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
Monday, November 30, 2015
November 13, 2015 McGuff Compounding Pharmacy Services, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
| November 13, 2015 | McGuff Compounding Pharmacy Services, Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not 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
A 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
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
PROSPECTUS SUPPLEMENT - Securities and Exchange ... www.sec.gov/.../form424b5.ht... U.S. Securities and Exchange Commission 23 hours ago - We are a pharmaceutical company focused on developing and commercializing innovative and high-quality proprietary compounded drug
PROSPECTUS SUPPLEMENT - Securities and Exchange ...
www.sec.gov/.../form424b5.ht...
23 hours ago - We are a pharmaceutical company focused on developing and commercializing innovative and high-quality proprietary compounded drug
U.S. Securities and Exchange Commission
From the Iowa Board of Pharmacy-- They get it!
TOP FAQ
-
Answer:Yes. It is a federal law and applies in all 50 states. It supersedes any state laws that might contradict it.
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
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
Opinion-Business Today-12 hours ago
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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 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 alertThursday, 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 ...
Appeals court revives Oregon suit over 'phantom recall' of Motrin
The Register-Guard-13 hours ago
The Register-Guard-13 hours ago
Explore in depth (40 more articles)
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 ...
Healthcare Major News- Pfizer Inc. (NYSE:PFE), Valeant ...
StreetWise Report (press release)-7 hours ago
StreetWise Report (press release)-7 hours ago
Valeant Pharmaceuticals Intl Inc.: Another Day, Another Controversy
The Motley Fool Canada-3 hours ago
The Motley Fool Canada-3 hours ago
Valeant mostly unscathed by short-seller report alleging ties to at ...
In-Depth-Financial Post-Nov 25, 2015
In-Depth-Financial Post-Nov 25, 2015
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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
Florida Politics (blog)-10 hours ago
Explore in depth (3 more articles)
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
Memphis Daily News (blog)-20 hours ago
Explore in depth (38 more articles)
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
| 09/18/2015 | 3006365166 | Grandpa’s Compounding Pharmacy, Inc. | 483 | CA | Compounding Pharmacy | 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 Showsmeningitis-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 ...
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, 2015 | Nature's Mojo Inc | New Jersey District Office | Unapproved New Drugs/Misbranded | Not Issued * |
October 15, 2015 Seeds of Light Enterprises Florida District Office Unapproved New Drugs/Misbranded Not Issued *
| October 15, 2015 | Seeds of Light Enterprises | Florida District Office | Unapproved New Drugs/Misbranded | Not Issued * |
October 22, 2015 Sandoz Private Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
| October 22, 2015 | Sandoz Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
November 03, 2015 Advanced Physician Solutions, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
| November 03, 2015 | Advanced Physician Solutions, Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
November 02, 2015 Triangle Compounding Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
| November 02, 2015 | Triangle Compounding | Atlanta District Office | CGMP/Finished Pharmaceuticals/Adulterated | Not 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, 2015 | Dr. Reddy's Laboratories Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not 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?
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
