Forum

× click the New Topic button to post

BCG Shortage?

1 year 2 months ago #54079 by sara.anne
A few years ago there was a severe shortage of BCG due to contamination in some of the manufacturing processes. So far we have not heard any official word of a shortage .
It is possible that the hospital pharmacy where you are did not have enough in stock .

However with only one supplier left in the market and this being a biological product it is likely to be subject to shortages in the future . Please keep your ears open and let us know if you hear any additional information .

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator

Please Log in or Create an account to join the conversation.

1 year 2 months ago - 1 year 2 months ago #54077 by Jack R
Mike M,

I have not heard of a shortage, nor have I seen BCG listed as in short supply.

The FDA monitors shortages and requires makers to provide advance notice of shortages and discontinued biologicals.

"The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. .."

More info and updated list of shortages at:

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm

At the bottom of the above webpage, there is a number for the FDA you can call to inquire.

Best
Jack

What's with this Bleeding ? 6/2015
DX: HG Papillary & CIS
2 Years and 24 BCG/BCG+Inf
T0 CIS comes back.
BC clear as of 5/17 !
RCC found in my one (only) kidney 10/17
Begin Chemo; Cisplatin and Gemzar
8/18 begin Chemo , round 3

Please Log in or Create an account to join the conversation.

1 year 2 months ago #54076 by Mike M
Hello Friends,
Just completed my 3rd BCG maintenance course (#21) only to learn from my Uro there is an apparent shortage of BCG. Has anyone else heard this and if so, do you have any further information? I've read there is only one maker in the US...Merck, and the other source, Sanofi, in Canada no longer produces BCG. Thanks!

12/15 - DX - Ta HG, 1.5cm Pap, Focal CIS; Treatment: SWOG Protocol...currently BCGx27

Please Log in or Create an account to join the conversation.

  • Not Allowed: to create new topic.
  • Not Allowed: to reply.
  • Not Allowed: to add attachements.
  • Not Allowed: to edit your message.
Moderators: Cynthiaeddiek

Users

Total Online: 0 Users and 405 Guests 

Statistics

Total Messages: 50829 Total Sections: 1 Today Open: 0 Today Total Answer: 0
Total Subjects: 6513 Total Categories: 11 Yesterday Open: 3 Yesterday Total Answer: 9
Total Users: 7771 Latest User: Rev
Powered by Kunena Forum