Wednesday, February 20, 2019

House of pain: Feds detail alleged 'pill mill' scheme at Warren pain ...

The Detroit News-25 minutes ago
Warren — Pain pill scalpers roamed the parking lot at a Macomb County clinic embroiled in one of the nation's largest health care fraud cases, chugging booze, 

Judge: Convicted pharmacist Kim Jones must stay in jail pending ...

The News Journal-12 hours ago
A federal judge has denied a Williamsburg pharmacist's request to be released from jail as she awaits sentencing on charges of unlawfully dispensing controlled

Kentucky Medicaid releases report on pharmacy benefit program

Ohio County Monitor-18 hours ago
Get full access to the Ohio County Monitor and support quality local journalism with a $5 monthly subscription, or SAVE with a longer subscription. It costs less

Ohio AG says state owed $15.8M from pharmacy benefit manager

Dayton Daily News-18 hours ago
The Ohio Attorney General is arguing the state is owed $15.8 million from a company that manages pharmacy benefits for Ohio Bureau of Workers' ...

Hope Thomley pleads guilty in compounding pharmacy fraud scheme



Mississippi woman pleads guilty in massive pharmacy fraud

Minneapolis Star Tribune-3 hours ago
Prosecutors have said Advantage Pharmacy, partly owned by Hope Thomley, took in $192 million in revenue from TRICARE alone over several years.

Welch unveils legislation to allow importation of cheap insulin from ...

vtdigger.org-2 hours ago
... the importation of insulin from countries like Canada, where the drug comes at a ... The problem is compounded, he said, with the middlemen — the insurance ..

United States: DOJ Expands New Enforcement Tactic – Obtains TRO ...

Mondaq News Alerts-19 hours ago
"Pharmacies and pharmacists have a legal obligation to dispense controlled substances properly, so as not to put patients' health at risk," said Assistant Attorney .

Attorney General Dave Yost seeks $16 million repayment from ...

The Columbus Dispatch-19 hours ago
After nearly a year of investigating, Ohio is taking its first steps to recover money from pharmacy middlemen who do billions of dollars worth of business with state

Report cracks open 'black box' of Kentucky's Medicaid pharmacy system

Courier Journal-7 hours ago
FRANKFORT — A long-awaited state report appears to confirm legislators' suspicions that industry middlemen, known as pharmacy benefit managers, are ...

FDA Milestones

Quality Digest-14 hours ago
Requires drug wholesalers to be licensed by the states; restricts reimportation ... more authority to regulate and monitor the manufacturing of compounded drugs.

BakerHostetler FDA and Pharmacy Weekly Digest - February 19, 2019

Lexology-1 hour ago
FDA Finalizes Compounding Rule – The FDA announced the finalized rule setting out six bulk drug substances that can be compounded and four that cannot be .

Tulsa doctor pays fine for alleged kickback scheme

KRMG-4 hours ago
TULSA - Federal prosecutors in Tulsa say a physician will pay the government nearly $85,000 to settle allegations he was involved in a kickback scheme.

Express Scripts seeking $20 million won in court judgment against compounding pharmacy

Express Scripts seeking $20 million won in court judgment against ...

STLtoday.com-10 hours ago
ST. LOUIS • A compounding pharmacy that sued Express Scripts more than four years ago has paid nearly $367,000 in attorney's fees and costs for misconduct, 

Sarasota pharmacy pays $775000 to settle kickback claims

Sarasota Herald-Tribune-10 hours ago
The owners of a Sarasota compounding pharmacy will pay at least $775,000 to resolve claims that they engaged in an illegal kickback scheme. The U.S. 

Oklahoma doctor to pay $84666 in alleged kickback scheme

KTUL-12 hours ago
Shores says the settlement resulted from an investigation into health care providers who wrote prescriptions for pain creams compounded and sold by OK ...
02/11/2019Bella Pharmaceuticals, Inc.Detroit District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
02/11/2019United PharmacyDallas District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
01/29/2019Hangzhou SunKing Nonwovens Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
1/29/2019Vipor Chemicals Private Ltd.Center for Drug Evaluation and ResearchVipor Chemicals Private Ltd., CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *

Monday, February 18, 2019

Pharmacy reprimanded over opioid prescriptions

Northern Virginia Daily-18 hours ago
The Virginia Board of Pharmacy recently reprimanded a Front Royal pharmacy for what the board stated was a failure “to take appropriate steps to determine the ...

