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| International Journal of Pharmaceutical Compounding Volume 23, Number 5 September/October 2019
Table of Contents |
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Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Important Announcement
Alternatives to USP Chapters for SBOP
At the CompoundingToday.com website “Homepage�, there is an option to access “Alternatives to USP <795>, <797>, and <800>� documents. These documents are easily modifiable, bullet-point versions in Microsoft Word of the new chapters for use by State Boards of Pharmacy (SBOP).
The purpose of these “Alternatives� is to make it easier and more convenient for SBOP to “customize� the chapters and make them more appropriate and specific for their individual states and to ensure patient access to medications, both manufactured and compounded.
Once these have been customized and approved, they can be incorporated into the regulations of the state. In the future, these can be easily updated as needed and determined by the SBOP since they will be specific for that individual state and not dependent and changed by a national entity.
- Go to http;//compoundingtoday.com
- Click on “Alternatives to USP <795>, <797>, and <800> for state boards
- Enter your email address, first name, last name and company/organization
- Click on “Submit�.
- You will receive an email from “info@compoundingToday.com�
- Open and download the documents needed.
- Open a document, then cut, paste and modify your document until it is right for your state.
Once accomplished, the regulations will be state specific and will have been determined by the individual SBOP.
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News
Changes to USP <797>, Addition of <800> Having Enormous Impact on Hospital Pharmacies
For most hospital pharmacies, enforcement of these chapters means big changes to practice, budget, and physical environment. These changes often costs hundreds of thousands of dollars in capital, with additional tens of thousands each year coming out of the operating budget. In addition, these construction projects are often complicated by the physical constraints of aging hospital buildings.
Additional cleaning requirements from the updated chapters will add time to the duration of the process. Also, it is incumbent upon the pharmacy to create efficient workflows in departments where the timely procurement of compounded parenteral products is a matter of life and death. Often, this means having emergency departments compound their own products in certain situations. Pharmacy managers must work with emergency department managers to ensure that compliance with the updated chapters is maintained.
https://www.pharmacist.com/article/changes-usp-addition-having-enormous-impact-hospital-pharmacies
Metrix Recalls Specific Lots of Empty IV Flexible Containers Used in IV Admixture Programs
The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bags) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection to the patient. The empty bag is filled with parental admixtures by a compounding pharmacist under normal sterile compounding pharmacy conditions.
https://www.americanpharmaceuticalreview.com/1315-News/517613-Metrix-Company-Recalls-Specific-Lots-of-Empty-IV-Flexible-Containers/
Fred's Inc., Serving Smaller Towns, Files Bankruptcy
Fred’s Inc., a discount pharmacy retailer, has filed for bankruptcy protection and will shut down all of its stores after trying unsuccessfully for more than a year to turn around the company. The 72-year-old company generally serves families in towns with populations of 15,000 people or less in the southeastern United States.
https://www.wsj.com/articles/freds-inc-files-for-voluntary-chapter-11-bankruptcy-11568034612
Midazolam Nasal Spray: From Compounded to FDA-approved Product
Midazolam Nasal Spray (Nayzilam), a formerly compounded preparation, has been approved by the FDA for the treatment of intermittent, stereotypic episodes of frequent seizure activity. Nayzilam nasal spray is a clear, colorless to yellowish colored liquid at a concentration of 5 mg/0.1 mL in a solution containing ethanol, PEG-6 methyl ether, polyethylene glycol 400, propylene glycol, and purified water with a pH range of approximately 5.0 to 9.0.
https://www.rxlist.com/nayzilam-drug.htm#indications
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Did You Know ...
…that Walt Disney said the following?
“Everyone falls down. Getting back up is how you learn how to walk.�
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Tip of the Week
It is in life’s trials and challenges that we grow mentally, physically, socially, professionally, and spiritually. Without any trials and challenges, think about what we might become if everything went our way. Not that the issues we face are enjoyable when going through them, but handled properly, they can make us better than we are and capable of doing things we thought we could never do.
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Looking Back
To every man,
His shave is best,
Until he makes,
The final test!
Burma-Shave
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