AHHA Special Updates Archives - American Holistic Health ...

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4 days ago — “The three treatment options are lifestyle changes, medication, and surgery. ... 'bioidentical hormones' are compounded drugs, which are not FDA-approved.

 

Blue Cross and Blue Shield of North Carolina - MyPrime.com

www.myprime.com › prime › forms › AuthorForms › HIM

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2 days ago — To be eligible for coverage, compounded medications must contain at least one ingredient that is defined as a prescription medication and must not be a copy of .

 

The FDA Announces Delays in DSCSA Compliance ...

www.quarles.com › publications › the-fda-announces-d...

6 days ago — In October, the Food and Drug Administration (FDA) released guidance documents affecting wholesale distributors, state boards of pharmacy and compounding .

 

11/17/2020

11/06/2020

Family Pharmacy of Statesville, Inc.

Division of Pharmaceutical Quality Operations II

Compounding Pharmacy/Adulterated Drug Products

 

11/17/2020

11/10/2020

MXL Comercial, SA de CV

Center for Drug Evaluation and Research | CDER

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

 

11/17/2020	10/08/2020	WCS Trading, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
11/17/2020	10/28/2020	Ventura Foods LLC	Division of Human and Animal Food Operations East V	Food Labeling/Misbranded
11/17/2020	11/03/2020	Half Hill Farm Inc	Division of Human and Animal Food Operations East V	New Drug/Misbranded
11/17/2020	11/03/2020	World Candy Store LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
11/17/2020	11/04/2020	E&H Distributors LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
11/17/2020	11/05/2020	Quten Research Institute, LLC	Division of Human and Animal Food Operations East II	New Drug/Misbranded
11/17/2020	11/05/2020	Etai's Food, Inc.	Division of Human and Animal Food Operations West IV	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
11/17/2020	11/06/2020	Grupo Asimex de Mexico SA de CV	Center for Drug Evaluation and Research	Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

 Opioid Settlements: Four Companies Close in on $26 Billion Deal

McKesson, Cardinal Health, AmerisourceBergen and Johnson & Johnson are closing in on a $26 billion deal with state and local governments, putting an end to thousands of lawsuits over their role in the pandemic. Read more.

 

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 ..