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Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
July 2, 2021  |  Volume 18  |  Issue 26
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
The FDA, Part 13

Below is a summary table of the last three issues of this Newsletter looking specifically at the six questions to be used for evaluating whether bHRT drug products and categories of drug products are difficult to compound under sections 503A and 503B of the FD&C Act.

CRITERIA YES NO
1 – Complex Formulation X
2 – Complex Drug Delivery Mechanism X
3 – Complex Dosage Form X
4 – Complexities in Achieving and/or Assessing Bioavailability X
5 – Complex Compounding Process X
6 – Complex Physicochemical or Analytical Testing X

In summary, it is quite apparent from the information presented in the last three issues of this Newsletter that bHRT compounding is NOT complex and does NOT produce complex preparations that require complex analytical methods.


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

International Journal of Pharmaceutical Compounding
CompoundingToday.com

 

Did You Know (On Patriotism)...

...that on December 9, 1998, Peggy Noonan spoke at The Heritage Foundation in Washington, D.C., on the topic of "Patriotism"?

"What is patriotism? We all know what it is. It is love of country. It is pride in what a country stands for and was founded on. It is the full-throated expression of that love and that pride.

America has been throughout its history an especially patriotic country. I believe the reason has to do with a particular assumption, a particular habit of mind. Our patriot fervor was the result of the old and widespread belief in the idea of American exceptionalism-the idea that America was a new thing in history, different from other countries.

Other nations had evolved one way or another: evolved from tribes, from a gathering of the clans, from inevitabilities of language and tradition and geography. But America was born-and born of ideas: that all men are created equal, that they have been given by God certain rights that can be taken from them by no man, and that those rights combine to create a thing called freedom. They were free to pursue happiness, free to worship God, free to talk and speak in public of their views, and to choose their leaders.

American patriotism was the repetition, reaffirmation, and celebration of our founding ideas, and it gave rise to a brilliant tradition of celebration, and of celebration's symbols: the flag-that beautiful flag; the parades and bands and bunting; Betsy Ross, Uncle Sam, the tradition of patriotic speeches, the reading aloud of the Declaration of Independence; the sparklers like the candles on a birthday cake.

And all these symbols come together on the big birthday: July 4, the day America was born.

All this has served America well. This celebration of our continued adherence to ideas made those ideas new again, young again, vital again, so that in each generation they were continued and reborn. Jefferson famously said the tree of liberty must be watered by the blood of patriots. But it receives vital water as well from the tears, the honest tears, of those moved at the thought of the blessings of our country, the blessings of the freedoms guaranteed here.

Our patriotism has been beneficial in other ways. America was-perhaps is-a big, lonely country, huge and sprawling, and was from the beginning full of disparate people from different places with different beliefs. In a big, disparate, far-flung country, our patriotic feeling was one of the unifying forces that kept us together, that bound us in shared agreement.

Love of country was one of the things the wild agnostic mountain man of the West had in common with the temperance-loving schoolmarm of Philadelphia. Pride in America was shared by common men and intellectuals, by the Irish immigrant of Hell's Kitchen and the high WASP patrician of old Boston. They had something in common: they loved America. This feeling has helped sustain us and lift us up.

 

Thought of the Week (On Americanism)

"Of 'Americanism' of the right sort we cannot have too much. Mere vaporing and boasting become a nation as little as a man. But honest, outspoken pride and faith in our country are infinitely better and more to be respected than the cultivated reserve which sets it down as ill bred and in bad taste ever to refer to our country except by way of deprecation, criticism, or general negation." (Henry Cabot Lodge)

 

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

Man passes doghouse,
Dog sees chin,
Dog gets out,
Man gets in!
     Burma-Shave

 

Classifieds

Granbury Drug has three items for sale.
Two "Baxter Flo-Gard 6201" Volumetric Infusion Pumps
One "Cadd-Prizm 6100" Series Ambulatory Infusion Pump
One Gako Unguator Basic Model.
Make an offer if interested

Granbury Drug
817-279-3189 call/text

 
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