FDA Commissioner Claims Resistance to Compounding Pharmacy Inspections - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Commissioner Claims Resistance to Compounding Pharmacy Inspections



In an FDA blog, FDA Commissioner Margaret Hamburg stated that recent FDA inspections of 31 compounding pharmacies known to produce sterile drugs resulted in a discovery of inappropriate sterile-manufacturing conditions and FDA-483 observation results for all but one of the companies inspected. The companies were cited for incidents ranging from rust and mold in cleanrooms to unidentified black particles in vials of sterile product. Some of these FDA-483 notices have led to voluntary product recalls.

According to Hamburg, FDA was met with resistance from some of the pharmacies that were included in the inspections. She claims that some inspections were either delayed or inspectors were denied full access to records, thus requiring court-issued warrants. “These inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country–problems that could potentially affect the health of patients. To carry out this proactive inspection effort, FDA had to shift resources from other areas, and this is not a sustainable approach for the longer term,” Hamburg stated on FDA.gov.  

Hamburg also stated that FDA is working with Congress on legislation for FDA oversight of compounding pharmacies and is evaluating the agency’s surveillance and enforcement approach.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here