"Getting it right!" is extremely important in order to get standards accepted and utilized in practice. If it isn't appropriate, it will be neglected, ignored, and other standards put in its place.

The following information is from the "Sterile Compounding Consensus Group," which is composed of practitioners, surveyors, microbiologists, and representatives from associated industries such as PEC manufacturers and HVAC experts. It should be reviewed by all those involved in sterile compounding. Also, don't forget that your comments are due to USP by November 30, 2018! Please read the following from the informal chair of the Sterile Compounding Consensus Group:

To all,

Please take a moment to read the summary of the Sterile Compounding Consensus Group's (SCCG) comments concerning the latest draft of USP <797> on sterile compounding. Click the link provided below to download the SCCG comments.

While generally an improvement over the first draft, some issues of significant concern either remain, or have been introduced. I encourage all sterile compounders to review these comments and share this with your colleagues. More important considerations are highlighted in yellow.

If you don't vote, don't complain. Comments may be submitted by following the link shown below.

The deadline is November 30! Please submit your comments before then.

L. R. (Rad) Dillon RPh
Pharmacy Consultant and Accreditation Surveyor
Loveland, CO
LRDillon123@gmail.com

Important Dates:

November 30, 2018 Public Comment Period for <797> will close.
June 1, 2019 Intended Publication Date of <797> in USP-NF.
December 1, 2019 Anticipated Official Date for <797>

Download SCCG's Summary of Comments here:

https://gallery.mailchimp.com/19d4d6aa2675d2081365faabb/files/81
91e797-9d28-4e62-86d9-d945bc7c865f/SCCG_Comments.02.pdf

The current proposed chapter is posted online with line numbers at:

http://www.uspnf.com/notices/general-chapter-797-proposed-revisions

Submit comments using the form available at:

https://usp.az1.qualtrics.com/jfe/form/SV_3dDhnN2ZVCYh5yJ.

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

Express Scripts Rightfully Nixed Pharmacy Contract
HM Compounding Services LLC clearly breached its contract with Express Scripts Inc. by refusing to collect copayments from customers, a Missouri federal judge has ruled, giving the pharmacy benefit manager a boost just days before trial.
https://www.law360.com/health/articles/1100583/express-scripts-rightfully-nixed-pharmacy-contract

State Regulators Uncovered Evidence of NECC Violations before Outbreak
The Tennessean reported that during the federal trial of six employees of New England Compounding Center recently, regulators from Oregon, Colorado, and Missouri testified that they uncovered evidence that NECC was "shipping drugs to health providers in their individual states in violation of laws and regulations" in 2011. The testimony was "clearly targeted at former NECC vice president and part-owner Gregory Conigliaro," the article said, as two of the witnesses described their conversations with him.
http://mailview.bulletinhealthcare.com/mailview.aspx?m=2018111201ashp&render=y&r=3276068-7c1f#S3

The FDA to Curb E-cigarette Sales-Concerns about Surge in Teen Vaping
The FDA is expected to impose severe restrictions on the sale of e-cigarette products throughout the U.S. The FDA Commissioner will likely announce a ban on the sale of most flavored e-cigarettes in tens of thousands of convenience stores and gas stations across the country, according to senior agency officials. The agency reportedly will also impose such rules as age-verification requirements for online sales. The Commissioner also is expected to propose banning menthol in regular cigarettes.

The FDA's initiatives on vaping are spurred by preliminary government data showing e-cigarette use increased 77% among high schoolers and almost 50% among middle schoolers in 2018. The only exception to the flavored-products ban in convenience stores involves mint and menthol e-cigarette products. The FDA will continue to permit sales of those flavors because menthol is permitted in regular cigarettes, and the agency does not want to give traditional cigarettes an advantage over e-cigarettes. But officials say the FDA may extend the sales restriction to those flavors if teen vaping does not decline.
https://www.washingtonpost.com/national/health-science/fda-plans-to-impose-severe-restrictions-on-e-cigarettes/2018/11/08/91253cf2-e3a1-11e8-8f5f-a55347f48762_story.html

Only One-quarter of Prescribed Opioids are Actually Used by Surgery Patients
Many surgeons write opioid prescriptions four times larger than what their patients will actually use after common procedures, according to a new study in JAMA Surgery. The study also indicates that the size of that prescription was the strongest predictive factor of how many opioids the patient will take, more so than their pain scores, the intensity of their operation, and personal factors. "It's striking to see the major discrepancy between the prescribed amount and the amount patients actually take," said Joceline Vu, MD, senior author of the paper. "This is not a phenomenon of a few outlier surgeons—it was seen across the state, and across many operations." Ryan Howard, MD, the paper's first author, said: "We hope that by shining a spotlight on the difference between prescription size and actual use, we can empower surgeons to change their prescribing habits, and be a better steward to both their patient and the broader community."
https://www.eurekalert.org/pub_releases/2018-11/mm-u-spu110518.php

Did You Know ...

�that Winston Churchill made the following statement"?

The POSITIVE THINKER sees the INVISIBLE, feels the INTANGIBLE, and achieves the IMPOSSIBLE.

Tip of the Week

This saying applies to individuals we often see as very successful. They tend to be very positive and forward thinking with a "Can-Do?" attitude. Being around negative people brings down others and stifles progress and innovation. Being around positive people can stimulate progress, innovation, and success. There is a statement above the door entering the football stadium from the locker room of the home team that states "Play like a champion today!" We can practice our profession like a champion not only just today, but every day! Think about all the patients you positively influence every day.

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Looking Back

The happy golfer
Finds with glee!
The shave that suits him,
To a tee!
     Burma Shave