46 min

How Safe Are Your Compounded Drugs? Safer Since FDA Involvement Spectrum

    • News & Politics

How safe are the special drug compounds you take or put in or on your body? Most people, today, think that they are pretty safe but that has not always been the case.
Back in 2012, the New England Compounding Center in Framingham, Massachusetts produced 18,000 vials of a contaminated steroid that was distributed across about 20 states.
The tainted compound, to date, has sickened 751 people with fungal meningitis and related illnesses. At last total, there were 64 deaths.
In 2015, the company reached a $200 million civil settlement to victims and various creditors but, as of today, nothing has been paid.
The federal government also has charged company head Barry J. Cadden, 50, with 96 criminal counts including 25 counts for racketeering acts of second-degree murder. A trial began in Boston on January 9 and the jury just started its deliberations on March 17.
No verdicts have been reached at the time of this recording. If convicted of the murder counts, Cadden could be facing life in prison.
Today, we talk with Ed Zatta, owner of RXQ Compounding LLC about new federal regulations to guarantee the safety of small batch drug compounding.
Before the New England Compounding Center disaster, each state regulated its own drug compounding firms. There are a patchwork of different laws and different safety inspection procedures.
After the tragedy, 18 states enacted new regulatory laws and the Federal Drug Administration created a new category of compounding called 503 (b) where each drug compound must be tested for sterility, potency, and whether any of its elements exceeded the “Beyond Use Date.” The new federal law began in January 2017
Zatta took advantage of the federal regulations and created a new “outsourcing facility” under the stricter federal guidelines before they were required.
It takes extra care and extra procedures to make drug compounds safe, according to Zatta. But, he thinks that the federal regulations ensure quality and safety for unsuspecting consumers. He asserts that the federal guidelines can prevent future tragedies such as the New England Compounding Center disaster.

How safe are the special drug compounds you take or put in or on your body? Most people, today, think that they are pretty safe but that has not always been the case.
Back in 2012, the New England Compounding Center in Framingham, Massachusetts produced 18,000 vials of a contaminated steroid that was distributed across about 20 states.
The tainted compound, to date, has sickened 751 people with fungal meningitis and related illnesses. At last total, there were 64 deaths.
In 2015, the company reached a $200 million civil settlement to victims and various creditors but, as of today, nothing has been paid.
The federal government also has charged company head Barry J. Cadden, 50, with 96 criminal counts including 25 counts for racketeering acts of second-degree murder. A trial began in Boston on January 9 and the jury just started its deliberations on March 17.
No verdicts have been reached at the time of this recording. If convicted of the murder counts, Cadden could be facing life in prison.
Today, we talk with Ed Zatta, owner of RXQ Compounding LLC about new federal regulations to guarantee the safety of small batch drug compounding.
Before the New England Compounding Center disaster, each state regulated its own drug compounding firms. There are a patchwork of different laws and different safety inspection procedures.
After the tragedy, 18 states enacted new regulatory laws and the Federal Drug Administration created a new category of compounding called 503 (b) where each drug compound must be tested for sterility, potency, and whether any of its elements exceeded the “Beyond Use Date.” The new federal law began in January 2017
Zatta took advantage of the federal regulations and created a new “outsourcing facility” under the stricter federal guidelines before they were required.
It takes extra care and extra procedures to make drug compounds safe, according to Zatta. But, he thinks that the federal regulations ensure quality and safety for unsuspecting consumers. He asserts that the federal guidelines can prevent future tragedies such as the New England Compounding Center disaster.

46 min

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