Archives for February 2016

Why senators blame the FDA for the spread of opioid addiction

WASHINGTON – The U.S. Food and Drug Administration is supposed to regulate pharmaceuticals and keep addictive drugs from being easily abused.

But when a U.S. senator say the FDA stands for “Fostering Drug Addiction,” you know there’s a problem.

3 compliance rules pharmacies must know

With 2016 well underway, pharmacies of all sizes should review recent regulatory updates to ensure compliance with rules already in effect, and preparation for those to be implemented soon. Three, in particular, warrant a close look.

FDA issues guidelines to prevent Zika virus spread

If you’re thinking about donating blood and have traveled recently to areas affected by the Zika virus, federal officials are saying hold off.

There have been no reports so far of the virus getting into the U.S. blood supply, the Food and Drug Administration said.

U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease

FOSTER CITY, Calif.–(BUSINESS WIRE)–Feb. 16, 2016– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.

USP 800 Chapter

USP Publishes Standard on Handling Hazardous Drugs in Healthcare Settings

Rockville, Md., February 1, 2016—The United States Pharmacopeial Convention (USP) published today an important new standard as part of a suite of healthcare quality standards included in the United States Pharmacopeia-National Formulary (USP-NF).

Hospital fined for leaving towel inside patient for three months after surgery

FRESNO, CA (WCMH) — A hospital in Fresno, California will have to pay an $86,000 fine for a mistake that nearly cost a patient his life by leaving a towel inside his body following surgery.