Pharmacists bottles

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill") [ enhanced version available to lexis.com subscribers ], which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal proposal for regulating...

Physician's Failure To Read Trumps Drug Company's Failure To Warn

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the drug, plaintiff’s claim that the label should...

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the annual...

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers , which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability...