Coronavirus (COVID-19) Update: November 13, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: At FDA’s request, the U.S. Department of Justice filed a civil complaint in the U.S. District Court for the District of New Jersey against Natural Solutions Foundation and two individuals associated with the entity, seeking to permanently enjoin them from distributing Dr. Rima RecommendsTM Nano Silver 10PPM in interstate commerce as a prevention or treatment for COVID-19 and other diseases. The complaint alleges that Natural Solutions Foundation and the individual defendants, Dr. Rima Laibow and Ralph Fucetola, violated the Federal Food, Drug, and Cosmetic Act by unlawfully distributing a misbranded and unapproved new drug. These are allegations which, if the case were to proceed to trial, the government must prove to receive a permanent injunction against defendants. FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to the defendants about their nano silver product. The defendants responded by removing some, but not all, public-facing claims from their websites. FDA is particularly concerned that products that claim to cure, mitigate, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. There are currently no vaccines or drugs approved to prevent COVID-19. FDA reminds the public to follow advice from federal agencies about how to prevent the spread of COVID-19 and urges people with questions about COVID-19 treatments to contact their health care provider.      Testing updates: As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.

 

FDA Compounding Guide Excludes Physicians From ...

insidehealthpolicy.com › daily-news › fda-compoundin...

4 days ago — ... from a key pharmacy organization that had argued safe compounding practices should not differ based on the setting in which the drugs are compounded

 

FDA: Takes Efforts to Protect Patients from Potentially Harmful ...

fdahealthnews.com › stories › 564811983-fda-takes-eff...

4 days ago — Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration's drug compounding ..

meningitis-etc: Cadden, Chin Hearing Thursday

meningitis-etc: Cadden, Chin Hearing Thursday: By Walter F. Roche Jr. A key hearing in the case of two former pharmacists charged with second degree murder is scheduled for Thursday i...

High Importance!! Accidental hormone exposure in pets an ongoing problem Solution requires recognition by physicians, veterinarians, pet owners; The products are sold as commercially manufactured drugs and as concoctions prepared by compounding pharmacies.November 9, 2020 (published) By Anna Lewis

https://news.vin.com/default.aspx?pid=210&catId=619&Id=9900166 

 

Meridian doctor, employee face trial in TRICARE case | Local ...

www.meridianstar.com › news › local_news › meridian-d...

5 days ago — Compounded medications are drugs made up of ingredients that have been combined or altered, according to the Food and Drug Administration. Pharmacies 

 

FDA Compounding Guide Excludes Physicians From ...

insidehealthpolicy.com › daily-news › fda-compoundin...

2 days ago — ... from a key pharmacy organization that had argued safe compounding practices should not differ based on the setting in which the drugs are compounded.

Pharmacies Sue Over Compounded Drug Distribution MOU ...

www.frierlevitt.com › articles › industry › life-sciences

5 days ago — If a compounding pharmacy is doing business in a state that has signed the MOU, the pharmacy will have increased regulatory burdens and requirements to .

Compounding Pharmacies Anticipate Increased Federal (and Potentially State) Regulation

https://www.jdsupra.com/legalnews/compounding-pharmacies-anticipate-37693/ 

 

Supreme Court justices seem unlikely to strike down full ACA

The justices focused on issues including whether challengers had legal standing and whether the entire law would have to fall if the individual mandate were unconstitutional.

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