Why USP 795 and Flavoring Don’t Mix
On October 31, 2023, over 3,100 pharmacies in California were offering flavoring for children’s medicines to help kids get better and make life easier for them and their parents. Most of those pharmacies had been providing this valuable service to their customers for decades.
The next day, the number of pharmacies offering flavoring to their patients dropped to 40, an astounding 99% reduction in access to the flavoring service, literally overnight. The reason? New regulations that made it extremely difficult, if not impossible, for pharmacies to continue flavoring. Nothing safety related. No complaints from parents. No concerns from pediatricians. Just more red tape.
Where any parent in California could get to a flavoring pharmacy in five or ten minutes one day, now they have to drive hours for the same service.
These maps tell the whole story.
Medication Flavoring Availability
Los Angeles Area Before Nov. 1, 2023
1,223 Pharmacies
Medication Flavoring Availability
Los Angeles Area After Nov. 1, 2023
6 Pharmacies
Medication Flavoring Availability
Sacramento Area Before Nov. 1, 2023
219 Pharmacies
Medication Flavoring Availability
Sacramento Area After Nov. 1, 2023
0 Pharmacies
Medication Flavoring Availability
San Diego Area Before Nov. 1, 2023
379 Pharmacies
Medication Flavoring Availability
San Diego Area After Nov. 1, 2023
3 Pharmacies
Medication Flavoring Availability
San Francisco Bay Area Before Nov. 1, 2023
818 Pharmacies
Medication Flavoring Availability
San Francisco Bay Area After Nov. 1, 2023
3 Pharmacies
Why did this happen so suddenly and so dramatically?
Quite simply, the California State Board of Pharmacy did a total reversal on how they choose to regulate medication flavoring. For 14 years, they’d said in rule that “the addition of flavoring agent(s) to enhance palatability” was not considered compounding. Thousands of pharmacies in California, most of whom had no business or desire being regulated as a Compounder, made the decision to offer flavoring to their customers based on that position. In April 2023, the California State Board of Pharmacy signaled their plan to change that stance and begin to heavily regulate medication flavoring in November. Most pharmacies, understandably, ceased offering the service when November 1 rolled around.
The option to get better tasting kid’s medicines is now virtually non-existent in California. We estimate roughly 300,000-500,000 California children were benefiting from medication flavoring annually, depending on the severity of cold/flu season. The parents of those children are now left to their own devices to figure out how to get the medicine down. As one mom wrote into us upon learning her pharmacy was no longer able to provide medicine flavoring:
“This is incredibly frustrating. Med pass is the worst part of both mine and my daughter’s day on a daily basis. Imagine the harm it can cause to her – constantly gagging and increasing risk of oral aversion.”
It’s important to point out that no underlying safety concern arose to change the California State Board of Pharmacy’s stance on flavoring medications. California pharmacies, and pharmacies all across the country for that matter, have flavored hundreds of millions of children’s medicines over two plus decades without a single incident of harm. Nothing at all happened to cause anyone to question the safety of flavoring. The flavors pharmacies used in California are tested to ensure they don’t impact the potency of the medication, change the pH of the solution, or change the concentration of the medication. In fact, many pharmacies in California had recently invested in technology to completely automate the process of flavoring to make it even more safe. The California State Board of Pharmacy points to changes with USP 795 as the reason for their new position, but that doesn’t explain why they opposed a bill that would have untied their hands from USP 795 thus protecting access to medication flavoring, and it certainly is a position far out of sync with how most states treat medication flavoring today.
Currently, California and Washington are the only State Boards of Pharmacy in the country that subject flavoring to the full suite of USP 795 standards. Predictably, access to this valuable pharmacy service has been wiped out within their borders. They serve as the cautionary tale to any other State that may choose to follow their lead. There should be no doubt what will happen and how children’s health will be negatively impacted by doing so. Thankfully, most State Boards of Pharmacy recognize the benefit of flavoring to children’s health and wellbeing and take a more pragmatic approach.
For more information on how each State Board of Pharmacy approaches medication flavoring, visit www.flavorx.com/regulatory.