Sarasota pharmacy owners agree to pay $775,000 settlement

Sarasota pharmacy owners agree to pay $775,000 settlement: A Sarasota pharmacy and its owners are out at least $775,000 to settle a federal lawsuit.

New Hazardous Waste Pharmaceuticals Rule: Significant Changes ...

JD Supra (press release)-Feb 14, 2019
Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; ... drugs;; Homeopathic drugs;; Compounded drugs;; Investigational new drug

Two Top Pharmakon Compliance Faced Criminal Conspiracy Charges

Two Top Pharmakon Compliance Faced Criminal Conspiracy Charges

Stocks Beat-Feb 13, 2019
These drugs, essentially, could be as much as 25 percent stronger than they ... least one Pharmakon employee to backdate batch records of compounded drug

FDA Final Rule Refines 503A Bulks List

Pharmacy Practice News-Feb 15, 2019
The FDA issued a final rule under section 503A of the Federal Food, Drug, and ... that compounders can use to compound drugs, known as the 503A bulks list,” 

AVMA teaches advocacy in symposium

American Veterinary Medical Association-Feb 13, 2019
Leaders of the NYSVMS have drafted, for example, legislation that would let members keep office stocks of compounded drugs. Dr. Wylegala also said she also ...

ATTORNEY'S OFFICE OF FLORIDA: Florida Compounding Pharmacy ...

Florida Record-13 hours ago
ATTORNEY'S OFFICE OF FLORIDA: Florida Compounding Pharmacy And Its Owners To Pay At Least $775,000 To Resolve False Claims Act Allegations.

Pharmacy compounding of patented medicines in the Netherlands

Lexology-8 hours ago
The pharmacy exemption came into force on 1 February 2019. In many other European countries (such as Germany, France and the UK), pharmacists were

Friday, February 15, 2019

Texas Proposed Legislation

In Texas, a bill, supported by the Texas Nurse Practitioners, has been introduced that would allow advanced practice nurses to practice with full authority - HB 1792. See more at

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients. 

We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. In doing so, we know that various factors may influence a manufacturer’s decision to develop and market a generic drug. For example, some drugs may not attract a high level of interest if there is a limited market for them. We also know that some drugs may ...


FDA advances new efforts to promote development of safe and effective regenerative medicine products

Today, the FDA finalized two guidance documents regarding regenerative medicine therapies. Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.

The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation andAccelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.  

Very High Importance!! FDA In Brief: FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use


Today, the U.S. Food and Drug Administration issued a final rule under section 503A of the Federal Food Drug and Cosmetic Act, placing, for the first time, six bulk drug substances on the list of substances that compounders can use to compound drugs, known as the 503A bulks list. This rule also identifies four bulk drug substances that are not included on the 503A bulks list, and therefore cannot be used in compounding under section 503A. The rule establishes the criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. These criteria include the physical and chemical characterization of the substance, safety issues raised by use of the substance in compounded drug products, evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance and historical use of ...



Wednesday, February 13, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. One of the fundamental elements of overseeing the quality and safety of pharmaceuticals is having a clear understanding of the specific processes and technologies used to manufacture drugs throughout their lifecycle. This starts before a product is even approved and brought to market, with the FDA’s premarket (or preapproval) review of drug applications. This includes a careful review of information about product and manufacturing quality, as well as, in many cases, premarket inspections of a company’s intended manufacturing facility to ...



Tuesday, February 12, 2019

Must Watch!! Dozens say they lost eyesight after routine surgery using compounded medications


Dozens say they lost eyesight after routine surgery using compounded ...

NewsWest9.com-16 hours ago
DALLAS — Curtis Cosby went in for what he believed was routine cataract surgery, but days after, he soon realized something had gone terribly wrong
14 hours ago - Drug compounding is often regarded as 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.
02/07/2019McKesson Corporation HeadquartersOffice of Regulatory AffairsDrug Product/AdulteratedNot Issued *
02/05/2019Capris Associates Inc. / BR NaturalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Emmbros Overseas Lifestyle PVT LTD.Center for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Gold Crown Natural ProductsCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Peak Nootropics LLC (aka Advanced Nootropics)Center for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019DK VitaminsCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued 
02/05/2019Blue Ridge SilverCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Nutrition Coalition IncCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019John Gray’s Mars Venus LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019TEK NaturalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Earth Turns, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Pure Nootropics, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *
02/05/2019Sovereign Laboratories, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued