FDA Publishes New Draft Guidance On Animal Drug ...

www.mondaq.com › unitedstates › food+drugs+law › FDA+Publishes+Ne...

16 hours ago - For example, if compounding with bulk substances pursuant to patient-specific prescriptions for nonfood-producing animals, FDA is stating that the drug should be compounded in accordance with applicable United States Pharmacope

Chapter 480-11. PHARMACEUTICAL COMPOUNDING

rules.sos.state.ga.us › gac

4 days ago - (25), "Pharmacy" means any place licensed in accordance with the laws and rules of this state wherein the possessing, displaying, compounding, dispensing, ...

Adverse Drug Events | JAMA Network

https://jamanetwork.com › collections › adverse-drug-events

7 hours ago - This Viewpoint examines the weak points in adverse event reporting requirements for producers of compounded drugs and offers solutions to improve adver

Federal Prosecutors Launch Criminal Probe of Opioid Makers, Distributors

Federal Prosecutors Launch Criminal Probe of Opioid ... - wsj.com

www.wsj.com/articles/federal-prosecutors-launch...

Federal Prosecutors Launch Criminal Probe of Opioid Makers, Distributors Authorities are using a criminal law more commonly used against drug dealers in pr

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health Clinic had significant donor eligibility violations, including donor screening and testing

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Clinic had significant donor eligibility violations, including donor screening and testing

The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis. “Patients use fertility clinics to help them become parents and they rely on these clinics to follow the appropriate regulatory requirements for screening and testing of donors of reproductive tissue. Patients should not have to worry about being at risk or becoming infected with a ...

States prepare Rx importation plans after Trump assurances

States prepare Rx importation plans after Trump assurances

State officials are moving forward with prescription-drug importation programs on President Donald Trump's repeated assurances that he wants to give states the authority to import drugs from Canada.

Amazon taps first pharmacy for Alexa Rx management JESSICA KIM COHEN

https://www.modernhealthcare.com/patients/amazon-taps-first-pharmacy-alexa-rx-management

Congressional Committee Takes Historic Step Toward Decriminalizing Marijuana McDermott Will & Emery

https://www.lexology.com/library/detail.aspx?g=884fc9c4-9368-465d-bfb3-b216b84120c3

The Most Common Pharmacy Penalties

https://www.drugtopics.com/latest/most-common-pharmacy-penalties

Costly claims against pharmacists rising: 8 things to know Maia Anderson - an hour ago

https://www.beckershospitalreview.com/pharmacy/costly-claims-against-pharmacists-rising-8-things-to-know.html

FDA's Bark May Be Worse Than Its Bite: Revised Guidance

FDA's Bark May Be Worse Than Its Bite: Revised Guidance ...

https://www.lexology.com › library › detail

19 hours ago - On November 19, 2019, the U.S. Food and Drug Administration (FDA) released revised guidance concerning the compounding of animal drugs from bulk drug ...

11/25/2019	11/22/2019	Sabai Ventures Ltd	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Organix Industries, Inc. dba Plant Organix	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Daddy Burt Hemp Co	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Apex Hemp Oil LLC	Center for Veterinary Medicine	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Red Pill Medical Inc.	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	CDRL Nutritional, Inc.	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Private I Salon, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Natural Native LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Unapproved New Drugs/Misbranded/Cannabidiol

11/25/2019	11/22/2019	KOI CBD LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Whole Leaf Organics, LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Mr. Pink Collections, LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Infinite Product Company LLLP DBA Infinite CBD	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Sunflora, Inc./The CBD Store, LLC dba Your CBD Store	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Bella Rose Labs	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/25/2019	11/22/2019	Noli Oil, LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

11/26/2019

11/18/2019

EPH Technologies, Inc.

Center for Drug Evaluation and Research | CDER

Unapproved New Drugs/Misbranded

11/26/2019

09/10/2019

Lohxa LLC

Division of Pharmaceutical Quality Operations I

CGMP/Finished Pharmaceuticals/Adulterated

Production at Teva API plant halted until next year

Production at Teva API plant halted until next year

Tuesday, November 26, 2019

Teva Pharmaceuticals is having issues with its API plant in Italy serious enough that it has had to stop production. 

European 'Brain-Boosting' Drug Pushed as Supplement in U.S. — Study finds FDA-rejected supplement can deliver doses high above EU-approved range by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today November 25, 2019

https://www.medpagetoday.com/neurology/generalneurology/83558?xid=nl_medpageexclusive_2019-11-26&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MPTexclusives_112619&utm_term=NL_Gen_Int_Medpage_Exclusives_Active

Searching for a killer: Inside the CDC’s scramble to solve a mysterious vaping disease

https://www.washingtonpost.com/health/2019/11/25/searching-killer-inside-cdcs-scramble-solve-mysterious-vaping-disease/

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks. “As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to ...

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Department of Justice

U.S. Attorney’s Office

Southern District of Mississippi

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FOR IMMEDIATE RELEASE

Friday, November 22, 2019

Nurse Pleads Guilty to Mail Fraud in Connection with Compound Pharmacy Fraud Scheme

Jackson, Miss. –   Fallon Deneem Page, 37, of Hattiesburg, pled guilty yesterday before Senior U.S. District Judge Keith Starrett to mail fraud in connection with a compound pharmacy fraud scheme, announced U.S. Attorney Mike Hurst and Special Agent in Charge Michelle Sutphin with the Federal Bureau of Investigation in Mississippi.   

