| 12/19/2017 | C. O. Truxton Inc. | New Jersey District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
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
Tuesday, December 26, 2017
| 12/19/2017 | Maine Natural Health, Inc. | New York District Office | CGMP/Dietary Supplement/Adulterated/Misbranded | Not Issued * |
| 12/14/2017 | Eden’s Answers Inc. and Sprigs Life Inc. | Cincinnati District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| 12/14/2017 | BrainAlert, LLC | Seattle District Office | CGMP/Dietary Supplement/Adulterated/Misbranded | Not Issued * |
| 12/13/2017 | AN Co. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/13/2017 | Dynamic Technical Formulations | Atlanta District Office | CGMP/Dietary Supplement/Adulterated/Misbranded | Not Issued * |
| 12/13/2017 | Amaros Co., Ltd | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/04/2017 | Fresenius Kabi Oncology Ltd | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
Sunday, December 24, 2017
Healthy individuals need not take dietary supplements, say experts
Malay Mail Online-11 hours ago
Dieticians advise healthy individuals that they do not need to take any dietarysupplements. — AFP file picALOR STAR, Dec 24 — It is not necessary for healthy individuals to take any dietary supplements, says the head of the Dietetics and Food Service Department at Sultanah Bahiyah Hospital, here. Khairul Nizam Mat ...
From Russian doping to FIFA bribery, 2017 proves dark time
Capital FM Kenya-6 hours ago
PARIS, France, Dec 24 – Russia being banned from the Winter Olympics stole the headlines but may also have overshadowed an otherwise sorry year for sport in terms of scandals. It was a particularly damaging year for sporting officials, not least from the world of football and FIFA in particular. Former Guam football ...
Carter reflects on 2017 in Washington
Savannah Morning News-15 hours ago
As the only pharmacist in Congress, I take my position on this committee and the Health Subcommittee very seriously. This year in the subcommittee, we worked to modernize the Food and Drug Administration's (FDA) regulation of over-the-counter drugs. We held a hearing to examine patient access to investigational drugs
The other big drug problem: Older people taking too many pills
Greensboro News & Record-13 hours ago
Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and ...
Winnipeg-based Internet pharmacy pioneer facing charges in US ...
CBC.ca-5 hours ago
Internet pharmacist Kris Thorkelson will have to make a personal appearance in a U.S. court this spring to plead guilty and be sentenced in a case involving the alleged sale of counterfeit cancer drugs, court documents show. Federal prosecutors in the U.S. have accused Thorkelson, CanadaDrugs.com, and affiliated ..
Kmart Settles Prescription Drugs Allegations Brought By Ohio ...
WCBE 90.5 FM-11 hours ago
Kmart, part of Sears Holdings Corporation, was sued in 2008 by former company pharmacist James Garbe, who worked in Defiance. The whistleblower lawsuit alleged Kmart offered discounted prices to customers who paid in cash through club programs but failed to report those discounts to federal health programs such ...
Tulsa pharmacy's new packaging adds convenience, compliance
NewsOK.com-1 minute ago
Couch Pharmacy recently implemented a new automated compliance strip packaging system that eliminates the need for pill bottles and pill planners. The system packages all prescription and nonprescription medications together in perforated pouches for each time of the day. The packages are in sequential order, and ...
Council approves model agreement for compounding and ...
19 hours ago - Council has approved a model agreement required by Alberta-based pharmacies holding a Compounding and Repackaging Licence that compound or repackage drugs for pharmacies located in Saskatchewan. This model agreement is reasonably consistent with that previously provided when serving community ...
| Head to Head Review: Imprimis Pharmaceuticals (IMMY) versus Its Competitors
Imprimis Pharmaceuticals, Inc. (Imprimis) is engaged in the development, production and dispensing of compounded pharmaceuticals. The Company operates through the business of developing drug therapies and providing such therapies through sterile and non-sterile pharmaceutical compounding ...
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Friday, December 22, 2017
16 New Tennessee Laws For 2018
Patch.com-15 hours ago
Prescription drugs: The Board of Pharmacy is authorized to create a voluntary prescription drug donation program, allowing people to donate prescription drugs and supplies. The drugs must be in their original sealed, tamper-evident packaging and must be inspected before they are dispensed by a licensed
Kmart pays $35.3M to settle hard-fought whistleblower case alleging ...
Markets Insider-39 minutes ago
The "qui tam" (whistleblower) case – filed in 2008 by Phillips & Cohen on behalf of former Kmart pharmacist James Garbe – alleged that from 2004 to 2016 Kmart charged Medicare, Medicaid and Tricare as well as private insurers more for generic prescription drugs than it charged customers who paid cash. Pharmacies are ...
