Content about Compounding

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 17, 2013

Hearing focuses on FDA response to meningitis outbreak

Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

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.

April 12, 2013

FDA investigation finds widespread problems at compounding pharmacies

An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

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.

March 11, 2013

'60 Minutes' report explores fungal meningitis outbreak

A report on CBS' "60 Minutes" Sunday explored the aftermath of the nationwide outbreak of fungal meningitis linked to the New England Compounding Center that, according to the Centers for Disease Control and Prevention, has sickened 720 people in 20 states and led to 48 deaths.

ALEXANDRIA, Va. — A report on CBS' "60 Minutes" Sunday explored the aftermath of the nationwide outbreak of fungal meningitis linked to the New England Compounding Center that, according to the Centers for Disease Control and Prevention, has sickened 720 people in 20 states and led to 48 deaths.

March 4, 2013

Reports: FDA investigating more than two-dozen compounding pharmacies

The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

NEW YORK — The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

Businessweek reported that the FDA started visits to the pharmacies started last month and would continue for the next two months. So far, unsanitary conditions were found at pharmacies in Chicago, Florida, Arkansas and Mississippi.

February 13, 2013

NCPA outlines legislative priorities

The National Community Pharmacists Association on Wednesday announced its federal and state legislative priorities with the release of the Independent Community Pharmacy Checklist.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday announced its federal and state legislative priorities with the release of the Independent Community Pharmacy Checklist. The one-page document details the main legislative actions NCPA and its members will advocate for this year at the federal and state levels.

February 12, 2013

NCPA to hold 45th annual Legislative Conference in May

The National Community Pharmacists Association announced it will hold its 45th annual Legislative Conference May 7 to 8 in Washington, D.C.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday announced it will hold its 45th annual Legislative Conference May 7 to 8 in Washington, D.C.

February 12, 2013

Tough new regulations for compounding pharmacies could be on the way, attorney says

Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.

WASHINGTON — Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.

LeClairRyan attorney Michael Ruggio said officials in several states were increasing scrutiny of compounding pharmacies in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center, which so far sickened 696 people and killed 45, according to the Centers for Disease Control and Prevention.

February 8, 2013

Reports: Mass. health authorities shut down 10 compounding pharmacies over violations

Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

NEW YORK - Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

State health authorities sent cease-and-desist letters to 11 pharmacies, telling 10 to stop compounding altogether and one to stop compounding the drug sildenafil citrate. Twenty-one other pharmacies were allowed to continue compounding, but were cited for minor violations.

January 23, 2013

New ad promotes independents' agenda in Washington

A lobbying organization for independent pharmacies has launched an ad campaign in The Hill, the Washington-based daily newspaper covering Congress.

ALEXANDRIA, Va. — A lobbying organization for independent pharmacies has launched an ad campaign in The Hill, the Washington-based daily newspaper covering Congress.

The National Community Pharmacists Association ad lays out the group's legislative agenda for the 113th Congress and the Obama administration.

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 20, 2012

Advocacy group says proposed compounding regulations would endanger public health

An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency's authority in congressional testimony last month and offering a plan that would effectively weaken the agency's oversight of drug manufacturing."

December 12, 2012

NABP implements nationwide effort to oversee compounding pharmacies

A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

MOUNT PROSPECT, Ill. — A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

The National Association of Boards of Pharmacy said Wednesday that it would implement a four-part action plan centered around inspection of compounding pharmacies and sharing data from the inspections among boards of pharmacies around the country.

December 10, 2012

Reports: Congressional committee looking into compounding industry group's practices

A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

NEW YORK — A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

Reuters reported that the House Energy and Commerce Committee had requested internal documents from the International Academy of Compounding Pharmacists, citing a news report about the organization.

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.

December 7, 2012

Mass. health department reorganizes pharmacy board, sanctions three compounding pharmacies amid meningitis outbreak

The state health department in Massachusetts has made changes to the state's pharmacy board and leveled sanctions against three pharmacies in the wake of a nationwide meningitis outbreak traced to a compounding pharmacy in the state, the department said.

BOSTON — The state health department in Massachusetts has made changes to the state's pharmacy board and leveled sanctions against three pharmacies in the wake of a nationwide meningitis outbreak traced to a compounding pharmacy in the state, the department said.

December 5, 2012

Walgreens acquires independent pharmacy with specialty compounding expertise

Walgreens last month acquired UCH Pharmaceutical Services, an independent retail pharmacy based in Indiana, the company that helped broker the deal announced Wednesday.

ADDISON, Texas — Walgreens last month acquired UCH Pharmaceutical Services, an independent retail pharmacy based in Indiana, the company that helped broker the deal announced Wednesday.

UCH is an independent retail pharmacy that provided specialty compounding services throughout Grant County, Ind.

The Transition Companies acted as UCH’s sole M&A advisor for this transaction, which closed in November 2012.

November 20, 2012

How tough should compounding oversight be?

When considering new, stiffer regulations governing the compounding of medicines in the wake of the meningitis outbreak, tread carefully and don’t throw the baby out with the bathwater.

That’s the message chain pharmacy had for Congress as lawmakers mull new restrictions on drug compounding by pharmacists.

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.

November 14, 2012

FDA wants more oversight of compounding pharmacies

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

November 14, 2012

NCPA submits comments in support of compounding to congressional committees

The National Community Pharmacists Association on Wednesday submitted comments to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center, including the the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions, respectively.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday submitted comments to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center, including the the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions, respectively.

November 13, 2012

NCPA survey: Most independents provide compounding services

As many as 85.5% of independent community pharmacies offer patients traditional compounding services, and while it accounts for a small portion of their business, the health-enhancing effect for patients can be dramatic, according to a new survey released Tuesday by the National Community Pharmacists Association.

ALEXANDRIA, Va. — As many as 85.5% of independent community pharmacies offer patients traditional compounding services, and while it accounts for a small portion of their business, the health-enhancing effect for patients can be dramatic, according to a new survey released Tuesday by the National Community Pharmacists Association.