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Monday, November 30, 2015

Texas: Surgical monitoring firms receiving scrutiny for doctor deals

Surgical monitoring firms receiving scrutiny for doctor deals

November 13, 2015 McGuff Compounding Pharmacy Services, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *

November 13, 2015McGuff Compounding Pharmacy Services, Inc.Los Angeles District OfficeCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedNot Issued *

Pharmacy award overruled Pharmacy News-14 hours ago A pharmacist seeking compensation from a former employer for alleged award breaches has suffered a setback after a court

Pharmacy award overruled

Pharmacy News-14 hours ago
pharmacist seeking compensation from a former employer for alleged award breaches has suffered a setback after a court

Feds step up drug enforcement of pharmacies Pharmacy Today, American Pharmacists Association, pharmacist.com-5 hours ago DEA has increased the amount of surprise inspections on businesses in recent years

Feds step up drug enforcement of pharmacies

Pharmacy Today, American Pharmacists Association, pharmacist.com-5 hours ago
DEA has increased the amount of surprise inspections on businesses in recent years, and the California Board of Pharmacy is considering making it mandatory

Edmond-Based Drug Company Responds To FDA Requests PR Newswire (press release)-

Edmond-Based Drug Company Responds To FDA Requests

PR Newswire (press release)-2 hours ago
Qualgen is a sterile compounding company based in Edmond, Oklahoma, that offers a wide range of compounded Estradiol

FDA DSCSA Deadline Passes Quietly | RxTrace

FDA DSCSA Deadline Passes Quietly | RxTrace

FDA Law Blog: Under Control: Some Controlled Substances May Have a Later Exclusivity Start Date With the Enactment of a New Law By Kurt R. Karst –

Sunday, November 29, 2015

Michigan to receive $5.4 million in drug company kickback scheme ...

Michigan to receive $5.4 million in drug company kickback scheme ...
The Daily Tribune-7 hours ago
Novartis, makers of the drug Exjade, was accused of providing kickbacks to specialty pharmacies

Two pharmacies, distributor raided The Express Tribune-

Two pharmacies, distributor raided
The Express Tribune-4 hours ago
The said pharmacy was found to be charging Rs80 more than the approved 

The top pharmacy challenges in 2016 ModernMedicine-17 hours ago

The top pharmacy challenges in 2016
ModernMedicine-17 hours ago
Health plans have been plagued by challenges on the pharmacy side of their benefits for years, and they don't

Saturday, November 28, 2015

Friday, November 27, 2015

High Importance! Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol)

[Posted 11/25/2015]
AUDIENCE: Pharmacy, Health Professional, Patient
ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol),  distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if leftuntreated. Patients suffering adverse effects from high Vitamin D levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.
BACKGROUND: Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.

RECOMMENDATION: Health care providers should quarantine and return any products subject to this recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.  Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

NY Times Steve Asmussen Fined for Violating Horse Racing Drug Rules

Victory! Asmussen Fined—Sweeping New Horse-Racing Rules Proposed | PETA's Blog | PETA

Victory! Asmussen Fined—Sweeping New Horse-Racing Rules Proposed | PETA's Blog | PETA

PETA asks New York Gaming Commission to change equine doping ... SBC News-13 hours ago The investigation points the finger at the trainer and his assistant, Scott Blasi, with 14 allegations of equine doping during the 2013

PETA asks New York Gaming Commission to change equine doping ...

SBC News-13 hours ago
The investigation points the finger at the trainer and his assistant, Scott Blasi, with 14 allegations of equine doping during the 2013 

Class Action Suit Filed vs GNC for 'False Statements,' 'Unlawful Sale ... The Articlebasis.com-7 hours ago Last month, Oregon's attorney general sued GNC alleging that it sold “nutritional and dietary supplements containing the illegal ingredients picamilon and

Class Action Suit Filed vs GNC for 'False Statements,' 'Unlawful Sale ...

The Articlebasis.com-7 hours ago
Last month, Oregon's attorney general sued GNC alleging that it sold “nutritional anddietary supplements containing the illegal ingredients picamilon and

The Era of Dietary Supplement Tablets is Ending.

