Texas Board of Pharmacy Meeting Scheduled for November 5, 2019

Details of the upcoming meeting are as follows:

Date: November 5, 2019

Time: 9:00 a.m. – Conclusion

Location: William P. Hobby, Jr. Building, 333 Guadalupe Street, Suite 2-225, Austin, Texas 78701

Materials: Posted here when available

Another Chinese threat to our national security: Prescription drugs BY TOM JUROWSKY, OPINION CONTRIBUTOR — 10/28/19 11:00 AM EDT 113THE VIEWS EXPRESSED BY CONTRIBUTORS ARE THEIR OWN AND NOT THE VIEW OF THE HILL

https://thehill.com/opinion/healthcare/467246-another-chinese-threat-to-our-national-security-prescription-drugs

10/29/2019	08/22/2019	TopVapors.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/29/2019	09/27/2019	Black Axis Juice Company LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/29/2019	10/17/2019	PETNET Solutions Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
10/29/2019	10/25/2019	E-Cigarette-Mart.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Workplace Laws Your Employer May Be Violating Here are some of the employee rights your boss may be breaking, either intentionally or inadvertently.

https://money.usnews.com/careers/articles/workplace-laws-your-employer-may-be-violating

FDA statement on root causes and potential solutions to drug shortages

One of the U.S. Food and Drug Administration’s top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our public health partners and industry to minimize their impact on patients and restore the availability of these drugs. A shortage of just one critical drug can have a major impact on a patient’s health, which underscores why government and industry need to act quickly to prevent future shortages. Today the FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions,” that attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs, but many of the same concerns apply to veterinary medicines used to treat service, companion, and food-producing animals.

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Federal Law Enforcement Action Involving Fraudulent Genetic Testing Results in Charges Against 35 Individuals Responsible for Over $2.1 Billion in Losses in One of the Largest Health Care Fraud Schemes Ever Charged

https://www.floridatrend.com/article/27961/federal-law-enforcement-action-involving-fraudulent-genetic-testing-results-in-charges-against-35-individuals-responsible-for-over-21-billion-in-losses-in-one-of-the-largest-health-care-fraud-schemes-ever-charged

Federal Health Care Fraud Takedown In Northeastern U.S. Results In 54

Federal Health Care Fraud Takedown In Northeastern U.S. Results In 54

Vance AFB Major Pleads Guilty to Kickbacks Involving Compounding Pharm

Vance AFB Major Pleads Guilty to Kickbacks Involving Compounding Pharm

16-Count Superseding Indictment Charges Owner Of Pain MD And Three Med

16-Count Superseding Indictment Charges Owner Of Pain MD And Three Med

Air Force Nurse, a Major, Pleads Guilty to Pharmacy Kickback Scheme
A nurse at Vance Air Force Base in Oklahoma on Oct. 15 pleaded guilty to a criminal health care fraud scheme, in which she accepted hundreds of thousands of dollars in kickbacks for referring patients to pharmacies offering compounded drugs. Air Force Times

HHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules

https://www.jdsupra.com/legalnews/hhs-s-regulatory-sprint-to-coordinated-66903/

Investigations Newsletter: DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases LinkedIn

https://www.jdsupra.com/legalnews/investigations-newsletter-doj-issues-25927/

Greer denies change of venue in alleged massive prescription drug fraud case By Robert Moore Tribune Staff Writer Oct 23, 2019 Updated Oct 23, 2019

https://www.citizentribune.com/news/local/greer-denies-change-of-venue-in-alleged-massive-prescription-drug/article_6ee4b9d2-f5ad-11e9-9e10-c3eb8cf46596.html

Duo in multi-million prescription fraud ask for reduced sentence

https://www.citizentribune.com/news/local/duo-in-multi-million-prescription-fraud-ask-for-reduced-sentence/article_ff8b0d0e-f672-11e9-ad0f-1f79424f52da.html

Officer at Vance pleads guilty to health care fraud By James Neal | CNHI News Oklahoma Oct 17, 2019 Updated Oct 18, 2019

https://www.normantranscript.com/oklahoma/news/officer-at-vance-pleads-guilty-to-health-care-fraud/article_3ce74173-d67f-548a-b447-20d74baa4fc0.html

IN BRIEF: Ex-employees of pharmacy in 2012 meningitis outbreak lose acquittal bids Nate Raymond 1 MIN READ

https://www.reuters.com/article/health-meningtis/in-brief-ex-employees-of-pharmacy-in-2012-meningitis-outbreak-lose-acquittal-bids-idUSL2N27225Y

20 CSR 2220-2.200 - Missouri Secretary of State

https://www.sos.mo.gov › cmsimages › adrules › csr › current

15 hours ago - any prescribed drug, medicine or poison compounded or dispensed by a person other than a licensed pharmacist. (C) No pharmacy shall be licensed under

PCCA Names Jasper Lovoi III, PharmD, RPh, as the 2019 ...

https://www.businesswire.com › news › home › PCCA-Names-Jasper-Lovo...

7 hours ago - HOUSTON--(BUSINESS WIRE)--PCCA has named Jasper Lovoi III, PharmD, RPh, of The Woodlands Compounding Pharmacy in Shenandoah, Texas, as its M. George Webber, PhD, 2019 Compounding Pharmacist of the Year and has awarded Co

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock. M.D., on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely available in the marketplace. Homeopathic products, however, are marketed without FDA review and may not meet modern standards for ...

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FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases. “Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and...

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10/22/2019

10/11/2019

DSM Nutritional Products, LLC

Division of Human and Animal Food Operations West III

Adultered Animal Food/Misbranded

10/22/2019

10/10/2019

Rooted Apothecary LLC

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

10/22/2019

09/30/2019

OTT Enterprises, LLC d/b/a Tobacco Barn

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

10/22/2019

09/27/2019

James Audi d/b/a The Broke Smoker

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

10/22/2019

09/10/2019

Jiangsu NHWA Pharmaceutical Co., Ltd.

