Tuesday, September 29, 2015

Destroying Certain Imported Drugs: A New Rule to Protect Patients

By: Howard Sklamberg and Melinda K. Plaisier
Recently, FDA published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This new rule, which will take effect on October 15, 2015, provides FDA … Continue reading 

USP seeks feedback on one of two national standards for compounding Pharmacy Today, American Pharmacists Association, pharmacist.com‎ -

USP seeks feedback on one of two national standards for compounding
Pharmacy Today, American Pharmacists Association, pharmacist.com - 1 hour ago
The chapter is one of two national standards for compounding under USP. <797> specifically details requirements for the process, testing, and verification

FDA Warning Letter: Specialty Medicine Compounding Pharmacy, P.C. Compounding Pharmacy/Adulteration/Misbranding

August 31, 2015Specialty Medicine Compounding Pharmacy, P.C.Detroit District OfficeCompounding Pharmacy/Adulteration/MisbrandingNot Issued *

FDA Warning Letter Red Mill Farms, LLC Unapproved New Drugs/Misbranded

September 17, 2015Red Mill Farms LLCPhiladelphia District OfficeUnapproved New Drugs/MisbrandedNot Issued *

FDA Warning Letter TruVision Health LLC DMBA/Labeling/Dietary Supplement

September 21, 2015TruVision Health LLCCenter for Food Safety and Applied NutritionDMBA/Labeling/Dietary Supplements/AdulteratedNot Issued *