The Law of Compounding Medications And Drugs

Monday, July 23, 2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

Agency responds to citizen petition, announces agreements with universities, updates bulks categories and schedules advisory committee meeting

As part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the U.S. Food and Drug Administration is announcing several actions to protect public health related to the compounding of human drug products.

“We continue to implement the compounding provisions of federal law and advance a modern framework for the development of compounded drugs,” said FDA Commissioner Scott Gottlieb, M.D. “Our actions underscore our focus on protecting patients while making sure we have an enduring framework for better compoun

Saturday, July 21, 2018

Lynbrook pharmacy owner sentenced to jail for $1.5M Medicaid scam

liherald.com-15 hours ago

The owner of a Lynbrook pharmacy was sentenced to jail time in Queens Supreme Court on Friday for defrauding the state's Medicaid program out of $1.5 ...

Nassau Pharmacy Owner Sentenced For Defrauding Medicaid
Patch.com-18 hours ago

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Oklahoma State Bureau of Investigation is looking into whether the director of the State Board of Pharmacy tried to bribe a health department attorney

OSBI Investigates State Board Of Pharmacy Director For Bribery

news9.com KWTV-11 hours ago

The Oklahoma State Bureau of Investigation is looking into whether the director of the State Board of Pharmacy tried to bribe a health department attorney into ...

OSBI investigating Oklahoma Pharmacy Board executive director
NewsOK.com-10 hours ago

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CVS fires Fountain Hills pharmacist who denied hormone prescription ...

AZCentral.com-10 hours ago

She claims the pharmacist loudly questioned her in front of other customers and rejected her and her doctor's requests to transfer the prescription to another ...

Transgender Woman Says CVS Pharmacist Refused to Fill Hormone ...
New York Times-11 hours ago

Complaint: CVS Pharmacist Refused to Fill Prescription for ...
Rewire.News-19 hours ago

A transgender woman says a pharmacist refused to fill her hormone ...
Highly Cited-CNN-21 hours ago

CVS pharmacist fired after refusing to fill transgender woman's ...
Highly Cited-The Hill (blog)-18 hours ago

CDER announces sweeping structural changes--The Division of Compounded Drugs will take on the roles of the Compounding and Pharmacy Practice Branch

CDER announces sweeping structural changes in letter from ...

BioPharma Dive-19 hours ago

The Division of Compounded Drugs will take on the roles of the Compounding and Pharmacy Practice Branch, and work alongside the Division of Unapproved ...

Former sales rep arrested on violations of pretrial release Hawaii News Now-15 hours ago According to the Department of Justice, Diaz was “prescribing medically unnecessary compounded medications, some of which included Ketamine, a controlled

Former sales rep arrested on violations of pretrial release

Hawaii News Now-15 hours ago

According to the Department of Justice, Diaz was “prescribing medically unnecessary compounded medications, some of which included Ketamine, a controlled

Friday, July 20, 2018

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA Statement from Commissioner Scott Gottlieb, M.D.; Peter Marks, M.D., Ph.D., director, Center for Biologics Evaluation and Research; and Janet Woodcock, M.D., director, Center for Drug Evaluation and Research

The U.S. Food and Drug Administration has become aware of reports of severe illnesses and deaths resulting from the use of synthetic cannabinoid (marijuana) products that have been contaminated with brodifacoum, a very long-acting anticoagulant commonly used in rat poison. These unapproved products are being sold in convenience stores and gas stations as substitutes for marijuana under names such as “K2” and “Spice.” Use of these illegal products pose significant public health concerns for both individuals who may use the contaminated products and the U.S. blood supply, as there is the potential for contamination of blood products donated by those individuals who have used these substances.

New charges filed in New England Compounding Center case

New charges filed in New England Compounding Center case

Boston Business Journal

Federal prosecutors have charged another person in the sprawling New England Compounding Center case, accusing a former pharmacy buyer at a ...

New charges in New England Compounding Center case - Worcester Business Journal

Former hospital pharmacy tech charged in NECC-related case - WCVB Boston

Full Coverage

High Importance!! USP tackles 'hot mess' — veterinary compounding

USP tackles 'hot mess' — veterinary compounding

VIN News Service

Timeline for U.S. Pharmacopeia recommendations on hazardous drugs and compounded preparations Veterinary compounding in the United States ..

FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids

The U.S. Food and Drug Administration today announced a new batch of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs.

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

One of the ways that the U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.

These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate “high.” But it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose or death.

Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed

The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness.

The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.

State pharmacy board director allegedly offered job in exchange for controversial medical marijuana rule

State pharmacy board director allegedly offered job in exchange for ...

State pharmacy board director allegedly offered job in exchange for controversial

Wednesday, July 18, 2018

Brentwood Brothers Face Prison For Bogus Pharmacy Compounding Drug Pedaling

Brentwood Brothers Face Prison For Bogus Pharmacy Drug Pedaling

Patch.com-32 minutes ago

Dalibor "Dabo" Kabov and his older brother Berry -- operators of Global CompoundingPharmacy -- were convicted in January 2017 of being at the center of a ..

