Roxanol being pulled from the market by FDA

[doodlemom]

Also MSIR, Oxyfast....

Please notify your administrators. Get in touch with your legislators and start a campaign. If this happens, this will have a huge impact on our patients care. The only way to obtain the strength needed for our pt's will be to compound. If anyone has contact at NHPCO, contact them.

http://www.medpagetoday.com/ProductAlert/Prescriptions/13526

[Melinurse]

So why exactly is it being pulled? Is it just because someone forgot to go through the FDA red-tape? We have had no problems getting our Roxinal filled or even heard of any kind of ban/re-call. We occasionally do use oxyfast though and no problems there either in ordering. rngolfer53, I agree, sounds like bureucratic bologna to me too.

[heron, ASN, RN]

MSIR and oxyfast are being pulled, as well.

From my reading, not all brands, just those that don't comply. The only one that has no approved version is the 20:1 morphine concentrate, according to the linked article.

[Havin' A Party!, ASN, RN]

Why's this arising now?

And how did these meds get the original go-ahead without full approval?

[Compliance Guy]

As a FYI from someone in the drug industry. The drugs were allowed on the market for a while due to being "grandfathered" in. This means for drugs that had been manufactured prior to a certain date, they were allowed to be sold since they had already been in the market for a while. You may not have noticed since the FDA was very quiet about it, but they rescinded the warning letters and have allowed some of the manufacturers to remain on market. I know that a number of companies had already filed with the agency and had been waiting for approval when the warning letters came out.