The Era of Dietary Supplement Tablets is Ending. This Company is ...

SmallCap Network-6 hours ago
Send Message Add to Contacts Follow. It's not been a great year for the dietarysupplement industry. In fact, it's been a very bad year for dietary supplements

Dr Reddy's reels under heat of US FDA action; warning details send ...

Dr Reddy's reels under heat of US FDA action; warning details send ...

Economic Times-Nov 26, 2015
Market analysts expressed pessimism about an early resolution of the issues raised by the FDA. The company had alerted investors about the warnings as soon ...
The Dr Reddy's effect: Pharma companies need a lifestyle change
Opinion-Business Today-12 hours ago
Explore in depth (109 more articles)

Pharmacies promise 'big battle' against Quebec's drug pricing plan CTV News-6 minutes ago But Quebec's association of pharmacy owners says it is prepared

Pharmacies promise 'big battle' against Quebec's drug pricing plan

CTV News-6 minutes ago
But Quebec's association of pharmacy owners says it is prepared

Turing reneges on cutting price, rival sells well

    Turing reneges on drug price cut, rival's version sells well

    Fox News-7 hours ago
    Mass-produced drugs must be approved by the Food and DrugAdministration. Imprimis, like other compounding pharmacies, instead makes up individual ...
    Turing reneges on drug price cut
    San Antonio Express-News (subscription)-19 hours ago
    Turing reneges on pill price cut
    WBAY-22 hours ago
    Explore in depth (132 more articles)

    Turing reneges on cutting $750-a-pill drug's price, rival's new 99 ...

    The Augusta Chronicle-21 hours ago
    Turing's move comes after a pharmacy that compounds prescription drugs for ... Imprimis, like other compounding pharmacies, instead makes up individual ...

Glades Drugs' compounded multivitamins receive alert from ... www.wall-street.com › Health 6 hours ago - The U.S. Food and Drug Administration has issued an alert

Glades Drugs' compounded multivitamins receive alert from ...

www.wall-street.com › Health
6 hours ago - The U.S. Food and Drug Administration has issued an alert

Thursday, November 26, 2015

Oregon lawsuit over Motrin maker's 'phantom recall' revived on appeal OregonLive.com

Oregon lawsuit over Motrin maker's 'phantom recall' revived on appeal

OregonLive.com-16 hours ago
In July 2009, a concerned secret shopper employed by WIS International alerted the Oregon Board of Pharmacy, which then notified the U.S. Food and Drug ...

Injunction bid denied in dispute on Rx law Arkansas Online-10 hours ago A federal judge refused Wednesday to halt the enforcement of Act

Injunction bid denied in dispute on Rx law

Arkansas Online-10 hours ago
A federal judge refused Wednesday to halt the enforcement of Act 

Hedge fund questions alleged alleged Valeant ties to more pharmacies

Valeant shares seesaw after hedge fund links drugmaker to more ...

USA TODAY-Nov 25, 2015
Bronte Capital, an Australia-based hedge fund with bearish financial bets on Valeant stock, published a list of more than 70 pharmacies it suggested the ...
Massive Fraud Alleged by Camarillo Pharmacist
JD Supra (press release)-19 hours ago
Healthcare Major News- Pfizer Inc. (NYSE:PFE), Valeant ...
StreetWise Report (press release)-7 hours ago

FDA Alerts On Compounded Vitamin Capsules Distributed By ... RTT News-14 hours ago

FDA Alerts On Compounded Vitamin Capsules Distributed By ...

RTT News-14 hours ago
The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded

Feds Expect $30M From FCA Deals With Fla. Pharmacies Law360 (subscription)-19 hours ago The settlements resolve False Claims Act allegations that were developed

Feds Expect $30M From FCA Deals With Fla. Pharmacies

Law360 (subscription)-19 hours ago
The settlements resolve False Claims Act allegations that were developed

Wednesday, November 25, 2015

Feds step up drug enforcement of pharmacies The San Diego Union-Tribune-2 hours ago

Feds step up drug enforcement of pharmacies

The San Diego Union-Tribune-2 hours ago
On July 13, 2012, a pharmacy technician ordered 1,000 hydrocodone pills through the San Diego pharmacy he worked for. But it was not a sanctioned order

Prescription Drug Ads: Advertising Group Bucks Medical ... Associations Now-5 hours ago Western States Medical Center, a Supreme Court case that involved the marketing of compounded drugs. “Banning DTC advertising

Prescription Drug Ads: Advertising Group Bucks Medical ...

