https://floridapolitics.com/archives/361713-debate-continues-over-expanded-role-for-pharmacists
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
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Tuesday, August 25, 2020
FDA faces a reputation crisis amid Trump pressure for fast COVID action—and that's bad news for pharma
FDA faces a reputation crisis amid Trump pressure for fast COVID action—and that's bad news for pharma: The flip-flop emergency approval of convalescent plasma by the FDA sparked a social media wildfire of criticism—and cast a shadow on the agency’s reputation. Many criticized the FDA and Commissioner Stephen Hahn over the plasma EUA for COVID-19 patients and the appearance of President Trump's involvement.
How the FDA continues to fail vulnerable patients
How the FDA continues to fail vulnerable patients: For the first time in recent memory, the FDA is moving at a record pace to remove barriers and speed approval to provide treatment options and a vaccine for COVID-19.
1 day ago - The guidance documents permit compounding by outsourcing facilities registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act, as
| 08/25/2020 | 08/14/2020 | Hot Podz d/b/a Buy Pods Now | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/25/2020 | 08/14/2020 | Eon Pods, LLC d/b/a Eon Smoke Pods | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| 08/25/2020 | 08/13/2020 | Wintac Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| 08/25/2020 | 08/06/2020 | Custom Nutraceuticals, LLC | Division of Human and Animal Food Operations East I | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| 08/25/2020 | 07/30/2020 | Chicago Indoor Garden, Inc. | Division of Human and Animal Food Operations East VI | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | ||
| 08/25/2020 | 07/31/2020 | Crafty E-Liquids Limited | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/25/2020 | 07/31/2020 | Pure Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/25/2020 | 07/31/2020 | Damokee, LLC d/b/a Daily Dose E-Liquid and Damokee Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/25/2020 | 07/31/2020 | Vapor Plus OK | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Resources for Animal Food Producers in Southeast and Gulf Coasts Affected by Storms Marco and Laura
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Health Standards to Advance Transparency, Integrity, Science, Technology Infrastructure, and Confidential Statistics Act of 2020 (Health STATISTICS Act) - H.R.8080.
The House of Representatives has introduced a new bill, the "Health Standards to Advance Transparency, Integrity, Science, Technology Infrastructure, and Confidential Statistics Act of 2020 (Health STATISTICS Act) - H.R.8080." The bill would direct the United States Department of Health and Human Services to share health data it collects from reporting entities with collected the Centers for Disease Control and Prevention, other public health agencies, and the public. The bill would also require that the individual's privacy be maintained.
U.N. cautions that virus plasma treatment still experimental
The World Health Organization on Monday cautioned that using blood plasma from COVID-19 survivors to treat other patients is still considered an experimental therapy, voicing the concern as a U.S. boost for the treatment has many scientists afraid formal studies will be derailed. |
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Tuesday, August 18, 2020
| 08/17/2020 | 08/14/2020 | SilveryGuy | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 08/12/2020 | 07/23/2020 | AkivaMed Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 08/12/2020 | 07/23/2020 | Holistic Health International, LLC | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 08/18/2020 | 07/24/2020 | East Coast Vapors, LLC d/b/a VapeScorpion.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/18/2020 | 07/31/2020 | LDA Industries, LLC d/b/a Vapor Dynamix | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/18/2020 | 07/31/2020 | Lufkin Vapor Supply/Vapin Texas LLC d/b/a Toot Juice & Vapor Supply | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/18/2020 | 08/05/2020 | Winter Gardens Quality Foods, Inc. | Division of Human and Animal Food Operations East II | Food Labeling/Misbranded | ||
| 08/18/2020 | 08/06/2020 | Heritage Tobacco | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/18/2020 | 08/10/2020 | Nixteria, Crafted by JuicyVapor, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 08/18/2020 | 08/10/2020 | Pero Family Farms Food Company, LLC | Division of Human and Animal Food Operations East IV | Food Labeling/Misbranded |
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Coronavirus outbreak: FDA flags accuracy problem with widely used coronavirus test
Live updates from Modern Healthcare on the coronavirus outbreak and how COVID-19 is affecting the healthcare industry. |
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Sunday, August 16, 2020
FDA finds new toxic hand-sanitizer ingredient, expands warning to 157 products
Regulators find toxic 1-propanol as well as methanol in some products.Read in Ars Technica: https://apple.news/
Friday, August 14, 2020
Former Vance AFB Major Sentenced to Two Years in Federal Prison for Taking Kickbacks Involving Compounding Pharmacies. Major she gave military members pre-printed prescription pads and induced them to ask their doctors for specific compounded drugs. The Major admitted she then sent the prescriptions or caused them to be sent to specific pharmacies.
Department of Justice
U.S. Attorney’s Office
Western District of Oklahoma
FOR IMMEDIATE RELEASE
Monday, August 10, 2020
Former Vance AFB Major Sentenced to Two Years in Federal Prison for Taking Kickbacks Involving Compounding Pharmacies
OKLAHOMA CITY – ROMEATRIUS MOSS, 40, a nurse and former Air Force Major stationed at Vance Air Force Base in Enid, Oklahoma, was sentenced today to serve 24 months in prison for health care fraud in which she accepted kickbacks for referring TRICARE beneficiaries to pharmacies furnishing compounded drugs, announced U.S. Attorney Timothy J. Downing. Moss was also ordered to pay restitution in the amount of $622,459.00.
According to a felony information filed on September 30, 2019, Moss solicited and received $73,823.06 in return for referring prescriptions for members of the U.S. military to compounding pharmacies that were reimbursed by TRICARE, a health insurance program for military members. Because of resulting cost increases and infringement on patient choice, it is a crime to solicit or receive payments for referrals to health care providers for an item or service that could be paid, in whole or in part, by a federal health care program.
Moss pleaded guilty on October 15, 2019, before U.S. District Judge Patrick R. Wyrick. She admitted that while she was employed in the medical unit at Vance AFB, she gave military members pre-printed prescription pads and induced them to ask their doctors for specific compounded drugs. Moss admitted she then sent the prescriptions or caused them to be sent to specific pharmacies. Moss admitted she was paid a kickback that was a percentage of the gross reimbursement the pharmacies received from TRICARE for filling the prescriptions.
Today, Judge Wyrick sentenced Moss to 24 months in the custody of the Bureau of Prisons, followed by three years of supervised release. Judge Wyrick also ordered Moss to pay restitution to TRICARE in the amount of $622,459.00, the total amount of kickbacks she received in the referral scheme. She was also ordered to forfeit her residence in Enid.
The case is the result of an investigation by the Defense Criminal Investigative Service, the Air Force’s Office of Special Investigations, and the Federal Bureau of Investigation–Oklahoma City Division. Assistant U.S. Attorneys Jessica Perry and Amanda Maxfield Green prosecuted the case.
Reference is made to court filings for further information. To download a photo of U.S. Attorney Downing, click here.
Topic(s):
Health Care Fraud
Component(s):