USP Rules
The revised USP rules are a difficult fit for physicians’ offices. Because they have granted a 1-hour exemption, you will have to use buffered lidocaine and reconstituted botulinum toxin in 1 hour or less, then discard it under these rules. This means you cannot draw up all your buffered lidocaine for the day in the morning and use it throughout the day; never mind that there are good data showing redrawn syringes of buffered lidocaine and botulinum toxin are stable for several weeks in a refrigerator (J Clin Neurol. 2013 Jul;9[3]:157-64).
I think these rules eventually will be settled by a restraint of trade lawsuit. After all, none can be shown to improve patient care; in fact, they degrade it and increase the costs to patients and physicians. We may end up being grateful that the U.S. Supreme Court emasculated state professional boards in the famous 2015 North Carolina tooth-whitening ruling.
The USP is accepting comments about the rules until Nov. 30th. The American Academy of Dermatology has a suggested letter to the USP Compounding Expert Committee on its website, which suggests that you ask for at least a 12-hour exemption.
I strongly suggest you write and explain why pharmacy board regulations that interfere with a physician’s ability to administer individualized, customized medication will hurt your patients and will cost more. Physicians have been treating their patients with individualized, customized medications for more than 2,000 years. It seems unreasonable to hand this skillful and essential part of medicine over to pharmacists in the absence of any compelling evidence.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.