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Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
April 23, 2021  |  Volume 18  |  Issue 16
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
The FDA, Part 4

Continuing the federal laws related to pharmaceuticals and the FDA, this week, we present the

  • Drug Quality and Security Act (DQSA) of 2013

H.R. 3204 Drug Quality and Security Act (DQSA) of 2013

The DQSA incorporates and brings up to date the court decisions regarding the Food and Drug Modernization Act of 1997. It resulted from the New England Compounding Center (NECC) tragedy where there were 64 deaths and hundreds sickened in 14,000 patients. The outbreak of fungal meningitis occurred in 2012 and was traced to fungal contamination in three lots of compounded methylprednisolone suspension for epidural steroid injections.

The law amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs; it exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. It establishes requirements for 503a traditional compounding pharmacies and for 503b outsourcing facilities.

Next week. we will review the DQSA and discuss its implementation.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition

 

Did You Know...On "The Brain"...

...that Francis Collins said the following? "The brain is the most complicated organ in the universe. We have learned a lot about other human organs. We know how the heart pumps and how the kidney does what it does. To a certain degree, we have read the letters of the human genome. But the brain has 100 billion neurons. Each one of those has about 10,000 connections."

 

Thought of the Week

A brain is known by its fruits. (H.G. Wells)

A mob has many heads but no brains. (Anon)

Enthusiasm without intelligence is disaster. (Herbert V. Prochnow, Jr.)

Average intelligence: To be less stupid than half of the people and more stupid than the other half. (Herbert V. Prochnow)

There is nobody so irritating as somebody with less intelligence and more sense than we have. (Don Herold).

Most people invariably arrive at their beliefs not on the basis of proof (evidence) but on the basis of what they find to be attractive to them. (Pascal)

 

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Tell them they can get their own free copy of the weekly Compounding Today newsletter at

https://CompoundingToday.com/Newsletter/!!

 

Looking Back

She eyed his beard,
And said "No dice!"
The weddings off-
"I'll cook the rice!"
     Burma-Shave

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