News & Analysis as of

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

FDA Regulatory Update: International Crack Down on Online Pharmacies Identifies Over 1,900 Websites Selling Unapproved or...

By participating in the organized, global action known as Operation Pangea VII, the U.S. Food and Drug Administration (“FDA”) made good on its promise to continue working with the international community to investigate online...more

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

$100 Million for Victims of Meningitis Outbreak

We’ve previously written about the 2012 meningitis outbreak caused by contaminated drugs originating from the New England Compounding Pharmacy (NECC). The meningitis outbreak from these tainted steroids was linked to 64...more

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

FDA Issuing Referral Letters To State Boards Of Pharmacy Against Traditional Pharmacies

FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to...more

Compounding Problems

In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders...more

Breaking News: FDA Testifies Before Senate HELP Committee, Questioned On Recent Compounding Quality Act Enforcement

Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He...more

FDA Issues First Compounding Pharmacy Warning Letter Under DQSA/503B

On January 17, FDA issued its opening sally in the new compounding pharmacy enforcement regime by issuing a Warning Letter to Avella of Deer Valley in Phoenix, AZ. The letter is based on a nearly year-old inspection (February...more

New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act addresses two hot-button issues relating to marketed drug products: the extent of federal...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Draft Guidance: Pharmacy Compounding Of Human Drug Products Under Section 503A Of The Federal Food, Drug, And Cosmetic Act

Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal...more

Health Reform + Related Health Policy News - December 2013

In This Issue: - Top News ..CMS Releases Payment Rules for the Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System, Renal Dialysis and Home Health ..President Signs the Drug Quality...more

Compounding Quality Act: Critical Implementation Begins Now For Stakeholders

On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more

Compounding Pharmacies Now Subject to Federal Oversight

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee...more

Key Points: Compounding Quality Act

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that...more

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

Congress Passes Compounding Quality Act

The Senate approved a human prescription compounding bill (H.R. 3204) Monday by voice vote, sending it to President Obama for his signature. The bill had been in the works since last year, when a meningitis outbreak from...more

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

Possible Legislative Changes To Compounding Pharmacies

Often times it seems that compounding pharmacies operate in a "gray area" between state legislative oversight and federal legislative oversight. However, due to the attention created by several sterile compounding pharmacies,...more

Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small...more

Regulation of Compounding Pharmacies Continues to Evolve with House Passage of "Drug Quality and Security Act"

In the current environment it seems that few, if any, pieces of legislation are moving through Capitol Hill. However, there is one area that has seen significant activity: the regulation of compounding pharmacies....more

Misbranded Drugs: A Danger To Physicians And Patients

Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

Bipartisan Agreement Reached on Legislation Granting FDA Greater Authority to Regulate Drug Compounders

Last week, Democrat and Republican leaders of both houses of Congress agreed to the terms of a bill that would give the U.S. Food and Drug Administration (FDA) greater authority to regulate drug compounding and would revamp...more

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