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OIG Arrests New York Pharmacist

On December 12, 2013, a New York pharmacy owner was arrested and charged for engaging in a scheme to defraud Medicaid and Medicare through the sale of illegally diverted prescription drugs. The complaint, which resulted from a joint DOJ, FBI and IRS investigation, alleged that the defendant had perpetrated a multi-million dollar scheme to defraud New York State Medicaid and Medicare programs through the sale of diverted pharmaceutical drugs. The...

The Drug Quality and Security Act is Signed by President, but How Does the FDA Intend to Enforce it?

On November 27, 2013, President Obama signed into law the Drug, Quality and Security Act. The bill contained a section known as the "Compounding Quality Act" which endeavored to regulate both "traditional" and "non-traditional" compounding. With respect to traditional compounders, the Compounding Quality Act removed certain provisions from Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be unconstitutional by the U.S. Supreme Court...

Senate Passes the Drug Quality and Security Act (H.R. 3204), Awaits Signature by President

The Drug Quality and Security Act (H.R. 3204), while still only a Bill, was passed on November 18,2013, without amendments, by voice vote in the Senate.  The Drug Quality and Security Act (the “Act”) grants the FDA complex new regulatory oversight of certain compounding pharmacies or other facilities. The Act provides the FDA with oversight authority only over pharmacies (or facilities) that do any sterile compounding. The Food, Drug and...

Senate Moves Closer to Passage of Drug Quality and Security Act (H.R. 3204)

The Drug Quality and Security Act (H.R. 3204), while still only a Bill, is one step closer to passage by the Senate.  The Drug Quality and Security Act (the “Act”) grants the FDA complex new regulatory oversight of certain compounding pharmacies or other facilities. The Act provides the FDA with oversight authority only over pharmacies (or facilities) that do any sterile compounding. The Food, Drug and Cosmetics Act of 1938...

Status of H.R. 3204 – The Compounding Quality Act

Frier Levitt has been actively tracking H.R. 3204 through the Senate. What follows is a daily chronology of the  Bill as it is making its way through the Senate, as well as a summary of the current status of the Bill in the Senate. Please stay tuned as we will continue to keep you posted on the progress of the Bill. 11/4/2013: Read the first time. Placed on Senate Legislative...