Center for Drug Evaluation and Research

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

10/22/2019

08/22/2019

Busscatello Enterprises LLC d/b/a Route 66 Vapes

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

10/22/2019

08/22/2019

VapeLoft Inc.

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

0/22/2019

07/12/2019

Bowser Trading Corporation d/b/a High Seas E Liquid Trading Company

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

10/22/2019

06/04/2019

Paisley Farms, LLC dba Paisley Farm & Crafts

Division of Human and Animal Food Operations East V

CGMP/Dietary Supplement/Adulterated/Misbranded

Four drug companies reach a last-minute $260 million opioid settlement with two Ohio counties PUBLISHED MON, OCT 21 20198:14 AM EDTUPDATED MON, OCT 21 20192:29 PM EDT

https://www.cnbc.com/2019/10/21/four-drug-companies-reach-a-settlement-as-opioid-trial-was-set-to-begin.html

United States: FDA Partners With The National Association Of Boards Of Pharmacy To Create An Information-Sharing System For Drug Compounding Activities

United States: FDA Partners With The National Association Of Boards Of Pharmacy To Create An Information-Sharing System For Drug Compounding Activities

Reed Smith

On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP)

Independent pharmacies being driven out of business by ‘predatory middlemen’ | Opinion By RON PATEL SPECIAL TO THE SUN SENTINEL | OCT 21, 2019 | 6:00 AM

https://www.sun-sentinel.com/opinion/commentary/fl-op-com-patel-independent-pharmacies-business-pbm-20191021-rwhhydjgnvehxlvcdy47ncfvge-story.html

Flint-based Diplomat Pharmacy sells subsidiary assets to pay down debt KURT NAGL

https://www.crainsdetroit.com/health-care/flint-based-diplomat-pharmacy-sells-subsidiary-assets-pay-down-debt

NJ, NY pharmacy owner convicted of defrauding IRS MyCentralJerseyPublished 4:30 p.m. ET Oct. 21, 2019

https://www.mycentraljersey.com/story/news/crime/2019/10/21/piscataway-nj-bronx-ny-pharmacy-owner-convicted-defrauding-irs/4056903002/

Baby powder manufacturer voluntarily recalls products for asbestos FDA advises consumers to stop using affected products

Baby powder manufacturer voluntarily recalls products for asbestos

FDA advises consumers to stop using affected products

The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Consumers who have Johnson’s Baby Powder lot #22318RB should stop using it immediately and contact Johnson & Johnson for a refund. The FDA stands by the quality of its testing and results and is not aware of any adverse events relating to exposure to the lot of affected products. During talc mining, if talc mining sites are not selected carefully and steps are not taken to purify the talc ore sufficiently, the talc may be contaminated with asbestos. Asbestos is a known carcinogen. It is ...

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CDC: 200 More Vape Illnesses in a Week

As flu season begins, agency wants docs to ask patients with URI symptoms about vaping history FULL STORY

Teva's $15B free drug opioid settlement might be a great deal in the long run: analyst

Thursday, October 17, 2019

Instead of fighting it out in court, Teva is reportedly offering $15 billion in free drugs to escape a massive opioid litigation in Cleveland that has ensnared some of the industry’s biggest players.

FDA is expanding criminal enforcement operations!!

Expanding Criminal Enforcement Operations Globally to Protect Public Health

The American public relies on the U.S. Food and Drug Administration to help ensure the quality and safety of FDA-regulated products available to consumers, many of which are sourced or manufactured overseas. As the volume of globally produced products and suppliers expands daily, the risk of fraudulent, intentionally adulterated, and/or other illegal products shipping into the U.S. also increases. Every day, thousands of illicit products are shipped to the U.S. from overseas, across the spectrum of things the FDA regulates, including unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products. These products can be outright forgeries of items produced for the American market, as well as “gray market” products manufactured for use in another country but shipped illegally to the U.S.  These products are unsafe: they may contain contaminants or be adulterated, and are not shipped and handled under conditions designed to preserve product stability and sterility.

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Man is dead after pharmacy medication mix-up Updated: Oct 15, 2019 - 6:02 PM

https://www.fox13memphis.com/top-stories/man-is-dead-after-pharmacy-medication-mix-up/997776393

Mississippi pain cream scheme: Court papers show businessman's ties to pharmaceuticals lab Lici Beveridge, Mississippi Clarion LedgerPublished 10:17 a.m. CT Oct. 15, 2019 | Updated 12:54 p.m. CT Oct. 15, 2019

https://www.hattiesburgamerican.com/story/news/crime/2019/10/15/pharmacist-doyle-beach-partner-pharmaceuticals-lab/2433550001/

10/15/2019	08/20/2019	Vanilla Vapes Limited	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/15/2019	09/24/2019	JUSTFOG USA YB Sales, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/15/2019	09/27/2019	North Texas Vapor Shop	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/15/2019	09/30/2019	Freshvaping.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

10/15/2019

10/01/2019

The Skin Atelier, Inc. d.b.a. Skinprint

Division of Pharmaceutical Quality Operations I

CGMP/Finished Pharmaceuticals/Adulterated

10/15/2019

10/03/2019

Glenmark Pharmaceuticals Limited

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

10/15/2019

10/04/2019

Herbal Doctor Remedies

Division of Pharmaceutical Quality Operations IV

CGMP/Finished Pharmaceuticals/Adulterated

10/15/2019

10/08/2019

Torrent Pharmaceuticals Limited

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

10/15/2019

10/09/2019

Coral Pharmaceuticals LTD

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated