California Board of Pharmacy License for Medical Devices??

#1
Hello,

We have a customer that is insisting the DC needs a California Board of Pharmacy License before they can ship a Convenience Kit to them that contains a scalpel. There are no drugs in the kit so i disagree with needing a drug license.
Can anyone help shed some light as to what they might be referring to. I am at a loss :confused:
Thanks!
Vicki
 
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#5
Why not ask the customer what they're referring to and where they got the information?
Thanks Jim,
We currently sell to ...many... DC's and we do not require a drug license unless the kit has a drug in it. The part in question is a scalpel in the kit. When I read the 2021 California Lawbook for Pharmacy it mentions dangerous device but i still do not understand the need for a drug license when a scalpel is clearly not a drug.

Posing the question to them might open a can of worms so i wanted to check with the forum before i reached out to them.
Thanks again for your help!
 
#6
Thanks Jim,
We currently sell to ...many... DC's and we do not require a drug license unless the kit has a drug in it. The part in question is a scalpel in the kit. When I read the 2021 California Lawbook for Pharmacy it mentions dangerous device but i still do not understand the need for a drug license when a scalpel is clearly not a drug.

Posing the question to them might open a can of worms so i wanted to check with the forum before i reached out to them.
Thanks again for your help!
I saw that sutures and syringes are mentioned in the dangerous devices list in the California Lawbook for Pharmacy. I worked for a 503B Pharmacy in Quality and Manufacturing a few years ago and remember that the California regulations seem to be much more comprehensive than other states. I'd agree that making an inquiry to learn where the request is coming from is a great idea.
 
#7
I saw that sutures and syringes are mentioned in the dangerous devices list in the California Lawbook for Pharmacy. I worked for a 503B Pharmacy in Quality and Manufacturing a few years ago and remember that the California regulations seem to be much more comprehensive than other states. I'd agree that making an inquiry to learn where the request is coming from is a great idea.
Thank you Vagabondbettie.
It just seems strange that we sell to one of the largest medical device distributors in the country and they are saying they can't ship from their Texas facility to their California facility because of a scalpel. We ship this kit to 3 of their other facilities with no issues. Is this just a California thing?
Thanks again!
 
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