Extra steps urged for regulating compounding pharmacies

Extra steps urged for regulating compounding pharmacies

(HealthDay)—Additional steps are needed for regulating compounding pharmacies, according to a perspective piece published online Dec. 25 in the New England Journal of Medicine.

Noting that the 2012 fungal meningitis outbreak was linked to the New England Compounding Center (NECC) in Farmington, Mass., Kevin Outterson, J.D., L.L.M., from the Boston University School of Law, discusses limitations of the Drug Quality and Security Act as a potential solution for regulating compounding pharmacies.

The author notes that the new Act goes some way to improve regulation, including reenactment of Section 503A. However, to avoid a similar tragedy as that involving the NECC, new state legislation is needed. Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering . The U.S. Food and Drug Administration has clearer authority, but needs support from other stakeholders, including adequate funding from Congress. Furthermore, providers and health plans can play a role by insisting compounded drugs are exclusively sourced from FDA-regulated facilities.

"The Drug Quality and Security Act may have been a good first step, but patients will not be protected unless states, the FDA, and and plans act quickly to fill in the gaps left by Congress," Outterson writes.

More information: Full Text

Related Stories

FDA starts regulating compounding pharmacies

date Dec 02, 2013

(HealthDay)—The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies, which create new drug combinations or alter drugs to suit individual patient needs.

FDA chief seeks new powers to police pharmacies

date Nov 14, 2012

(AP)—The country's top medical regulator is preparing to tell Congress that new laws are needed to police large specialty pharmacies like the one at the center of a deadly meningitis outbreak.

Congress investigating compounding trade group

date 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

date 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 ...

Senate questions pharmacy boards after outbreak

date 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.

Recommended for you

Philippines confirms second MERS case (Update)

date 6 hours ago

A foreigner who flew to the Philippines from the Middle East has become the second confirmed case of MERS in the country, the health department said Monday, as a deadly outbreak in South Korea spreads alarm across Asia.

Immigrant children given adult dose of hepatitis A vaccine

date Jul 04, 2015

About 250 immigrant children were given an adult dose of a hepatitis A vaccine at a Texas detention facility where they were being held with their mothers, according to U.S. Immigration and Customs Enforcement officials.

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

Shootist
Dec 31, 2013
Pharmacies are almost regulated to uselessness now.

Lower the cost of healthcare, return the power of the prescription to the Pharmacists.
Shootist
Dec 31, 2013
Pharmacies are almost regulated to uselessness as it stands.

Lower the cost of healthcare, return the power of the prescription to the Chemist.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.