Compounded Medicines

The Academy believes physicians must have office-use access to all compounded and repackaged drugs that are vital to patients' vision. Compounded and repackaged medications — especially for treatments that preserve sight, like those involving Avastin — are essential to delivering timely, effective, and affordable eye care.  

The Academy's position centers on a key priority:

 

The FDA should advance its regulatory framework for compounded drugs to promote quality, while ensuring timely patient and physician access to critical treatments. 

The Academy is working directly with the U.S. Food and Drug Administration (FDA), Congress, and other stakeholders to protect physician and patient access to compounded drugs. Specifically, the Academy has:

• Repeatedly urged the FDA to provide regulatory flexibility to ensure ophthalmic compounded drugs are available for office-use.
• Supported legislation that promotes the ability of 503B outsourcing facilities to play a larger role in addressing drug shortages.

The Drug Quality and Security Act, passed in late 2013, created a new regulatory structure for compounding pharmacies and the products they distribute. The law defines federal oversight authority over large-volume compounding facilities while preserving a pathway for ophthalmologists to access certain compounded drugs for office use.

Under the law, two categories of compounding facilities operate under distinct requirements:

• 503(A) traditional compounding pharmacies require a patient-specific prescription for all compounded drugs.
• 503(B) outsourcing facilities do not require a prescription but must meet higher federal standards for safety, sterility, and quality control.

The law delegated much of its implementation to the FDA. In 2018, the FDA finalized a policy enabling ophthalmology's continued access to sight-saving drugs such as Avastin.