797 where the BUDs will be capped.  

 

Q: Do you think/feel that justification of scientifically based decisions being used by some 503b facilities will come to be accepted by the FDA? i.e. validation of the processes that ensure sterility and stability instead of sampling every batch

 

A:  I do not!  Aseptic processing using people presents the greatest risk of contamination and CGMPs require sterility testing to be done for every batch for these types of manually prepared drugs.  Media fills and additional environmental monitoring CANNOT be used to extend dating and it is only a matter of time before the FDA takes significant action against those 503B operations that refuse to comply with the draft 503B guidance and CGMPs. There is NO provision in either of those documents to support the position that these companies are taking.  

 

Q: Has FDA changed the exemption of GMP for Phase 1 trials?

 

A: Not that I am aware of, however, I recently visited an operation that was involved in this type of work and when the FDA audited them, there wasn't any focus on the compounding quality systems being used.  

 

Q: Are 503B pharmacies allowed to provide non-sterile office use compounds if their state allows office use compounding? 

 

A: Interesting question.  503B outsourcing facilities need to do sterile compounding first and foremost and can also do non-sterile compounding.  They cannot manufacture OTC meds so these non-sterile doses need to be "legend drugs" (drugs that require a prescription).  The FDA's position on compounding for office use is that it must be done by a 503B outsourcing facility so technically, the state rules don't come into play here since the federal rules would supersede state rules, or whichever is more strict.  

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Advisor
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Re: Webinar on the Current State of Compounding Standards: What Happens Next?

Thank you for your webinar and insight in to 797

rayasam

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Re: Webinar on the Current State of Compounding Standards: What Happens Next?

Were do we find a copy of the slides that were presented?

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Re: Webinar on the Current State of Compounding Standards: What Happens Next?