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Advisor
Posts: 24
Registered: ‎09-22-2017
0

WI state pharmacy.. need storage RH.. max 40%

The state of Wisconsin is looking at a Max 40% humidity for drug storage. Anyone else see this? Driven by new federal regs/standards?
Current is 45 to 60%.. I believe.
Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: WI state pharmacy.. need storage RH.. max 40%

Can you send me the regulation that states this requirement?  I have no idea what is driving this unreasonable expectation.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 24
Registered: ‎09-22-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

http://dsps.wi.gov/Documents/Board%20Services/Agenda%20Materials/Pharmacy/2017/20170921PHMOpenSessio...

Page 15-17.

First paragraph. Pg 17.. states it best
"Dry place". Max Rh 40%

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: WI state pharmacy.. need storage RH.. max 40%

Brian,

 

I reached out to my temperature and humidity gurus on an asinine requirement and asked for their thoughts.  Here is an excerpt of one of the responses.  They are pharma scientists and one of them wrote the attached article that was published in PF.  It is a very technical document but the conclusion is where it all comes together. 

 

The issue of relative humidity control is challenging because most people, and here I include scientists, do not stop to think what relative humidity actually is: the ratio of the amount of moisture in the air to the amount that the air could hold at a given temperature. It is this link between relative humidity and temperature that is often lost. The amount of moisture in the air is negligible at refrigerator temperatures, but the RH is high because the air can hold very little moisture at those temps. I have attached a copy of the USP Stimuli article I wrote with some colleagues on this topic. Here is the key conclusion:

 

            Because of the moisture protection afforded by proper packaging, humidity excursions of 7 days or less are unlikely to result in loss of product quality.

 

It is hard to imagine that controlling humidity in pharmacies is value-added. Pharmacies where there is no temperature control where the resulting high temperatures could involve relative humidities that are significant, but I would still worry more about the risk to product quality from the high temperatures than the humidity.

 

Hope this helps. 

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 24
Registered: ‎09-22-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

Thanks! I did a quick read, I'll print and read again. Wow, by your reaction, WI appears to have really jumped beyond USP 797. Several have just finished USP 800/797 remodels and several underway.. IF accepted, more huge HVAC remodels after the current program. I'm the CETA member who sat behind you before/after your Tampa presentation. Same guy who probably started all the BCG and USP 797/800 discussion a few years back. Thanks!
Advisor
Posts: 13
Registered: ‎09-25-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

Our  VPP inspection included non-compliance in VPP # 42.00 - 42.03 Humidity in nonsterile compounding and VPP 49.00 Sterile compounding -  "Humidity-in the compounding area is maintained to provide humidity in the ranges warranted by specific drug product storage requirements. If drug produts require storage in a "dry place", humidity is not to exceed 40%. Generall recommended range is 35-60%.  I am looking for how to respond to VPP. 

Advisor
Posts: 24
Registered: ‎09-22-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

Who is vpp?
Advisor
Posts: 13
Registered: ‎09-25-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

Verified Pharmacy Program - through the National Association of Boards of Pharmacy.  The NABP VPP inspection was in lieu of the State Board of Pharmacy (MI) inspection, as MI does not have enough trained compounding inspectors. 

Occasional Advisor
Posts: 8
Registered: ‎09-23-2016
0

Re: WI state pharmacy.. need storage RH.. max 40%

That is kind of how I read the WI requirement as well. If a drug storage requirement is a dry place, then it must be stored as such. If the manufacturer does not require it, then 30%-60% is fine.

Advisor
Posts: 13
Registered: ‎09-25-2017
0

Re: WI state pharmacy.. need storage RH.. max 40%

Where do I find the humidity requirements in USP?  I only find general requirements in USP 795, not in USP 797.  I did find USP 659 Packaging and Storage Requirements (official May 1, 2019), however no mention is made regarding humidity standards.

Thank you!