Monday, November 29, 2021
Tuesday, November 23, 2021
Non-Resident Compounding Pharmacy Responsible Person ...
"Nov. 2, 2021: Update – In October 2020, FDA was sued by seven compounding pharmacies in the U.S. District Court for the District of Columbia regarding the final standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products. In September 2021, the Court remanded the MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. FDA is evaluating the Court’s decision.
Monday, November 22, 2021
Court Enjoins California Company from Manufacturing and Distributing Adulterated Sterile Animal Drugs
A federal court enjoined a California company from distributing adulterated sterile animal drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice announced.
In a complaint filed on Oct. 27, 2020 in the Central District of California, the United States alleged that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that Med-Pharmex Inc. (MPX) manufactured and distributed animal drugs under conditions that fell short of the minimum regulatory requirements to ensure safety and quality, including a failure to maintain sterility. According to the complaint, the FDA issued a warning letter to MPX in 2017 regarding numerous deficiencies found at the company. The complaint further alleged that the company failed to adequately investigate reports regarding the death or illness of animals receiving certain MPX drugs, and failed to properly clean and disinfect areas used to manufacture sterile drugs, as required by the FDCA. MPX and company president Gerald P. Macedo agreed to settle the suit and to be bound by a consent decree of permanent injunction that resolves the case.
Saturday, November 20, 2021
Thursday, November 18, 2021
Wedgewood Pharmacy Appoints Veterinary Advisory Board
California State Board of Pharmacy Intends to Enter the Food and Drug Administration’s Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products November 17, 2021 —
Tuesday, November 16, 2021
Investigations Newsletter: DOJ Files Complaint in AWP False ...
Wednesday, November 10, 2021