To keep everyone up-to-date, the USP published this notice on September 23, 2019.

USP General Chapters <795>, <797>, <800>, and <825>

On June 1, 2019, USP published revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>.

In accordance with USP’s Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals (see Decisions on Appeals to USP <795> and <797> and <825>). In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel.

USP’s Bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending. Therefore, USP is postponing the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice. In the interim, the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official. The decisions on the appeals to <795>, <797>, and <825> do not foreclose the possibility of future revisions to these chapters.

General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health.

USP plays no role in enforcement. State and other regulators may make their own determinations regarding the enforceability of <800>. USP remains committed to advancing public health and to promoting the quality of compounded preparations and the safe handling of hazardous drugs. USP will continue to communicate updates on the compounding chapters and the appeals process. For any questions, please contact the Healthcare Quality & Safety Team at CompoundingSL@usp.org.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Scandal: Novartis to Put AveXis into Protective Custody After Data Manipulation
Generally, Big Pharma companies take an initial hands-off approach when they acquire a biotech to avoid stifling the innovation for which they have sometimes spent billions of dollars. However, that approach led to a serious credibility issue for Novartis as a data manipulation scandal has unfolded at gene therapy biotech AveXis. Going forward, Novartis says, it will be hands-off no longer.
https://www.fiercepharma.com/manufacturing/novartis-to-put-avexis-into-protective-custody-after-data-manipulation-scandal

Criminal Probe of Juul by Federal Prosecutors
Federal prosecutors in California are conducting a criminal probe into e-cigarette maker Juul Labs Inc. The fast-growing company has come under increasing scrutiny by state and federal officials, and the FTC, FDA, and several state attorneys general are investigating its marketing practices. The FTC’s probe is focused on whether Juul used social-media influencers and other marketing techniques to appeal to minors, while the FDA is conducting a more wide-ranging investigation covering marketing and outreach as well as the high nicotine content of Juul’s refill pods.
https://www.wsj.com/articles/federal-prosecutors-conducting-criminal-probe-of-juul-11569268759

Did You Know ...

…the following?

Comment: It seems like our politicians and the media are out of control and most of what we hear are outright lies, half-truths, and misrepresentations, at the national, state, and local level. I wonder if there is enough soap available to wash their mouths out, but it would be fun to try. I honestly don’t know how they can sleep at night or look at themselves in the mirror. I honestly hope that citizens will look at what is going on and get involved to reaffirm what our nation was founded on before we lose it all. I thought it might be interesting to look at a few quotations on “lies� since we are exposed to them every day.

LIES:
“The telling of a falsehood is like the cut of a sabre; for though the wound may heal, the scar of it will remain.� (Saadi)

“A lie is like a snowball; the longer it is rolled, the larger it is.� (Luther)

“The great masses of the people…will more easily fall victim to a big lie than to a small one.� (Adolf Hitler, Mein Kampf, 1933).

“The benevolent despot who sees himself as a shepherd of the people still demands from others the submissiveness of sheep.� (Eric Hoffer, The Passionate State of Mind, 1954).

Tip of the Week

“Slander, lies, character assassination — these things are a threat to every single citizen everywhere in this country. When even one American — who has done nothing wrong — is forced by fear to shut his mind and close his mouth, then all Americans are in peril. It is the job of all of us — of every American who loves his country and his freedom — to rise up and put a stop to this terrible business.� (Harry S. Truman, Speech on McCarthyism).

The phrase, “lie through your teeth,� is to tell an outright lie without remorse (From “The Horse’s Mouth� — Oxford Dictionary of English Idioms).

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Looking Back

As you journey,
Down the years,
Your mirror is,
The glass that cheers!
If you use
     Burma-Shave