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


FDA Compounder Inspections May Help Set New Enforcement Standard

Executive Summary

Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.

You may also be interested in...

Track And Trace: FDA Seeks Wholesaler Info Beyond Legal Requirements

FDA wants wholesalers and third-party logistics providers to give disciplinary information even though not required by DQSA; agency then plans to release the data.

GMP Flexibility For Compounders Signaled In FDA Draft Guidance

Agency seeks comments on how to minimize burden of some testing requirements for registered outsourcing facilities.

Compounding Oversight May Hinge On How FDA Treats Office Stock

Pew asks FDA to look at large-scale compounders of office stocks and help encourage them to register, but IACP argues regulation of the office stock should remain with the states.

Related Content


Latest Headlines
See All



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