The Law of Compounding Medications And Drugs

Friday, October 12, 2018

9/25/2018	3011127887	Allegheny Health Network Home Infusion, LLC	483	PA	Producer of Sterile Drug Products	10/12/2018

8/31/2018	3008927138	Morton Drug Company dba Morton LTC	483	WI	Producer of Sterile Drug Products	10/12/2018

08/17/2018	3014616172	HV Pharmacy Inc. dba Hunt Valley PharmaLab	483	MD	Producer of Sterile Drug Products	10/12/2018

09/11/2018	3004378804	Central Admixture Pharmacy Services Inc	483	CA	Outsourcing Facility	10/12/2018

09/13/2018	30112866349	Qualgen LLC	483	OK	Outsourcing Facility	10/12/2018

2 hours ago - A study of dietary supplements found prescription drugs taint 20% of vitamins and minerals, and the FDA failed to recall many tainted pills.

Hundreds of Dietary Supplements Are Tainted with Prescription Drugs

Scientific American-7 hours ago

Dietary supplements aren't regulated like pharmaceutical drugs, so that means they shouldn't contain pharmaceutical drugs. Yet over the last decade, more than ...

No Wonder It Works So Well: There May Be Viagra In That Herbal ...
NPR-9 hours ago

Hidden drugs and danger lurk in over-the-counter supplements, study ...
In-Depth-Philly.com-9 hours ago

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Very High Importance!! Diet, weight loss and sex supplements are tainted with unapproved ... Washington Post-9 hours ago Researchers found unapproved and sometimes dangerous drugs in 746 dietarysupplements, almost all of them marketed for sexual enhancement, weight loss ...

Diet, weight loss and sex supplements are tainted with unapproved ...

Washington Post-9 hours ago

Researchers found unapproved and sometimes dangerous drugs in 746 dietarysupplements, almost all of them marketed for sexual enhancement, weight loss ...

What's Actually in Your Dietary Supplements? Maybe Drugs, Study Says
Fortune-1 hour ago

Nearly 800 dietary supplements contained unapproved drug ...
CNN-9 hours ago

Hundreds of dietary supplements are tainted with potentially harmful ...
Science News-6 hours ago

Dietary Supplements Can Contain Viagra, Steroids, or Worse
In-Depth-WIRED-9 hours ago

Hidden dangers lurk in over-the-counter supplements, study warns
In-Depth-NBCNews.com-4 hours ago

2019 List of Prohibited Substances and Methods for Human Athletes

United States Eventing Association (press release) (blog)-8 hours ago

The World Anti-Doping Agency (WADA) has released the 2019 List of Prohibited Substances and Methods. This list comes into force on January 1, 2019 and is .

Round Up of Recent Endurance Doping Case Rulings

Horse-Canada.com (blog)-8 hours ago

Two endurance riders whose horses tested positive to Trometamol have been suspended for six months each – a reduced sanction for a banned substance

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

This document was updated on October 12, 2018, to add contacts for reconditioning requests in additional states affected by Hurricane Michael.

As Hurricane Michael makes landfall along the Florida Gulf Coast, the U.S. Food and Drug Administration’s Center for Veterinary Medicine reminds those who may be affected by weather events about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals.

The FDA reminds harvesters that crops harvested from flooded fields are often unacceptable because of contamination. Flood waters, which are different from pooled rain water, may contain sewage, pathogenic organisms, pesticides, chemical wastes, or other toxic substances. Mold growth is another serious concern for flood impacted crops intended for use in animal food. Some molds produce mycotoxins, which are toxic to certain animals and people.

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Wada: Anti-doping campaigner Beckie Scott says officials tried 'to bully ...

BBC Sport-6 hours ago

The chair of the World Anti-Doping Agency's (Wada) Athlete Committee says some of the organisation's most senior officials tried to "bully" her over her ...

Beckie Scott says some WADA executives attempted to 'bully' her
CBC.ca-5 hours ago

Russia accused of hacking sports world over doping scandal
LNR-4 hours ago

Scott claims "bullying" by WADA officials at meeting where Russia ...
Insidethegames.biz (blog)-4 hours ago

From Skeleton racer to politician: Ben Sandford on Wada, Russia and ...
In-Depth-New Zealand Herald-7 hours ago

meningitis-etc: NECC Defendant In Land Deals

meningitis-etc: NECC Defendant In Land Deals: By Walter F. Roche Jr. One of the remaining defendants in the criminal case stemming from a 2012 public health crisis has been involved i...

meningitis-etc: Plea Deal in NECC Related Case (Pharmacy Technician, plea agreement shows he lied)

meningitis-etc: Plea Deal in NECC Related Case: By Walter F. Roche Jr. The details of a plea agreement between a pharmacy technician and federal prosecutors shows that he lied when he w...

meningitis-etc: NECC Defendant Wants Money Hidden

meningitis-etc: NECC Defendant Wants Money Hidden: By Walter F. Roche Jr. A key defendant in the upcoming criminal trial stemming from a deadly outbreak does not want jurors to hear how mu...

meningitis-etc: Cadden Boat on Auction Block

meningitis-etc: Cadden Boat on Auction Block: By Walter F. Roche Jr. A federal judge has approved an order to put up for auction a sailboat seized from the president of a now defunct ...

meningitis-etc: 2018

meningitis-etc.blogspot.com/2018/

14 hours ago - Michael Carome of Public Citizen, an advocacy group, noted that the revision still includes a provision requiring states that sign an MOU to notify the FDA within 3 business days of any complaint relating to a drug product compounded by a pharmacist or pharmacist and distributed outside the state involving a serious .

Oklahoma State Board of Pharmacy (2018-357A) | Oklahoma Attorney ...

www.oag.ok.gov/oklahoma-state-board-of-pharmacy-2018-357a1

13 hours ago - Oklahoma State Board of Pharmacy (2018-357A). Document: A.G. Opinion 2018-357A. Posted on Thu, October 11, 2018 by Nina Slaney ...

CHA Submits Comments on Sterile Compounding Regulations ...

https://www.calhospital.org/.../cha-submits-comments-sterile-compounding-regulation...

1 day ago - CHA continues to participate in the regulatory review of sterile compounding regulations as a result of SB 294. Passed in 2014, the new law requires the Board ...

Thursday, October 11, 2018

Hmong Village Shopping Center Raided by FDA, Police, Board of ...

KSTP-18 hours ago

Experts from the Minnesota State Board of Pharmacy were on hand to help identify the confiscated products which are considered illegal because they don't ..

Westchester doctor, pharmacist illegally pushed oxycodone pills: Feds

The Journal News | LoHud.com-3 hours ago

A Yonkers doctor and a White Plains pharmacist have been accused of illegally distributing millions of oxycodone pills in exchange for vacations, cash, whiskey ...

Westchester Doctor, Pharmacist Illegally Sold Oxycodone Pills, Feds Say
Peekskill Daily Voice-2 hours ago

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2 massive healthcare deals just got approved by the DOJ - and they ...

Business Insider India-21 hours ago

Airline industry analyst Henry Harteveldt told Business Insider that the airline's demise was compounded by a few factors. "They started the airline as the airline

FDA's Insanitary Conditions Revised Draft Guidance: Required ...

www.fdalawblog.net/.../fdas-insanitary-conditions-revised-draft-guidance-required-re...

19 hours ago - FDA states that it “generally does not intend to take action under Section 501(a)(2)(A) against a physician who is compounding or repackaging a drug product, or who is mixing, diluting or repackaging a biological product, provided that such activities occur in the physician's office where the products are administered ...

Wednesday, October 10, 2018

Michigan pharmacy shut down after being identified as prolific opiate distributor | MLive.com

MLive.com › detroit › index.ssf › 2018/10

4 hours ago · A southeast Michigan pharmacy has been shut down after state officials deemed it a public heath threat as one of the most prolific suppliers of opiate prescription pills in Michigan. The state Office of Licensing ...

