Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Isomeric Enters Drug GMP Consent Decree As FDA's Crackdown On Drug Compounders Continues

Executive Summary

Drug compounding pharmacy Isomeric has entered a consent decree after turning a blind eye to a multitude of GMP problems with its injectable and ophthalmic drugs. This brings to six the number of consent decrees the Justice Department has reached with compounding pharmacies since the New England Compounding Center tragedy in 2012.

You may also be interested in...



Outsourcing Pharmacy Asks Court To Restrain FDA From Shutting It Down Over Contamination

 A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.

FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121265

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel