Searching in Pharma & Drug Safety · Search everything
2,368 changes Pharma & Drug Safety
Massachusetts Pharmacist Medication Administration Guidance Update
The Massachusetts Department of Public Health issued a circular letter updating guidance on pharmacist medication administration. This update authorizes pharmacists to administer testosterone for gender-affirming care, and medications for the prevention and treatment of HIV and sexually transmitted infections, in addition to existing authorizations for mental illness and substance use disorder treatments.
Massachusetts Pharmacist Administration of Medications Guidance
The Massachusetts Department of Public Health issued guidance allowing pharmacists and pharmacy interns to administer additional medications, including testosterone for gender-affirming care, and treatments for HIV and STIs. This guidance replaces a previous version and provides details on eligibility and administration requirements.
FDA Approves Higher Dose Wegovy (semaglutide) for Weight Loss
The FDA has approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, known as Wegovy HD, for weight management in certain adults. This approval was granted under the Commissioner's National Priority Voucher pilot program, aiming to expedite treatments for national health priorities.
Ortho Connect Medical Device Recall for Incorrect Test Results
Health Canada has issued a Type II recall for the Ortho Connect medical device manufactured by Biomedical Data Solutions Limited due to the potential for incorrect test results. The recall affects specific lot and model numbers, with a recall date of February 19, 2026.
Health Canada: Nitrous Oxide Chargers Sold for Inhalation Without Authorization
Health Canada has issued a recall for Nitrous Oxide Chargers sold by Polar Imports Canada for inhalation without market authorization. The agency warns consumers not to inhale these products for recreational purposes and to seek medical attention if side effects occur.
UniCel DxI 600 Total T4 Assay Recall
Health Canada has issued a Type II recall for the UniCel DxI 600 Access Immunoassay System-Total T4 Assay due to a negative bias that can cause false low patient results. The recall affects specific lot numbers and poses a medium safety risk. Healthcare providers are advised to contact the manufacturer for further information.
WHO Hub Berlin Highlights 2025 Achievements in Pandemic Intelligence
The WHO Hub for Pandemic and Epidemic Intelligence in Berlin released its 2025 Annual Report, detailing advancements in AI, data science, and genomics for global health threat detection. The report highlights collaboration with over 160 Member States and 190 partners to enhance pandemic preparedness.
Product Recall: Artis PL E and Artis Symbiose Intraocular Lenses
The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for Artis PL E and Artis Symbiose intraocular lenses manufactured by Cristalens Industrie. This safety action, registered under number R2606056, requires healthcare facilities to take immediate action regarding the affected lots.
Curosurf Safety Information and Lot Recall
The French drug agency ANSM, in agreement with Laboratoire Chiesi SAS, has initiated a recall of one lot (Lot 1204229, Exp 04/2026) of Curosurf 120 mg/1.5 ml suspension for endotracheobronchial instillation. This precautionary measure follows a deviation observed during environmental monitoring at the production site.
ANSM Security Alert for EdgeSuite Software and EdgeLab Module
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a security alert regarding the EdgeSuite software and EdgeLab module from In Log. Affected medical analysis laboratories have been notified directly by the company.
Kentucky Board of Pharmacy Suspends Wilson Family Pharmacy
The Kentucky Board of Pharmacy has issued an emergency suspension order for Wilson Family Pharmacy INC and pharmacist owner Jigna G Patel, effective August 15, 2025. The suspension follows preliminary findings of serious violations, including inadequate security of prescription drugs and dispensing medication without valid prescriptions, posing an imminent risk to public health.
KY Board Fines Med Save Pharmacy $5,000, Revokes Licenses
The Kentucky Board of Pharmacy has fined Med Save Pharmacy $5,000 and revoked its licenses following medication errors that led to the hospitalization of three pediatric patients. The pharmacy compounded misbranded and adulterated clonidine suspensions, violating multiple state statutes and regulations.
