Policyholder Services

FDA Guidance on Compounded Drugs Limits Distribution for Office Use to Approved Outsourcing Facilities

From AAO/ASRS Bulletin 7/2/2014

The U.S. Food and Drug Administration issued several policy documents on July 1 regarding compounded drug products for human use. This is part of the agency’s continuing effort to implement the Drug Quality and Security Act. Of primary concern to ophthalmology is final guidance for FDA policy on enforcement of section 503A for traditional compounding pharmacies.

The guidance outlines how the FDA interprets the law. The FDA intends that those facilities − whose oversight will remain at the state level − will require a patient-specific prescription for all drugs compounded. While not unexpected, the Academy and ASRS are deeply disappointed with the FDA’s interpretation.

This will conflict with state laws that currently allow for office use in several states. The outcome of those conflicts is unknown at this time; however, the guidance shows that the FDA intends to bring action against those traditional compounders that do not require prescriptions. As a result, smaller compounding facilities that have not registered with the FDA as 503B outsourcing facilities will likely choose to no longer provide compounded drugs, like repackaged Avastin, for office use without a prescription.

This leaves ophthalmologists with a final hope for office use from the new FDA-regulated 503B outsourcing facilities. The agency has yet to release guidance regarding what would be permitted, e.g. repackaging of Avastin by these pharmacies; however, the new outsourcing facilities will be required to meet higher federal safety, sterility and quality-control standards.

The Academy and ASRS continue to be actively involved in discussions with Congress and the FDA to ensure availability of Avastin as a core, sight-saving medication for hundreds of thousands of patients with wet macular degeneration. The ophthalmology associations are part of a coalition that sent a letter to the FDA in June, expressing concerns over the threatened availability of compounded drugs for ophthalmology patients.

The Academy and ASRS reiterated these issues in a meeting with the FDA last week. Additional advocacy efforts included urging Congress to send a letter to the agency expressing the importance of collaboration between the FDA and medicine as part of the process for implementing the Drug Quality and Security Act. More than 375 Academy and ASRS members sent letters to Congress, resulting in a Congressional letter to the FDA last week receiving signatures from 31 members of Congress.

The Academy and ASRS will continue to advocate on behalf of its members to ensure that you have reasonable access to these sight-saving medications for your patients. Members are encouraged to also make your individual voices heard on this issue by using tools to directly contact your Congressional representative, as well as writing to the FDA.
For more information, contact the Academy’s Government Affairs division at 202.737.6662.

Please refer to OMIC's Copyright and Disclaimer regarding the contents on this website

Leave a comment

Six reasons OMIC is the best choice for ophthalmologists in America.

Largest insurer in the U.S.

OMIC is the largest insurer of ophthalmologists in the United States and we've been the only physician-owned carrier to continuously offer coverage in all states since 1987. Our fully portable policy can be taken with you wherever you practice. Should you move to a new state or territory, you're covered without the cost or headache of applying for new coverage.