Bulk mixers of prescribed drugs get more scrutiny

by Matthew Perrone

Congress has taken a half step toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds of others.

The Senate approved the bill Monday by voice vote, sending it to President Barack Obama for his signature. The House passed the bill in September.

Last year's was traced to a now-closed pharmacy in Framingham, Mass., where inspectors found mold and other unsterile conditions.

Jurisdiction over large-volume compounders has been murky. Pharmacies are typically regulated by state boards, but the Food and Drug Administration regulates drug manufacturers. The gives the FDA authority to inspect large-volume compounders, but doesn't require them to register with the federal agency.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

House unveils bill to police specialty pharmacies

Sep 13, 2013

(AP)—House lawmakers have introduced legislation that would bring more federal oversight to large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year.

Senate questions pharmacy boards after outbreak

Nov 19, 2012

(AP)—A Senate committee investigating a deadly outbreak of meningitis wants to know how regulators in all 50 states oversee specialty pharmacies like the one that triggered the illness.

Congress investigating compounding trade group

Dec 07, 2012

(AP)—House lawmakers are investigating whether the industry group for compounding pharmacies coached the company responsible for a deadly outbreak of meningitis in dealing with regulators.

FDA chief renews push for specialty pharmacy rules

Dec 19, 2012

(AP)—The head of the Food and Drug Administration renewed her push for new rules to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest ...

Consumer watchdog asks FDA to revisit compounders

Nov 29, 2012

(AP)—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded ...

Recommended for you

Blood test for yeast infections approved

7 hours ago

(HealthDay)—The first blood test to detect five strains of yeast that cause rare blood infections in people with weakened immune systems has been approved by the U.S. Food and Drug Administration.

Discount generic drug programs grow over time

Sep 22, 2014

Generic discount drug programs (GDDPs, which charge nominal fees to fill prescriptions) have grown over time and their initial lower use by racial/ethnic minorities has evaporated, writes author Song Hee Hong, Ph.D., of the ...

Seniors successfully withdraw from meds

Sep 19, 2014

Elderly people have proved receptive to being de-prescribed medications, as part of a trial aimed at assessing the feasibility of withdrawal of medications among older people.

User comments