» Subscribe Today!
More of what you want to know.
The Daily News
X

Forgot your password?
Skip Navigation LinksHome >
VOL. 129 | NO. 8 | Monday, January 13, 2014

States Urged to Register Compounding Pharmacies

AP

Print | Front Page | Email this story | Comments ()

BOSTON (AP) – The commissioner of the U.S. Food and Drug Administration has sent letters to state agencies and other stakeholders across the country calling on them to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public.

The letter from Commissioner Dr. Margaret Hamburg, dated Wednesday, reminds stakeholders of a law passed last year in response to a meningitis outbreak from contaminated steroid pain injections that killed 64 people and sickened more than 750. The outbreak was traced to the now-closed New England Compounding Center pharmacy in Framingham.

Under the new law, large-volume compounding pharmacies that send medicine all over the country can voluntarily register with the FDA and submit to federal inspections and quality standards, much like drug manufacturers.

"If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide their patients with drugs that were compounded in outsourcing facilities," which are subject to manufacturing standards and increased oversight, said the letter to governors, state boards of pharmacy and health departments.

U.S. Sen. Tom Harkin, an Iowa Democrat who heads the Senate Health, Education, Labor, and Pensions Committee, said Friday that the law and the FDA's letter help "ensure the safety of compounded drugs and is aimed at helping to prevent a future public health crisis."

"We're already seeing progress with 14 outsourcing facilities registered with the FDA," Harkin said in a statement. "I urge state leaders in Iowa and around the country to continue this progress by working with the FDA and other health officials to move forward with the smooth and timely implementation of the law so that patients will have access to safe, high-quality compounded drugs."

President Barack Obama signed the bill into law in November.

Jurisdiction over such large-volume compounding pharmacies has long been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.

The law attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar operations to skirt both state and federal regulations.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Sign-Up For Our Free Email Edition
Get the news first with our daily email


 
Blog Get more from The Daily News
Blog News, Training & Events
RECORD TOTALS DAY WEEK YEAR
PROPERTY SALES 32 344 10,222
MORTGAGES 52 452 13,327
FORECLOSURE NOTICES 30 106 2,644
BUILDING PERMITS 0 783 24,307
BANKRUPTCIES 60 359 9,892
BUSINESS LICENSES 23 133 3,736
UTILITY CONNECTIONS 76 595 14,558
MARRIAGE LICENSES 23 104 3,167

Weekly Edition

Issues | About

The Memphis News: Business, politics, and the public interest.