The Drug Quality and Security Act, H.R. 3204 was signed into law by President Obama on November 27, 2013. This bill contains two titles. Title I, “The Compounding Quality Act,” distinguishes between traditional compounders and outsourcing facilities. It establishes a uniform set of rules for outsourcing facilities while preserving the states’ primary role in traditional pharmacy regulation. Title II, “The Drug Supply Chain Security Act,” provides a uniform, national drug tracing framework to track prescription drugs from the manufacturer to the pharmacy and raises the standards for prescription drug wholesalers across the U.S.
It is important to review the text of Title I with section 503A of the Federal Food, Drug and Cosmetic Act (FFDCA) in mind.
We have provided the text of section 503A on NHIA’s website and it can be accessed here.
The DQSA re-establishes section 503A as the principal federal recognition that traditional compounding pharmacies continue to be regulated by the states. In particular, traditional compounding will remain exempt from certain provisions of the FFDCA relating to drug manufacturing (chiefly cGMP) if performed in compliance with section 503A.
With 503A being the national law regarding traditional compounding pharmacies, the bill also created a new type of compounding entity called an “outsourcing facility. This option for a facility engaged in compounding of sterile drugs allows the facility to choose to register with the FDA as an outsourcing facility. A facility qualifying as an outsourcing facility, and which chooses to register with FDA, will be exempt from several provisions of the Federal Food, Drug and Cosmetic Act.
After the DQSA was signed into law the FDA initiated the process of implementing the legislation and has continued to carry out regulation pursuant to the law since. The FDA had developed a resource web page that lists all federal regulation over compounding pharmacies.
NHIA has been particularly interested in the “Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert STATE] and the U.S. Food and Drug Administration” regulation issued by the FDA on February 13, 2015.NHIA commented on how this regulation could prevent home infusion pharmacies from providing drugs over state lines. Read NHIA’s comments here.
Further revisions of the MOU are expected.
FDA Commissioner Scott Gottlieb Discusses Home Infusion and Compounding MOU
On January 30, 2018 FDA Commissioner Scott Gottlieb at a House Energy and Commerce Committee hearing entitled “Examining Implementation of the Compounding Quality Act” discussed the need to ensure home infusion and parenteral nutrition are not adversely affected by the upcoming Memorandum of Understanding (MOU). Watch the video.