Associations Now-5 hours ago
Western States Medical Center, a Supreme Court case that involved the marketing of compounded drugs. “Banning DTC advertising 

FDA Cautions 3 More Compounders, Bringing Warnings to 25 Nov. 30, 2015 The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry this year. Compounders have struggled to meet the agency’s guidelines as it adjusts to being regulated by the FDA and not solely by state pharmacy boards

Six local pharmacies named in new round of settlements with the federal government - See more at: http://www.actionnewsjax.com/news/news/local/six-local-pharmacies-named-new-round-settlements-f/npWxY/#sthash.0BLGfR8l.dpuf

Six local pharmacies named in new round of settlements with the ...

ActionNewsJax.com-2 hours ago
According to the U.S. attorney's office, six local compoundingpharmacies were ripping off a military health care program called Tricare by allegedly marketing ...
More prosecutions, arrests coming in Florida pharmacy fraud scam
Florida Politics (blog)-10 hours ago
Explore in depth (3 more articles)

HHS Rule Agenda Includes 340B, FDA Regulations Bloomberg BNA-42 minutes ago In the area of Food and Drug Administration regulation, the agenda includes a .... to compound drug products under Section 503A of the Federal Food,

HHS Rule Agenda Includes 340B, FDA Regulations

Bloomberg BNA-42 minutes ago

Auburndale pharmacy agrees to $4.1 million settlement over bogus ... Tampa Bay Business Journal-44 minutes ago In addition, the prescriptions were for the same compounded prescription substance, despite the patient's age, condition, or health

Auburndale pharmacy agrees to $4.1 million settlement over bogus ...

Tampa Bay Business Journal-44 minutes ago
In addition, the prescriptions were for the same compoundedprescription substance, despite the patient's age, condition, or health 

USP Urges FDA To Rethink Biosimilar Naming Guidance Pharmacy Practice News-21 hours ago ... a unique name is necessary,” said Gillian Woollett, MA, DPhil, the senior vice

USP Urges FDA To Rethink Biosimilar Naming Guidance

Pharmacy Practice News-21 hours ago
... a unique name is necessary,” said Gillian Woollett, MA, DPhil, the senior vice 

Pharmacy ownership 'should be opened up' Sky News Australia-20 hours ago

Pharmacy ownership 'should be opened up'

Sky News Australia-20 hours ago
The government has agreed to an independent review of pharmacyregulation which will report by 2017. The government will adopt

Pharmacy Kickbacks Lawsuit Spurs Novartis Settlement Pharmacy Times-1 hour ago Novartis was asked to acknowledge the claim that after seeing poor sales of Exjade, it told pharmacies that it would terminate the

Pharmacy Kickbacks Lawsuit Spurs Novartis Settlement

Pharmacy Times-1 hour ago
Novartis was asked to acknowledge the claim that after seeing poor sales of Exjade, it told pharmacies that it would terminate the 

Fred's Rerports Third-Quarter Profit, Sales Increase

Fred's sails past pharmacy headwinds

Chain Store Age-22 hours ago
“Despite a sales-mix shift and continued headwinds in the pharmacydepartment, we realized a 40-basis-point company-wide increase in gross margin as ...
Fred's Reports Third-Quarter Profit, Sales Increase
Memphis Daily News (blog)-20 hours ago
Explore in depth (38 more articles)

Prosecutor says 95 percent of the $1.4 billion spent on compounded drugs in 2014 by Tricare was fraud!

PROSECUTIONS, ARRESTS COMING IN FLORIDA PHARMACY COMPOUNDING FRAUD SCAM

USP 800 Still On the Horizon; Clouds in Sight? Pharmacy Practice News-58 minutes ago “But since NECC [New England Compounding Center] and the 2013 Drug Quality and Security Act put some teeth to that, we have seen

USP <800> Still On the Horizon; Clouds in Sight?

Pharmacy Practice News-58 minutes ago
“But since NECC [New England Compounding Center] and the 2013Drug Quality and Security Act put some teeth to that, we have seen 

Tuesday, November 24, 2015

FDA 483 09/18/2015 for Grandpa’s Compounding Pharmacy, Inc.CA Compounding Pharmacy posted 11/24/2015

FDA Warning Wire: Suspect Records At Sandoz, Dr. Reddy's Law360 (subscription)-1 hour ago Also featured are allegations of filthy conditions at a Walgreen compounding pharmacy and unreported adverse events at Heritage Pharmaceuticals.

FDA Warning Wire: Suspect Records At Sandoz, Dr. Reddy's

Law360 (subscription)-1 hour ago
Also featured are allegations of filthy conditions at a Walgreen compounding pharmacy and unreported adverse events at Heritage Pharmaceuticals.

Unreliable Lab Tests Harming Patients, FDA Warns https://www.schmidtlaw.com/unreliable-lab-tests-harming-patients-fda-w... 23 hours ago - Avella Specialty Pharmacy Recalls Compounded Drugs · Inaccurate Alere Blood Clot Test Strips Linked to 9 Injuries · Avastin Shows

Unreliable Lab Tests Harming Patients, FDA Warns

https://www.schmidtlaw.com/unreliable-lab-tests-harming-patients-fda-w...
23 hours ago - Avella Specialty Pharmacy Recalls Compounded Drugs · Inaccurate Alere Blood Clot Test Strips Linked to 9 Injuries · Avastin Shows

meningitis-etc: Lawyers Differ on Impact of Michigan Meningitis V...

meningitis-etc: Lawyers Differ on Impact of Michigan Meningitis V...: By Walter F. Roche Jr. Lawyers for Tennessee victims of the 2012 fungal meningitis outbreak say a verdict in a Michigan case clearing phy...

meningitis-etc: Court Gets First Estimate of Meningitis Awards to ...

meningitis-etc: Court Gets First Estimate of Meningitis Awards to ...: By Walter F. Roche Jr. A Boston attorney told a federal judge that victims of the 2012 fungal meningitis outbreak should not be expecting...

meningitis-etc: Efforts Underway to Protect Awards to Outbreak Vic...

meningitis-etc: Efforts Underway to Protect Awards to Outbreak Vic...: By Walter F. Roche Jr. Hundreds of victims of the 2012 deadly fungal meningitis outbreak have been put on notice that insurance companies...

meningitis-etc: First New York Outbreak Victim Steps Forward

meningitis-etc: First New York Outbreak Victim Steps Forward: By Walter F. Roche Jr. A New York woman has been given until Dec. 1 to file proof that she was one of the victims of the 2012 fungal meni...

meningitis-etc: Saint Thomas CEO Drew Top Salary

meningitis-etc: Saint Thomas CEO Drew Top Salary: By Walter F. Roche Jr. The former CEO at Nashville's Saint Thomas health care companies drew the largest salary for the second year ...

Grassley, McCain To HHS: Allow Case-By-Case Drug Imports From Canada Sens. Chuck Grassley (R-IA) and John McCain (R-AZ) are pressing HHS Secretary Sylvia Burwell to allow pharmacists, wholesale retailers and individuals to import cheaper Canadian versions of certain high

Sens. Chuck Grassley (R-IA) and John McCain (R-AZ) are pressing HHS Secretary Sylvia Burwell to allow pharmacists, wholesale retailers and individuals to import cheaper Canadian versions of certain high

Imprimis Pharmaceuticals Sees Unusually-High Trading Volume ... Putnam Standard-15 hours ago

Imprimis Pharmaceuticals Sees Unusually-High Trading Volume ...

