Saturday, March 31, 2018

FDA Study Reveals Presence of Pharmaceutical Drugs in Some dietary supplements

FDA Study Reveals Presence of Pharmaceutical Drugs in Some ...

WholeFoods Magazine-Mar 30, 2018
Washington, D.C. — A U.S. Food and Drug Administration (FDA) pilot study using portable screening devices has revealed the presence of pharmaceutical drugs in products marketed as dietary supplements. The FDA recently concluded a six-month pilot at two international mail facilities (IMFs) where the FDA monitors the ...

FDA shuts down New York supplement firm 30, 2018
In a consent decree entered in US District Court for the Eastern District of New York, a permanent injunction was filed against a company called Riddhi USA based in Ronkonkoma, NY and its owner Mohd M. Alam. The company, which is not currently manufacturing any dietary supplements, cannot resume unless and until ...

WADA strengthens anti-doping investigations

International Paralympic Committee-8 hours ago
Hosted by the Finnish Centre for Integrity in Sports (FINCIS), that country's National Anti-Doping Organisation (NADO), the meeting brought together representatives from 11 NADOs, two International Federations as well as representatives from Interpol and the World Anti-Doping Agency's (WADA's) Intelligence and ...

Ky. lawmakers delays recess to pass budget

Portsmouth Daily Times-12 hours ago
Senate Bill 6 would require a pharmacist to provide information about the safe disposal of certain prescription medicines, such as opiates and amphetamines. Terrorism. Senate Bill 57 would allow a person injured by an act of terrorism to file a claim for damages against the terrorist in state court. Police cameras. House Bill .

McKesson Advances Novel Argument to Avoid Opioid Liability

Bloomberg BNA-18 hours ago
Drug distributor McKesson Corp. says its $40 billion contract with the federal government to deliver pharmacy products—including opioids—should protect it from liability for the opioid epidemic. In papers filed in federal court, it says a prescription drug supply contract it signed with the Department of Veterans Affairs and the ...

AR Doctors Say It's Harder to Treat Patients Because Opioid Epidemic

KNWA-14 hours ago
If you've had surgery or have a disease like cancer, Bolding said opioids are very beneficial, but it can be trying for patients to continue taking the medicine prescribed to them. "We certainly have patients that need opioids to control their pain," said Bolding. Pharmacist Justin Boyd said insurance companies also play a part.

E-pharmacy Myra raises $1.84M from Tokyo firm

BSI bureau (press release)-3 hours ago
Bengaluru-based Metarain Software Solutions Pvt. Ltd, which runs online pharmacyapp Myra, has raised about Rs 12 crore ($1.84 million) in a fresh round. Tokyo-headquartered management consulting firm Dream Incubator led the round with an infusion of Rs 6.5 crore ($1 million), while existing investors Matrix Partners ..

Opposition to looming compounding practice changes

ModernMedicine-18 hours ago
Dr. Alam, who was among, the speakers at the “Pharmacy Compounding and the Dermatologist” session at the American Academy of Dermatology annual meeting in February, says two common and simple practices that dermatologists perform daily may be changing under new regulations. Dr. Alam. “One is the offi ce use ...

OIG Advisory Opinion 18-01: Excluded Individual May Serve as ...

JD Supra (press release)-Mar 30, 2018
In OIG Advisory Opinion 18-01, published February 27, 2018, the OIG concluded a proposed employment arrangement between an excluded individual and a for-profit company selling discounted emergency medications to long term care pharmaciesposed a "minimal risk" to federal health care program beneficiaries.

New Florida law approved to make prescription drug prices more

New Florida law approved to make prescription drug prices more ...

WKMG News 6 & ClickOrlando-13 hours ago
According to, in 2017 it was estimated that approximately 300,000,000 Americans currently have a PBM in some way managing their pharmacy benefits. There are more than a dozen PBM companies operating in the United States, but the three "Super PBMs" account for an estimated 80 percent of all ...

Pharmacy Owner Gets 13 Years For $4.3M Kickback Plot Law360-17 hours ago

Pharmacy Owner Gets 13 Years For $4.3M Kickback Plot

Law360-17 hours ago
Law360 (March 30, 2018, 7:37 PM EDT) -- The owner of an Orlando, Florida-area pharmacy was sentenced to more than 13 years in prison Friday after being convicted on charges stemming from his involvement in a kickback scheme that defrauded Tricare out of $4.3 million through claims for expensive prescription ...

