Supreme Court sides with doctors convicted of overprescribing opioids (msn.com)
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, June 27, 2022
Friday, June 24, 2022
Oklahoma Board of Pharmacy Request
Pharmacy Closing When Normally Open
The Oklahoma State Board of Pharmacy (OSBP) is requesting that pharmacies contact OSBP via email when the pharmacy is closing during normal business hours, and patients would expect the pharmacy to be open.
The OSBP needs the pharmacy to email the following information within 24 hours of closure to pharmacy@pharmacy.ok.gov:
- License number of the pharmacy.
- Name of the pharmacy.
- Address of the pharmacy.
- Name of the Pharmacist in charge (PIC).
- Date(s) that the pharmacy will be closed.
- Hours the pharmacy will be closed.
- Detailed explanation for closing.
Saturday, June 18, 2022
Wednesday, June 15, 2022
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, June 13, 2022
District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA
A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce. According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Compounding pharmacies must ensure that their products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance. “While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”
The defendants did not admit or deny the allegations in the government’s complaint, but agreed to settle the suit and be bound by a consent decree of permanent injunction. The consent decree requires, among other things, that the defendants stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to the FDA that they will comply with federal law. Judge Chief Judge Geoffrey W. Crawford of the U.S. District Court for the District of Vermont entered the order against the defendants.
The government was represented by Trial Attorney David G. Crockett of the Civil Division’s Consumer Protection Branch, with the assistance of Claudia Zuckerman of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Vermont provided valuable assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
Topic(s):
Consumer Protection
Component(s):
Press Release Number:
22-623
Updated June 13, 202
| Equine Podiatry Solutions, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Hybrid Pharma, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products | ||||
| Smitha C. Reddy, M.D./ACRC Studies, LLC | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
Tuesday, June 14, 2022
Oracle EHR database plan prompts skepticism from health IT experts |
While a national medical records database could prove useful, health IT experts question whether Oracle's plan will run into the same roadblocks the industry has seen the past decade. |
| READ MORE > |
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Warning from Oklahoma Board of Pharmacy
Fraudulent Rx’s for Promethazine with Codeine
Please be aware that there has been a rash of fraudulent prescriptions for Promethazine with Codeine lately.
These fraudulent prescriptions are being faxed in and are not being faxed on the official OBNDD prescription blanks.
These fraudulent prescriptions are also being phoned in as emergency prescriptions.
Several of these fraudulent prescriptions are submitted for a diagnosis of COVID.
These prescriptions may be accompanied by NON-CDS prescriptions in an attempt to make them appear legitimate.
OBNDD wants to remind all pharmacies and pharmacists that a faxed CDS prescription that is not faxed on the official OBNDD prescription blank is not a valid prescription.
Please fax all information regarding suspected forgeries to OBNDD at 405-524-7619 with “Attention Agent Martinez” on the coversheet.
Wednesday, June 8, 2022
Must Read Regarding testimony and details of compounded drug fraud
2 days ago — According to the U.S. Food and Drug Administration, drug compounding is the process of combining, mixing, or altering ingredients to create a medication ...
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter |
|---|---|---|---|---|---|---|
| Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Chrimar Enterprises LLC d/b/a VapeGeek | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Hainan Golden Spring Foods Co. Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Zhoushan Haichang Co. Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Valley View Milling LLC | Office of Human and Animal Food- West Division II | CGMP/Medicated Feeds/Adulterated | ||||
| BonZer BrandZ LLC d/b/a BonZer VapeZ, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Aire-Master of America, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Zerocig dba Aristo Electronic Cigars | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Thursday, June 2, 2022
FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals
Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume.
“Dietary supplements can be valuable to your health but taking some supplements can also involve health risks. It’s important for consumers to have a comprehensive understanding about dietary supplements as well as the ability to identify and safely use supplements that are beneficial to their health,” said Douglas Stearn, Deputy Director for Regulatory Affairs in the FDA’s Center for Food Safety and Applied Nutrition. “These Supplement Your Knowledge resources will help provide consumers and healthcare professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”
Every day, millions of Americans take dietary supplements for a variety of reasons, whether recommended by their healthcare professional or on their own. Some supplements can help consumers meet their daily requirements of essential nutrients or help improve or maintain their overall health. But dietary supplements may also come with health risks, so it’s important to stay informed. As part of the FDA’s ongoing efforts to build awareness around dietary supplements, Supplement Your Knowledge includes the following materials:
- For consumers: Public education videos and fact sheets with important information about dietary supplements, including how they are regulated and potential benefits and risks. These materials are also a helpful resource when talking to a physician, nurse, dietitian, pharmacist, or other healthcare professional before taking a dietary supplement.
- For educators: Teenagers can be particularly vulnerable targets for misunderstanding what dietary supplements are, and they are often unaware of the potential benefits and adverse effects dietary supplements can have on their bodies. To help high school students evaluate the accuracy and credibility of information they may see and hear about dietary supplements, the FDA has developed Science and Our Food Supply: Examining Dietary Supplements (2021 Edition). This curriculum aligns with current national education standards and supports educators seeking Science, Technology, Engineering, and Mathematics (STEM) activities for their classrooms. This curriculum can be customized to science, health, and other related classes.
- For healthcare professionals: The FDA, in collaboration with the American Medical Association (AMA), has developed a continuing medical education (CME) program to help physicians and other healthcare professionals understand how dietary supplements are regulated, provide information to patients on their use, and recognize and report adverse events to the FDA. This free CME program includes three videos and companion education materials and is available on the FDA’s Healthcare Professionals website. Interested physicians can also access these materials at no cost and earn 1 AMA PRA Category 1 Credit on the AMA Ed HubExternal Link Disclaimer.
The FDA advises consumers to talk to their doctor, pharmacist, or other healthcare professional before deciding to purchase or use any dietary supplement. One reason for this recommendation is because some supplements might interact with medicines or other supplements. If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their healthcare professional. The FDA also encourages consumers and healthcare professionals to report adverse reactions associated with FDA-regulated products to the agency using the Safety Reporting Portal.
Public health and safety regarding dietary supplement use are matters of great importance to the FDA. Supplement Your Knowledge is part of the agency’s plan of action to arm individuals with helpful information to make informed decisions about the use of dietary supplements. Help spread the word about this important initiative by using the FDA’s Dietary Supplements Social Media Toolkit and find additional information on dietary supplements at www.fda.gov/
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