USP wants new Rx label standards
February 1st 2011New draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels as early as 2012. Changes to USP Chapter 17, Prescription Container Labeling, include larger font, placement of the most important information at the top, more understandable language, and more white space.
FDA argues legal definition of compounding after deaths of 21 polo ponies
December 15th 2010A pharmacy that engages in veterinary compounding has been embroiled in a struggle with FDA since it compounded a vitamin supplement for administration to 21 polo ponies during the U.S. Open Polo Championships in April 2009. When they were injected with the compounded vitamin supplement, all 21 ponies collapsed and died. FDA's subsequent court challenge raises the question of when compounding becomes manufacture.
FDA restricts access to Avandia, cites increased cardiovascular risks
October 15th 2010FDA has determined to significantly restrict the use of formulations that contain rosiglitazone (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline) to patients with Type 2 diabetes who cannot control their diabetes with other medications.
FDA continues scrutiny of DTC genetic tests
September 15th 2010Underlying a recent FDA-hosted public meeting and workshop was the question of how FDA as a regulatory agency should increase its current oversight of clinical laboratories, specifically those developing genetic tests that may be offered at their own facilities or made available through direct-to-consumer channels.
Monitoring controlled substances
September 15th 2010Thirty-nine states now have a tool to help pharmacists identify at least some questionable prescriptions and suggest when a patient may be doctor-shopping or pharmacy-shopping in order to obtain controlled substances. That tool is the state prescription monitoring program.
FDA panel rejects REMS proposal for long-acting opioids
September 15th 2010FDA advisory committee members voted 25 to 10 to reject a proposed plan to establish a risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.