In case you missed it, the FDA sent an email clarifying several compounding policies in response to questions from…
FDA Issues Clarification on Compounding Policies
In case you missed it, the FDA sent an email clarifying several compounding policies in response to questions from…
Apr, Tue, 2020
More on FDA’s EUA for Hydroxychloroquine
More on FDA’s EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate Here’s what Eagle’s Chief Technical Officer and the current…
More on FDA’s EUA for Hydroxychloroquine
More on FDA’s EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate Here’s what Eagle’s Chief Technical Officer and the current…
Mar, Mon, 2020
FDA Issues EUA for the Use of Hydroxychloroquine and Chloroquine
On Sunday March 29, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to permit…
FDA Issues EUA for the Use of Hydroxychloroquine and Chloroquine
On Sunday March 29, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to permit…
Mar, Fri, 2020
Links: FDA & USP Guides on Compounding of Hand Sanitizer
To address shortages of hand sanitizer due to the rapidly evolving COVID-19 pandemic, the FDA issued a guidance document…
Links: FDA & USP Guides on Compounding of Hand Sanitizer
To address shortages of hand sanitizer due to the rapidly evolving COVID-19 pandemic, the FDA issued a guidance document…
Mar, Thu, 2020
USP Issues a Decision on: 795, 797, and 825
USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>,…
USP Issues a Decision on: 795, 797, and 825
USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>,…
Dec, Tue, 2019
USP <800> is Now Official
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help you ensure compliance with this…
USP <800> is Now Official
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help you ensure compliance with this…
Oct, Thu, 2019
Testing Alone is not Enough
A common misconception is the belief that finished product testing is sufficient to demonstrate quality. However, facilities that perform…
Testing Alone is not Enough
A common misconception is the belief that finished product testing is sufficient to demonstrate quality. However, facilities that perform…
Apr, Thu, 2019
A Summary of Proposed Changes to USP 797
Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.
A Summary of Proposed Changes to USP 797
Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.
Apr, Fri, 2019
Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress…
Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress…
Dec, Tue, 2018
The Compounder’s Crash Course to FDA and 503A Exemption Audits
The Compounder’s Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared?
The Compounder’s Crash Course to FDA and 503A Exemption Audits
The Compounder’s Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared?