Pharma & Drug Safety

California Board of Pharmacy Updates and AB 1503 Changes

The California Board of Pharmacy is updating its regulations effective January 1, 2026, due to Assembly Bill 1503. Key changes include a transition to a Standard of Care practice model for certain pharmacist-provided services and new requirements for nonresident pharmacies operating in California, effective July 1, 2026.

California Board of Pharmacy Updates on SCRA, AB 1503, and Nonresident Pharmacies

The California Board of Pharmacy issued a news roundup detailing updates on the Servicemembers Civil Relief Act (SCRA), Assembly Bill 1503 impacting pharmacist practice, and new requirements for nonresident pharmacies. Key changes include the transition of certain pharmacist-provided patient care services to a standard of care model and new PIC designation rules for out-of-state pharmacies operating in California.

FDA Requests Removal of Suicidal Behavior Warning from GLP-1 RA Medications

The FDA is requesting that drug manufacturers remove the warning about suicidal ideation and behavior from the labeling of GLP-1 RA medications approved for weight reduction. This action follows a comprehensive review that found no increased risk associated with these drugs.

MHRA Medical Devices Exceptional Use Authorisations List Updated

The UK's MHRA has updated its list of medical devices granted exceptional use authorisations. This guidance document provides transparency on manufacturers and devices that have received exemptions, including those whose authorisations have expired or been cancelled.

MHRA: Stop using non-sterile alcohol-free wipes due to infection risk

The MHRA and UKHSA are advising the public not to use four specific non-sterile alcohol-free wipe products due to contamination with Burkholderia stabilis bacteria. These products have been withdrawn from sale, but may still be in homes, and are linked to 59 cases, including one death.

MHRA: Quetiapine Oral Suspension Recalled Due to Incorrect Active Ingredient

The MHRA has issued a recall for all batches of quetiapine oral suspension manufactured by Eaststone Limited due to an incorrect amount of the active ingredient, potentially leading to overdose. Approximately 166 bottles manufactured between October 2025 and January 2026 are affected. Patients are advised not to stop medication without consulting a healthcare professional.

MHRA Updates GLP-1 Guidance on Pancreatitis Risk

The MHRA has updated product information regarding the small risk of severe acute pancreatitis associated with GLP-1 medications. Healthcare professionals and patients are reminded to be alert to symptoms, and the MHRA is investigating genetic factors influencing this risk.

MHRA Updates Semaglutide Guidance on NAION Risk

The MHRA has updated its guidance for semaglutide prescribers and patients regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION). The update alerts healthcare professionals and patients to the symptoms and advises immediate medical attention if vision changes occur. This guidance follows three reports of NAION associated with semaglutide since 2018.

FDA Guidance on Promotional Labeling for Biosimilar Products

The FDA has issued new guidance addressing promotional labeling and advertising considerations for prescription reference products, biosimilar products, and interchangeable biosimilar products. The guidance aims to ensure promotional communications are accurate, truthful, and non-misleading for manufacturers and their representatives.

FDA Finalizes Guidance on Drug Dispute Resolution

The FDA has finalized guidance for industry on formal dispute resolution and administrative hearings for drugs subject to final administrative orders under section 505G of the FD&C Act. This guidance provides recommendations for resolving scientific and medical disputes between the Center for Drug Evaluation and Research (CDER) and drug sponsors.