LYNN LA • AUGUST 2, 2023
If you’re a parent, you know how difficult it can be to get your kids to take medicine that tastes bad.
Parents can remedy this by requesting their children’s prescription medicine to be flavored at the 3,000 pharmacies in California that are able to do so. But an unintended consequence of a 2019 law may make this long-standing practice run afoul with not only a nationwide standard, but also with the federal government.
A new bill this session aims to correct this by codifying that drug “compounding does not include… the addition of a flavoring agent to enhance palatability.”
But the California Board of Pharmacy is preparing to oppose the bill, despite a social media campaign (#MomsforFlavor) for the measure and supporters warning that a change would increase regulatory red tape.
The board had been scheduled to meet Tuesday and today, but canceled due the lack of a quorum so the debate will continue.
Let’s back up: In 2019, the state passed a law that required California pharmacists to prepare drugs in a way that met the rules outlined by the United States Pharmacopeia — a not-for-profit organization that sets standards for how drugs are prepared. This includes drug compounding, where pharmacists combine, mix or alter ingredients to meet the needs of individual patients.
At the time, Assemblymember Jacqui Irwin, a Democrat from Thousand Oaks and author of the law, said the goal was to ensure that Californians received drugs that met national health and safety standards, citing a 2012 multistate outbreak of fungal meningitis that killed 64 people due to the unsafe compounding of a steroid. The board approached her office, seeking to establish minimum standards for drug compounding and identifying U.S. Pharmacopeia as the baseline for compliance.
The status quo in California remained relatively fine until November, when the U.S. Pharmacopeia updated its guidelines to clarify that flavoring medicine falls in the scope of drug compounding. And because California must match its drug preparation standards by law, that would further regulate how pharmacists flavor medication, and may discourage them from offering the service altogether.
Thus, the bill, which passed the Assembly in March, and after some twists and turns in the Senate is now before the appropriations committee.
Irwin, a co-author of the bill, says she wants the board and key legislators to find a solution that protects consumer safety, while ensuring access to flavored medicine.
In a statement to CalMatters, Assemblymember Tom Lackey, a Republican from Palmdale and another co-author with Democrat Assemblymember Tina McKinnor of Inglewood, said that flavored medicines “have zero downside” and described the board’s opposition to the bill as “curious.”
- Lackey: The board’s “position will put a chokehold on the supply of flavored medication because your neighborhood pharmacy will not adopt these unnecessary and onerous requirements…. Being a parent is tough enough. California’s absurd regulations should not make caring for a sick child more difficult than it already is.”
Though the board turned down my request for further comment, it has reason to play it safe and push back against the measure. The U.S. Pharmacopeia sets rules that can be enforced by state agencies as well as the federal Food and Drug Administration. If the proposal were to pass, the bill analysis warns of a “potential conflict” with federal requirements.
