ARTICLES, PUBLICATIONS, INFORMATION, EVENTS, UPDATES & MORE
Here you will find articles, publications, information, events, and more for people interested in the pharmacy compounding world. From pharmacist to patient, this news is for you. It is our commitment to provide your organization with the tools to operate and maintain compliance within a highly regulated environment.
Facility Design and Construction Requirements | USP 795 & 797 Revisions
It is important to note that there have been significant changes made to the regulations governing...
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual...
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and...
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit...
ashp Midyear Clinical Meeting 2023, 12/03 – 12/07
What a week it's been @ #ASHP2023 Midyear! As we reflect on the highlights of Midyear, we're...
PCCA International Seminar 2023, 10/26 – 10/28
It was an honor to participate as both an exhibitor and educator at this year's PCCA International...
HCP Hospital Pharmacy Fall Conference, 10/23 – 10/25
Thank you, Health Connect Partners (HCP), for organizing this worthwhile event! It was our...
2023 PDA Pharmaceutical Microbiology Conference, 10/02 – 10/04
Eagle attended the 2023 PDA Pharmaceutical Microbiology Conference taking place this October 2nd –...
2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20
Eagle attended the 2023 PDA/FDA Joint Regulatory Conference in the nation's capital. This year's...
APC: Compounders on Capitol Hill, 09/19 – 09/20
APC's Compounders on Capitol Hill was a great event. Eagle would like to thank everyone who was...
Compounding Pharmacy Compliance, 08/17 – 08/18
Eagle went to Boston! Did you attend the presentation by Dr. Ross A. Caputo, Ph.D. at the...
Water Activity | USP 795 & 797 Revisions
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described...
ashp Summer Meeting & Exhibition, 06/10 – 06/14
If you're looking for a chance to meet Eagle in person, you're in luck! The Eagle team will be...
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be...
Health Connect Partners 2023, 05/22 – 05/24
Eagle is heading to Indianapolis for Health Connect Partners #HCP23! Make sure and stop by our...
PCCA Sterility Assurance Training cohort visits Eagle, 05/11
Today, it was our honor to host a group of dedicated pharmacists who are attending...
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for...
OPA Annual Conference, 04/14 – 04/16
Eagle in flight to Ohio! Eagle is on the move and is attending the OPA Annual Conference and Trade...
PDA Annual, 04/03 – 04/05
Join Eagle at the Parenteral Drug Association (PDA) annual meeting. booth #115, in New Orleans,...
APC 2023, 03/26 – 03/28
We are in Point Clear, Alabama for the Alliance for Pharmacy Compounding Owner (APC) 2023...
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using...
HRT & Functional Medicine Symposium, 02/23 – 02/25
Visit Eagle's table at PCCA's HRT & Functional Medicine Symposium taking place in Las Vegas,...
USP 3rd Annual Compounding Implementation Workshop, 02/07 – 02/08
Eagle is excited to join USP volunteers and other esteemed compounding colleagues in a deeper...
PCCA’s Advisory Council #8 visits Eagle, 02/06
Last Friday Eagle had the opportunity to host PCCA’s Advisory Council #8. It was our pleasure to...
Robert Hernandez named the 2022 Eagle Employee Of The Year
Congratulations to Robert Hernandez, Senior Quality Control Specialist, on being the recipient of...
Eagle New Year Party & Eagle Employee Of The Year Award Ceremony, 01/14/23
On Saturday, January 14th, 2023, Eagle celebrated our employees and announced the winner of the...
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are...
Dr. David Hussong published in Microorganisms
Dr. David Hussong, Ph.D., is part of a distinguished group of microbiologists who published a...
🦅 Abraham Gomez named Eagle’s 2021 Employee Of The Year
Congratulations to Abraham Gomez, Analytical Chemist I on being the recipient of the Eagle 2021...
EAGLE Seminar Conference 2021 | 🦅 EVENT NOTICE
"Compliance Readiness Is a Mindset" Wednesday, October 20, 2021 │ In-Person Attendance Only...
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile...
Cost of Quality and the Price of Nonconformance
As the world becomes more aware of the benefits of personalized medicine, the result is increased...
Pharmaceutical Supply Chain Infiltrated with Methanol
Methanol Found in Pharmaceutical Supply ChainAccording to FDA, the pharmaceutical supply chain has...
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement...
What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at...
Eagle Virtual Compliance Seminar – Edutainment at its Best
Registration for this Session is Now Closed We will be posting information on upcoming seminars...
Dexamethasone Sodium Phosphate Added to the List of Drugs for Temporary Compounding
The FDA has added Dexamethasone Sodium Phosphate to the list of drugs for temporary compounding by...
Unsung Heroes of the Fight Against COVID-19
On March 24, 2020, Houston Mayor Sylvester Turner announced the "Stay Home, Work Safe" Order...
COVID-19 Exposure Action Plan for Eagle Employees
We take the health and safety of our employees very seriously and want to assure you that we are...
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, "Postmarketing Adverse Event Reporting for Medical...
What It Means When Your Sample is Out-Of-Specification
When sending samples for testing at third-party facilities, most clients want to ensure that...
Updates to FDA’s Purple Book: Database of Licensed Biological Products
This week the FDA updated the Purple Book: Database of FDA-Licensed Biological Products. The...
FDA Announces Update on MOU for Compounding Pharmacies
On May 13, a standard memorandum of understanding, also known as a MOU, between the FDA and the...
FDA Updates Temporary Policy Regarding PPE for Compounders
The FDA has issued an update to its Temporary Policy Regarding Non-Standard PPE Practices for...
Morphine Sulfate & Epinephrine added to COVID-19 Compounding List
FDA has updated two guidance documents that describe temporary policies for the compounding of...
FDA’s Guidance for 503A Compounding of COVID-19
Following our previous posts on FDA’s guidance released this week, Dr. David Hussong discusses the...
503A’s Can Temporarily Compound Certain Drugs
The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound...
Updates to FDA’s Policy for Compounding of Hand Sanitizer
On April 15, FDA updated the Policy for Temporary Compounding of Certain Alcohol-Based Hand...
FDA Relaxes Restrictions on 503Bs for COVID-19
On April 16, 2020, the FDA issued the guidance document “Temporary Policy for Compounding of...
FDA Issues Temporary Policy on PPE for Compounders
FDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns...
FDA Issues Clarification on Compounding Policies
In case you missed it, the FDA sent an email clarifying several compounding policies in response...
More on FDA’s EUA for Hydroxychloroquine
More on FDA’s EUA for Hydroxychloroquine Sulfate and Chloroquine PhosphateHere’s what Eagle's...
Our New Social Distancing Lab Hours
At Eagle, we’re implementing measures to help our laboratories and staff maintain safety during...
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...
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...
Currently No Closures. No Delays. We’re Here for You
At Eagle, we have been closely monitoring the COVID-19 situation and are taking it very seriously....
A Scientific Response to the SARS-CoV-2 Coronavirus: Covid-19 Disease
As Eagle Scientists, we want you to know that we understand the position you’re in today as a...
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...
Eagle’s ScanRDI®Rapid Sterility Test!
Did you know you can get your sterility test results in as little as one business day? Eagle’s...
Environmental Monitoring & Why it Matters: Part 3
Read Previous Article: Environmental Monitoring and Why it Matters - Part 2Counting CFU's Ain't...
Environmental Monitoring & Why it Matters: Part 2
Read Previous Article: Environmental Monitoring and Why it Matters - Part 1The Importance of...
Environmental Monitoring & Why it Matters: Part 1
Avoid Relying on Sterility Tests Alone Sterility tests cannot reliably detect contamination in...
Eagle’s ScanRDI® Fastest Rapid Sterility Test!
Get sterility test results in as little as 1 business day with Eagle’s ScanRDI® rapid sterility...
USP <800> is Now Official
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help...
Dr. Scott Gottlieb Tours the New Eagle Facility
Dr. Scott Gottlieb Visits Eagle's New Facility Former FDA Commissioner Dr. Scott Gottlieb visited...
EagleTrax Sample Management System
EagleTrax is our new full-featured system that allows you to track your samples, print reports at...
Testing Alone is not Enough
A common misconception is the belief that finished product testing is sufficient to demonstrate...
Take a Tour of Our New Facility
Eagle’s state-of-the-art 35,000 square foot facility and laboratory feature innovative...
EagleTrax Tutorial Video
EagleTrax is our new full-featured system which allows you to track your samples, print reports at...
Compounding’s Most Essential Seminar for Compliance & Patient Safety
Eagle presents the most important seminar that sterile and non-sterile compounders must attend to...
Tracking Your Sample’s Progress Just Became Possible.
We’re pleased to announce EagleTrax™ EagleTrax is our new customer portal that allows you to track...
A Summary of Proposed Changes to USP 797
On July 27, 2018, the Compounding Expert Committee of the United States Pharmacopeia (USP)...
Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England...
Important Considerations For Cleanroom Design
When designing a cleanroom, there are many aspects to take into consideration. While regulations...
FDA Inspections of Compounding Pharmacies
The U.S. Food and Drug Administration (FDA) inspects both 503A and 503B compounding pharmacies to...
The Compounder’s Crash Course to FDA and 503A Exemption Audits
The Compounder's Crash Course to FDA and 503A Exemption Audits The Compounders' Crash Course to...
What to Test – When to Test – Why to Test
The United States Pharmacopeial (USP) Guidelines have identified specific testing requirements...
🔺 USP 795 & 797 NEWS
Know Where Your Pharmacy Needs Attention
Patient Safety + Worker Safety x Environmental Protection = SurfaceShield