Kentucky Pharmacy Technician Regulations Updated
The Kentucky Board of Pharmacy has updated regulations concerning pharmacy technicians, specifically 201 KAR 2:045 and 2:165. These amendments clarify technician roles, delegate new responsibilities to certified technicians, and centralize initial application requirements, including mandatory registration for an NABP e-profile.
KY Board of Pharmacy Alert on Compounded GLP-1/GIP Drugs
The Kentucky Board of Pharmacy issued an alert regarding the compounding and dispensing of GLP-1/GIP drugs like semaglutide and tirzepatide from 503B outsourcing facilities. The alert clarifies when such compounding is permissible, referencing FDA guidance and court decisions concerning drug shortage lists and enforcement discretion.
DEA Extends Telemedicine Flexibilities for Controlled Medications
The DEA, in conjunction with HHS, has extended current telemedicine flexibilities for prescribing controlled medications through December 31, 2026. This allows DEA-registered practitioners to remotely prescribe Schedule II-V controlled medications, including certain narcotic medications for opioid use disorder treatment, without a prior in-person evaluation.
WV Pharmacy Board Adopts CDC COVID-19 Vaccine Recommendations
The West Virginia Board of Pharmacy has adopted the CDC's recommendations for the 2025-2026 COVID-19 vaccines. This guidance allows pharmacists, technicians, and interns to administer vaccines to individuals aged 3 years and older, based on individual decision-making and CDC risk factor guidelines.
WV Board of Pharmacy Warns of Phone Scam Targeting Licensees
The West Virginia Board of Pharmacy has issued a warning regarding a phone scam targeting its licensees. Scammers are impersonating Board investigators, claiming disciplinary action and attempting to solicit payment over the phone. The Board reminds licensees that it will never request payment in lieu of an investigation.
WV Board of Pharmacy CSMP Modernization to RxGov System
The West Virginia Board of Pharmacy is modernizing its Controlled Substances Monitoring Program (CSMP) by transitioning from the CSAPP platform to the RxGov system. This upgrade aims to improve performance, data quality, and reporting capabilities. Key transition dates are outlined, with a full cutover expected in early March 2026.
Louisiana Board of Pharmacy Office Closure Due to COVID-19
The Louisiana Board of Pharmacy announced its office is closed to visitors effective immediately due to COVID-19 illness impacting staff levels. Licensees and applicants are directed to use mail or email for submissions and inquiries, as phone lines are on auto-attendant.
Louisiana Pharmacy Credential Renewal Notice
The Louisiana Board of Pharmacy has issued a notice regarding the credential renewal cycle for pharmacists and pharmacies. The renewal period for licenses and permits will be open from November 1 to December 31, 2021, with options for online or paper applications.
Louisiana Board of Pharmacy Office Closure due to Hurricane Ida
The Louisiana Board of Pharmacy announced an extension of its office closure due to Hurricane Ida, now through September 5, 2021. The office will remain closed to visitors due to staffing impacts from COVID-19, with materials to be deposited via mail slot or submitted electronically.
Louisiana Board of Pharmacy Office Closure Due to Hurricane Nicholas
The Louisiana Board of Pharmacy announced the closure of its state office on September 15, 2021, due to anticipated severe weather from Hurricane Nicholas. The office is expected to reopen for business, though not for visitors, on September 16, 2021, unless the closure order is extended.
Louisiana Board of Pharmacy Office Reopens to Business, Remains Closed to Public
The Louisiana Board of Pharmacy has reopened its office for business following Hurricane Ida closures. However, due to insufficient staffing, the office remains closed to public visitors. Deliveries can be made via the mail slot, and inquiries should be directed to the general email address.
