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 Should Drop Ban On Office Compounding, US House Members Say

Executive Summary

Commissioner Gottlieb stands pat (actually he was sitting) during hearing where lawmakers suggest FDA has gone overboard in implementing DQSA. And while he acknowledges that '503 lite' isn't the best term to use, Gottlieb says agency’s plan to create different risk tiers for drug outsourcing pharmacies offers the flexibility that can entice more traditional pharmacies to register as outsourcing centers, and thus be subject to GMP oversight.

You may also be interested in...



FDA Highlights Advanced Drug Manufacturing Approaches In Budget Plan

FDA wants more companies to adopt continuous manufacturing, which could expand the US manufacturing base.

FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities

To encourage drug compounding pharmacies to register as 503B drug outsourcing facilities, FDA plans to propose assigning these pharmacies a lower risk category, thus subjecting them to less stringent GMP controls if they make limited volumes of drugs as part of a “2018 Compounding Policy Priorities Plan” announced by FDA Commissioner Scott Gottlieb.

FDA Works To Encourage Office-Use Compounding In Advance Of Legislation

FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.

Topics

Latest News
UsernamePublicRestriction

Register

PS122420

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