Medication reviews being offered at nearly 400 Ohio pharmacies

The Columbus Dispatch-15 hours ago
To prevent medicine combinations that could lead to side-effects like dizziness, drowsiness and confusion, the state will offer free, confidential medicine reviews for older adults next week at more than 400 Ohio pharmacies. The goal is to minimize the risk of dangerous falls, according to a news release from the Ohio ...

Walmart's talks with an insurance giant tell you everything about ...

Business Insider-Mar 30, 2018
One of Walmart's biggest pharmacy competitors, CVS, is already trying to do this, working on a $69 billion takeover of the insurance giant Aetna. The logic of a Humana deal would be pretty much the same for Walmart: It's a way to gain more leverage over drugmakers and medical-device companies as costs rise, the ...

FDA moves to regulate medicines produced in bulk

ModernMedicine-20 hours ago
If approved, the new rule will steer physicians toward FDA-approved drugs that have met safety and effi cacy standards established in a clinical trials process. Raw substances used in compounded medications can still be used, but only after the prescribing physician has successfully established a clinical need that cannot .

Proposed USP General Chapter Pharmaceutical Compounding ...
22 hours ago - Compounding Standards. Sterile Compounding <797> · Nonsterile Compounding <795> · Safe Handling of Hazardous Drugs <800> · Other General Chapters · Compounded Preparations Monographs (CPMs) · CPM Donation Program · Bulk Substances · Expert Committee · Legal Recognition · Education & Implementation ...

Thursday, March 29, 2018

FDA Lays Out Test For Showing Clinical Need For Compounding From Bulks

Inside Health Policy · 3 hours ago

Must Watch and Read!! High Importance

Pharmacy owner tried to defraud insurance program out of more ...

Insurance Business-11 hours ago
He also owned a company called Apotheca Supply, which was licensed to relabel and repackage pharmaceuticals, and had a 20% stake in Medworx Sunflower, an affiliate of Mississippi pharmacy Medworx Compounding. Prosecutors said that between 2015 and 2016, Lemley and others conspired to defraud TRICARE, ..
Blue Cross and Blue Shield dissuades using opioids as primary pain treatment
The Blue Cross and Blue Shield Association has adopted a new standard that opioids should not be the first or second treatment options to manage pain, guidelines lauded by pharmaceutical experts.  READ MORE

Wednesday, March 28, 2018

Report: Opioid Drugs Dragged 1 Million Americans Out of the ...

Breitbart News-5 hours ago
Overall, roughly one-quarter of the 4 million Americans who quit the workforce were also entangled in drugs, says the AAF report, which does not offer any recommendations for fixing the drug-and-workforce problem. ... [27] Moreove

Pharmacy Owner Gets Prison for Plotting Health Care Fraud

U.S. News & World Report-6 hours ago
The owner of a compounding pharmacy who pleaded guilty to plotting to defraud a federal health insurance program out of more than $10 million has been sentenced ... Lemley owned a Decatur pharmacy operating as Southern Compounding, as well as Apotheca Supply and a 20 percent membership interest in Medworx ...

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

Products marketed as dietary supplements contained undisclosed active pharmaceutical ingredients
A federal court ordered a Florida-based company to stop selling drugs and dietary supplements until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. Continue reading.

David A. Rochefort, owner of Eastern States Compounding, said he is buying The Apothecary's assets, with the sale being finalized Friday. At that time, all customer records and files will be transferred to his company, and the pharmacy at 35 Main St. in Keene will close its doors after nearly 50 years in ...

Local pharmacy, lawmaker applaud passage of bill regulating ...

Mcrecordonline-20 minutes ago
“I would just say that it's wonderful,” she said recently at the pharmacy on North Gaskill. “The bill is wonderful for pharmacists and pharmacies across the whole nation. Arkansas is leading this fight. I'm very proud of the pharmacists in our state and our Arkansas Pharmacists Association for heading this up and doing all the

Sentencing continued for Bettendorf doctor in fraud case

Quad City Times-18 hours ago
Federal prosecutors say Bolger "knowingly and willingly" made false statements as he authorized prescription drugs and indicated the prescriptions were medically necessary. He signed ... Bolger authorized 1,375 prescriptions for compoundedmedications from March through April 2015 to a total of 432 patients. He issued .

