Showing posts with label compounders. Show all posts
Showing posts with label compounders. Show all posts

Wednesday, September 25, 2013

Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession


New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

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Friday, March 15, 2013

FDA Focus On cGMP Compliance By Compounders

Updated June 10, 2022

Some of the links broke.

You might also be interested in:

---  the original post follows below  ---

The FDA continues to focus on pharmacy compounders.

This is evidenced by the growing number of the FDA's Form 483s (Inspectional Observations) that are being posted:  FDA - 2013 Pharmacy Inspections

Earlier this month, the FDA sent a "Warning Letter" to Medi-Fare Drug and Home Health Center 3/7/13.  It highlights the myriad touchpoint issues, including pharmacy regulations, and the FDA's regulations on current good manufacturing practices (i.e., the FDA's cGMPs).

You might also be interested in:
21 CFR 211: Pure, Safe, and Effective - Online training - An orientation to the FDA's cGMPs

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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