FDA readies for GDUFA-driven surge in supply chain data

August 24, 2012

By Nick Taylor

The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain. And it is a familiar scenario, with the FDA drawing heavily on the 2009 electronic drug registration and listing guidance.

Read more: here.

Compounders Sent Letters Regarding Prascend (Pergolide)

IACP is reporting that  it has become:

aware of letters being sent to compounders by Boehringer Ingelheim about their product Prascend (pergolide). The manufacturer cautions all pharmacists that any compounding of pergolide for veterinary use must only be done using their finished drug product and not the active pharmaceutical ingredient (API). If you’ve received that letter and want to know the specifics, contact us at iacpinfo@iacprx.org

To read more information on the IACP website, click here

Denver Pharmacy To Pay $87,500 In Settlement - Topix

Denver Pharmacy To Pay $87,500 In Settlement - Topix

U.S. appeals court strikes down FDA tobacco warning label requirement

August 24, 2012 12:19 PM(CBS/AP) 

Today, the U.S. Court of Appeals in Washington upheld a decision barring the federal government from requiring tobacco companies to put large graphic health warnings on cigarette packages to show that smoking can disfigure and even kill people.  Although not a compounding decision, this case is a significant decision relating to the FDA and warning labels.   To read more about this case, click here.

Cutting the red tape: Is the FDA a threat to patient health? - Pharmaceutical Technology

Cutting the red tape: Is the FDA a threat to patient health? - Pharmaceutical Technology