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| Letter from the Editor |
| Did You Know? |
| Thought of the Week |
| IJPC now on Facebook and Youtube |
| Looking Back |
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| Info@CompoundingToday.com or (800) 757-4572 ext 1 |
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| To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or (405) 513-4236 |
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| Insanitary Conditions at Compounding Facilities |
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(FDA Guidance for Industry)
November 2020
A drug is considered adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health..." Drug products prepared, packed, or held under insanitary conditions could become contaminated and cause serious adverse events, including death. The guidance describes examples of "insanitary conditions" that the FDA has observed in compounding facilities.
"Compounding Facilities," for the purpose of the Guidance, includes drugs (including biological products) produced by:
- Pharmacies,
- Federal facilities, and
- Outsourcing facilities
that compound or repackage drugs, or that mix, dilute, or repackage biological products.
The Guidance is divided into the following sections:
- INTRODUCTION
- BACKGROUND
- POLICY
- Examples of Insanitary Conditions
- Insanitary Conditions Applicable to the Production of Sterile and Non-Sterile Drugs
- Insanitary Conditions Applicable to the Production of Sterile Drugs Only
- Gowning and Aseptic Practices
- Equipment/Facilities
- Sterilization
- Cleaning and Disinfecting
- Other Insanitary Conditions
- Preventative and Corrective Actions for Insanitary Conditions
- Regulatory Action
As we have done for years, we will look at the various parts of the Guidance over the next few weeks.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Did You Know...
...that George Eliot wrote the following in his classic "Silas Marner"?
"Nothing is worth doing wrong for!"
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Thought of the Week
Despite the many hardships in his life, Silas Marner worked hard, endured, and was quite successful in many ways. With what Silas Marner and all of us have endured this past year, I am reminded of a song by Oscar and Hammerstein that was very popular back in the 1950s and 1960s and recorded by many including choirs, big bands, groups, and even Elvis Presley, "You'll Never Walk Alone."
When you walk through a storm,
Hold your head up high,
And don't be afraid of the dark,
At the end of a storm, there's a golden sky,
And the sweet silver song of a lark.
Walk on thorough the wind,
Walk on through the rain,
Though your dreams be tossed and blown...
Walk on, walk on, with hope in your heart,
And you'll never walk alone,
You'll never walk alone.
Yes, regarding the pandemic, the sky is finally starting to clear!
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Spread the word ...
... forward this newsletter to someone that needs it.
Tell them they can get their own free copy of the weekly Compounding Today newsletter at
https://CompoundingToday.com/Newsletter/!!
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Looking Back
Famous last words,
About lights that shine,
If he don't dim his,
I won't dim mine!
Burma-Shave
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Just Released, ASTPC, Sixth Edition
Completely revised and updated, the 6th Edition covers all aspects of compounding including the regulatory, technology, scientific foundation, and clinical consulting regarding the dosage forms that can be compounded. It also contains example formulas for all dosage forms along with the ingredients, quantities, use of each ingredient, and instructions for preparation. In addition to formulation development including flavoring, sweetening, preservation, and compliance and compatibility considerations, quality control and areas of potential errors are also presented.
KEY FEATURES:
- Covers all aspects of nonsterile and sterile as well as nonhazardous and hazardous compounding
- Blends the scientific and technologic aspects of compounding to support an understanding of the importance of each compounded dosage form
- Presents different technologies for compounding various dosage forms, as well as example formulations for all dosage forms presented in the book
- Features an entirely new chapter emphasizing the pharmacist's role in addressing incompatibilities and their potential clinical effects
- Introduces potential for error, error prevention, and correction
- Covers new and innovative dosage forms such as 3D printing and self-emulsifying products
- Includes guidance for preventing and correcting potential compounding errors
- Features compounding options in response to the COVID-19 pandemic in the chapter Compounding for Terrorist Attacks and Natural Disasters
Get your copy via Amazon through the Compounding Today compounding pharmacy bookstore at:
CompoundingToday.com/Books
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Announcement
Be sure you and your team are staying sharp and staying smart - and compliant. Ethical practice is the focus of APC's EduCon Virtual 2021, and it's just a few days away - February 4 - 5. Get info, get registered, and get your team to go:
https://a4pc.org/APC/Conferences/EduCon2021/EduCon2021.aspx
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