Big Pharma's billion-dollar scramble to invest in start-ups to fuel ...

CNBC-1 hour ago
The worldwide prescription drug market is growing at 6.5% compounded annually and is expected to reach $1.06 trillion by 2022. Start-ups are driving pharma innovation, accounting for 63% of all new prescription drug approvals over the last five years, HBM Partners reports. Drug companies have established venture ...

Federal Register :: Agency Information Collection Activities ...
5 hours ago - FDA Response to Issue One: Under section 503B(d)(2), if a drug is not identical or nearly identical to an approved drug or a covered over-the-counter monograph (OTC) drug, and a component of the compounded drug is a bulk drug substance that is a component of an approved drug or a covered OTC drug, then the drug is ..

Federal Register :: Agency Information Collection Activities ...
5 hours ago - FDA Response to Issue One: Under section 503B(d)(2), if a drug is not identical or nearly identical to an approved drug or a covered over-the-counter monograph (OTC) drug, and a component of the compounded drug is a bulk drug substance that is a component of an approved drug or a covered OTC drug, then the drug is ..

Tuesday, March 27, 2018

Despite member's protest, board of pharmacy moves forward with ...

The Advocate-5 hours ago
GB Sciences operates a licensed cultivation center in Nevada and was selected last year to develop the LSU AgCenter's state-approved medical marijuana program. The state Board of Pharmacy is in the process of selecting pharmacies to dispense medical marijuana produced by LSU and Southern University AgCenter .

Decision on New Orleans marijuana pharmacy permit postponed ... hours ago
The Louisiana Pharmacy Board postponed awarding a permit for a medical marijuana pharmacy to operate in the metro New Orleans area during its meeting Tuesday (March 27) in Baton Rouge. Instead, the board took all of the applications, including two that are seeking to open dispensaries in Metairie, under advisement 

Battle over resuming California executions heads to court hours ago
The state regulations allow for buying the drugs from compounding pharmacies, but those businesses may have trouble importing the ingredients, said Ana Zamora, formerly an ACLU criminal justice policy director. Zamora also questioned how the state would guarantee the chemicals would be properly mixed, increasing

Meningitis outbreak trial: Defendants seek ban on patient harm ...

The Tennessean-6 hours ago
Citing the risk of unfair prejudice, nine remaining defendants in the deadly fungal meningitis criminal case are asking a federal judge to bar the use of any evidence of harm caused to victims of the 2012 outbreak that sickened nearly 800 patients, killing 76 of them. In a joint motion filed Tuesday in U.S. District Court in .

Decatur pharmacists sentenced for massive health care fraud

WAAY-1 hour ago
Lemley was accused of defrauding TRICARE, the U.S. Department of Defense's health care program, by improperly getting prescriptions referred to Southern Compounding, his pharmacy on Highway 31 in Decatur. He also was accused of selling misbranded over-the-counter medication as prescription drugs, prosecutors ...

Federal Register :: Request for Nominations for Voting Members on a ...
20 hours ago - The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (Committee), Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical,...

High Importance!

