FDA In Brief: FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications

The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.

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HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs

https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html

07/23/2019

07/16/2019

Indoco Remedies Limited

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

7/23/2019

07/22/2019

Curaleaf, Inc

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

07/23/2019

07/02/2019

High Chemical Company, Div of National Generic Distributors

Division of Pharmaceutical Quality Operations I

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

07/23/2019

06/28/2019

Scientific Solutions Global LLC

Division of Pharmaceutical Quality Operations I

CGMP/Finished Pharmaceuticals/Adulterated

07/23/2019

06/26/2019

Westlab Pharmacy, Inc. dba Westlab Pharmacy

Office of Pharmaceutical Quality Operations, Division II

CGMP/Drug Products/Adulterat

07/30/2019

06/11/2019

Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc.

Division of Human and Animal Food Operations East I

CGMP/Dietary Supplement/Adulterated/Misbranded

Texas Board of Pharmacy Meeting August 6, 2019 Agenda Attached

AUGUST 6, 2019

AGENDA

Stonegate Pharmacy LP, Austin, TX., SRL dated 04/24/2019 - FDA

https://www.fda.gov/media/124964/download

Apr 24, 2019 - The purpose of this letter is to refer to the Texas State Board of Pharmacy (BOP) for appropriate follow up, the U.S. Food and Drug ...

Please watch Video Texas Pharmacy who compounded drug and made error left golf ball-sized hole in Leander woman’s arm Josselyn Stevens called the KVUE Defenders after the medicine she received left her with a hole in her arm.

https://www.kvue.com/article/news/investigations/defenders/pharmacy-error-left-golf-ball-sized-hole-in-leander-womans-arm/269-03e58e22-40ca-4dfc-9888-ec0548484433

Ex-medical sales rep in Arkansas-based Tricare scheme given 28 months in prison

Ex-medical sales rep in Arkansas-based Tricare scheme given 28 months in prison: A Tennessee man who is one of several former medical sales representatives accused of participating in an Arkansas-based scheme to defraud Tricare, the U.S. military's health insurer, was sentenced Wednesday to 28 months in federal prison.

Ex-medical sales rep in Arkansas-based Tricare scheme given 28 months in prison

Ex-medical sales rep in Arkansas-based Tricare scheme given 28 months in prison: A Tennessee man who is one of several former medical sales representatives accused of participating in an Arkansas-based scheme to defraud Tricare, the U.S. military's health insurer, was sentenced Wednesday to 28 months in federal prison.

The Death Penalty Is Already a Farce. William Barr’s Plan Might Make It Torturous. By Zak Cheney-Rice

http://nymag.com/intelligencer/2019/07/barr-death-penalty-pentobarbital.html

Latest News – The Horse

https://thehorse.com/news/

19 hours ago - Compounded Unapproved Drugs Linked to Three Horse Deaths. Jul 24, 2019 | Article, Equine Protozoal Myeloencephalitis (EPM), Horse Care, Horse Industry ..

Handling a critical drug shortage: The case of the effect of Hurricanes ...

https://advancingthescience.mayo.edu/2019/07/29/handling-a-critical-drug-shortage/

10 hours ago - Mayo Clinic pharmacy staff compounded (mixed) each patient's PN in custom preparations, as ordered by the care team, to meet individual needs based on ...

The effective date for USP <800> implementation is Dec. 1, 2019 - Safety

https://www.healthcarefacilitiestoday.com/.../The-effective-date-for-USP-800-impleme...

20 hours ago - However, USP 797 only serves as a guideline for sterile compounding and ... place, but also anywhere someone may come into contact with hazardous dr

Agency Information Collection Activities; Proposed ... - Federal Register

https://www.federalregister.gov/.../agency-information-collection-activities-proposed-...

13 hours ago - Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also presen

DOJ to Use Pentobarbital in Executions. Here's Why That's ...

https://time.com › U.S. › Courts

2 hours ago - Compounding pharmacies, which are companies that produce mixtures of drugs, are not as heavily regulated as drug manufacturers, and anti-death pen

FDA Invites Compounding Outsourcing Facilities' Comments

https://www.natlawreview.com/.../fda-invites-compounding-outsourcing-facilities-com...

3 hours ago - FDA Invites Compounding Outsourcing Facilities' Comme

Unsealed exhibits reveal pressure to push pills

https://www.columbiadailyherald.com/news/20190724/unsealed-exhibits-reveal-pressure-to-push-pills

Amazon’s PillPack Threatens Surescripts Lawsuit

https://www.managedhealthcareexecutive.com/news/amazons-pillpack-threatens-surescripts-lawsuit

Former Marine Pleads Guilty In Military Health Fraud Scheme Wednesday, July 24, 2019 By City News Service

https://www.kpbs.org/news/2019/jul/24/former-marine-pleads-guilty-in-military-health/

