04-03-2014 04:05 PM
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.
A: -->The 5% rule has to do with compounding/dispensing for office use. You need to understand what the non-resident pharmacy laws and licenses are in the states that you are shipping into so you don't have any surprises. The boards are getting tough on out-of-state pharmacies that are not licensed in the state that they shipping into.
Q: Could EK comment on "NABP Certified" pharmacy board inspectors?
A--> I know that NABP has been hired by some states to inspect their pharmacies. I am not aware of a formal program that certifies this 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?
A-->Great question and I believe this one was the last question I answered. The FDA will go in if they get a complaint or a MedWatch report is filed. This will take some coordination but will be difficult. I think that the FDA was putting people on notice that they will find "you" if you are not following the new law.
Q: So for ambulatory clinics or hospitals that are accredited through TJC then TJC will look for 797 compliance due to the FDA 503a?
A:-->I know the TJC is reviewing their position on USP 797, in light of the NECC event and this new law. There hasn't been any official statement from TJC on what they plan to do post DQSA.
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?
A:-->FDA can do whatever they want :-) but they could be keeping those 483s open because they were not satisified with the pharmacy's remediation plan or they have ongoing concerns with their findings.
Q: What is the Joint Commission’s, stand/comment, on using these compounded products when brought into a health system?
A:-->TJC requires you to evaluate any provider of services that is purchased by the hospital. The TJC standard that appears is:
LD.04.03.09: Care, treatment, and services provided through contractual agreement are provided safely and effectively.
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?
A:-->All good questions, none of which I can answer. You will need to keep your eyes and ears open re: NYS regulations. NYS BOP will decide what they expect re: compliance dates. I would imagine that they will give everyone sometime to get in compliance. Compliance cannot happen overnight.
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
A:-->If you are 503B pharmacy, the FDA will expect you to have specifications for accepting drugs, supplies, etc and a way to prove that your product is approved for use. If you are a 503A pharmacy, there isn't any requirement to verify purity and content.
Q: Is the $15000 registration and annual or one time fee with the FDA for 503B?
A:-->I believe the registration.fee will be annual or bi-annual. This is one of the aspects of the law that needs to be finalized.
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?
A:-->You want to look for labs that ISO 17025 and GLP. Dr. Scott Sutton who has presented with me in the past is doing a webinar on Contract Testing Labs. You can sign up by visiting: https://www3.gotomeeting.com/register/915502302
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.
A:-->If your state board of pharmacy allows you to supply your clinics with compounded medication, then you don't need to register as a 503B pharmacy. The default position for pharmacies is 503A. There is nothing you need to do.
Q: Are hospitals going to be held to the same standards as Compounding Manufacturers in regards to FDA inspections?
A:--> No, not to my knowledge. The FDA won't require regionalized compounding operations to register as a 503B pharmacy unless your state board of pharmacy doesn't permit that activity.