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Occasional Contributor
Posts: 4
Registered: ‎05-08-2016
0

Medication stored at room temperature

Curious as to how others handle the temperature of medications stored in compounding areas.  We stock a limited supply of mediation in our pharmacy clean and anteroom, however, our temperature in those area will sometimes stabilize at 64° F.  USP Chapter <797> notes a controlled room temperature range of 68 to 77° F.   

 

-     Because USP Chapter <797> also notes working clean room temperatures of less than 68° F, is there anything that permits medications to be stored in those areas at colder temperatures (64° F ) for an extended period of time?   

 

-     Should the USP Chapter <797> temperature range of 68 to 77° F be viewed as an absolute (allowing for short lived excursions for a MKT of 77° F) for medication storage?

 

USP Chapter <659> notes a wider temperature range, however, the last sentence under Temperature and Storage notes “Drug substances are exempt from this standard.” 

 

Our state board of pharmacy is in alignment with USP Chapter <659> temperature range for medication storage, thus setting up the situation where USP Chapter <797> is more stringent.  

 

Any incite will be greatly appreciated. 

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

Re: Medication stored at room temperature

WI state pharmacy is looking at setting a Max humidity of 40% on all storage of meds. Has anyone else seen this? Is this coming from a federal level or change to USP 797?
Occasional Contributor
Posts: 4
Registered: ‎05-08-2016
0

Re: Medication stored at room temperature

I would greatly appreciate Eric's or someones comments on this question as to the storage of meds used in IV compounding in an ante / clean room that is below 20 C. 

 

Thanks again!