What's New

Hospira Recalls Sterile Water for Injection

Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, and is supplied only in single-dose containers. Read the FDA recall notice.
FDA Updates Authorized Serology Test Performance Data

The FDA provided new information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response.
FDA Revokes EUA for Battelle Decontamination System

At the request of the company, the FDA revoked emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System. The system was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. Battelle has ceased all Battelle CCDS site operations and marketing activities as of March 31, 2021, after the FDA and NIOSH recommended that healthcare providers transition from use of decontaminated respirators in early April. Read the FDA recommendation letter.
Expert Panel Establishes Targets to Improve Hospital Antibiotic Prescribing

A panel of health experts convened by The Pew Charitable Trusts and the CDC developed the first national targets to reduce inappropriate antibiotic prescribing in U.S. hospitals. The targets were based on a CDC prevalence survey showing that in 2015, more than half of antibiotics prescribed in U.S. hospitals did not follow recommended prescribing practices. The study focuses on four categories of antibiotic prescribing that together account for the most common inpatient prescribing. These four included two conditions (community-acquired pneumonia [CAP] and urinary tract infections [UTI]) and two types of antibiotics (fluoroquinilones and vancomycin).
Scented Hand Sanitizer Recalled

Scentsational Soaps & Candles is recalling scented hand sanitizers and hand sanitizer spray from its Black and White Collection, Photo Real Collection, and Ulta Beauty Collection after its own testing revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were distributed nationwide in the U.S. through Ulta Beauty, TJ Maxx, and Marshalls retail stores. Read the FDA recall announcement.
FDA Issues Warning Letters to Marketers of Unapproved Products

The FDA issued warning letters to two companies marketing unapproved drugs. One letter was to the operator of the website pharmacygeoff.md for marketing unapproved drugs for multiple diseases, including COVID-19.
CDC Updates Guidance for Fully Vaccinated People

CDC has released updated infection prevention and control guidance for healthcare personnel (HCP) and others who are fully vaccinated for COVID-19. Please note that CDC will continue to revise recommendations as more information becomes available.
Emergent BioSolutions Pauses Production of COVID-19 Vaccine

Following an FDA inspection of its manufacturing facility, Emergent BioSolutions has agreed to pause new production of the J&J COVID-19 vaccine while it works with FDA to resolve potential quality issues. Read the FDA announcement.
ASTM and NIOSH Develop Standard for Barrier Face Coverings

In collaboration with the CDC’s National Institute for Occupational Safety and Health (NIOSH), ASTM International (formerly known as the American Society for Testing and Materials) developed ASTM F3502-21, a consensus standard to establish a set of uniform testing methods and performance criteria for barrier face coverings (BFCs). BFCs are not respirators or surgical masks, but may prevent the wearer from spreading larger droplets that can carry infectious organisms, such as the SARS-CoV-2 virus. The new ASTM standard is a consensus standard developed by a non-federal entity, so it is a recommendation but does not have the force of law. Read more.
ACIP Recommends Resuming J&J COVID Vaccinations with Warning Notice

The Advisory Committee on Immunization Practices (ACIP) has recommended to CDC Director Walensky that Johnson & Johnson COVID-19 vaccinations be resumed, but with a warning about the increased risk of very rare but severe blood clots. Both CDC and FDA will be updating guidance and communications relating to this vaccine.

Coronavirus Facts

With coronavirus disease (COVID-19) at the forefront of the news and lawmakers minds, now is an important time to help educate your state lawmakers about the virus.
Support Transparent and Accurate Data Reporting

Urge your Members of Congress to continue working with the Centers for Disease Control and Prevention (CDC) and NHSN data collection efforts to combat COVID-19.
Science Policy Should be Nonpartisan

IPs rely on the best scientific evidence to limit the spread of infection in their facilities. Tell your Members of Congress to not politicize science!
Masking Works.

While the COVID-19 vaccine is being dispensed to millions of Americans, now is the most important time to keep social distancing and masking. Contact your governor and tell them to support evidence-based practices of social distancing and masking.