This is the second part of the "Safety and Effectiveness" category of the Key Conclusions from the report. As one looks at these "conclusions," it is interesting to keep in mind that the committee making these conclusions were actually not very familiar with or intimately involved in compounding pharmacy and requested speakers to "educate them" in the earlier meetings of the committee.

When one looks at the "conclusions" of the report, it is apparent that some of these are the requirements for mass manufacturing of FDA-approved drugs and not for individual patient compounded medications with hundreds of different bHRT formulations making compliance with FDA regulations impossible. Also, appropriately, compounded medications are exempt from FDA New Drug requirements, and these formulations have been compounded for decades and are not difficult to compound.

Let's continue with looking at the conclusions from the report.

Safety and Effectiveness
(Second four of eight in this category.)

• There is a dearth of high-quality evidence-data from studies that would meet FDA's requirements for granting regulatory approval to a drug product-available to establish whether cBHT preparations are safe and effective for their prescribed uses. (Chapter 7)

• Well-designed and properly controlled clinical trials are needed to provide reliable evidence about the safety and effectiveness of cBHT preparations. (Chapter 7)

• The majority of marketing claims about the safety and effectiveness of cBHT preparations, whether in absolute terms or in comparison to FDA-approved BHT, are not supported by evidence from well-designed, properly controlled studies. (Chapter 7)

• There are concerns with the voluntary and incomplete nature of adverse events reporting for compounded preparations. The lack of an easily accessible safety database limits assessment of the frequency, type, and severity of adverse events related to the use of cBHT. Improved monitoring of adverse events is required to characterize the safety of these compounded preparations. (Chapter 7)

Next week, we will continue looking at the "Conclusions" from the findings of the Report.

Did You Know ...

...that a smile has been said to be something that adds to your face value?

Thought of the Week (on Contentment)

To see the value of a "smile," just try talking to someone first with a frown or a mean look and then with a smile...it makes a difference in how they feel and how you communicate. Some of us have both grandchildren and great grandchildren, and, when they are very young, they will more likely come to you if you are smiling then if you are frowning. This is an easy lesson to learn that does not take much effort to implement.

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

Looking Back

Spring has sprung,
The grass has riz,
Where last year's
Careless drivers is!
     Burma-Shave