FDA’s Handling Of Authority To Regulate Compounding Sparks Growing Chorus Of Criticism

https://khn.org/morning-breakout/fdas-handling-of-authority-to-regulate-compounding-sparks-growing-chorus-of-criticism/

Stat: McKesson Failed To Follow Procedures When Notified Of Illegitimate Products Amid regulatory concerns over counterfeit medicines, one of the largest U.S. wholesalers failed to follow proper procedures after being notified by customers that illegitimate products had been shipped, according to a recent inspection by the Food and Drug Administration. Specifically, McKesson (MCK) failed to identify and then quarantine “suspect or illegitimate” products. The wholesaler also did not retain samples or promptly notify other customers there was reason to believe illegitimate products were shipped. (Silverman, 10/9)

With safety and cash at stake, a squabble over drug compounding puts the FDA in a bind

WASHINGTON — It’s been five years since Congress gave FDA sweeping authority to regulate compounding, but lawmakers — many of ...

Tuesday, October 9, 2018

October 09, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Santa Rosa doctor Thomas Keller indicted on drug distribution, fraud ...

Santa Rosa Press Democrat-Oct 3, 2018

Keller also faces two counts of health care fraud stemming from allegations that he submitted two fraudulent claims to insurers Anthem Blue Cross of California ...

Santa Rosa Doctor Indicted On Charges Of Illegally Distributing Opioids
CBS San Francisco-Oct 3, 2018

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Thousands of insurance appeals went to doctor feds say is fraud

Indianapolis Business Journal-Oct 2, 2018

But even as he was waiting to be sentenced, federal prosecutors say, Panos was ... Advanced Medical Reviews in federal court in the Eastern District of Texas.

Guilty Plea in Fraud Case From Forest Park Surgeon and Founder

D Healthcare Daily-Oct 8, 2018

Dr. Wade Neal Barker admitted to being part of a $200 million fraud, bribery and kick back scheme in federal court on Friday, the The Texas Lawbook reports. The bariatric ... He could end up with a sentence of seven years in federal prison.

Texas Dr. Pleads Guilty In $40M Med Center Bribery Scam

Law360-Oct 5, 2018

A date for Barker's sentencing had not been set as of Friday afternoon. Barker pled guilty to two charges — conspiracy to pay and receive health care bribes and .

Doctor who prescribed pain meds that led to 7 overdose deaths ...

Dallas News (blog)-Oct 5, 2018

A North Texas doctor who prescribed unnecessary and powerful painkillers that contributed to the ... That sentence is subject to the approval of a federal judge.

Texas phys

Texas doctor accused in overdose deaths pleads guilty to federal ...

kfor.com-Oct 8, 2018

SHERMAN, Texas – A Texas doctor has agreed to spend the next two ... He agreed to a sentence of 20 years in federal prison, waived his right to appeal and ...

Doctor Pleads Guilty To Drug Distribution, Fraud
Patch.com-Oct 8, 2018

View allician guilty of federal drug charges for opiods
EastTexasMatters.com-Oct 5, 2018

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Colorado AG raises lawsuit against maker of OxyContin | VailDaily ...

https://www.vaildaily.com/.../colorado-ag-sues-oxycontin-manufacturer-alleging-it-un...

2 hours ago - ... Wheat Ridge pain clinic in May 2010 and couldn't help but notice something odd. ... Vail Valley arts patron Alberto Vilar finishes 10-year prison sentence with ...

Private-Label Drugs Drive Concern About Topical Medications ...

https://ww3.workcompcentral.com/.../d155d26ad53a0a17c0eed96aec01aeee3f492728

18 hours ago - Private-Label Drugs Drive Concern About Topical Medications ... comp industry has reined in spending on custom-made compounded pain creams, ot…

Prior Authorization and Step Therapy Guidelines - Blue Cross Blue ...

https://www.bcbsm.com/.../prior-authorization-and-step-therapy-guidelines.pdf

20 hours ago - The criteria for drugs that need prior authorization or step therapy are based on current medical ...... The compound is medically necessary for the member's.