Content about McGuff Companies

March 18, 2014

Avella Specialty Pharmacy announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act.

PHOENIX — Avella Specialty Pharmacy on Tuesday announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act. Outsource facilities must consent to greater federal oversight including more frequent inspections and are required to demonstrate their adherence to specific “good manufacturing practices,” Avella noted. 

January 28, 2014

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

History

December 5, 2013

Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

NEW YORK — Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

November 22, 2013

On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama's desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.

The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.

On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama's desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.

October 7, 2013

State representatives in Massachusetts have unanimously passed a bill that would allow patients to check the safety records of compounding pharmacies there, according to published reports.

NEW YORK — State representatives in Massachusetts have unanimously passed a bill that would allow patients to check the safety records of compounding pharmacies there, according to published reports.

The Boston Globe reported that the state Senate would take up a bill that would require the publishing of the pharmacies' safety records in light of the nationwide fungal meningitis outbreak last year linked to the New England Compounding Center. The bill would also require pharmacists who prepare sterile drugs to take continuing education classes.

September 26, 2013

Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.

NEW YORK — Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.

September 25, 2013

A bill under consideration by the Senate could force more than 40% of compounding pharmacies to abandon compounding, according to a new survey.

HOUSTON — A bill under consideration by the Senate could force more than 40% of compounding pharmacies to abandon compounding, according to a new survey.

May 9, 2013

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 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

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

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

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

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.

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.

November 15, 2012

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.