Florida MQA releases 2025-26 Q2 performance report
Florida MQA releases 2025-26 Q2 performance report
MS Board of Pharmacy Accepting Applications for 2 Positions
The Mississippi Board of Pharmacy is seeking applications for two positions: a Compliance Agent and a Staff Attorney. The job posting for the Compliance Agent will remain open until February 4, 2026, and includes statewide field work. The Staff Attorney position requires at least five years of legal experience and familiarity with administrative law.
MS Board of Pharmacy Resolution for State of Emergency Ice Storm
The Mississippi Board of Pharmacy has issued a resolution acknowledging the state of emergency due to an ice storm. This resolution outlines temporary measures and guidance for pharmacies to ensure continued patient access to medications during the emergency period.
Contract Award for Pharmacy Professionals Recovery Services
The Mississippi Board of Pharmacy has announced a contract award for pharmacy professionals recovery services. This notice serves to inform stakeholders about the selection of a service provider to offer support and resources for pharmacy professionals facing substance abuse or other challenges.
Mississippi Board of Pharmacy Final Rule Effective
The Mississippi Board of Pharmacy has filed a final administrative rule with the Secretary of State. This rule will become effective on March 13, 2026, impacting healthcare providers within the state.
MEAC Medical Equipment Advisory Committee Meeting Announcement
The Mississippi Board of Pharmacy has announced a meeting for the Medical Equipment Advisory Committee (MEAC) on December 2, 2025. The meeting will cover topics related to medical equipment and is scheduled to take place at the Board's office in Jackson, Mississippi.
DEA Warns About Methamphetamine and Street Names
The DEA issued a public safety alert warning about methamphetamine, listing its various street names such as Crank, Crystal, and Ice. The alert directs readers to a DEA factsheet for more information on the drug and its effects.
DEA Public Safety Alert: Fentanyl Affects All Communities
The DEA issued a public safety alert via Twitter, emphasizing that fentanyl affects all communities regardless of race, age, or economic status. The alert, from DEA SAC D. Olesky, reiterates the DEA's goal of a fentanyl-free America and mentions a joint effort with Aurora Police to combat drug trafficking.
FDA Guidance on Pyrogen and Endotoxin Testing
The FDA has issued guidance for biological product, drug, and device firms regarding pyrogen and endotoxin testing. This document provides recommendations based on current FDA thinking concerning USP and AAMI standards for bacterial endotoxin and pyrogen tests.
FDA Warning Letter to Vedic Lifesciences for GLP Violations
The FDA issued a warning letter to Vedic Lifesciences Pvt. Ltd. for violations of Good Laboratory Practice (GLP) regulations during the inspection of nonclinical laboratory studies. The company failed to prepare accurate final reports for investigational drug studies, misrepresenting testing facility and personnel information.
Angiographic Catheters Recalled Due to Molded Hub Non-Conformance
Health Canada has issued a recall for AngioDynamics' Soft-Vu and Accu-Vu 4 FR Angiographic Catheters due to a molded hub non-conformance. The defect may prevent guidewire passage, though no injuries have been reported in Canada. Healthcare providers should contact the manufacturer for information.
Health Canada Recalls Vacuum Bag SU Large Due to Leakage Risk
Health Canada has issued a Type II recall for the Milestone S.R.L. Vacuum Bag SU Large due to a risk of leakage from the specimen container. Healthcare providers are advised to contact the manufacturer for additional information.
EMA Enhances PRIME Scheme to Accelerate Medicine Development
The European Medicines Agency (EMA) has launched three new features for its PRIME scheme, designed to accelerate the development of medicines targeting unmet medical needs. These tools aim to streamline scientific dialogue and provide developers with faster answers and better preparation for marketing authorisation applications.
Mama Grande Tortilla Factory Recalls Gorditas for Undeclared Wheat and Soy
Mama Grande Tortilla Factory is recalling Gorditas de Azucar and Doraditas de Azucar due to undeclared wheat and soy. The recall impacts products distributed in Texas between February 2, 2026, and March 5, 2026. No illnesses have been reported.