In October 2014, Page, a registered nurse, received $100 for each patient she referred to Medical Solutions of Ocean Springs, a company owned and operated by Dr. Shahajan Sultan.  Each patient had to have health insurance benefits that would cover the cost of expensive compound medications manufactured and dispensed by a pharmacy located in Jackson County, Mississippi.  If the patient was covered by health insurance, Page and others performed cursory medical examinations, sometimes in public locations such as parking lots, playgrounds, and gas stations.  During the short assessments, the patients were prescribed expensive compound medications and their insurance companies were billed.

On October 23, 2014, Page provided a patient’s health insurance information to Medical Solutions of Ocean Springs and/or the pharmacy in Jackson County.  The patient actually never had a consultation with the doctor.  As a result of Page providing the information, the pharmacy shipped via Federal Express the compound medications.  Page admitted to knowing there was no medical necessity for the expensive prescriptions, and she further admitted that she knew by submitting the claim, the health insurance company would pay.  In total, the insurance company reimbursed the pharmacy for the October 23, 2014, prescriptions approximately $34,047.00.

Page will be sentenced by Judge Starrett on February 26, 2020, and faces a maximum penalty of 20 years in prison and a $250,000 fine.

The case was investigated by the FBI and the Department of Defense Criminal Investigative Service.  Assistant Chief Dustin M. Davis and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Kathlyn R. Van Buskirk prosecuted the case.

Topic(s): 

Health Care Fraud

Component(s): 

USAO - Mississippi, Southern

Updated November 22, 2019

Hattiesburg nurse pleads guilty for role in compounding pharmacy fraud scheme

https://www.wlox.com/2019/11/23/hattiesburg-nurse-pleads-guilty-role-pharmacy-fraud-scheme/

Statement from Acting FDA Commissioner Adm. Brett P. Giroir, M.D., on efforts to help make development of biosimilar and interchangeable insulin products more efficient

Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness. And consistent, lifelong access to insulin is imperative to patient survival and quality of life. However, we are aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products. This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products. The FDA is committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice. This includes facilitating the development of safe and effective insulin products for the treatment of patients with Type 1 and Type 2 diabetes, including products that are biosimilar to...

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FDA In Brief: FDA explains policy for manufacturers of battery-operated tobacco products and e-liquids who are considering making limited safety-related modifications to their products

Today, the U.S. Food and Drug Administration issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out the FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications. On Aug. 8, 2016, all e-cigarettes and other electronic nicotine delivery systems (ENDS) products became subject to...

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3 more plead guilty in Mississippi health care fraud - Hattiesburg

https://www.hattiesburgamerican.com › story › news › crime › 2019/11/21

10 hours ago - Two doctors and a nurse pleaded guilty in federal court to health care and mail fraud in a scheme to bilk millions through pricey pills and creams.

Department of Justice

U.S. Attorney’s Office

Southern District of Mississippi

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FOR IMMEDIATE RELEASE

Thursday, November 21, 2019

Two Doctors Plead Guilty to Conspiracy to Commit Health Care Fraud in Compound Fraud Scheme

Hattiesburg, Miss. – Shahjahan Sultan, M.D., 37 of Madison, Mississippi and Thomas Edward Sturdavant, M.D., 56, of Kingsport, Tennessee, pled guilty today before Senior U.S. District Judge Keith Starrett to conspiring to commit health care fraud, announced U.S. Attorney Mike Hurst and Special Agent in Charge Michelle Sutphin with the Federal Bureau of Investigation in Mississippi. 

“These doctors violated their oaths and harmed our military, our veterans, and every American taxpayer by defrauding TRICARE. I want to commend our law enforcement partners, DOJ trial attorneys, and our federal prosecutors for bringing these criminals to justice.  We will continue to aggressively pursue criminals who pilfer our national treasury and do all that we can to protect victims of these crimes,” said U.S. Attorney Hurst.

In May 2014, Sultan entered into a contract with a pharmacy located in Jackson County, Mississippi.  Pursuant to the contract, Sultan agreed to prescribe expensive compound medications to individuals in exchange for the pharmacy paying Sultan 35% of the reimbursements it received for the prescriptions.  Health care benefit programs, including TRICARE, were billed for the compounded medications. 

Sultan employed others who identified individuals in places like Jones County, Mississippi, who had insurance which covered the expensive compounded medications.  Sultan met with the insured individuals over telemedicine video-chat sessions.  However, during the meetings, he did not perform thorough examinations of the individuals and did not determine the medical necessity of the compounded medications he prescribed. Sultan knew that some of the added ingredients in the compounded medication were not effective and were added solely to increase the reimbursement value.  On occasion, Sultan and Sturdavant even called in compounded medications for individuals they had never previously examined.  

Sultan hired Sturdavant in September 2014 and agreed to pay him $900,000 annually to perform telemedicine services and to prescribe the compounded medications dispensed by the pharmacy.  From May 2014 through October 2014, health care benefit programs, including TRICARE, reimbursed the pharmacy more than $5,000,000 based on claims submitted by the pharmacy in connection with the expensive compounded medications ordered by Sultan and Sturdavant.

Sultan and Sturdavant will be sentenced by Judge Starrett on February 26, 2020 in Hattiesburg.  They each face a maximum penalty of 10 years in prison, 3 years of supervised release, and a $250,000 fine.

The case was investigated by the FBI and DCIS.  Assistant Chief Dustin M. Davis and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Kathlyn R. Van Buskirk of the Southern District of Mississippi prosecuted the case.

Component(s): 

USAO - Mississippi, Southern