Feds accused a Wichita pharmacist of taking part in a drug conspiracy. Jurors agreed. BY AMY RENEE LEIKER

https://www.kansas.com/news/local/crime/article233072117.html

Wichita pharmacist convicted of unlawfully dispensing opioids

https://www.pratttribune.com/news/20190724/wichita-pharmacist-convicted-of-unlawfully-dispensing-opioids

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

https://www.jdsupra.com/legalnews/florida-board-of-pharmacy-initiates-57765/

Andover pharmacy under investigation for opioid dispensing

https://www.bostonglobe.com/business/2019/07/24/andover-pharmacy-under-investigation-for-opioid-dispensing/yBCeO3LE7WBq549RNVT9xN/story.html

Adamis Pharmaceuticals Provides Update on Litigation with Belcher Pharmaceuticals GlobeNewswire•July 24, 2019

https://finance.yahoo.com/news/adamis-pharmaceuticals-provides-litigation-belcher-130000544.html

Mandatory Public Drug Qua;ity Standards Increase Access to Biosimilars in Europe

https://www.usp.org/sites/default/files/usp/document/our-work/biologics/biosimilars-eu-white-paper.pdf

07/23/2019

07/22/2019

Curaleaf, Inc

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

07/23/2019

07/16/2019

Indoco Remedies Limited

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

07/23/2019

07/02/2019

High Chemical Company, Div of National Generic Distributors

Division of Pharmaceutical Quality Operations I

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety

Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

Today, the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. “As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to ...

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Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths

Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths

The U.S. Food and Drug Administration is alerting horse owners and veterinarians that one lot of a compounded combination drug product containing pyrimethamine and toltrazuril has been associated with adverse events in at least three horses. Two horses in Maine and one in Ohio ultimately died or were euthanized as a result.

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For all the compounding pharmacies that have received a 483 from the FDA the last several years what, if anything, have state boards of pharmacy done to fine or followup with these pharmacies? For state boards of pharmacy who have received referral letters from the FDA, how many of these pharmacies have state enforcement action been taken against? Are state boards of pharmacy doing a better or worse job since the DQSA was passed?

These pharmacies distributed the most opioids in Houston-area counties, according to DEA report Peter Dawson , Chron.com / Houston Chronicle July 21, 2019

https://www.houstonchronicle.com/news/houston-texas/houston/article/Top-opioid-drug-stores-in-counties-in-Harris-14108780.php

Company sent nearly 5 million opioids to a pharmacy in a town of only 1,400 people

https://wtvr.com/2019/07/20/miami-luken-indicted-sent-nearly-5-million-opioids-to-springboro-ohio/

Exclusive: Canada warns U.S. against drug import plans, citing shortage concerns

https://www.reuters.com/article/us-canada-pharmaceuticals-exports-exclus/exclusive-canada-warns-u-s-against-drug-import-plans-citing-shortage-concerns-idUSKCN1UD2LN

Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions

The U.S. District Court for the Western District of Arkansas ordered J and L Grocery, LLC. of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne, to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. According to the amended complaint, J and L Grocery held FDA-regulated products under insanitary conditions in which they may have become contaminated with filth, including widespread insect, rodent and other live animal infestation, in violation of federal law. “U.S. consumers rely on the oversight and inspection efforts of the FDA to ensure that their foods and medical products are safe. We will not tolerate insanitary conditions at facilities—like J and L Grocery— that serve U.S. consumers. Product safety at all points in the supply chain must be a high priority, and distributors have a critical responsibility to ensure products are kept safe for Americans to consume or use,” said FDA Acting Commissioner Ned Sharpless, M.D. “When adulterated products make their way into the U.S. marketplace, it places consumers at risk. The FDA will continue our vigorous oversight and will take action to prevent the distribution of potentially contaminated products to the American people.”

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Ohio lawmakers vote to decriminalize CBD oil, hemp ... - Springfield

https://www.springfieldnewssun.com/news/local/.../TrQ7RmK6BIAKeLkbpBRceK/

4 hours ago - Under current state law, hemp is considered a Schedule I drug because it ... and it would further prohibit the state's Board of Pharmacy from listing hemp as a ..

State of Pharmacy? (For new grads) : pharmacy - Reddit

https://www.reddit.com/r/pharmacy/comments/.../state_of_pharmacy_for_new_grads/...

20 hours ago - My pharmacist was telling me to consider changing my major before I get too far in ... I sometime blame our board for allowing a Max if 5 tries on a Naplex

Excellent Resource: Missouri Board of Pharmacy Practice Guide

Board of Pharmacy Practice Guide - Missouri Division of Professional ...

https://pr.mo.gov/boards/pharmacy/practiceguide.pdf

No information is available for this page.

USP <795>, <797>, <800>-Delayed Compliance Application Process ...

https://pharmacy.iowa.gov/press.../2019.../usp-delayed-compliance-application-proces...

22 hours ago - As of 12/1/19, the Iowa Board of Pharmacy will require full compliance with United States Pharmacopoeia (USP) General Chapters <795>, <797>, and <800