State Regulation of In-Office Compounding is Often Unclear, Impacting Popular IV Solution Bars
Facilities that provide IV solutions (“Providers”) containing combinations of vitamins, minerals, amino acids, and antioxidants continue to increase in popularity because they deliver quick fixes for everything from hangovers to skin that may have lost some of its glow. As BAnter has discussed previously, providing IV solutions is generally considered to be the practice of medicine. Recently, another important, but often overlooked, issue with IV solutions has come to the forefront–preparation of IV solutions involves compounding.
Compounding, according to the FDA, is the process by which a properly trained person combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Most states, though, have their own definitions of compounding, which not only vary somewhat from state-to-state but also tend to be broad. Accordingly, the mixing of IV solutions, even though they are made from vitamins, minerals, amino acids, and antioxidants, is considered compounding, so preparation of the solutions must meet the requirements set forth by the laws of the particular state in which the Provider practices. State laws governing compounding by a pharmacy tends to be well-developed and clear, so Providers who source their solutions from compounding pharmacies do not have trouble maintaining compliance. However, some Providers choose to create custom IV solutions for patients that are compounded in-office, and oversight of on-site drug compounding often goes unaddressed by state law, making compliance difficult.
Due to an outbreak of fungal meningitis in 2012 that killed 25 people and sickened 732 that was traced back to a compounding pharmacy, compounding oversight has been a hot topic both nationally and at the state-level. Despite the increased regulation and oversight of pharmacies, a 2016 survey by the U.S. Government Accountability Office on state of regulation of compounding demonstrated that many respondents, which included state boards of pharmacy, were unsure which entity had oversight responsibility over non-pharmacist compounding and whether their states had any laws addressing non-pharmacist compounding. Additionally, a Pew Charitable Trust Survey from February 2016 on the same topic found that 24 of the 43 responding pharmacy boards stated that they did not have an oversight system in place to ensure non-pharmacist compliance with compounding regulations. Interestingly, since this lack of oversight has been brought to light, in some states the boards of medicine, pharmacy, and even nursing are now at odds with each other over which board has final say over which licensees and what role those licensees may play in aspects of in-office compounding.
So, what is a Provider who compounds in-office to do? First, talk to their healthcare counsel to ensure that they understand their state’s compounding regulations and use that information to assess the compliance of their compounding practices. Providers may also want to look at the U.S. Pharmacopeial Convention’s chapter 795 and 797 compounding standards, which address, respectively, non-sterile and sterile compounding. Second, Providers must ensure that all staff involved in compounding is competent to do so by education, training, and experience and that all competencies are thoroughly documented. Third, the Provider must ensure that all staff involved in compounding has proper initial and on-going training to remain current on compounding regulation.