s_07504_12142020 HOUSE SUBSTITUTE FOR SENATE ...
4 days ago — controlled substance that is compounded for a drug shortage, as. 25 determined by the FDA. An out-of-state pharmacy shall comply with. 26 this part and the ...
Wednesday, December 23, 2020
| 12/22/2020 | 08/25/2020 | Customceutical Compounding | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
| 12/22/2020 | 12/11/2020 | Campimex, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||
| 12/22/2020 | 12/16/2020 | Whole Foods Market | Center for Food Safety and Applied Nutrition (CFSAN) | Food Labeling/Misbranded | ||
| 12/22/2020 | 12/22/2020 | New Leaf Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| 12/22/2020 | 12/22/2020 | NextL3vel Services Group, LLC dba This Stuff Is Good For You | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| 12/22/2020 | 12/22/2020 | Wellness BioSciences Rx | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| 12/22/2020 | 12/22/2020 | G & L Wellness, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| 12/22/2020 | 12/22/2020 | Bee Delightful | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded | ||
| 12/21/2020 | 12/18/2020 | Rowpar Pharmaceuticals | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 12/16/2020 | 12/15/2020 | Phoenix Biotechnology, Inc. | CDER Office of Compliance | Finished Pharmaceuticals/Unapproved new drug |
FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.
While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.
To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to:
- Decrease unnecessary exposure to prescription opioids and prevent new addiction;
- Support the treatment of those with opioid use disorder;
- Foster the development of new and effective pain therapies; and
- Take action against those who contribute to the illegal importation and sale of opioid products.
Part of our regulatory authority efforts include requiring Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.
Today, we took further steps to strengthen the REMS program for...
Thursday, December 17, 2020
FDA Statement on Vaccines and Related Biological Products Advisory Committee MeetingThe following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution. Additional Resources: |
FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients
Agency Urges Online Marketplaces, Other Websites and Retailers to Stop Selling These Male Enhancement and Weight Loss Products to American Consumers
The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. The FDA purchased these products on Amazon and eBay and agency testing found that the products contain active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.
Despite FDA consumer warnings about similar products over the past decade, the agency continues to find potentially dangerous products available for purchase on the internet, including from online marketplaces like Amazon and eBay, as well as in retail stores. The agency urges consumers to beware of purchasing or taking these products.
“Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant and communicate about products and companies that place U.S. consumers at risk,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “While the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past, we believe they can do more to...
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