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
UsernamePublicRestriction

Compounding Law: How Many “Outsourcing Facilities” Will Emerge?

This article was originally published in The Pink Sheet Daily

Executive Summary

As bill heads to President, voluntary registration system for compounders likely means not all large-scale operations will subject themselves to FDA oversight.

You may also be interested in...



Express Scripts Turns To Compounding To Fight High-Priced Off-Patent Drugs

Pharmacy benefit manager's anti-Daraprim effort signals new direction in pricing battles, but the strategy can only be used in limited circumstances.

FDA Compounding Definition Brings States Into Oversight Fold

State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.

Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility

After the House and Senate question whether FDA needs more authority to regulate compounders like the New England Compounding Center, Sen. Lamar Alexander suggests clearly designating who has jurisdiction may be the answer.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132115

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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