Compounding Update: Drug Quality and Security Act – Outsourcing Facilities

The Drug Quality and Security Act establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.”

What qualifies as an outsourcing facility? 

To qualify as an outsourcing facility, an entity must compound sterile drugs with or without patient specific prescriptions and comply with the Drug Quality and Security Act’s new rules, which include registering with the Food and Drug Administration (FDA).

Does an outsourcing facility need to be a licensed pharmacy?

An outsourcing facility is not required to be a licensed pharmacy. However, while registering as an outsourcing facility is voluntary, entities that do not register may be prohibited from compounding drugs for office use and will be required to obtain patient specific prescriptions.

What is the cost to register as an outsourcing facility?

Annual registration as an outsourcing facility is required. Currently, if the facility has under $1 million dollars in sales, the registration fee is $5,000. For sales greater than $1million dollars, the registration fee is $15,000.

What are the FDA reporting requirements?

Each registered outsourcing facility must report the drugs that are being compounded to the FDA twice a year, in June and December. Outsourcing facilities that do no register will be subject to FDA rules regarding new drug application and approvals and drug, directions for use and supply chain security requirements.

Presently, the Drug Quality and Security Act does not regulate traditional pharmacy compounding, but only time will tell if there will be a push to make changes in those regulations and standards too.  More to come.