Header graphic for print
Focus on Regulation

Tag Archives: pharmacy

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state

Price discrimination in the pharmaceutical sector: new decision, but plaintiffs face same challenges

The Second Circuit recently affirmed a lower court ruling dismissing claims brought by retail pharmacies against Johnson & Johnson, Caremark, Express Pharmacy Services of PA, and American Home Products, alleging that lower prices offered to certain “favored purchasers” amounted to unlawful price discrimination under the Robinson-Patman Act.  Among other things, the Robinson-Patman Act makes it illegal

New UK Registration Requirements for Online Medicine Retailers

From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together