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FDA issues guidance to pharmacists on Tamiflu compounding and
updates emergency use Q&A
Preparing oral suspension from tablets necessary when commercial
product is unavailable.
On November 2, 2009, FDA
issued detailed guidelines to pharmacists for the preparation
of oseltamivir oral suspension from commercially available Tamiflu
(Roche) capsules. The agency also said that it will not object to
pharmacies compounding in advance of receipt of prescriptions for the
anti-influenza product as long as the amount is limited to what can be
reasonably anticipated within the following 24 hours.
Prescribers and pharmacists have faced a shortage of commercially
available Tamiflu for Oral Suspension for several weeks, as cases of
2009 novel A/H1N1 influenza have swept through schools, colleges, and
workplaces. CDC now reports “widespread” influenza in 48
states along with related hospitalizations and deaths.
The FDA guidance, which APhA has reformatted into a
document suitable for posting in pharmacies, outlines specific
procedures for compounding oseltamivir oral suspension, including types
of dispensing bottles to used, amount to be prepared for patients of
various weights, preferred vehicles, and storage requirements.
Emergency use for Tamiflu and Relenza Q&A updated
The FDA has also amended their original, July 2009, Emergency Use
Authorizations (EUAs) for both Tamiflu and Relenza that authorized
the use of certain lots of expired or expiring Tamiflu for Oral
Suspension that were still good for use beyond their expiration
dates. The amended EUAs, released October 30, 2009, expand the
EUAs to lots of Tamiflu Capsules and Relenza Inhalation Powder. The FDA
has posted updated Questions
and Answers addressing the EUAs.
Web links
Related resources on pharmacist.com
L. Michael Posey, BPharm (mposey@aphanet.org)
Posted
November 3, 2009, 4:00 pm EST
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