Alerts

FDA and Pharmacy Weekly Digest - February 19

Alerts / February 19, 2020
Food/Dietary Supplements

FDA and CDC Announced the End of a Salmonella Outbreak in Fresh Fruit – The Food & Drug Administration (FDA) completed its investigation into an outbreak of illnesses caused by Salmonella that sickened 165 people. The outbreak began in December 2019 and was traced to fresh cut fruit processed by a single firm. The FDA inspections of the firm identified these general deficiencies: “[The] firm’s hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control; the firm did not identify a preventive control for a hazard when one was needed; and the firm did not maintain the plant in a clean and sanitary condition and keep the plant in repair.” The firm is working with the FDA to address the deficiencies.

Drugs

FDA Works With India to Protect American Consumers – The FDA announced its first bilateral enforcement operation with the government of India. The FDA and Indian officials targeted an internal mail facility from Jan. 28 through Jan. 30. Together, they stopped approximately 500 shipments of illicit and potentially dangerous unapproved prescription drugs and combination medical devices from reaching American consumers.

The FDA Approved Three Drugs for Over-the-Counter (OTC) Sales – The approvals came through the prescription(Rx)-to-OTC switch process. The FDA approved a topical gel for the temporary relief of arthritis pain and two ophthalmic drops for the temporary relief of itchy and/or red eyes due to pollen, ragweed, grass, animal hair or dander.

FDA To Host Public Meeting on Patient-Focused Drug Development for Stimulant Use Disorder – The FDA announced it will hold a public meeting on March 10 to “provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, methamphetamine, crystal meth, or misuse of prescription stimulants.”

Drug Manufacturer Withdraws Drug After FDA’s Request – A drug manufacturer withdrew its FDA-approved weight-loss drug after the FDA requested that it voluntarily withdraw the drug because a safety clinical trial shows an increased occurrence of cancer.

Medical Devices

Device Manufacturer Issues Class I Recall – A company issued a recall of insulin pumps, and the FDA has identified this as a Class I recall, the most serious type of recall. The firm had received a total of 26,421 complaints because the insulin pumps were missing a retainer ring or had a broken retainer ring. This ring helps lock the insulin cartridge into place in the pump’s reservoir. The firm is aware of 2,175 injuries and one death.

Tobacco

FDA Seeks Information on the Use of Vaping Products Associated With Recent Lung Injuries – The FDA opened a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the agency could take to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”

Pharmacy

FDA Commissioner Stephen M. Hahn Outlines FDA’s Response to Coronavirus – Hahn states that the FDA’s “work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.” Read the full statement here.

FDA Extends the Comment Period for Compounding Animal Drugs From Bulk – The FDA extended the comment period for a revised draft guidance, Compounding Animal Drugs from Bulk Drug Substances. The new deadline to receive comments is June 17. Under the revised draft guidance as written, only bulk drug substances on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals can be compounded into drugs for office stock or for antidotes for food-producing animals

Authorship Credit: Marc N. Wagner

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