FDA Finds Fungus in Nasal Solution

Tue, 10/01/2013 - 2:31pm

The U.S. Food and Drug Administration is alerting patients and health care providers that budesonide solution, which is used for nasal irrigation, from The Compounding Shop in St. Petersburg, Fla., may be contaminated and should not be used or administered to patients.

 

FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market.

 

Drug products that are for oral inhalation— such as the budesonide solution from the Compounding Shop, which is labeled “for inhalation only”— are required to be sterile. Contaminated drug products, whether used by inhalation or otherwise, put patients at risk for infection. Patients and health care providers who have this product on hand should not use it.

 

The budesonide solution from the Compounding Shop is also labeled for nasal irrigation, which may be confusing to consumers.

Congress Speaks Up for Community Pharmacies’ Compounding Services Published October 1, 2013

By Kevin Schweers

Three days before today’s government shutdown produced by partisan gridlock, Republicans and Democrats came together to approve drug safety legislation and re-affirm their support for compounding services provided by independent community pharmacies.

On a voice vote, the House of Representatives approved H.R. 3204, The Drug Quality and Security Act, legislation endorsed by NCPA, that responds to the tragic 2012 meningitis outbreak and adopts supply chain protections. The legislation is currently awaiting approval by the Senate. In the debate preceding the vote, lawmakers discussed how the bill protects community pharmacies’ ability to continue to compound drugs for their patients and asserted their intent to monitor its implementation to ensure it does not inadvertently infringe upon long-accepted compounding pharmacy practices.

“Mr. Speaker, this bill upholds the current section 503(a) of the law, and provides it with the clarity that FDA needs by eliminating the unconstitutional provisions,” said House Energy and Commerce Committee Chair Fred Upton (R-Mich.). “The bill also requires FDA to engage in meaningful communication with State boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That’s why the bill has the support of the National Community Pharmacists Association, and I would like to thank them for working with us so closely.”

Health Subcommittee Chair Joe Pitts (R-Penn.) opened his remarks noting that, “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak – one of the largest public health crises in recent memory.” He also cited NCPA as one of the bill’s supporters, among other industry groups.

From the Democratic side of the aisle, Health Subcommittee Ranking MemberFrank Pallone (D-N.J.) added that, “The bill will permit compounders who wish to practice outside the scope of traditional pharmacy to register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated as they are under current law.”

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