Alerts

FDA and Pharmacy Weekly Digest - March10

Alerts / March 10, 2020
Food/Dietary Supplements

FDA Launched Webpage on Agricultural Biotechnology – The webpage is part of the Feed Your Mind education initiative to help consumers better understand genetically engineered foods, commonly called GMOs or genetically modified organisms. The education initiative explains what GMOs are and lists GMO crops commonly sold in the United States.

FDA Released Action Plan to Advance the Safety of Leafy Greens – The FDA developed this plan “due to the reoccurring nature of outbreaks associated with leafy greens.” The FDA plans to advance work in the prevention of and response to outbreaks and address knowledge gaps concerning leafy greens.

Drugs

FDA Updated List of Extended Use Dates to Assist With Drug Shortages – The update is based on stability data provided by the manufacturers and reviewed by the FDA. This list is intended for healthcare professionals and patients. It displays dates through which some products may be used beyond the manufacturer’s labeled expiration date due to continued intermittent supply interruptions of critical drugs.

FDA and FTC Warned 7 Manufacturers for Unapproved Products Related to the Coronavirus Disease – The warnings were sent to manufacturers offering products for sale in the United States that are intended to mitigate, prevent, treat, cure or diagnose COVID-19. The FDA warned that these products are unapproved and misbranded. The products include essential oils, colloidal silver products, teas and tinctures.

Medical Devices

FDA Bans Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior – In the final rule, the FDA notes that these devices “are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person’s skin to reduce or cease such behaviors.” The ban will take effect on April 6, but institutions with devices currently in use that are subject to a physician-directed transition plan have until Sept. 2 to comply. After the effective date, the FDA will consider these banned devices to be adulterated devices subject to enforcement action.

FDA Announced a Public Meeting on the Reauthorization of the Medical Device User Fee Amendments – The notice seeks public comment at a public meeting on April 7. The purpose of the meeting is to hear stakeholder views on medical device user fee reauthorization as the FDA considers recommendations to Congress for the next medical device user fee program for Fiscal Years 2023 through 2027.

Tobacco

FDA Launched a Webpage for Tobacco 21 – The webpage contains resources for retailers and commonly asked questions on the legislation that immediately raised the federal minimum age for the sale of tobacco products from 18 to 21 years.

Pharmacy

FDA Limits Pharmacy Compounding – In an email to stakeholders, the FDA notified compounders of changes taking effect March 23. This transition affects compounding under sections 503A and 503B. Compounders will no longer be able to compound NDAs that are being transitioned to BLAs. For more details on this change, see our alert.

West Virginia Passed Pharmacist Reimbursement Bill – The bill provides for health plan coverage of pharmacist care rendered within the pharmacist’s scope of practice if benefits would be provided for such services performed by other healthcare providers.

Authorship Credit: Marc N. Wagner

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