Putnam Standard-15 hours ago
The Company focuses on developing and commercializing compounded drugtherapies and making these therapies available to physicians and patients

November 12, 2015 Nature's Mojo Inc New Jersey District Office Unapproved New Drugs/Misbranded Not Issued *

November 12, 2015Nature's Mojo IncNew Jersey District OfficeUnapproved New Drugs/MisbrandedNot Issued *

October 15, 2015 Seeds of Light Enterprises Florida District Office Unapproved New Drugs/Misbranded Not Issued *

October 15, 2015Seeds of Light EnterprisesFlorida District OfficeUnapproved New Drugs/MisbrandedNot Issued *

October 22, 2015 Sandoz Private Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *

October 22, 2015Sandoz Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *

November 03, 2015 Advanced Physician Solutions, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

November 03, 2015Advanced Physician Solutions, Inc.Los Angeles District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *

November 02, 2015 Triangle Compounding Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

November 02, 2015Triangle CompoundingAtlanta District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *

November 05, 2015 Dr. Reddy's Laboratories Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *

November 05, 2015Dr. Reddy's Laboratories LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *

Monday, November 23, 2015

Question of the Day November 23, 2015 Will state boards of pharmacy take action or open their own investigations against compounding pharmacies who have entered into settlement agreements with the federal agreement even if the agreement admit to no wrong doing? Why or why not? Will state boards of pharmacies who issued non-resident license to these pharmacies also take action or investigate? Why or why not?


Pennsylvania House Committee Finds 'Compromise' In Bill To Fund Drug Testing - Horse Racing News | Paulick Report

Pennsylvania House Committee Finds 'Compromise' In Bill To Fund Drug Testing - Horse Racing News | Paulick Report

FDA Finds More Dietary Supplements with Hidden Ingredients

FDA Finds More Dietary Supplements with Hidden Ingredients

www.empr.com/fda-finds-more-dietary-supplements-with.../2893/
2 hours ago - ... conditions Company · MPR >; FDA Finds More Dietary Supplementswith Hidden Ingredients. FDA Finds More Dietary Supplements with Hidden 

Congressional Hearing Examines Competition in PBM Industry The National Law Review-4 hours ago

Congressional Hearing Examines Competition in PBM Industry

The National Law Review-4 hours ago
Last week, pharmacy benefit manager (PBM) and independentpharmacy representatives provided testimony to the House Judiciary 

PBMs Scrutinized for LTC Pharmacy Payment Practices Pharmacy Times-6 hours ago

PBMs Scrutinized for LTC Pharmacy Payment Practices

Pharmacy Times-6 hours ago
Just a day after a US House of Representatives subcommittee held a hearing on the state of competition in the pharmacy benefit manager 

"The $30 million settlement finalized last week will be the first in a wave of settlements, Mehta said, as this type of scam happened in every major city in the country. Last year, the government paid $1.4 billion to compounding pharmacies."

quoted from http://www.bizjournals.com/jacksonville/news/2015/11/23/jacksonville-pharmacies-accused-of-bilking.html

The companies included in the agreement are: MedMatch Pharmacy, which is paying $4.7 million; OHM Pharmacy, $4.1 million; WELLHealth Pharmacy, $3 million and 50 percent of net profits for five years; Topical Specialists, $2.2 million; Durbin Pharmacy for $2.1 million and 50 percent of net profits for five years; North Beaches Pharmacy for $10,000 and 50 percent of net profits for five years.

source: http://www.bizjournals.com/jacksonville/news/2015/11/23/jacksonville-pharmacies-accused-of-bilking.html

Must Read! Jacksonville pharmacies accused of bilking military healthcare ... Jacksonville Business Journal-2 hours ago The U.S. Attorney's Office has accepted more than $30 million from several Jacksonville compounding pharmacies to settle allegations


Jacksonville pharmacies accused of bilking military healthcare ...

Jacksonville Business Journal-2 hours ago
The U.S. Attorney's Office has accepted more than $30 million from several Jacksonville compounding pharmacies to settle allegations 

Save the Date for 2016 Developments in Pharmacy Law Seminar XXVII November 10 – 13, 2016 Hilton Austin Austin, Texas

Colorado Board of Pharmacy Post Minutes for June, July and October 2015 Meetings: Begin actions against a number of compounding pharmacies