The Law of Compounding Medications And Drugs

Thursday, May 24, 2018

FDA warns teething medicines are unsafe, wants them off shelves

WKRN News 2-13 hours ago

Orajel is displayed for sale in a pharmacy in New York Wednesday, May 23, 2018. (AP Photo/Stephanie Nano). FDA warns teething medicines are unsafe, ...

FDA targets teething medicines
Leader-Telegram-17 hours ago

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Ohio Delays Awarding Licenses To Medical Marijuana Dispensaries

WOSU-4 hours ago

The Ohio Board of Pharmacy said it canceled Wednesday's special meeting two days after it was announced because information gathering was incomplete.

DEA targets opioid crisis with Operation Safe Haven

The Pioneer News-2 hours ago

In conjunction with Operation Safe Haven's enforcement activities, DEA Diversion Investigators visited more than 100 pharmacies in 70 cities throughout .

Views Why Trump's drug plan fails employers

Employee Benefit Adviser-13 hours ago

We add employers to this list of those not benefiting, as pharmacy spend is one of the ... and PBMs, wholesalers, pharmacies and pharmaceutical manufacturers.

Kickback Allegation Settlements Pile Up for Pharmaceutical Companies

Regulatory Focus-6 hours ago

Omnicare, a nursing home pharmacy, also in 2016 agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks from Abbott ...

Department of Justice, CVS Caremark, Fraud and Whistleblowers

American Council on Science and Health-8 hours ago

They control 26% of pharmacy benefit manager (PBM) market serving 3,150,000 Medicare beneficiaries. A specific subsidiary, SilverScript is the CVS ...

Former Hillsboro doctor gets five years

Hillsboro Times Gazette-43 minutes ago

According to the State of Ohio Board of Pharmacy, the case began with a joint investigation between the pharmacy board, the Drug Enforcement Agency, the .

New bill aims to make sure Medicare customers get drug discounts

Washington Examiner-1 hour ago

A bipartisan House bill would require discounts for drugs in Medicare's prescription drug program to be applied when the medicine is bought at the pharmacy, ..

Mountain pharmacy owners charged in drug-trafficking scheme

TheSpec.com-21 hours ago

It's not quite business as usual at a Mountain pharmacy that's the subject of an RCMP probe into alleged opioid trafficking. But customers can still fill their

NASP Applauds Bipartisan Legislation Introduced to Reduce Drug ...

PR Newswire (press release)-3 hours ago

The Phair Pricing Act of 2017 ensures that medication savings are passed along to seniors at the pharmacy counter and not otherwise used to manipulate drug ..

Missouri bill will protect customers from overpaying on prescriptions

KSHB-28 minutes ago

Pharmacy benefits managers negotiate drug prices for insurance companies. The intention is to help insurance companies get certain drugs for cheaper rates.

Federal Circuit Issues Two Decisions Impacting Standing to Challenge Validity of Pharma Patents Patterson Belknap Webb & Tyler LLP

https://www.lexology.com/library/detail.aspx?g=78916daa-1523-4108-9884-daa13ee0c0c6

A New Era of Compounding Pharmacies in Massachusetts

A New Era of Compounding Pharmacies in Massachusetts - High ...

https://www.high-profile.com/a-new-era-of-compounding-pharmacies-in-massachusetts/

7 hours ago - by Susie Festel. A meningitis outbreak in 2012 was traced back to contaminated drugs coming from a bulk prescription compounding company, New England ...

Must Read!! Athlete Advisory: What athletes need to know about Pharmacy--Compounded Drugs

Athlete Advisory: What athletes need to know about Pharmacy ... - Usada

https://www.usada.org/athlete-advisory-pharmacy-compounding/

16 hours ago - Compounded drugs may be more susceptible to human error than commercially manufactured drugs, which can result in lower or higher than expected doses, or completely different medications than intended.

Pfizer Settles Kickback Case Related To Drug Copay Assistance For ...

https://www.usatoday.com/.../pfizer-settles...copay-assistance-kickback.../641736002/

3 hours ago - Pfizer will pay the government nearly $24 million as part of a settlement to resolve allegations that it funneled money through a foundation ...

