Tuesday, September 17, 2019

Buderer Drug Company, Avon, OH. 483 Issued 02/14/2019
California Specialty Pharmacy Inc., Whittier, CA. 483 Issued 05/17/2019
Colonia Care Pharmacy, Colonia, NJ. 483 Issued 04/29/2019
Complete Pharmacy and Medical Solutions, LLC dba Complete Pharmaceutics, Miami Lakes, FL. 483 issued 01/23/2019
Compound Care Pharmacy, Louisville, KY. 483 Issued 05/16/2019
Custom Compounding Center, Little Rock AR. 483 issued 06/04/2019
ImprimisRx, Ledgewood, NJ., 483 Issued 04/09/2019
Nubratori Inc. dba Nubratori Rx, Torrance, CA. FMD-145 Letter dated 05/15/2019
Pacifico National, Inc. dba AmEx Pharmacy, Melbourne, FL. 483 issued 05/31/2019
Pharmacy Plus, Inc. dba Vital Care Compounder, Hattiesburg, MS. 483 issued 05/16/2019
Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy, Poulsbo, WA. 483 Issued 04/17/2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center, Federal Way, WA. 483 Issued 06/13/2019
QuVa Pharma, Inc., Bloomsbury, NJ. 483 Issued 05/31/2019
Rancho Park Compounding Pharmacy, Los Angeles, CA. 483 Issued 05/07/2019
Total Vein Pharmacy LLC dba Total Vein Pharmacy, Houston, TX. 483 issued 05/09/2019

Monday, September 16, 2019

18 NJ Docs, Nurse Now Face Opioid, Sex Or Other Criminal Probes

https://patch.com/new-jersey/wayne/18-nj-docs-nurse-now-face-opioid-sex-or-other-criminal-probes

FDA to Participate in National Institutes of Health 2019 Pain in Animals Workshop

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is announcing its upcoming participation in the 2019 Pain in Animals Workshop to be held on October 2-3, 2019. The workshop is hosted by the National Institutes of Health and held at Natcher Conference Center, 10 Center Dr, Bethesda, Maryland 20814.

The conference will focus on the measurement of acute pain across species and will promote the translational benefit to humans and animals in hopes of advancing the need to better assess and measure acute pain across species.  This workshop is intended to help accelerate the discovery and approval of safe and effective non-opioid pain therapies for both people and animals.

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/krs-global-biotechnology-inc-issues-voluntary-nationwide-recall-all-human-and-animal-sterile-drug-0?utm_campaign=CDER%20New%2009%2F16%2F2019&utm_medium=email&utm_source=Eloqua&elqTrackId=c5293f5562dc47918f7c8b814a226d17&elq=b0db40cad1de4454ae0ef600d5b6a923&elqaid=9471&elqat=1&elqCampaignId=7877

Purdue in Chapter 11

https://www.cnbc.com/2019/09/16/oxycontin-maker-purdue-pharma-files-for-bankruptcy-protection.html

Wednesday, September 11, 2019

Putnam County pharmacist found guilty of illegally dispensing pain medications

https://www.wdtv.com/content/news/Putnam-County-pharmacist-found-guilty-of-illegally-dispensing-pain-medications-560042171.html

Why Canada can't be America's pharmacy Canada doesn't have enough drugs to share, and it doesn't want that role

https://www.washingtontimes.com/news/2019/sep/11/why-canada-cant-be-americas-pharmacy/

It just got very hard for Amazon’s online pharmacy to access patient medication data PUBLISHED WED, SEP 11 2019 10:09 AM EDT

https://www.cnbc.com/2019/09/11/surescripts-makes-it-difficult-for-amazon-pillpack-to-access-patient-data.html

Feds Warns CBD Marketers Again — Pain News Network

Feds Warns CBD Marketers Again — Pain News Network: By Pat Anson, PNN Editor The Federal Trade Commission (FTC) has warned three companies that sell cannabidiol (CBD) oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses. In letters to the companies, which the FTC is not id

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products FDA compliance policy would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes

Today, the Trump Administration announced that as part of its ongoing work to tackle the epidemic of youth e-cigarette use, the FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said Health and Human Services Secretary Alex Azar. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Today’s announcement comes as ...

Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance


CVM is sharing this recall announcement because these products went to veterinary distributors.

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.

In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot.

BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

OWNERS OF PASCO MARKETING FIRM PLEAD GUILTY TO HEALTHCARE-RELATED PLOT TBadmin | September 11, 2019: They used profits from the conspiracy to buy, among other things, luxury cars, including a Bentley Continental; a Lamborghini Aventador; a Maserati, and a Fisker Karma, according to the U.S. Attorney’s Office.

http://www.tbreporter.com/courts/owners-of-pasco-marketing-firm-plead-guilty-to-healthcare-related-plot/

Tampa Bay Residents Plead Guilty To Healthcare Kickback Conspiracy By SUSAN GILES WANTUCK • 20 SECONDS AGO

https://wusfnews.wusf.usf.edu/post/tampa-bay-residents-plead-guilty-healthcare-kickback-conspiracy

United States: Recent Traction In FDA's Development Of The 503A And 503B Bulks Lists Last Updated: September 11 2019 Article by Rachael G. Pontikes and Kelly A. Kearney Reed Smith

https://www.lifescienceslegalupdate.com/2019/09/articles/regulatory-developments/recent-traction-in-fdas-development-of-the-503a-and-503b-bulks-lists/?utm_source=Mondaq&utm_medium=syndication&utm_campaign=View-Original

FDA Bulk Drug List Updates Could Lead To Litigation

Law360 (September 11, 2019, 2:37 PM EDT) -- Just as the U. S. Food and Drug Administration promised https://www.law360.com/health/articles/1197546/fda-bulk-drug-list-updates-could-lead-to-litigation

Purdue Pharma tentatively settles thousands of opioid cases


https://www.msn.com/en-us/money/companies/purdue-pharma-tentatively-settles-thousands-of-opioid-cases/ar-AAH9ojF?ocid=spartanntp

Monday, September 9, 2019

Wyoming State Board of Pharmacy September 2019 Newsletter

September

Tennessee Board of Pharmacy September 2019 Newsletter

September

North Dakota State Board of Pharmacy September 2019 Newsletter

September

New Mexico Board of Pharmacy September 2019 Newsletter

September

Kentucky Board of Pharmacy September 2019 Newsletter

September

Kansas State Board of Pharmacy September 2019 Newsletter

September

Idaho Board of Pharmacy September 2019 Newsletter

September

CBD is everywhere, but is it legal? Here’s what you need to know. Sep. 4, 2019 at 6:00 am

https://www.seattletimes.com/explore/shop-northwest/cbd-is-everywhere-but-is-it-legal-heres-what-you-need-to-know/

Hearing delayed for Ruidoso trainer accused of doping; here's how the drugs affect horses Pamela L. Bonner, Ruidoso NewsPublished 7:00 a.m. MT Sept. 6, 2019 Performance-enhancing drugs like Albuterol often mask pain, allowing horses to race and train with injuries that would otherwise be too painful to run on, experts say.

https://www.ruidosonews.com/story/news/local/community/2019/09/06/ruidoso-horse-trainer-trey-wood-hearing-delayed-doping-case-albuterol/2028880001/

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation 
Today, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA’s ongoing investigation related to JUUL.

“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or...

September 9, 2019 Improving Adverse Event Reporting for Compounded Drugs Julie Dohm, JD, PhD1; Jenny Kim, PharmD, BCPS1; Janet Woodcock, MD1

Viewpoint

JAMA Intern Med. Published online September 9, 2019. doi:10.1001/jamainternmed.2019.3830
During a routine inspection unrelated to compounded drugs, US Food and Drug Administration (FDA) investigators found records of 4202 adverse events, none of which had ever been reported to the agency.1 The reports, kept in a company-generated data file, concerned the possible association of compounded hormone pellets marketed by BioTE Medical (BioTE) with cancers (including endometrial and prostate cancers), strokes, heart attacks, deep vein thrombosis, cellulitis, and pellet extrusions, as well as adverse events known to be caused by supratherapeutic hormone concentrations.
The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is hosting its 2nd Annual Exploratory Workshop on September 19, 2019.  The title of the Workshop is Privacy and Health Research in a Data-Driven World.  It will be webcast live and recorded, and is available free of charge. 
The Workshop will explore issues around conceptions of privacy, ways to protect data confidentiality, and how IRBs and review bodies can learn more about protections and ethical oversight of important research.
Sessions will include:
•            Is Privacy a Casualty of Advancing Research?
•            Approaches to Protecting Privacy and Confidentiality
•            Protecting Privacy and Confidentiality: A Shared Responsibility

Extremely Important!! Statement from Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on improving adverse event reporting of compounded drugs to protect patients