Health Canada Task Force on Pharmaceutical Access and Innovation
Health Canada and Innovation, Science and Economic Development Canada have launched a joint Pharmaceutical and Life Sciences Sector Task Force. The task force will support access to pharmaceuticals and identify solutions to drive innovation and growth in the Canadian life sciences sector.
FDA Early Alert: Handy Solutions Heating Pad Issue
The FDA issued an Early Alert regarding a potentially high-risk issue with Handy Solutions Neck & Shoulders Heating Pads manufactured by Navajo Manufacturing Company. The device can overheat and cause burns or property damage, with four serious injuries reported.
HSA Warns Public About Products with Banned or Potent Medicinal Ingredients
The Health Sciences Authority (HSA) in Singapore has issued a warning regarding four products found to contain banned or potent medicinal ingredients, including steroids and sibutramine. Three consumers experienced serious adverse effects after consuming these products. HSA is working to remove listings and investigate sellers.
FDA Indexes New Drug for Ornamental Finfish Parasites
The FDA has added Prazi-Med, a praziquantel powder for immersion, to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. This drug treats internal and external parasites in ornamental finfish, providing a faster and less expensive pathway to market for such products.
WHO Report: Child Mortality Slows, 4.9 Million Die Before Five
A new UN report indicates that while child deaths have fallen globally since 2000, the pace of reduction has slowed significantly since 2015. In 2024, 4.9 million children died before their fifth birthday, with preventable causes like malnutrition and infectious diseases being major factors. The report highlights disparities in healthcare access, particularly in sub-Saharan Africa and conflict-affected regions.
Atropine Eye Drops: Medication Error Risk in Children Under 3
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice regarding the risk of medication errors with atropine eye drops in children under 3 years old. The notice highlights specific risks and provides recommendations to prevent these errors.
FDA Early Alert: Insulet Omnipod 5 Pods May Not Deliver Insulin
The FDA has issued an Early Alert regarding Insulet Omnipod 5 Pods that may have a tear in internal tubing, potentially leading to under-delivery of insulin and high blood glucose levels. Insulet has issued a voluntary correction recommending affected pods not be used, with 18 serious injuries reported.
ANSM Safety Alert for Soltive SuperPulsed Laser Systems
The French ANSM has issued a safety alert (R2607992) regarding Soltive SuperPulsed laser systems, following a security action initiated by Olympus. Affected users have been notified directly by the manufacturer.
ANSM Safety Alert: B. Braun Infusion Sets and Mentor Tissue Expanders
The ANSM has issued a safety alert regarding specific lots of B. Braun infusion sets and Mentor tissue expanders. A lot recall has been implemented by the manufacturer, B. Braun Medical Inc., and Mentor. Affected users have been notified.
FDA Draft Guidance on New Approach Methodologies in Drug Development
The FDA has issued draft guidance for industry on the use of New Approach Methodologies (NAMs) in drug development. The guidance provides a validation framework and recommendations to improve human relevance and reduce animal testing, encouraging NAMs in regulatory submissions.
SC Board of Pharmacy: Revised Vaccine Administration Protocol
The South Carolina Board of Pharmacy has revised its protocol for vaccine administration by pharmacists, effective September 17, 2025. The primary change allows pharmacists, interns, and technicians to administer FDA-approved COVID-19 vaccines without a practitioner's order, following specific professional recommendations.
Idaho Board of Pharmacy Grants Medication Authority to Naturopaths
The Idaho Board of Pharmacy has announced that naturopaths are now granted medication authority. This change expands the scope of practice for licensed naturopathic physicians in Idaho, allowing them to prescribe certain medications.
Idaho Pharmacy Licensure Renewal Cycle and Fee Updates
The Idaho Board of Pharmacy is updating its licensure renewal cycles and fees effective July 1, 2025. Pharmacist licenses will now expire on the licensee's birthday, with renewals shifting to a two-year cycle, and associated fees will double for biennial renewals.