U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for regulating products within the U.S. such as human drugs, medical devices, vaccines, blood products, radiation emitting products, and most food products. The AANA monitors FDA activities and regulations which may affect CRNA practice or the products and devices that CRNAs utilize.
Emergency Use Authorization of Fresenius Propoven 2%
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (ICU) setting.
Bupivacaine Shortage Information and Resources
- American Society of Health-System Pharmacists (ASHP)
- Centers for Disease Control and Prevention (CDC)
- U.S Food and Drug Administration (FDA) Bupivacaine Drug Shortage Detail
Shortages, Recalls, and Safety Alerts
- Anesthesia Specific Drug Shortages, Drug and Device Recalls, and Safety Alerts (Login Required)
- General FDA Information
- ASHP: Drug Shortages and Management
FDA Reports and News
- FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic, June 19, 2020
- Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps, June 3, 2020
- FDA Drug Shortages Report: Root Causes and Potential Solutions, October 2019
- FDA Drug Shortages Infographic, October 22, 2019
- FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions, January 11, 2019
- FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution, March 1, 2018
AANA Comment Letters to FDA
- AANA submits comment letter to the FDA regarding drug shortages, January 11, 2019
- AANA submits comment letter to the FDA's Opioid Policy Steering Committee regarding prescribing intervention strategy implementation, March 13, 2018
- AANA submits comment letter to FDA supporting a multidisciplinary patient-centered approach to provider education on pain management and safe opioid use, July 10, 2017
- AANA submits comment letter to the FDA regarding the use of prescription opioids analgesics for the pediatric population, September 30, 2016
- AANA submits comment letter to FDA regarding the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, June 3, 2016
- AANA supports FDA's proposed powdered glove ban to mitigate the adverse events related with these devices and promote patient and healthcare worker safety, May 9, 2016
- AANA submits comments to FDA regarding labeling of injectable medical products in multi-dose, single-dose, and single-patient-use containers, December 21, 2015
- AANA submits comments to FDA regarding patient involvement and input in the medical device lifecycle and engagement and integration of patient preference data into device research and communication with the patient, November 18, 2015
- AANA submits comments to FDA regarding patient involvement and input in the medical device lifecycle and engagement and integration of patient preference data into device research and communication with the patient, November 5, 2015
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Report a Safety Issue to the FDA
MedWatch is the FDA’s medical product safety reporting program where health professionals, patients and consumer can voluntarily report observed or suspected adverse events for human medical products to FDA.
FDA Drug Shortages App
Download the FDA's drug shortages app to receive notifications when there is new or updated information about a drug product shortage or a drug within selected therapeutic categories.