Department of Justice
U.S. Attorney’s Office
Northern District of Alabama

Tuesday, March 27, 2018

Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

BIRMINGHAM – A federal judge today sentenced the owner of a Decatur compounding pharmacy to five years in prison for conspiring to defraud a federal health insurance program out of more than $10 million. U.S. Attorney Jay E. Town, Food and Drug Administration, Office of Criminal Investigation, Miami Field Office, Special Agent in Charge Justin D. Green and Defense Criminal Investigative Service Special Agent in Charge John F. Khin announced the sentence.
U.S. District Judge R. David Proctor sentenced JOHN CHRISTOPHER LEMLEY, 51, of Decatur, for the health care fraud conspiracy and ordered him to forfeit nearly $1 million as proceeds of the crime. Most of that amount – $918,234 – already has been seized from bank accounts held by Lemley or his businesses, along with a 2015 Lexus Gx-460 Premium bought with criminal proceeds, according to court documents. The judge also ordered Lemley to pay $918,234 in restitution to the federal military health insurance program. Lemley pleaded guilty to the conspiracy charge in November. He must report to prison June 20.
“Every dollar stolen from TRICARE is a dollar that weakens our overall military posture and makes healthcare for our troops even more embattled,” Town said. “Whether $10 million or $10,000, those who intend to defraud the federal government, especially our DOD components, will be joining Mr. Lemley soon.”
“This sentencing, resulting from a complex and widespread investigation by DCIS and other law enforcement partners, is a strong warning to anyone who believes they can get away with conspiring and scheming to fleece the Defense Department's TRICARE system,” Khin said. “Fraud and corruption in our health care programs, especially involving deceptive practices with prescription medications, is far from a ‘victimless’ crime. This defendant selfishly put greed and personal gain before the safety and well-being of our military members, their families, and retirees, who deserve proper medications and the best care available.”
“U.S. consumers rely on the FDA to ensure they receive drugs which are safe, effective, and properly labeled,” Green said. “We remain fully committed to pursuing those individuals who endanger the public health by distributing misbranded products.” 
Lemley owned a Decatur pharmacy that operated as Southern Compounding. He also owned Apotheca Supply, which was licensed to relabel and repackage pharmaceutical drugs. Apotheca was located in a suite adjoining Southern Compounding on U.S. Highway 31 South. Lemley also had a 20 percent membership interest in Medworx Sunflower LLC, an affiliate of Medworx Compounding, a pharmacy in Ridgeland, Miss., according to the charges against Lemley and the government’s sentencing memorandum.
Between February 2015 to January 2016, Lemley conspired with others at Medworx Sunflower and Southern Compounding to defraud TRICARE, a U.S. Department of Defense health care program, as well as third-party prescription-drug program administrator Express Scripts Incorporated, according to the court documents. Southern Compounding submitted prescription reimbursement claims to TRICARE as part of ESI’s pharmacy network.
As part of the conspiracy, Lemley conducted the fraud by various means that included improperly contracting with Medworx Compounding to refer prescriptions to Southern Compounding. He also paid kickbacks to independent sales representatives as incentive to refer TRICARE prescriptions, sold misbranded over-the-counter medications as prescription drugs, and failed to reverse claims on prescriptions he knew were forged, according to court documents.
Although ESI’s regulations prohibited Southern Compounding from subcontracting any of its work, Southern entered a management agreement with Medworx in early 2015 whereby Medworx referred prescriptions to Southern Compounding. Southern filled the prescriptions, billed third-party administrators for them and sent almost all the payments received to Medworx. Medworx then returned a portion of those payments directly to Lemley. The amount returned totaled $918,234, representing a distribution for Lemley’s 20 percent membership interest in the Medworx affiliate, Medworx Sunflower.
Southern Compounding’s billings to TRICARE soared in the two months after Southern entered its agreement with Medworx, according to court documents. In the 13 months prior to the agreement, TRICARE paid claims of about $215,561 to Southern. In the two months following the February 2015 agreement, TRICARE, through ESI, paid about $10.5 million in claims to Southern. More than 90 percent of that was profit.
In accordance with Southern’s management agreement with Medworx, Lemley transferred most of the money – about $10.2 million – to Medworx. Most of the transferred money was to fund kickbacks to the independent sales representatives, according court documents.
            FDA-OCI and DCIS investigated the case, which Assistant U.S. Attorney Chinelo Dike-Minor prosecuted.
Updated March 27, 2018

Decatur compounding pharmacy owner gets 5 years in prison for health care fraud · 6 hours ago

Decatur compounding pharmacy owner gets 5 years in prison for health care fraud · 6 hours ago
The FDA is alerting pet owners and veterinary professionals about the recall of certain Milo’s Kitchen pet treats after FDA testing found thyroid hormones in products eaten by four dogs that showed symptoms of hyperthyroidism, a disease that is rare in dogs.

The FDA’s evaluation of the test results of Milo’s Kitchen treat samples indicates that the treats contain thyroid hormones in substantial amounts. Consuming these treats can trigger hyperthyroidism in dogs. Hyperthyroidism caused by pet food or treats is generally reversible if the dog stops eating the product containing thyroid hormones, but prolonged consumption may result in permanent heart damage and death.

Read entire article.

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