Phoenix, AZ — “If 90 percent of the compounding pharmacies decide not to compound anymore, close their doors, Arizona citizens will suffer,” said Boesen & Snow Partner and Co-founder Mark Boesen, Pharm.D., J.D., while speaking before the Arizona State Board of Pharmacy on August 16, 2023, about the ramifications of the Board adopting future United States Pharmacopeia General Chapters ‹795›, ‹797›, and ‹800›. Representing the Arizona Pharmacy Association and the Arizona Independent Pharmacy Coalition, he explained these compounded medications are drugs of last resort for patients who use them. By motion after hearing from Mr. Boesen as well as Boesen & Snow Senior Attorney Michael Raine, the Board voted to rescind its prior order to adopt and enforce the chapters on November 1, 2023, and will now have its task force further evaluate the issue.
Mr. Boesen explained to the Board that when the USP publishes Chapters ‹795›, ‹797›, and ‹800› on November 1, 2023, it is not obligated to adopt the chapters. Mr. Boesen told the Board that it is not “hamstrung by Arizona or Federal law.”
Boesen & Snow Senior Attorney Michael Raine explained to the Board that state law does not allow the Board to incorporate by reference the USP and all its future amendments. Mr. Raine asked that the Board get engaged in discussion with the compounding community.
Mr. Boesen talked about how other states are addressing USP ‹800› and explained that so far only a minority have adopted it, and that many are presumably not expressing intent to adopt because it is too onerous, and the states are worried about access to compounded medication. He explained that many of the compounding pharmacies in Arizona are small and that it would be difficult for the pharmacies to comply with these USP chapters.
“I am not here to tell pharmacies that they ought not to do it, but I am here to say that there may be pharmacies that are engaged in low-risk activities that this board would be comfortable considering a different level of care,” Mr. Boesen explained.
Mr. Boesen emphasized that a one size fits all policy does not work, “why do we have to treat all of the drugs exactly the same” and that it should instead be based on the risk of the physical properties of the drug, level of danger, risk with exposure, as well as batch size. He said that there is a lack of science behind the USP process quoting industry expert Loyd Allen who stated, “My view of the revised Chapters 795 and 797 is that they are generally not scientifically supported by any evidence, but rather by opinions and what some individuals think ‘should be done.’” (Letter from L. Allen to USP Appeals Panel, Jan. 21, 2020)
Fields marked with an * are required