FDA and Pharmacy Weekly Digest - April 16

Alerts / April 16, 2019
Food/Dietary Supplements

Agencies Announce Food Waste Reduction Strategy – The FDA, USDA and EPA released a food waste strategy. The strategy focuses on six priorities, including enhanced coordination between agencies and increased consumer education/outreach.


FDA Issues Hand Sanitizer Final Rule – The FDA published a final rule aimed “to help ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them.” The rule outlines prohibited active ingredients in these products. In addition, “three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products.”

FDA Approves New HIV Treatment Regime – The FDA announced approval of Dovato, the first two-drug, fixed-dose treatment regimen for adults with HIV. It is “a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.”

FDA Announces Label Changes for Opioid Analgesics – The FDA announced that it will be “requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting.” The FDA stated, “These changes will provide expanded information to health care providers on how to safely decrease the dose in patients who are physically dependent on opioids. This information is intended to be used when the health care provider and the patient have determined together that a decrease in dose or discontinuation of the opioid is appropriate.” FDA also issued a drug safety communication to patients and providers warning that healthcare providers “should not abruptly discontinue opioids in a patient who is physically dependent” on them.

FDA Releases Pharmacogenomic Guidance – The FDA issued a guidance meant “to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development. The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on (1) when to submit pharmacogenomic data to the Agency during the drug or biological drug product development and review processes, (2) what format and content to provide for submissions, and (3) how and when the data will be used in regulatory decision making.”

Medical Devices

FDA Warns Against Use of Home Use Test Strips – The FDA issued a warning to patients and healthcare providers against the use of at-home test strips that are pre-owned or not authorized for U.S. sale. FDA is concerned that these test strips “may potentially cause infection or lead to inaccurate test results, which can cause serious harm, including death.”

FDA Cautions Against Use of Concussion Diagnosis Devices – The FDA issued a warning to consumers not to use devices “that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.” FDA cautions that certain concussion detecting devices, like smartphone apps, are not FDA cleared or approved.

FDA Addresses Shortage of Pediatric Breathing Tubes – The FDA continues to address concerns about medical device shortages, including pediatric breathing tubes, due to the closure of two sterilization facilities.


FDA Issues Warning Letters to Certain E-liquid Producers – The FDA sent warning letters to two e-liquid producers for manufacturing and/or distributing e-liquids with misleading labeling and/or advertising imitating cough syrups.


FDA Will Hold Public Meeting on Compounding – On May 21, 2019, FDA plans to hold a public meeting on drugs compounded for office stock. The purpose of the meeting is “to provide health care professionals, outsourcing facilities, and other stakeholders with an opportunity to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance "Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Registration closes on May 7, 2019.

Authorship Credit: Lindsay P. Holmes

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