Under the new compounding and track-and-trace law, what does FDA consider to be an “established relationship” between a pharmacist and a prescriber? What is an “inordinate amount” of “commercially available” products if the drug product is in shortage?
These are among the questions related to office-use compounding that APhA raised in February 3 comments to FDA on FDA’s draft guidance for traditional compounding, one of three compounding draft industry guidances released by the agency shortly after the Drug Quality and Security Act was signed into law.
While APhA anticipates that pharmacists and pharmacies engaged in traditional compounding will continue to be regulated by state boards of pharmacy if they comply with the draft guidance, some provisions of the guidance require more clarity, the Association wrote. Such “clarification would be highly beneficial for providers who want to ensure that they are in compliance with FDA expectations while still maintaining patient access to compounded medications.”
For example, the draft guidance sets forth conditions that would need to be met for pharmacists to compound before the receipt of a patient-specific prescription. One condition would require that any such compounding is done in an “established relationship” between a pharmacist and a prescriber, but APhA members do not have clarity on how FDA will interpret the term, according to the Association’s comments.
The Association encouraged FDA to provide more detail regarding the definition of “established relationship,” and to defer to existing state laws.
As another example, more detail is needed on the terms “inordinate amount” and “commercially available” products, APhA wrote. “If, in response to a situation that threatens patient safety and needs, such as a regional drug shortage, a pharmacy experiences a spike in the compounding of the drug in shortage, would that spike be considered an ‘inordinate amount’?”
The Association asked that FDA provide clearer limits on what would be considered appropriate and to defer to state boards of pharmacy in determining such limits.
APhA’s comments raised concerns about the draft guidance’s “arbitrary limits” on out-of-state distribution of compounded drug products, including the 5% limit on such drug products and the Memorandum of Understanding (MOU) between FDA and the states, and suggested that FDA work with the states on “more effective” methods for regulating interstate distribution.
APhA asked for clarity on how the agency would arrive at the “total prescription orders” number used to calculate the 5% limit, and noted that enforcement of the 5% limit could cause hardship for patients who live near state borders.
The Association encouraged FDA not to include the 5% limit as the default non-MOU metric and “instead continue to work with stakeholders to identify a more effective method for ensuring the safety and availability of high-quality compounded drug products.”
APhA also asked for clarity on FDA’s timeline for enforcing the 5% limit until 90 days after the MOU, and requested that the agency consider extending the timeline to 120 days “to avoid confusion and patient access issues that could result from regulatory volatility related to changes to compounding requirements.”
The Association suggested that FDA not use the 1999 MOU between FDA and the states as a starting point for developing the new MOU because the 1999 MOU included percentage limitations on interstate distribution of compounded drug products. “States—and particularly State boards of pharmacy, which are the recognized regulators for the pharmacy profession—should have the discretion to work cooperatively with the FDA to determine the most effective method for the regulation of drug compounding and the distribution of such compounded drug products to out-of-state patients,” the Association wrote.
“We urge the FDA to work with States to develop the most appropriate control on a State-by-State basis, rather than applying arbitrary limits that may impede patient access to vital compounded drugs.”