The Law of Compounding Medications And Drugs

Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues

Monday, November 30, 2015

Texas: Surgical monitoring firms receiving scrutiny for doctor deals

Surgical monitoring firms receiving scrutiny for doctor deals

- November 30, 2015 1 comment:

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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 *

- November 30, 2015 1 comment:

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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

- November 30, 2015 No comments:

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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

- November 30, 2015 No comments:

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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

- November 30, 2015 No comments:

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FDA DSCSA Deadline Passes Quietly | RxTrace

- November 30, 2015 No comments:

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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 –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/11/under-control-some-controlled-substances-may-have-a-later-exclusivity-start-date-with-the-enactment-.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

- November 30, 2015 No comments:

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Sunday, November 29, 2015

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

- November 29, 2015 No comments:

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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

- November 29, 2015 No comments:

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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

- November 29, 2015 No comments:

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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...

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

- November 28, 2015 No comments:

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From the Iowa Board of Pharmacy-- They get it!

TOP FAQ

Question: Does the Drug Quality and Security Act apply to me and my pharmacy?
Answer:
Yes. It is a federal law and applies in all 50 states. It supersedes any state laws that might contradict it.

- November 28, 2015 No comments:

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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

- November 27, 2015 1 comment:

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NY Times Steve Asmussen Fined for Violating Horse Racing Drug Rules

http://www.nytimes.com/2015/11/24/sports/steve-asmussen-fined-for-violating-horse-racings-drug-rules.html?_r=3

- November 27, 2015 No comments:

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

- November 27, 2015 No comments:

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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

- November 27, 2015 No comments:

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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

- November 27, 2015 No comments:

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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

- November 27, 2015 1 comment:

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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

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- November 27, 2015 No comments:

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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

- November 27, 2015 No comments:

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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

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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 ...

- November 27, 2015 No comments:

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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

- November 27, 2015 No comments:

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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 ...

Appeals court revives Oregon suit over 'phantom recall' of Motrin
The Register-Guard-13 hours ago

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- November 26, 2015 No comments:

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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

- November 26, 2015 No comments:

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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

Hedge fund questions alleged Valeant ties to more pharmacies
The Globe and Mail-22 hours ago

Healthcare Major News- Pfizer Inc. (NYSE:PFE), Valeant ...
StreetWise Report (press release)-7 hours ago

Valeant Pharmaceuticals Intl Inc.: Another Day, Another Controversy
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

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- November 26, 2015 No comments:

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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

- November 26, 2015 No comments:

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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

- November 26, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

http://www.fdanews.com/articles/print/174257-fda-cautions-3-more-compounders-bringing-warnings-to-25

- November 25, 2015 No comments:

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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

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- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

- November 25, 2015 No comments:

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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

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- November 25, 2015 No comments:

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