Pharmacists in California Stop Flavoring Medication for Children Due to New Rules

Over 3,000 pharmacies in California ended the practice of flavoring medication for children this month as they await rules from a state regulator that has been tasked with applying new federal guidance, CalMatters reported.²

What’s the Issue?

Pharmacists in the state have long provided a service where they flavored medications, such as Tamiflu, amoxicillin, and Augmentin, to make them more palatable for children. However, new guidance from the United States Pharmacopeia—which advises the federal government—now characterizes the practice as drug compounding.

• US Pharmacopeia released updated compounding guidance in 2022 that included more strict regulations. This was followed by a supplement that said flavoring medicine has been considered compounding since 2004.
• California pharmacies need to follow the guidance due to a law Governor Gavin Newsom signed in 2019 that requires the state’s Board of Pharmacy to adopt regulations from the US Pharmacopeia.

Why it Matters

The state’s Board of Pharmacy is currently working on new rules that will adopt the guidelines, which they say will not ban flavoring. However, it will require pharmacists to follow more strict regulations.

• Complying with the new regulations would require pharmacies to document the process and follow strict hygiene standards set forth by US Pharmacopeia, which some fear may drive up costs.
• Parents are worried that children will not want to take medication without the addition of flavoring. This is especially a concern for the winter months when respiratory illness and infections tend to increase.
• Around 50 pharmacies are left in the state that provide the service, which means some families may have to travel further to get their children to take medication.

Expert Commentary

• “When we talk about flavoring, we’re really talking about products that are manufactured, have expiration dates, and are quality controlled from the manufacturer themselves,” Sonya Frausto, pharmacist and owner of a Sacramento pharmacy, told CalMatters.¹ “We’re not making a new compound.”
• “For over a decade, more than 3,000 community pharmacies in California flavored 300,000-500,000 medications every year without a reported adverse event or incident of harm,” Taryn Roberts, a mother of 4 who lives in California, wrote in The Observer.² “There are 6 million children under the age of 11 that live in California. For a child struggling to take their medicine, and caregivers struggling to administer it, flavoring can be a lifesaver.”
• “California’s community pharmacies provide a simple and safe service to flavor medications for our customers,” Sonya Frausto, pharmacist and owner of Ten Acres Pharmacy in Sacramento, California, wrote in the Mercury News.³ “This new regulation the California State Board of Pharmacy is considering will take away this service that pharmacists can offer to sick children and worried parents alike.”

In Depth Insights

Pharmacists in California attended a Board of Pharmacy meeting in April where they urged state regulators to exempt flavoring from the compounding rules.

• Maria Serpa, vice president of the California Board of Pharmacy, said during the meeting that “such action would run contrary to the board’s authority and would create conflict with federal law. California cannot adopt a lesser standard than those established…” by US Pharmacopeia, according to CalMatters.¹

Extra Reading

• The Debate over Flavored Medicine for California Kids. (CalMatters)
• Medication Flavoring for Children Belongs in All California’s Pharmacies, Not Just a Few. (Our Weekly)

References

1. Agrawal S. New California rules target flavors in kids’ medication, leading pharmacies to end service. News Release. CalMatters. November 29, 2023. Accessed November 30, 2023. https://calmatters.org/health/2023/11/california-pharmacies-flavored-medication/

2. Roberts T. California parents fight to keep medicine flavoring for children. News Release. The Observer. September 6, 2023. Accessed November 30, 2023. https://sacobserver.com/2023/09/parents-fight-back-as-state-regulators-try-to-restrict-local-pharmacies-from-flavoring-childrens-medications/

3. Frausto S. Opinion: Flavoring medicine is vital for kids. California may make it harder. News Release. Mercury News. April 25, 2023. Accessed November 30, 2023. https://www.mercurynews.com/2023/04/25/opinion-flavoring-medicine-is-vital-for-kids-california-may-soon-make-it-harder/