Although prescribers who provide in-office dispensing must satisfy applicable state and other requirements, a recent ruling against Allergan's attempt to shut down Prescriber's Choice appears to pave the way for expansion of these services, according to Wm. Philip Werschler, M.D.
Since the onset of healthcare reform, in-office dispensing of prescription medications has exploded, says Dr. Werschler, a Spokane, Wash.-based dermatologist in private practice and a clinical teaching professor at the University of Washington.
Currently, Dr. Werschler says, a sizeable number of the approximately 14,000 dermatologists practicing in the United States utilize Prescriber's Choice dispensing services, as he does. Such services grew out of the Federal Food, Drug and Cosmetic Act Section 503B, which was issued after the New England Compounding Center (NECC) tragedy. As a result of contaminated NECC compounding, more than 800 patients contracted meningitis infections starting in 2012, resulting in 76 deaths.
In revisiting compounding regulations, says Dr. Werschler, who presented on this topic at Fall 2018 Cosmetic Bootcamp, the new section of the law known as the Drug Quality and Security Act created new opportunities for physicians. Chief among the changes is the ability to order from an FDA-registered 503B outsourcing facility. This new entity type is required to follow Current Good Manufacturing Practices (CGMP). "Ultimately," he says, "Congress and the FDA recognized the need for compounded medications but insisted that they be made in a quality environment."
The new law allows physicians to keep compounded inventory on hand, rather than having to write individualized prescriptions that each patient provides to a compounding pharmacy. "The FDA essentially allowed physician offices to maintain office stock." Although FDA guidance does not specify how much, he adds, dermatologists generally interpret this guidance as a 90-day supply. "That was a significant fundamental change in how a dermatology office operates."
In-Office Dispensing vs Pharma
The new legal landscape underlies both the explosion in physician dispensing, Dr. Werschler says, and the pharmaceutical industry's associated concerns. In 2017, Allergan sued Prescriber's Choice and its affiliated FDA-registered 503B outsourcing facility, Sincerus, both based in Pompano Beach, Fla., claiming that these companies were selling unapproved drugs under the guise of compounding.
In January, a California federal judge ruled against Allergan, saying that Sincerus is permitted to operate as an outsourcing facility provided it complies with FDA regulations and guidance, according to published accounts. "That's the big lawsuit that other pharmaceutical companies were watching. And I don't see any other impediments," says Dr. Werschler. Had Allergan prevailed, he says, drug manufacturers most likely would have filed similar lawsuits against outsourcing facilities.
Dr. Werschler dispenses Prescriber's Choice but has no ownership interest in the company. He did not receive compensation for the lecture or this article, which also includes comments from a January 23 phone interview with Dr. Werschler.
W Philip Werschler MD. "Make Dispensing Work for You: Don't Let It Create More Work," Fall Cosmetic Bootcamp. Napa, Calif. October 2018.