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Administrator
Posts: 578
Registered: ‎02-22-2010
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Webinar on the Compounding Quality Act

[ Edited ]

Thanks for joining the webinar with Eric S. Kastango, "Compounding Quality Act, Title I of the Drug Quality and Security Act of 2013: Understanding its compounding and outsourcing."

View the recording or download the slides.

 

Have a question for Eric? Post it here for him to answer.

Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: Webinar on the Compounding Quality Act

Here are questions that were asked during the live presentation that we did not have time for:

 

Q: Can you go over any restrictions to shipping patient specific compounds across state lines under 503A?  We have heard 5% limit but want to see if this is correct.

Q: Could EK comment on "NABP Certified" pharmacy board inspectors?

Q: If FDA can go into 503a's if not compliant with 795 or 795, then how will they be alerted to this?  especially in states that are not enforcing 797?

Q: So for ambulatory clinics or hospitals that are accredited through TJC then TJC will look for 797 compliance due to the FDA 503a?

Q: I thought that many of the 483 citations on the Web site that lists the suppliers that have applied for a 503B outsourcer pre-dated the official 503A versus 503B legislation, so how can the FDA keep those open?  

Q: What is the Joint Commission’s, stand/comment, on using these compounded products when brought into a health system?

Q: For 503A compounding pharmacies - it speciifically says that the products must be compounded by a pharmacist.  Therefore, are pharmacy technicians excluded from compounding?

Q: I work in NY and you mentioned that NY is moving towards the green states? How will this apply to us and when? Also, if we don't have a USP 797 IV room. Will we be penalized?

Q: Do you recommend requesting certificates of purity and analysis for even sterile products purchased through our wholesaler/manufacturer? i.e. furosemide 40mg/2ml vial from APP bought through Cardinal

Q: Is the $15000 registration and annual or one time fee with the FDA for 503B?

Q: If testing labs/facilities are not wanting to be overseen by the FDA because of 503B, who are some contracting testing labs that have oversight by the FDA now?

Q: Does a health system that batches local anesthetic syringes for clinics within the system need to register with 503A.  The syringes are part of the procedure and are not prepared persuant to a prescription.

Q: Are hospitals going to be held to the same standards as Compounding Manufacturers in regards to FDA inspections?

Occasional Visitor
Posts: 3
Registered: ‎04-02-2014
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Re: Webinar on the Compounding Quality Act

Eric Kastango also touched on non-registered (503A/503B) facilities preparing anticipatory doses (not patient specific) based on order history, etc. and that this will not likely trigger a federal-level enforcement by the FDA. Any comments on a non-registered facility selling non- patient- specific anticipatory doses to another pharmacy in the same state (CA) but not in the same health system? The receiving pharmacy has them on hand as anticipatory doses based on usage and then dispenses them to a specific patient once an order is received.

Expert
Posts: 1,167
Registered: ‎02-23-2010
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Re: Webinar on the Compounding Quality Act

Tracy, 

 

A point of clarifications, A 503A pharmacy is by default a traditional pharmacy that is compounding sterile medications pursuant to a prescription.  No special registration is required.  Based on the information you provide, I believe that the compounding activity you are engaged in is not permitted by the California Board of Pharmacy

There is a license you can get to do for anticipatory compounding but only for your own health system to service inpatients.  I order to do what you are doing, you would need to registered as a manufacturer. I would advise you to contact the CA BOP to verify your compounding is permitted.  

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Visitor
Posts: 3
Registered: ‎04-02-2014
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Re: Webinar on the Compounding Quality Act

Thank you for your response. My pharmacy is actually the receiving pharmacy and the compounding pharmacy providing the anticipatory doses is also registered as a manufacturer. Given that information, do you think that practice is appropriate? Thank you for your insight.

Established Member
Posts: 5
Registered: ‎04-20-2011
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Re: Webinar on the Compounding Quality Act

For Eric - Please provide a response to this question that was asked during the Webinar, but there was not time to answer.

 

Q: For 503A compounding pharmacies - it speciifically says that the products must be compounded by a pharmacist.  Therefore, are pharmacy technicians excluded from compounding?

Senior Member
Posts: 1
Registered: ‎03-31-2014
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Re: Webinar on the Compounding Quality Act

Does the health-system exemption also apply when a facility distributes non-patient-specific compounded products across state lines to other faciltiies within the health-system, assuming that governing state boards of pharmacy will allow this activity?

Expert
Posts: 1,167
Registered: ‎02-23-2010
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Re: Webinar on the Compounding Quality Act

Dan,

 

Nice find!  I read it but it didn't hit me.  I believe this is one of those situations where the law was narrowly crafted and has unintended consequences.  I don't believe that the intent of the law was to exclude technicians.  I will reach out to my contacts at the FDA and see if I can get this clarified.   Thanks. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010
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Re: Webinar on the Compounding Quality Act

Larry,

 

I believe that the health-system exemption applies despite the interstate commerce language, especially since governing state boards allow this activity. Since you are in the same health-system and have some type of relationship with the patient.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: Webinar on the Compounding Quality Act

Tracy,

 

The additional information sheds additional light on the matter.  If this operation is registered with the FDA, then I don't see any issue. Have you confirmed their registration and have they provided you with information about their inspections?   Thanks. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.