For Immediate Release:
Statement From:
Director - Center for Drug Evaluation and Research
Janet Woodcock M.D.
Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.  Along with the development of policy and enforcement of the law, and collaboration with states and industry, our inspections of compounding facilities are vital aspects of this effort. Understanding the nature of the activity these compounders—especially outsourcing facilities— are engaged in helps minimize the risks to patients. While the FDA inspects outsourcing facilities regularly according to our risk-based schedule, we also rely on them to do their part in alerting us to issues that may endanger the health of patients.
As part of this work, several colleagues and I recently called attention toExternal Link Disclaimer a particular issue associated with compounded hormones (specifically, in the form of pellets). During an inspection in 2018 of BioTE Medical, our investigators uncovered information about 4,202 adverse events that had never been reported to the agency. The adverse event information our investigators found suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion. However, because the reports lacked certain critical information, the FDA was able to attribute only a small percentage of the adverse events (61 reports), such as pellet extrusion and cellulitis, to the use of compounded hormone pellets containing testosterone. The company that collected the adverse events did not send them to us during the five years they occurred between 2013 and 2018. However, in light of this discovery, the FDA is continuing to take multiple steps to help protect patients, which we wanted to highlight today in the interest of public health.
Compounded bioidentical hormone replacement therapy (BHRT) products such as progesterone and testosterone, are used at times instead of FDA-approved drugs for hormone replacement therapy. Some compounders market BHRT products as superior to FDA-approved drugs by making assertions that they are more natural, safer or better for patients than FDA-approved drug products. FDA-approved hormone therapy treatments have been reviewed for safety and effectiveness for specific uses, and the FDA has measures in place to ensure quality during manufacturing. However, because, compounded BHRT products are not approved by the agency, there is no assurance of safety and efficacy. Outsourcing facilities, such as those that produced these products, are required to report certain adverse events to the FDA.
The agency uses adverse event reports to monitor safety issues to help protect the public. Adverse event reports can assist the FDA in identifying potential safety problems with a particular product. However, this is more difficult when information is outdated or missing. We maintain a public database to ensure patients and health care professionals can access adverse event data about drugs. Outsourcing facilities are required to report adverse events to the agency and include adverse event reporting information on compounded drug labeling, and we encourage all companies, health care professionals and patients to report adverse events as soon as they know about them. Every year, the FDA receives adverse event reports of patient illnesses and deaths associated with compounded drugs. Information on the safety history of compounded drugs, through the reporting of adverse events is vital to protecting the public health.
Because compounding can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug, we must work to protect patients from the risk of contaminated or otherwise harmful products. As we develop our policy and oversight program, the FDA continually strives to strike a balance between preserving access to compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not made in accordance with applicable quality standards or other requirements.
In this case, outsourcing facilities, Carie Boyd’s Prescription Shop and AnazaoHealth Corporation, produced the pellets, but they were marketed by BioTe Medical, which was not registered with the agency as an outsourcing facility. While BioTe had an online portal to collect adverse event data from its customers, it never reported that information to the FDA nor did it provide this information to the outsourcing facilities.
The FDA is still investigating this matter, with respect to Carie Boyd’s Prescription Shop, AnazaoHealth Corporation or BioTe and we cannot discuss the status. Outsourcing facilities are subject to regulatory and enforcement action if they do not appropriately label their drugs with adverse event reporting information and to report events to the FDA. The agency intends to take appropriate action if outsourcing facilities do not comply with the adverse event reporting requirements. We remind outsourcing facilities to develop thorough procedures to compile and investigate adverse event reports and share them with the FDA.
We’re also using the information we learned from this episode to take steps to improve adverse event reporting and analyses to ensure we’re doing the most we can to protect patients. We will continue to work with outsourcing facilities to improve mechanisms for obtaining reports of adverse events associated with their products and for providing adverse event reports to the agency.  Furthermore, we continue to work with our state regulatory partners to finalize a standard memorandum of understanding under which states would agree to, among other things, investigate complaints of adverse events associated with certain compounded drugs from pharmacies operating under section 503A and report serious adverse events and serious product quality issues to the agency. States that sign the memorandum of understanding with the FDA will agree to investigate and share their findings. Collaboration with states has the potential to help prevent serious and widespread problems by helping to better identify adverse events and product quality issues across the country. For example, if a compounder distributes drugs to multiple states, it can be difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem. Collaboration with our state partners would be crucial in such an instance. While adverse event reports have some limitations, this information is one of the best safety tools we have at our disposal. The FDA is dedicated to increasing public awareness about drug safety issues and we’re continuing our efforts to improve reporting for all types of drugs, including compounded medicines. We anticipate finalizing our MOU with the states later this year.
To further enhance our understanding of the safety of compounded hormones, the FDA has contracted with the National Academy of Sciences, Engineering, and Medicine (NASEM) to conduct a study on the risks associated with compounded hormone products. Our collaboration with NASEM will also continue to examine the clinical utility of treating patients with compounded products and the available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams. The FDA plans to share updates about this study with the public as information is available.
We’ll continue to work to ensure patients have appropriate access to compounded medications. However, we must also ensure that all steps are taken to help reduce risks to patients. Patient health and safety is the FDA’s highest priority.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###

Inquiries

Media:
 Jeremy Kahn
 301-796-8671
Consumer:
 888-INFO-FDA


Wednesday, September 4, 2019

From Oklahoma State Board of Pharmacy

To clarify portions of yesterday’s email blast titled “USP 800:”

  • None of the Rules in the 2019 Rule revisions are in effect.
  • They were not published in the Oklahoma Administrative Code as required by the Oklahoma Rules on Rule making - which makes them null and void.
  • The Board plans to take new Rulemaking action before the next legislative session.

The Rules provided in the link included in yesterday's email are NOT IN EFFECT.