The US FDA has defined compounding pharmacies as ‘outsourcing facilities’ in new guidance issued days after the Drug Quality and Security Act (DQSA) became law .
The three draft guidance documents – which give an overview of the Food and Drug Administration’s (FDA) thinking on compounding, facilities and registration – are designed to improve oversight of this specialist sector of contract manufacturing industry.
Under the guidance on manufacturing sites the agency explains that compounding labs that choose to register as ‘outsourcing facilities’ will be inspected to check it complies with current good manufacturing practices (cGMP).
Those compounders that do register as a “Human Drug Compounding Outsourcing Facility“ will need to do so before December 31, providing details of the site’s location, a unique identifier for the plant and a point of contact.
Registrants are also required to notify the agency if they will make a drug that is included on its drug shortage list or if sterile bulk substances are used.
The law does not require compounding pharmacies to register with the FDA, which is something the agency previously described as critical to preventing any recurrence of the contamination problems of 2012 that resulted in the death of 64 US citizens.
Instead, supporters of the new legislation argue that the voluntary registration system will work if physicians only buy drugs from compounds who do register with the FDA.
Track and trace
The DQSA also sets the stage for a country wide track and trace system for pharmaceutical products in the US, which has been welcomed by pharmaceutical manufacturers and contractors that make products for the world’s largest market.
Swedish contract manufacturing organisation (CMO) Recipharm is a case in point. Outsourcing-pharma.com visited the firm’s packaging facility just outside Stockholm last week and US track and trace was a key discussion topic.
Site manager Ulf Hagström told us that: “We like many drugmakers were concerned that there would be many different systems in the US, but now with this new legislation all the States will have the same track and trace requirements which is a positive thing.”
Recipharm CEO Thomas Eldered, who accompanied in-Pharmatechnologist.com on the tour, also welcomed the laws as a good thing for customers making drugs for the US market but did point out that, although the rules will be harmonized across that country, the new track and trace system will be different to the one in place in Europe.