06/13/2023

05/22/2023

Carolina Infusion

Division of Pharmaceutical Quality Operations II

Compounding Pharmacy/Adulterated Drug Products

 

06/20/2023	06/12/2023	Vitang Technology LLC	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
06/20/2023	06/12/2023	Warrior Labz SARMS	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
06/20/2023	06/14/2023	Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.	Center for Drug Evaluation and Research | CDER	Clinical Investigator (Sponsor)
06/20/2023	06/09/2023	Juice Man LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
06/16/2023	06/15/2023	Mid Cities Vapor LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
06/13/2023	06/01/2023	A&Z Pharmaceutical, Inc.	Division of Human and Animal Food Operations East I	New Drug/Misbranded

Department of Justice: Midwest Veterinary Supply Sentenced for Misbranding Veterinary Drugs Company Will Pay More Than $11 Million in Fines and Forfeiture

 

Department of Justice: Midwest Veterinary Supply Sentenced for Misbranding Veterinary Drugs

Company Will Pay More Than $11 Million in Fines and Forfeiture

ABINGDON, Va. – Midwest Veterinary Supply (Midwest), a Minnesota-based company that supplies prescription drugs for animals to veterinarians, farms, feedlots, and other businesses, was sentenced today to one year of probation for introducing misbranded drugs into interstate commerce. In addition, Midwest Veterinary Supply agreed to pay over $ 11 million in criminal fines and forfeiture.

“This case is an example of how seriously the United States Attorney’s Office takes the distribution of misbranded prescription drugs, whether for human or animal consumption,” United States Attorney Christopher R. Kavanaugh said today. “The law is designed to ensure that prescription drugs are kept within a controlled chain of distribution to prevent diversion and inappropriate use, and companies must be held accountable when they go outside of that chain. I am grateful for the work of the FDA and Virginia State Police in bringing justice in this case and their continued work keeping our prescription drug programs here in Virginia safe for all.”

 

• On Tuesday, the FDA posted information about medications containing semaglutide marketed for type 2 diabetes or weight loss. There are currently three FDA-approved semaglutide products which are only available with a prescription. Due to two of the drugs being in shortage, these two drugs are able to be compounded if they meet certain requirements in the Federal Food, Drug, and Cosmetic Act. The FDA has received adverse event reports after patients used compounded semaglutide. The FDA has also received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which have not been shown to be safe or effective. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA.

FDA Newsroom

 

FDA issues warning about some compounded versions of ...

CNN.com

https://www.cnn.com › fda-compounding-semaglutide

1 day ago — FDA issues warning about some compounded versions of semaglutide for diabetes, weight loss ... “Compounding includes the combining of two or more drugs.”.

 

05/23/2023	05/18/2023	Champaklal Maganlal Homeo Pharmacy Private Limited	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
05/23/2023	04/25/2023	Krishiv Foods, LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
05/23/2023	05/12/2023	H.E.A.L. Marketplace	Division of Human and Animal Food Operations East III	New Drug/Misbranded
05/23/2023	03/24/2023	Sure-Biochem Laboratories, LLC	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated

 

05/30/2023	05/16/2023	New England Life Care, Inc. dba Advanced Compounding Solutions	Division of Pharmaceutical Quality Operations I	Compounding Pharmacy/Adulterated Drug Products
05/30/2023	05/22/2023	citypharma.us	Center for Drug Evaluation and Research | CDER	Unlawful Sale of Unapproved and Misbranded Drugs to United Sta

FDA Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss

 What is semaglutide?

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

There are currently three FDA-approved semaglutide products:

• Ozempic injection and Rybelsus tablets are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.
• Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight), who also have weight-related medical problems, to lose weight and keep the weight off, in addition to diet and exercise.

All three medications are only available with a prescription, and there are no approved generic versions.

What is compounding?

Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.

Can semaglutide be compounded?

When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.

Are there concerns with compounded semaglutide?

FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.

Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded. On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products.

What should patients know?

Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.

Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.

Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards. If you choose to use an online pharmacy, FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.

What should health care professionals know?

Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.

Reporting issues to the FDA

FDA encourages health care professionals, patients, and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

quoted from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss

FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy

 FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy

 

FDA and European Union Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs

The U.S. Food and Drug Administration (FDA) and the European Union (EU) are announcing today their decision to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals (also called “animal drugs”). This MRA entered into force on November 1, 2017, but initially included only pharmaceuticals intended for human use. Today’s action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and EU regulatory systems.

An MRA is an agreement between two or more countries to recognize a specific process or procedure of the other country, and this is the first step toward strengthening use of each other’s animal drug inspection expertise and resources. The overall goal of the MRA is to produce greater efficiencies for both regulatory systems and provide a more practical means for both the FDA and the EU to oversee the facilities that manufacture animal drugs. By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and the EU to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas where there may be greater risk.