Ga. doctor prescribed weight-loss drug to patients she never saw
MyAJC-9 hours ago
In one particularly notable case, a Miami pharmacist received a nine-year prison sentence after orchestrating a scheme in which doctors wrote prescriptions for phentermine based on the answers to brief questionnaires submitted online. One of those who obtained the drug, a 46-year-old Texas woman, died of an overdose.
When it came to launching legal battles, Apotex founder Barry ...
Toronto Star-9 hours ago
Tom McAnulty, a pharmacist who formerly worked in the brand-name pharmaceutical industry, said that brand-name companies “detested” Sherman's litigiousness. “Barry was one of the most aggressive,” McAnulty said. “Apotex, they would challenge all sorts of rulings by the government.” But the pair of them personally got ..
Falls Drug pharmacist pleads guilty to one count, sentenced to ...
Rexburg Standard Journal-9 hours ago
According to Fica, the federal government charged Allen after it alleged he knowingly gave the painkiller Tramadol to an individual without a perscription on March 12, 2016, at his pharmacy, Falls Drug and Hardware, located at 23 N. Bridge St. in St. Anthony. The individual in question was an undercover informant.
Herpes trial on Americans without FDA oversight gets little response ...
Philly.com-7 hours ago
Compounding the problem, the U.S. is the only developed nation that does not guarantee care for those injured in trials, experts said. “In cases like these, in which subjects are claiming harm from a cuckoo experiment, the system is set up to punish the institution rather than give redress to the subject,” said NYU's Caplan.
Dangerous Fake Opioids A Concern For Law Enforcement
www.localmemphis.com-11 hours ago
Prosecution can get challenging since the fakes are not exactly illegal, compoundingon the already, far-reaching opioid epidemic. "The enforcement piece of that, how do we stop these people and hold them accountable? It's a moving targ
Thursday, December 21, 2017
High Importance!! Primus Pharmaceuticals, Inc. FDA Requested Recall Letter
Importance
| 12/18/2017 | 3006052875 | Primus Pharmaceuticals, Inc. | FDA Requested Recall Letter | AZ | 12/19/2017 |
Sound policy, more transparency can help companies fight opioid ...
Jackson County Newspapers-18 hours ago
Given that distributors like us are responsible for helping to deliver safely physician-prescribed medications to pharmacies, we have a unique perspective into how this supply chain works — and the ways it can be subverted by bad actors. This is why I know that what would be most effective would be better collaboration, ...
Community pharmacy: plans for the new year
Australian Journal of Pharmacy (blog)-21 hours ago
The recent pharmacy Barometer found that community pharmacy is slightly more positive than a year ago, but owners and staff are still concerned about challenges they face to secure their future, explains Mr Quilty. “Pharmacy owners and staff see the future of
$515 million sale of local pharmacy benefits firm wraps up
St. Louis Business Journal-9 hours ago
Diplomat Pharmacy Inc. has closed on its acquisition of St. Louis-based LDI Integrated Pharmacy Services for $515 million in cash and about $80 million in Diplomat stock. Flint, Michigan-based Diplomat bought LDI, a pharmacy benefit management firm, from investment firms Nautic Partners LLC and Oak HC/FT Partners ...
India pharma exports to touch $20 bln by 2020: study
Business Standard-14 hours ago
Indian pharmaceutical exports are likely to touch $20 billion by 2020 from the current level of around $16.5 billion, registering a compounded annual growth rate (CAGR) ... India is the third-largest global generic Active Pharmaceutical Ingredient (API) manufacturer in terms of market share and generic drugs form the largest ...
Compounders Who Skirt The FDA: Who Is The Expert Here?
Compounders Who Skirt The FDA: Who Is The Expert Here?
The National Law Review-6 hours ago
Is it true? According to Allergen, it's not. The statement in question is a claim made for a compounded drug. These drugs are not fully tested and approved by the FDA, combine active ingredients with FDA-approved drugs, and then claim superiority to them. Now it sits in the form of two lawsuits filed in California by Allergen
United States: FDA 2017 Year In Review: Therapeutic Products, Part 2
Mondaq News Alerts-8 hours ago
As alluded to above, FDA inspections of traditional compounders and outsourcing facilities continue be very high priority as the Agency seeks to reform the drug compounding industry under the congressional mandate that is the DQSA. Compliance Director Ashley's year-end presentation (see above) reported that, ...
FDA Clarifies Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle
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Wednesday, December 20, 2017
AmerisourceBergen makes push to curb opioid diversion, misuse
Pharmacy Today, American Pharmacists Association, pharmacist.com-12 hours ago
The health care distributor said that since 2007, it has provided DEA with daily reports of all opioid-based medication orders that include quantity, type, and receiving pharmacy, which it says has led to tens of thousands of halted shipments
Workers' comp firm dumping control of controversial mail-order ...
Philly.com-7 hours ago
Legal and medical ethicists say the lawyer-owned pharmacy could lead to conflicts of interest and drive up medical costs. Workers First has billed insurance carriers upward of $4,000 per tube of compounded pain cream, which are not approved by the Food and Drug Administration. “That's worrisome. They're sending ...
USP 800 Checklist: Priority Areas to Address
Pharmacy Times-11 hours ago
To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards. A presentation held at the ASHP 2017 Midyear Clinical Meeting and Exhibition provided an overview of the key steps pharmacists should take to improve their compounding practices.
Former presidents of pharmacist watchdog received questionable ...
MetroNews Canada-21 hours ago
McKesson's relationship with pharmacists has come under scrutiny in another part of Canada. In 2013, the wholesaler agreed to pay $40 million to Quebec's health insurance board after an investigation into a “compliance program” in which pharmacists stocked certain brands of generic medications in exchange for
Michigan cities, counties' opioid lawsuit targets drug companies ...
Fox News-4 hours ago
A pharmacist holds prescription painkiller Oxycontin, manufactured by Purdue Pharma, at a pharmacy in Provo, Utah, April 25, 2017. (Reuters). Nine cities and counties in Michigan have filed a lawsuit against 21 drug companies, distributors and pharmacies, accusing them of helping fuel the national opioid epidemic -- and ...
Florida city of Palmetto may join lawsuits against pharmacy ...
Pharmacy Today, American Pharmacists Association, pharmacist.com-57 minutes ago
Palmetto, FL, joined municipalities across Florida and the country in potentially filing a lawsuit against big pharmaceutical manufacturers and distributors for their alleged role in the current opioid epidemic. Palmetto, FL, joined municipalities across Florida and the country in potentially filing a lawsuit against big ...
Executives at NJ pharmacy that shipped tainted drugs avoid prison
Reuters-15 hours ago
Two executives of a New Jersey-based pharmacy that shut down after it distributed drugs containing mold to a Connecticut hospital in 2013, leading to a recall of all its products, avoided prison sentences on Tuesday. Federal prosecutors in Brooklyn had sought to have Gerald Tighe, Med Prep Consulting Inc's founder and ...
Independent Pharmacy Says Giant Insurer Shuts It Out
Courthouse News Service-13 hours ago
HOUSTON (CN) – A pharmacy owner claims the nation's largest health insurer, UnitedHealth Group, is trying to squeeze it out of the $100 billion specialty drug business, according to an antitrust lawsuit filed in federal court. Lead plaintiff Cedra Pharmacy Houston accuses UnitedHealth Group of blocking its new pharmacies ...
Tuesday, December 19, 2017
Designer drugs can only be fought if budget is increased, say ...
Telegraph.co.uk-1 hour ago
Sporting authorities need extra funding to tackle designer drugs, one of the world's leading experts in doping has said. Robin Parisotto, an Australian scientist who helped to develop one of the tests for EPO, told the Telegraph that if funds to detect drugs in sport were not increased, then doping “is never going to be reined ...
Google's Foreign Pharmacy Ad Ban Cut Traffic to Uncertified Drug ...
hcanews.com-20 minutes ago
In 2011, Google agreed to pay $500 million to the Justice Department (DOJ) for hosting advertisements for offshore (and sometimes unregistered or illegal) online pharmacies. The company subsequently banned advertising from pharmacies not registered with the National Association of Boards of Pharmacy (NABP) in ..
Focus on Safety Ahead of USP 800
Pharmacy Times-6 hours ago
Under USP <800>, all hazardous drugs must be stored and compounded in a room that has air pressure with a negative pressure of 0.01 to 0.03” to adjacent space, ... A Containment Segregated Compounding Area, CACl in negative room with 12 air changes per hour, and a BSC outside of cleanroom are also allowed if ...
Over dependence on drug imports from China harmful for India: IPCA
Economic Times-6 hours ago
The Indian Pharmaceutical Congress is a national annual event of pharmacist from all walks of pharmacy profession to deliberate various issues relating to industry, regulatory, academia, hospital and community pharmacy and to evolve collective wisdom for formulating newer policies for the country in the relevant fields ...
Here's where the nation's biggest drug lobby spent money in 2016
PBS NewsHour-1 hour ago
Facing bipartisan hostility over high drug prices in an election year, the pharma industry's biggest trade group boosted revenue by nearly a fourth last year and spread the millions collected among hundreds of lobbyists, politicians and patient groups, new filings show. It was the biggest surge for the Pharmaceutical ...
Mass. General Hospital Raises Red Flag About National Shortage ...
WBUR-14 hours ago
And the pharmacists adjusted too, Britton says — the small IV bags were in short supply, but they had large bags of fluid and the needed medications, so they started working overtime to mix the small bags themselves. "Our pharmacists started doing what we call compounding," he says. "[They] mix the medication ...
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