Today, USP <85> continues to serve as the gold standard for Bacterial Endotoxin Testing (BET), relying exclusively on Limulus…
A New Era for Endotoxin Testing: USP <86> Introduces Sustainable Recombinant Alternatives to LAL
Today, USP <85> continues to serve as the gold standard for Bacterial Endotoxin Testing (BET), relying exclusively on Limulus…
Jul, Thu, 2025
FDA Investigator’s Manual
We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
FDA Investigator’s Manual
We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
Jul, Thu, 2025
Lessons Learned in Interpreting and Operationalizing USP 795 and USP 797 Updated Requirements
When industry veterans gathered in Boston for the 2025 Compounding Pharmacy Compliance (CPC) Conference, all eyes were on one…
Lessons Learned in Interpreting and Operationalizing USP 795 and USP 797 Updated Requirements
When industry veterans gathered in Boston for the 2025 Compounding Pharmacy Compliance (CPC) Conference, all eyes were on one…
May, Tue, 2025
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
Apr, Mon, 2025
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Jul, Wed, 2024
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
Oct, Tue, 2023
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 Nonsterile Preparations and…
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 Nonsterile Preparations and…
Oct, Thu, 2023
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sep, Thu, 2023
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Jul, Tue, 2023
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…
Jun, Wed, 2023
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…
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…
May, Tue, 2023
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Apr, Wed, 2023
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
Mar, Thu, 2023
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Sep, Mon, 2022
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Jul, Fri, 2021
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
Mar, Wed, 2021
Cost of Quality and the Price of Nonconformance
Recalling and disposing of products, enduring lengthy litigation proceedings, processing reimbursements, and repairing a damaged reputation are among the daunting tasks that no compounding business ever wants to face.
Cost of Quality and the Price of Nonconformance
Recalling and disposing of products, enduring lengthy litigation proceedings, processing reimbursements, and repairing a damaged reputation are among the daunting tasks that no compounding business ever wants to face.
Jan, Wed, 2021
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Nov, Fri, 2020
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
Oct, Wed, 2020
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 compounding facilities.
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 compounding facilities.
Jul, Wed, 2020
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 outsourcing facilities and…
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 outsourcing facilities and…
May, Thu, 2020
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
May, Fri, 2020
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 update is part of a…
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 update is part of a…
May, Fri, 2020
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 states…
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 states…
May, Thu, 2020
FDA Updates Temporary Policy Regarding PPE for Compounders
The FDA has issued an update to its Temporary Policy Regarding Non-Standard PPE Practices for Pharmacy Compounders During 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 Pharmacy Compounders During the…
May, Mon, 2020
Morphine Sulfate & Epinephrine added to COVID-19 Compounding List
FDA has updated two guidance documents that describe temporary policies for the compounding of certain human drugs during the…
Morphine Sulfate & Epinephrine added to COVID-19 Compounding List
FDA has updated two guidance documents that describe temporary policies for the compounding of certain human drugs during the…
Apr, Fri, 2020
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 terms stipulated by the…
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 terms stipulated by the…
Apr, Mon, 2020
503A’s Can Temporarily Compound Certain Drugs
The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound certain medications without the requirement…
503A’s Can Temporarily Compound Certain Drugs
The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound certain medications without the requirement…
Apr, Fri, 2020
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 Sanitizer Products during the COVID-19 public health emergency.
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 Sanitizer Products during the COVID-19 public health emergency.
Apr, Thu, 2020
FDA Relaxes Restrictions on 503Bs for COVID-19
On April 16, 2020, the FDA issued the guidance document “Temporary Policy for Compounding of Certain Drugs for Hospitalized…
FDA Relaxes Restrictions on 503Bs for COVID-19
On April 16, 2020, the FDA issued the guidance document “Temporary Policy for Compounding of Certain Drugs for Hospitalized…
Apr, Fri, 2020
FDA Issues Temporary Policy on PPE for Compounders
FDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns regarding PPE in light of current…
FDA Issues Temporary Policy on PPE for Compounders
FDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns regarding PPE in light of current…
Apr, Wed, 2020
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…
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>,…
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products
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?
Dec, Tue, 2018
What to Test – When to Test – Why to Test
Join Eagle CEO, Dr. Ross Caputo as he shares the testing requirements for your compounding facility: helping you navigate the “what, when & the why’s” of testing.
What to Test – When to Test – Why to Test
Join Eagle CEO, Dr. Ross Caputo as he shares the testing requirements for your compounding facility: helping you navigate the “what, when & the why’s” of testing.