FDA's Fall Regulatory Agenda Adds Several New Proposed ...

https://www.fdanews.com › articles › 205867-fdas-fall-...

14 hours ago — The FDA aims to establish the minimum current good manufacturing practice (cGMP) requirements for human drug products compounded by an outsourcing facility.

 

Former guidance counselor gets prison term for prescription ...

https://www.courierpostonline.com › news › 2021/12/20

11 hours ago — It said an administrator for the state plans paid the compounding pharmacy “over $50 million for compounded medications mailed to individuals in New Jersey.”.

FDA NEWS:

 

Fulfilling Essential Public Health Needs in 2022

The U.S. Food and Drug Administration’s response to the COVID-19 pandemic has brought the FDA’s critical public health role into sharper focus. The FDA’s public health mission, although most apparent during emergencies, is actually in operation every day of every year, protecting the American public from many threats. In the coming weeks we will release a report highlighting some of the agency’s key accomplishments over the past year and illustrating the FDA’s profound impact in protecting Americans’ health and safety. As we close out 2021, however, I want to offer some insight into the themes that will continue to guide our public health agenda as we move into 2022. First and foremost, public health and consumer protection activities will continue to be the primary focus of FDA regulatory and compliance actions. We’ve made great strides in this area, as demonstrated, for instance, by our recent guidance to begin lowering the sodium content of foods, or the actions we’ve taken to reduce exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels, and by limiting fruit and other flavored vaping products that can be so attractive to young people. Through our initiative, “The New Era of Smarter Food Safety,” we are bringing new tools to bear on the longstanding problem of foodborne illness. read more here

 

Four people sentenced to prison for roles in multimillion-dollar ...

https://www.irs.gov › compliance › criminal-investigation

19 hours ago — Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient.

 

Updated December 17, 2021

https://www.fda.gov › media › download

PDF

11 hours ago — Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by. Pharmacy Compounders not Registered as Outsourcing Facilities During the ..

 

12/14/2021	11/29/2021	Sanitor Corporation	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
12/14/2021	12/15/2021	Cooper Institute	Office of Biological Products Operations – Division 2	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
12/14/2021	11/23/2021	DeVilbiss Healthcare LLC	Office of Medical Device and Radiological Health Operations (Division 1)	Medical Device Reporting/Misbranded
12/14/2021	11/30/2021	Dental Technologies Inc.	Division of Pharmaceutical Quality Operations III	CGMP/QSR/Medical Devices/Adulterated
12/14/2021	10/22/2021	ITC Global Trading Inc.	Division of Southwest Imports Compliance Branch	Foreign Supplier Verification Program (FSVP)

 

Determination of estradiol and progesterone content in ...

https://journals.lww.com › oaks.journals › downloadpdf

7 hours ago — Some compounded drugs, including those used for HT, have been suspected of contamination and potency issues.5,6 US. FDA surveys conducted in 2001 and 2006, to ...

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  Safety assessment of compounded non-FDA-approved ...

  https://journals.lww.com › oaks.journals › downloadpdf

  7 hours ago — tific evidence supporting these claims is lacking. Compounded medications are not mass-produced commer- cially available drugs, but are retail only and sold ...

 

FDA Plans Rules On 503A Compounding, Product ...

https://insidehealthpolicy.com › daily-news › fda-plans-...

4 hours ago — FDA Plans Rules On 503A Compounding, Product Classification, Tobacco. By Beth Wang / December 13, 2021 at 6:38 PM. Share. FDA plans to issue a handful of ..

Pharmaceutical Manufacturers Pay Hundreds of Millions to Settle Price-Fixing Charges December 10, 2021 Skylar Kenney, Assistant Editor Pharmacy Times, December 2021, Volume 87, Issue 12

https://www.pharmacytimes.com/view/pharmaceutical-manufacturers-pay-hundreds-of-millions-to-settle-price-fixing-charges 

 

HOPE MEDICAL ENTERPRISES, INC. V. FAGRON ...

https://law.justia.com › cases › federal › appellate-courts

4 hours ago — HOPE MEDICAL ENTERPRISES, INC. V. FAGRON COMPOUNDING SERVICES, No. 21-55165 (9th Cir. 2021) case opinion from the US Court of Appeals for the Ninth Circuit.