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…
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…
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…
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…