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May 9, 2013

Senators propose legislation to carve out 'compounding manufacturers' subject to FDA regulation

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

April 16, 2013

Two compounding pharmacies start voluntary recall of sterile drugs

Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

SILVER SPRING, Md. — Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

The Food and Drug Administration said Tuesday that ApotheCure had recalled all sterile drug products made at its pharmacy, while NuVision Pharmacy had recalled sterile freeze-dried or lyophilized drug products made at its facility. Both recalls were described as voluntary.

March 22, 2013

FDA commissioner calls for power to regulate compounding pharmacies

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013

Ga. compounding pharmacy recalls all lots of sterile products

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

January 7, 2013

Mass. governor proposes new compounding pharmacy legislation

Massachusetts Gov. Deval Patrick has introduced legislation that would give the state government broader power over compounding pharmacies, the governor's office announced.

BOSTON — Massachusetts Gov. Deval Patrick has introduced legislation that would give the state government broader power over compounding pharmacies, the governor's office announced.

December 7, 2012

Black holes and gray areas: State, federal authorities take a closer look at pharmacy compounding

Authorities in Massachusetts are looking to tighten regulations on compounding pharmacies as the state health department announced some changes to the makeup of the Massachusetts Board of Pharmacy and sent cease-and-desist notices to three compounding pharmacies for alleged violations.

Retail pharmacies looking to get into sterile compounding and exercise greater control over that supply chain — as Walgreens did last month when it bought an independent specialty compounding pharmacy in Indiana — should take note because it seems there will be increased scrutiny on the practice following a nationwide outbreak of meningitis linked to alleged unsanitary conditions at the Framingham, Mass.-based New England Compounding Center.

November 15, 2012

NACDS emphasizes importance of Rx compounding amid congressional hearings on meningitis outbreak

As the U.S. Senate and House of Representatives examined the meningitis outbreak this week, the National Association of Chain Drug Stores distinguished between the types of pharmacy compounding and the settings in which they take place, and emphasized the critical, life-saving benefits of pharmacy compounding.

ALEXANDRIA, Va. — As the U.S. Senate and House of Representatives examined the meningitis outbreak this week, the National Association of Chain Drug Stores distinguished between the types of pharmacy compounding and the settings in which they take place, and emphasized the critical, life-saving benefits of pharmacy compounding.

NACDS stated that it has sent a letter to members of the U.S. Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce — both of which held hearings on the outbreak on Nov. 14.