Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 Proposes Banning Outsourcers From Bulk Compounding Of Three Drugs

Executive Summary

FDA’s proposal would, if finalized, protect pharmaceutical manufacturers like Endo, maker of Vasostrict, from competition by outsourcing facilities regulated under Section 503B of the Food, Drug and Cosmetic Act, at least for vasopressin and two other drugs.

You may also be interested in...



Vasopressin Ruling May Greenlight More FDA Limits On Bulk Drug Compounding

By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?

FDA Begins Restricting Bulk Compounding With First DQSA Determinations

FDA has taken its first action on the 503B bulks list since DQSA was enacted five years ago by banning two bulk drug substances – vasopressin and nicardipine hydrochloride – from the list of bulk drug substances that outsourcing facilities can use to compound drugs. The agency also issued final guidance addressing its polices for developing the 503B bulks list. Legal observers say that these actions should prompt outsourcing facilities to be wary of using bulk drug substances not approved by FDA.

FDA Proposes Criteria For Allowing Bulk Compounding To Address Unmet Clinical Need

FDA’s draft guidance spells out criteria for which bulk drug substances outsourcing facilities can use to address unmet clinical needs, yet uncertainty lingers as to whether the draft guidance resolves a pending lawsuit.

Topics

UsernamePublicRestriction

Register

PS123791

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