Pharmacies have been flavoring kids’ medications in California for decades.
Let’s keep it that way.
AB 782 Must Become Law!
AB 782 Passed the California Senate & Assembly Unanimously! All “Ayes”, No “Nays”! Thank You Senators & Assemblymembers!
AB 782 Passed the California Senate & Assembly Unanimously! All “Ayes”, No “Nays”! Thank You Senators & Assemblymembers!
Why AB 782 is Necessary
The California State Board of Pharmacy is poised to bury the simple flavoring of children’s medications under layers of regulatory red tape. If this happens, pharmacies will cease offering this valuable service because the time and effort it takes to comply is just too great.
AB 782 prevents the California State Board of Pharmacy from doing this.
AB 782 is good for:
- Pharmacists as it means they aren’t saddled with extra and wholly unnecessary work when they are already so strapped for time.
- Physicians as it ensures they aren’t bothered unnecessarily to write a prescription every time a parent asks the pharmacist to flavor their child’s medicine.
- Parents as they will continue to have widespread access to a service that helps make medicine-time easier for them and their kids.
- Most importantly, AB 782 is good for children so they can continue to take the medications they so desperately need without all the tears and fears.
What AB 782 Accomplishes
AB 782 fixes an unintended consequence of the passage of AB 973 (Irwin) back in 2019, which said that pharmacies in California must comply with USP standards when compounding medications.
While the California State Board of Pharmacy has, since 2010, said in rule that compounding does not include “the addition of flavoring agent(s) to enhance palatability”, the Board has decided to wipe out this language.
The reason for the Board’s about-face on flavoring is unclear as nothing has occurred to warrant the change. No child has been harmed by having his or her medicine flavoring. No parent has complained about having their child’s medicine flavored. USP’s position is unchanged.
AB 782 merely codifies the California Board of Pharmacy’s long-standing position so that, by law, pharmacies in California will not be subjected to arduous compounding regulations for simply flavoring kids’ medicines.
Why Flavoring is Important
Most kids hate taking medicine. The reason almost always comes down to taste. If parents can get the medicine in their kids at all, it’s usually after a lot of begging, pleading, screaming and crying.
Flavoring fixes that. By letting kids choose how their medicine tastes and improving the underlying flavor, pharmacists all across the country are helping kids take their medicine so they can get better without a fight.
Flavoring also means:
- Illnesses don’t linger.
- Costly repeat visits to the doctor’s office are avoided.
- New medications don’t need to be prescribed and paid for.
- Kids miss less school.
- Parents miss less work.
Who Supports AB 782
AB 782 is a bi-partisan bill, authored by Assemblymember Tina McKinnor and co-authored by Assemblymembers Tom Lackey and Jacqui Irwin.
Assemblymember Irwin was the author of AB 973, which the California Board of Pharmacy is using to justify their about-face on flavoring. Assemblymember Irwin is co-authoring AB 782 as that was never her intention with AB 973 and she wants it fixed.
AB 782 passed through the California Senate Business, Professions & Economic Development Committee on July 10, 2023 with 13-0 unanimous vote.
AB 782 is supported by:
- California Coalition for Children’s Safety and Health
- California Community Pharmacy Coalition
- Children’s Specialty Care Coalition
- Jordan’s Guardian Angels
How Do Other States Treat Flavoring
Currently, 49 out of 50 states choose not to regulate flavoring of children’s medications to the level being considered by the California State Board of Pharmacy. In fact, most states have language that mirrors that of AB 782 saying, in one form or another, flavoring is not compounding.
This map shows how states across the country treat flavoring.
If AB 782 does not pass, California will stand with Washington as the only states to require strict adherence to USP standards for flavoring. The Washington State Pharmacy Quality Assurance Commission (their version of a Board of Pharmacy) started regulating flavoring in 2020. Overnight, nearly every pharmacy in Washington ceased providing the service to their patients for fear of running afoul of pharmacy inspectors.
This cannot be allowed to happen in California.
AB 782 must pass.
AB 782: Myth vs Fact
The passage of AB 782 creates confusion among pharmacists.
AB 782 protects the STATUS QUO in place for almost 14 years.
Nothing could be less confusing.
USP 795 only requires documentation.
There are at least 82 check-list items to be USP 795 compliant. And parents would need a physician’s prescription to get their child’s medicine flavored.
Without AB 782, pharmacies will continue to flavor medications, so children will not be deprived of care.
The reality is, pharmacies WILL NOT continue to flavor medications without the passage of AB 782.
AB 782 creates a conflict with federal 503A provisions, which prevail over state law.
503A accreditation is not concerned with flavoring. Furthermore, recent case law has determined that the Board cannot enforce 503A provisions if there is a conflict with state law.
The passage of AB 782 comes at a high price.
AB 782 protects the status quo, therefore it has ZERO COST. In fact, if AB 782 does not pass, there is enormous financial cost to the state – from education of pharmacists and physicians, to enforcement, to the massive cost of children not taking their medicine as the availability of flavoring dwindles.
Flavors are destabilizing products that affect how medications work.
Pharmacies use inert flavors that are tested to ensure they do not impact medications. These flavors have been in use in pharmacies for decades.
AB 782 would put California on an island in terms of flavoring services.
Currently, 49 out of 50 State Boards of Pharmacy, including CALIFORNIA, do not regulate flavoring as compounding to USP standards. Without AB 782, the Board would be on an island in terms of how it cares for children.
Frequently Asked Questions
Yes. AB 782 codifies in statute the language the California State Board of Pharmacy has had in rule since 2010. Over the course of those 13 ½ years, over 6.5 million medications have been flavored in pharmacies all across the state of California, with zero reported incidents of harm. The California State Board of Pharmacy’s hands were tied by the passage of AB 973. AB 782 unties the Boards hands.
No. States are free to regulate and enforce non-sterile compounding standards as they see fit. In fact, Illinois has had a statute in place similar to AB 782 for 10 years and has not once run afoul of the Feds.
Furthermore, if AB 782 were in fact to violate federal law, then the California State Board of Pharmacy would have been breaking the law since 2010. The number of pharmacies who have gotten in trouble with the Feds for flavoring medicines in California from 2014 to today is ZERO. This is a hollow argument.
It depends on who you ask and on what day. At first, the Board claimed they were changing their position on flavoring because their hands were tied by AB 973. AB 782 fixes that. Now the Board is claiming that AB 782 is a violation of federal law. This is not true. The Board also claims that if AB 782 does not pass, it’s no big deal since pharmacies will only be required to document the addition of flavoring to medications. This is also not true and is incredibly misleading.
Not even close. The California State Board of Pharmacy has made it very clear that they intend to enforce USP non-sterile compounding standards on pharmacies that flavor. In fact, the Board has indicated they may go even further. The new requirements are overwhelming, time-consuming, and costly. You can find the checklist here.
Additionally, if AB 782 does not pass, parents will need a prescription from their child’s physician to get their child’s medicine flavored. This won’t happen. Pharmacists do not have time to wait on the phone for authorization. Physicians can’t be pulled out of exam rooms to simply authorize flavoring. What’s more, most medications get flavored when pediatrician’s offices are closed. The prescription requirement alone will prevent most parents from getting their child’s medicine flavored.
Absolutely not. AB 782 simply codifies the California State Board of Pharmacy’s long-held stance on flavoring, which is in line with how most other states treat this core pharmacy service. In fact, only one state, Washington, requires full adherence to USP standards when it comes to flavoring. Pharmacies in Washington state do not flavor any longer because of that.
This map shows where other states stand on flavoring.
Yes. FLAVORx is the trusted supplier of flavorings to over 38,000 pharmacies across the country. Those pharmacies have flavored over 200 million medications with FLAVORx over the past 25 years. Not a single adverse event has been reported. FLAVORx ingredients are inert and are tested to ensure they do not impact the potency of a drugs active pharmaceutical ingredient or change the pH of liquid medicines.
Just ask! You can call (800) 884-5771 and ask to speak to a member of the FLAVORx regulatory team. Or you can email [email protected].
Who is FLAVORx?
As former Surgeon General C. Everett Koop said, “Drugs don’t work in patients who don’t take them.” That is especially true of children’s medications. And that is why FLAVORx exists.
FLAVORx was established in 1995, when a community pharmacist created unique flavor options to help his granddaughter take her foul-tasting epilepsy medications. Today, over 38,000 pharmacies in the U.S. utilize the FLAVORx program, with 16 flavor options for children to choose from for thousands of drugs.
FLAVORx empowers kids to choose the taste of their medication, making medicine-time easier for little ones and their parents. From providing standardized formulas for the manual flavoring of medication to the manufacturing of the automated filling equipment, FLAVORx, to borrow a line from Mary Poppins, “helps the medicine go down”.
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