May 5, 2016
On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA’s interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act). The three guidance documents apply to compounding activities of hospital pharmacies, non-hospital pharmacies and outsourcing facilities. While the guidance does not establish legally enforceable responsibilities, it reflects the FDA’s current thinking and recommendations on these topics.

Key takeaways from the guidance include:

1. The guidance clarifies that Section 503A entities should not distribute compounded drugs without a valid prescription for an identified patient. The guidance also addresses the requirements of the limited quantity exception.

2. The guidance recommends that non-503B compounding pharmacies may only distribute those medications to other entities within a one-mile radius owned and controlled by that pharmacy. These prescriptions should also be compounded pursuant to a patient-specific order and can only be administered within the facility.

3. The guidance also reiterates that all drugs compounded at a single geographic location of an outsourcing facility must meet the requirements of 503B.

Facilities that engage in drug compounding should contact Polsinelli’s experts to submit comments on the draft guidance, due July 14, 2016.

To view the full alert, click here.