• Today, the FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.

 

247 CMR 17.00 - STERILE COMPOUNDING Section 17.01

https://www.mass.gov › doc › download

7 days ago — (2) A pharmacy shall have a dedicated changing area for sterile compounding personnel. Commented [CM(1]: Board discussion. Page 3. 247 CMR BOARD OF ..

 

01/17/2023	01/10/2023	HIS Enterprise Inc dba Adam’s Secret USA, LLC	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/17/2023	12/13/2022	Optum Infusion Services 308 LLC	Division of Pharmaceutical Quality Operations IV	Compounding Pharmacy/Adulterated Drug Products

IV Hydration Clinics: Are Your Therapies FDA Compliant?

https://www.jdsupra.com/legalnews/iv-hydration-clinics-are-your-therapies-6343697/ 

Three Death Row Inmates File Lawsuit against Texas for Planning to Use Expired Execution Drugs in Upcoming Executions Posted by Gracyann JoslinDate: January 05, 2023

https://www.davisvanguard.org/2023/01/three-death-row-inmates-file-lawsuit-against-texas-for-planning-to-use-expired-execution-drugs-in-upcoming-executions/ 

Judge rules against expired compounding drugs Brenda Poe, Editor Jan 10, 2023

https://www.itemonline.com/news/city_of_huntsville/judge-rules-against-expired-drugs/article_5388d5ca-9135-11ed-8a74-1fe2a55f187d.html 

FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices Regulatory News Regulatory News | 11 January 2023 | By Joanne S. Eglovitch

https://www.raps.org/news-and-articles/news-articles/2023/1/fda-cites-sun-pharma-with-litany-of-gmp-violations 

US Pharmacy Groups Ask FDA To Allow Compounding OTC Pain Relief Doses 10 Jan 2023 NEWS

https://hbw.pharmaintelligence.informa.com/RS153255/US-Pharmacy-Groups-Ask-FDA-To-Allow-Compounding-OTC-Pain-Relief-Doses 

 

01/06/2023

01/05/2023

PharmaCanna

Center for Drug Evaluation and Research | CDER

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

 

01/11/2023	01/10/2023	Purecraft LLC	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/11/2023	01/10/2023	Medical Mikes, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/10/2023	12/07/2022	San-Rey Produce Inc.	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
01/10/2023	12/15/2022	Sun Pharmaceutical Industries Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
01/10/2023	11/22/2022	Florida Gold Foods LLC	Division of Human and Animal Food Operations East IV	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
01/10/2023	12/20/2022	Auto-Chlor System LLC	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
01/10/2023	11/02/2022	Aizu Olympus Co., Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
01/10/2023	12/12/2022	Olympus Medical Systems Corporation	Center for Devices and Radiological Health	Medical Device Reporting/Misbranded
01/10/2023	01/09/2023	Distributor RFR, LLC	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/10/2023	01/06/2023	pharmahealthonline.com	Center for Drug Evaluation and Research | CDER	Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet