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

FDA Cites Respi Care As Part Of Pharmacy Compounding Enforcement

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency issues its second “warning letter” in a month citing a pharmacy’s compounding operations as comparable to that of a drug manufacturer. The agency also notes cGMP violations observed during an inspection of Respi Care’s facility in Puerto Rico.

You may also be interested in...



FDA Compounding Policy To Have Day In Court In December

Ten pharmacies challenging the agency's compounding policy say the lawsuit is an effort to stop "FDA's end-run on the Western States decision," which threw out restrictions on advertising for compounding products.

FDA Compounding Policy To Have Day In Court In December

Ten pharmacies challenging the agency's compounding policy say the lawsuit is an effort to stop "FDA's end-run on the Western States decision," which threw out restrictions on advertising for compounding products.

Pharmacy's Compounding Resembles Rx Manufacturing Operation, FDA Says

FDA "warning letter" states that Lincare and Reliant Pharmacy produce "essentially copies of commercially available drugs" without documented patient-specific medical need. This practice goes beyond the scope of traditional compounding, the letter states.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060815

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