Missing: m

How fake drugs can make you sicker — even if you never take them The Verge

How fake drugs can make you sicker — even if you never take them
The Verge

Bitter Pills follows the global, and growing, problem of counterfeit medicine Read the full story

Wednesday, May 23, 2018

Verrica seeks $86M IPO to take on compounded dermatology drug ...

https://www.fiercebiotech.com/.../verrica-seeks-86m-ipo-to-take-compounded-dermat...

18 hours ago - Biopharma is a fast-growing world where big ideas come along daily. Successful execution of the strategy would likely see Verrica sell its product for a significantly higher price than is charged by compounding pharmacies.

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The Food and Drug Administration announced today that the Center for Veterinary Medicine (CVM) is evaluating the design of studies intended to support the standard of substantial evidence of effectiveness for new animal drugs to prevent heartworm disease in dogs. Currently, there are gaps in knowledge that prevent the FDA from fully evaluating which alternative approaches are suitable for meeting the standards of effectiveness. The need to evaluate alternative approaches is emphasized by the evolving susceptibility of Dirofilaria immitis larvae to heartworm preventatives containing macrocyclic lactones.

Read entire press release.

Tuesday, May 22, 2018

Texas Board of Pharmacy Minutes from meeting held on FEBRUARY 6, 2018

MINUTES

Texas Board of Pharmacy Agenda from Meeting Held on May 1, 2018

MAY 1, 2018

AGENDA

Aborn Pharmacy, PHY 43166, Administrative Case AC 6300
San Jose, CA
Accusation Filed 3/9/2018; Case pending.
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Alisal Pharmacy, PHY 50019, Administrative Case AC 5851
Salinas, CA
Second Amended Accusation Filed 3/5/2018; Case pending.
View the accusation

Care Rx Pharmacy, PHY 51049, Administrative Case AC 5903
Fresno, CA
Accusation Filed 3/8/2018; Case pending.
View the accusation

Kohana Pharmacy and Center for Regenerative Medicine, PHY 50264, Administrative Case AC 5556
San Luis Obispo, CA
Second Amended Accusation Filed 3/28/2018; Case pending.
View the accusation

Mid Valley Health Services, PHY 37093, Administrative Case AC 6241
Ceres, CA
Accusation Filed 3/30/2018; Case pending.
View the accusation

Mid Valley Health Services, LSC 100004, Administrative Case AC 6241
Ceres, CA
Accusation Filed 3/30/2018; Case pending.
View the accusation

Nuevo Pharmacy, PHY 50826, Administrative Case AC 6347
Perris, CA
Accusation Filed 3/30/2018; Case pending.
View the accusation

Park Compounding Inc., PHY 53360, Administrative Case AC 6271
Irvine, CA
Accusation Filed 3/28/2018; Case pending.
View the accusation

Park Compounding Inc., LSC 100771, Administrative Case AC 6271
Irvine, CA
Accusation Filed 3/28/2018; Case pending.
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Pharmacy Resources Incorporated, NSC 99697, Statement of Issues Case AC 6091
Denver, CO
Statement of Issues Filed 3/9/2018; Case pending.
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Riverwalk Pharmacy, PHY 49858, Administrative Case AC 6239
Riverside, CA
Accusation Filed 3/11/2018; Case pending.
View the accusation

Sierra Nevada Memorial Hospital Pharmacy, HSP 20878, Administrative Case AC 6247
Grass Valley, CA
Accusation Filed 3/30/2018; Case pending.
View the accusation

Sierra Nevada Memorial Hospital Pharmacy, LSC 100095, Administrative Case AC 6247
Grass Valley, CA
Accusation Filed 3/30/2018; Case pending.
View the accusation

Specialty Compounding Pharmacy, PHY 48534, Administrative Case AC 5691
Sherman Oaks, CA
Accusation Filed 3/11/2018; Case pending.
View the accusation

Tustin Community Pharmacy, PHY 30023, Administrative Case AC 6160
Tustin, CA
Accusation Filed 3/12/2018; Case pending.
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05/09/2018	Montana Compounding Pharmacy PC	Los Angeles District Office	Compounding Pharmacy/Adulterated Drug Products	Not Issued

05/09/2018	Nox Bellcow Cosmetics Co. Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued

