FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance The following is attributed to Patrizia Cavazzoni, M.D., Acting Director, FDA Center for Drug Evaluation and Research.

 

FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance The following is attributed to Patrizia Cavazzoni, M.D., Acting Director, FDA Center for Drug Evaluation and Research. Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration’s drug compounding program, and we are committed to protecting patients. While compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, these drugs have not been reviewed by the FDA for safety, effectiveness or quality. The FDA through its oversight of compounded drugs strives to help improve the quality of compounded drugs and reduce risk to patients. Under federal law, a drug is considered adulterated if it is prepared, packed or held under insanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA investigators continue to...

 

DHA supports DOJ to fight compound drug fraud ...

www.forthoodsentinel.com › living › healthworks › dha-s...

13 hours ago — The medicine in large pills can be mixed into a solution by the pharmacist and given orally. This action is commonly called “compound drugs,” such medications ...

 

Express Rx Acquires Cantrell Drug Co.'s Retail Business - AMP

armoneyandpolitics.com › AMP News

18 hours ago — ... of Cantrell Drug Company's retail pharmacy and compounding operations on ... The purchase makes Express Rx one of the few pharmacies in the state with ..

 

NCPA counters California attempt to restrict animal ...

ncpa.org › newsroom › qam › 2020/11/04 › ncpa-coun...

18 hours ago — NCPA counters California attempt to restrict animal compounding. NCPA November 4, 2020. In a letter to the California Board of Pharmacy, NCPA highlighted

 

Compounding Activities | COVID-19 | FDA

www.fda.gov › drugs › coronavirus-covid-19-drugs

4 days ago — The agency's guidance aims to protect patients from unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients. Outsourcing ...

Compounding Information for States | FDA

www.fda.gov › drugs › human-drug-compounding › c...

7 days ago — FDA's compounding program closely collaborates with state officials. FDA collaborates with state officials in a variety of ways, including by sharing information ..

 

11/03/2020

10/09/2020

Surgery Pharmacy Services Inc

Division of Pharmaceutical Quality Operations II

Compounding Pharmacy/Adulterated Drug Products

11/03/2020

10/15/2020

Cosmax USA, Inc.

Division of Pharmaceutical Quality Operations II

CGMP/Finished Pharmaceuticals/Adulterated

 

11/03/2020

10/16/2020

Immusist, LLC

Division of Human and Animal Food Operations West VI

New Drug/Misbranded

 

11/03/2020	10/22/2020	Handylee USA Corp.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
11/03/2020	10/23/2020	4E Global, S.A.P.I. de C.V.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
11/03/2020	10/23/2020	Grupo Insoma, S.A.P.I de CV	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
11/03/2020	10/27/2020	Real Clean Distribuciones SA de CV	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
11/03/2020	10/29/2020	Asiaticon, SA de CV	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

 

11/03/2020	10/05/2020	Physician 360, Inc.	Center for Devices and Radiological Health	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/03/2020	10/15/2020	LVWellness & Aesthetics	Center for Devices and Radiological Health	Unapproved, Adulterated, and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/03/2020	10/29/2020	Trask and Roth Inc. dba Trask & Roth Research and Manufacturing	Center for Devices and Radiological Health	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/03/2020	11/02/2020	NovaBay Pharmaceuticals, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/02/2020	10/30/2020	Spartan Enterprises Inc. dba Watershed Wellness Center	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)