PFE : Novartis next to halt drug price hikes
4:49 am, Wed, Jul. 18, 2018

CareZone sues Express Scripts for defamation following contract fight

FierceHealthcare-18 hours ago

A mounting battle between Express Scripts and online pharmacy CareZone just got a little more heated. Weeks after CareZone accused Express Scripts of ...

Amazon eyes India pharmacy space, to invest in pharmacy chain ...

Entrackr-Jul 16, 2018

US e-tailer major Amazon is in early talks to invest in India's second largest pharmacychain Medplus. Amazon, which considers India to be one of its key ...

After PillPack, Amazon in Talks to Acquire India's No. 2 Pharmacy ...
BW Businessworld-18 hours ago

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Amazon's Reach Now Extends To Pharmacies

Global Finance-12 hours ago

Online marketplace Amazon disrupted the entire pharmacy industry—for a day at least—with its $1 billion purchase of PillPack, an online pharmacy that uses ...

Viewpoint: Amazon will have a hard time disrupting health care
Boston Business Journal-15 hours ago

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Wedgewood Pharmacy and Diamondback Drugs Animal-Health ...

Arizona Daily Star-10 hours ago

As the top compounding pharmacy in the U.S., the new, combined company ... pharmacy to become the largest animal-health compounding pharmacy in the.

Doggone it: Wedgewood Pharmacy acquires Arizona competitor
Philadelphia Business Journal-8 hours ago

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Allergan Awarded $27K In Sanctions In Compounding Suit

Law360 · 9 hours ago

06/27/2018	3012289984	Well Care Discount Pharmacy, LLC	483	NV	Producer of Sterile Drug Products	07/17/2018

07/02/2018	3003780900	People’s Custom Rx and Clinical Care, LLC	483	TN	Producer of Sterile Drug Products	07/16/2018

05/16/2018	1450114	Akorn, Inc.	483	IL	Drug Manufacturer	07/16/2018

07/03/2018	AniCell Biotech	Los Angeles District Office	Unapproved New Animal Drug/Adultered	Not Issued *

07/03/2018	bB BioChem Laboratories Inc.	Los Angeles District Office	CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug	Not Issued *

07/05/2018	Claris Injectables Limited	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *

07/06/2018	Aegle Nutrition LLC	Dallas District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *

Monday, July 16, 2018

Miracle Hills landlord wants to evict Kohll's Pharmacy over horse-drug conviction Jul 13, 2018

https://www.omaha.com/content/tncms/live/

FDA Proposes Amendment to Vending Labeling Rule Requirement for Font Size

Posted: 16 Jul 2018 01:46 AM PDT

By Riëtte van Laack —

In 2010, the Federal Food, Drug, and Cosmetic Act (FDC Act) was amended to include a requirement that certain vending machine operators engaged in operating and owning 20 or more vending machines provide calorie declarations for certain articles of food sold from vending machines. FDA issued a final implementing regulation on Dec. 1, 2014 with a compliance date of Dec. 1, 2016.

Have you reviewed TSBP’s red flag checklist lately?
Failure of pharmacies and pharmacists to detect patterns of inappropriate dispensing of prescription drugs is unprofessional practice and constitutes grounds for disciplinary action. View our list of red flags here.

Saturday, July 14, 2018

TX: Houston Doc Pleads Not Guilty to Charges in Compounding Scam

https://www.workerscompensation.com/news_read.php?id=29946

Friday, July 13, 2018

High importance!! FDA warns of imposters sending consumers fake warning letters Scammers are targeting consumers who have purchased medicines online

warning letters

Scammers are targeting consumers who have purchased medicines online

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

Based on the agency’s experience with criminals posing as FDA employees, the FDA is concerned that these fake warning letters are linked

FCA Alert: Medical judgment can be "false" under False Claims Act

JD Supra (press release)-7 hours ago

Two weeks ago, the Sixth Circuit reversed a judgment that had acquitted a cardiologist charged with criminal healthcare fraud stemming from his interpretations

Sessions targets 10 areas in US for crackdown on the sale of fentanyl

Washington Post-9 hours ago

CONCORD, N.H. — Attorney General Jeff Sessions on Thursday ordered federal prosecutors in 10 areas that have been especially hard-hit by overdose deaths ...

AG Sessions promises to drop federal hammer on dealers of deadly ...
The Union Leader-7 hours ago

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Attorney General: 'Fake' doctor bills $1M out of Denville office

Daily Record-7 hours ago

Marrero allegedly used the personal information of a Hudson County family physician to submit fraudulent insurance claims to United Healthcare Insurance Co.

Columbus doctor indicted in fraud investigation

WRBL-6 hours ago

COLUMBUS, GA - A Columbus doctor of 16 years has been indicted in a massive healthcare fraudinvestigation. The Ledger-Enquirer reports Dr. Alap Shah ..

Monday, July 23, 2018

Saturday, July 21, 2018

Friday, July 20, 2018

Wednesday, July 18, 2018

Monday, July 16, 2018

Saturday, July 14, 2018

Friday, July 13, 2018

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