05/15/2018	Cerno Pharmaceutical	Dallas District Office	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *

05/18/2018	Front Range Kratom	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *

05/18/2018	Pharmacy Direct, PDU	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued

05/18/2018	GliSODin Skin Nutrients	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *

05/18/2018	Revibe, Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *

05/18/2018	Kratom Spot	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *

05/18/2018	Sunergized LLC	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *

ADHD medication poisonings, abuse increasing, says study

Washington Times-13 hours ago

A pharmacist at Marquier's Pharmacy in Newark, N.J., holds a bottle of the prescription drug Ritalin on March 26, 1996. Ritalin, manufactured by Ciba

Commissioner Gottlieb's Proposals on Drug Prices Need To Be ...

American Council on Science and Health-10 hours ago

... patient for a drug is difficult to obtain, there is no database to access and the closest person to knowing the price for the patient, the pharmacist, is prohibited by .

Hamilton pharmacist charged with trafficking opioids

CBC.ca-4 hours ago

A Hamilton pharmacist is facing charges in connection with diverting powerful prescription painkillers and selling them, the RCMP announced Tuesday

House committee OKs crackdown on pharmacy-benefit managers

The Columbus Dispatch-7 hours ago

A House committee Tuesday recommended passage of bipartisan legislation aimed at lowering drug prices by targeting little-known middlemen in the pharmacy ...

A pharmacy startup is alleging its former business partner is a 'peddler ...

Business Insider-9 hours ago

Pharmacy startup Blink Health's lawsuit with its former business partner MedImpact is heating up. In a new complaint filed Monday night, Blink Health alleged ...

Court Filing Accuses MedImpact of Fueling Opioid Crisis & Blocking ...
Business Wire (press release)-8 hours ago

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High Importance!! Former Valeant Pharmaceuticals International Inc. executive Gary Tanner was found guilty of accepting a $10 million bribe for manipulating the company's ...

Ex-Valeant Executive Guilty of Taking Pharmacy CEO's Bribe

Bloomberg-11 hours ago

Former Valeant Pharmaceuticals International Inc. executive Gary Tanner was found guilty of accepting a $10 million bribe for manipulating the company's ...

Ex-Valeant executive found guilty of taking pharmacy CEO's bribe
The Globe and Mail-11 hours ago

The CEO of Valeant's secret pharmacy and a former Valeant ...
Business Insider-10 hours ago

Former Valeant executive is found guilty in kickback scheme
STAT-7 hours ago

Ex-Valeant, Philidor executives convicted of kickback scheme
Highly Cited-Reuters-11 hours ago

Worsening drug shortages leave providers scrambling for alternatives

ModernHealthcare.com-May 21, 2018

"It is probably worse than it appears because the pharmacy deals with so much in ... Cleveland Clinic plans to build a 503B-compliant compounding facility tha

FDA Eyes Limits on 503B Bulk Substances List

Pharmacy Practice News-8 hours ago

An FDA draft guidance limiting the bulk drug substances that 503B facilities can use in compounding may trigger several unintended consequences, including a .

USP Compliance Opens Door to Pharmacy Redesign

Pharmacy Practice News-8 hours ago

For some institutions, renovations have been limited to the sterile compoundingspace, but in others, the new guidelines have provided an impetus to take on the.

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.Continue reading.

Deadly Chinese Fentanyl Is Creating a New Era of Drug Kingpins
Bloomberg

The opioid’s potency has transformed the global trafficking — and policing — of narcotics. Yan is accused of trafficking fentanyl on an industrial scale out of factories, but the drug's potency makes it as easy as dealing it from a living room. Outside the gates of a residential complex called Oak Bay, a construction frenzy tears up the central Chinese city of Wuhan, a metropolis of 11 million racing to catch up with Beijing and Shanghai. The aural assault of jackhammers and cement trucks fades Read the full story

New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada

Posted: 21 May 2018 07:38 PM PDT

By Serra J. Schlanger & Alan M. Kirschenbaum —

On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the Vermont Agency of Human Services (VAHS) to design a wholesale prescription drug importation program that complies with federal drug importation laws (21 U.S.C. § 384), including requirements for safety and cost savings. The program must: