April 1, 2022
APC to submit amicus brief to preserve California patients’ access to glutathione and methylcobalamin
Supported by its Legal Action Fund, APC will file an amicus brief on behalf of La Vita Compounding Pharmacy in San Diego, which is facing enforcement action from the California Board of Pharmacy.
At issue: California compounders’ ability to compound glutathione and methylcobalamin.
Almost a year ago, the California BoP determined that it would not take enforcement action against pharmacies that compounded sterile preparations from bulk ingredients that are on the FDA’s 503A Category 1 bulk substances list, but do not have USP/NF drug monographs. Despite saying that, however, the board continued to initiate enforcement actions in those cases — including targeting APC member Christine Givant, RPh, of La Vita Compounding Pharmacy, who compounded glutathione and methylcobalamin.
APC used its Legal Action Fund to retain attorneys Stephen Snow and Jennifer Bellis of Bendin Sumrall & Ladner, LLC, to write the brief in support of La Vita and all other California-licensed pharmacies. The LAF is funded by an annual voluntary $50 dues-bill gift from renewing APC members. Our goal is to protect patient access to glutathione and methylcobalamin — and to prevent the board’s unlawful prohibition against using these bulk substances to compound sterile drug products.
“The California Board of Pharmacy is trying to impose an arbitrary restriction that is not supported by FDA regulations or California law,” said APC CEO Scott Brunner, CAE. “We’re concerned not only about Christine and La Vita Pharmacy, but that if the California board is able to get away with this, other states will try to follow — and it’s patients who will suffer.”
(The California BoP strenuously objected to APC even being allowed to submit the brief, but the judge was not persuaded by the BoP’s arguments and will allow it.)