Posts Tagged 'compounding pharmacies'

House inches toward oversight of compounding

Congress is wrangling with the issue of where to draw the line between state and federal oversight of large-scale compounding pharmacies in light of a series of infections — including a deadly fungal meningitis outbreak — linked to the facilities. There now appears to be general agreement the FDA needs more clear authority over compounding manufacturers — pharmacies that compound bulk supplies of drugs in advance of a patient prescription.

Read more about the oversight of compounding pharmacies…

St. Petersburg drug compounder recalls medications

A local compounding pharmacy has agreed to recall all its sterile drugs after a recent inspection uncovered potential safety problems, the U.S. Food and Drug Administration said Wednesday. Federal health inspectors discovered “exposed rust” and “numerous splattered brownish stains” on equipment used to prepare injectable drugs and eye medications at the Compounding Shop, raising the possibility that the medications could be contaminated.

Read more about the compounding pharmacy recall…


States take lead on compounding pharmacies

Several states are taking matters into their own hands to boost oversight of large-scale pharmacies like the one behind the deadly fungal meningitis outbreak last fall as the outlook for congressional action is somewhat murky. So far, 15 states have taken up bills to step up the regulation of facilities like the one linked to the outbreak.

Read more about the compounding pharmacy regulation…

Balanced Solutions Compounding Pharmacy recalls sterile drug products

A Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns that the products may contain bacteria, federal regulators said Sunday. The Food and Drug Administration asked hospitals and other health-care providers who received sterile products, including all injectables, from Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy of Lake Mary, Fla., to immediately check their medical supplies, quarantine the products and follow the company’s recall instructions.

Read more about the Balanced Solutions Compounding Pharmacy recall…

Compounding pharmacies linked to deaths over the past decade

A Washington Post investigation has found that shoddy practices and unsanitary conditions at compounding pharmacies like the New England Compounding Center (NECC) have been harming people for the past decade. At least four pharmacies have been linked to 51 deaths and 700 illnesses over the past ten years, including the 45 deaths linked to contaminated steroid injections shipped by the NECC.

Read more about the link between compounding pharmacies and death…

Two more New England Compounding Center drugs contaminated

Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal. The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of the ongoing outbreak of fungal meningitis.

Read more about the additional NECC contaminated drugs…

Report finds state oversight of compounding pharmacies lax

The Massachusetts Department of Health said over the weekend that it had closed a second compounding pharmacy, Infusion Resource, after a state inspection found unsanitary conditions. Released by Massachusetts Rep. Edward J. Markey, the report stems from the national fungal meningitis outbreak linked to a steroid from the New England Compounding Center that has
sickened 354 people in 19 states and killed 25.

Read more about compounding pharmacy regulations…

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