Academy Urges FDA to Establish Temporary Pathway to Access Compounded Treatments

With the Food and Drug Administration working on its 503B outsourcing facility policy for compounding drugs, the Academy is pushing for a temporary pathway to the drugs we need. The FDA wants to expand the number of available compounding pharmacies options, albeit through a lengthy policy-development process. In the meantime, we’re seeking a provisional policy that would allow traditional 503A compounding pharmacies to supplement the supply of low-volume compounded drugs until outsourcers make them available.

This process began in December, when the FDA proposed revisions to its manufacturing requirements for 503B compounding pharmacies. This new policy would establish less restrictive testing requirements for outsourcing pharmacies, which the Academy supports.

The agency believes that limiting existing, extensive restrictions on this class of pharmacies would increase the number of facilities willing to produce small batches of drugs for office use. This is a major issue for ophthalmologists for whom products for patients with sight-threatening conditions that require immediate treatment is a small market.

Until the agency finalizes its policy, the Academy is urging the FDA to consider an interim policy that would allow ophthalmologists to access compounded treatments through pharmacies that would otherwise require patient-specific prescriptions.

During a conference call in December, the agency directly briefed our staff and physician leaders on its proposal. Their outreach leads the Academy to believe that the FDA is on the right track for arriving at a final policy that will address our access needs. We believe the agency has a deep appreciation for the enormous implications for ophthalmologists’ access to important outsourcer-supplied treatments.

FDA staff told the Academy that the revised guidance was in response to stakeholder input, including ours. The guidance revises policies that limited the ability of outsourcing facilities to fill small orders and seeks to address physician concerns regarding the lack of availability of specific drugs from outsourcing facilities. 

The FDA says it wants to make it more feasible for compounding pharmacies to register as outsourcing facilities. This would enable more pharmacies to compound the drugs we need for office use. 

The Academy is also already preparing for another high-profile opportunity to lead on this issue. In May, the FDA will hold a public meeting on compounding and has already requested that the Academy present information on physician access and the impact of the new policy on our profession. Email Scott Haber, the Academy’s government affairs representative, at shaber@aao.org, with any issues you experience trying to obtain compounded drugs.