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14‑DAY TRIAL    FORMULATIONS    MY ACCOUNT 
Compounding This Week Newsletter from www.CompoundingToday.com
Brought to you by IJPC
Our Compounding Knowledge, Your Peace of Mind
January 6, 2023  |  Volume 20  |  Issue 1
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Amoxicillin Shortage Continues: Compounding Pharmacies Filling the Gap!
 

The number of amoxicillin products on back order has increased to between two and three dozen oral presentations of amoxicillin.

As of December 8, 2022, most drugmakers could not estimate a resupply date of amoxicillin, but Teva Pharmaceuticals has released the dates of January and February 2023, and Hikma Pharmaceuticals short-dated their allocated supply for August 2023.

The worsening supply issue could be connected to the surge in viral infections even though amoxicillin is not a recommended treatment for COVID-19, flu, or respiratory syncytial virus (RSV) infections. Amoxicillin is not recommended to treat RSV cases, but some physicians will prescribe antibiotics when they are not medically necessary.

The original drug shortage may have sent a ripple effect through amoxicillin/clavulanate products - the recommended backup treatment for some infections if amoxicillin is not available - because 29 of them were in short supply as of late November 2022.

To obtain your own copy of the November 2022 FDA Guidance "Compounding Certain Beta-Lactam Products Under Section 504A of the Federal Food, Drug and Cosmetic Act," go to:

Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act | FDA

The following updated table lists amoxicillin formulas on the CompoundingToday.com website, along with some formulas for acetaminophen preparations which have also been reported in short supply in some areas.

A602* Amoxicillin 50 mg/mL in Ora-Blend or Ora-Blend SF
A603 Amoxicillin 50 mg/mL in Ora-Blend or Ora-Blend SF
A604 Amoxicillin 250-mg/5-mL Oral Suspension (SuspendIt)-PCCA
A605 Amoxicillin 400-mg/5-mL Oral Suspension (SuspendIt)-PCCA
A601 Amoxicillin 50 mg/mL in Oral Mix or Oral Mix SF
A600 Amoxicillin 50 mg/mL in PCCA Plus Oral Suspending Vehicle
803 Amoxicillin Trihydrate 25-mg/mL Powder for Oral Suspension
804 Amoxicillin Trihydrate 50-mg/mL Oral Suspension
818 Amoxicillin Trihydrate 125-mg in Fatty Acid Base Suppositories
819 Amoxicillin Trihydrate 250-mg Troches
A339 Acetaminophen 100 mg/mL in SyrSpend SF PH4
A145 Acetaminophen 25-mg/mL Syrup for Children
1785 Acetaminophen 10 mg/mL in Pluronic™ Rectal Solution
1263 Acetaminophen 65 mg/mL and Tramadol Hydrochloride 7.5 mg/mL in Oral-Plus and Ora-Sweet™ SF
1375 Acetaminophen 500-mg and Diphenhydramine Hydrochloride 25-mg Powder for Dilution in Hot Water
A157 Acetaminophen 125-mg Suppositories
A158 Acetaminophen 250-mg Suppositories
T218 Tramadol Hydrochloride and Acetaminophen Compounded Oral Suspension USP

*A letter preceding the number designates the General Formula Section.

No letter preceding the number designates the Documented Formula Section.

Also see:

https://www.fda.gov/​media/​163367/​download

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

International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On Resolutions) ...

...the following?

"In the New Year, I resolve to do just about what I did last year." (Anon)

"New Year's Day is every man's birthday." (Charles Lamb)

Thoughts for the Week (On Promises to Self!)

"Let us have faith that right makes might, and in that faith, let us to the end, dare to do our duty, as we understand it." (Lincoln)

From Out of the Past

Bristly beard
or silky fuzz,
Just shave 'em back
to where they was!
     Burma-Shave

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