Tuesday, September 25, 2018

Very High Importance!

Skip to main page content U.S. Food and Drug Administration Search FDA Submit search Popular Content Press Announcements FDA Statement Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

 morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration.

I would like to thank you all for traveling from near and far to be with us today to participate in our seventh intergovernmental meeting on drug compounding. Wherever you hail from, and whether this is your first or seventh meeting, we’re glad to have you join us to continue our ongoing dialogue about ways to reduce the risks associated with compounded drug products and improve collaboration between FDA and the states. We greatly value our work with you, and we feel strongly that our partnerships with you are critical to maintaining robust oversight of compounders to protect the public health.

Texas' First Free Pharmacy Opens in North Texas

NBC 5 Dallas-Fort Worth-4 hours ago
The Society of St. Vincent de Paul of North Texas has opened the first public free pharmacy in the state. The group soft launched the pilot pharmacy program ...

PhRMA unlikely to get Part D changes in opioid bill

Politico-21 hours ago
The branded drug lobby also is not anticipated to succeed in using the opioid bill to .... Compounded medicine blamed for serious vision problems — At least 68 ...

Ex-employees of pharmacy in meningitis outbreak win separate trials

Reuters-13 hours ago
A federal judge on Monday ruled that two pharmacists accused of helping fill fake prescriptions while working at a Massachusetts compounding pharmacy linked .

Prosecutors Can Tell 3rd NECC Jury About Meningitis Pain

Law360-13 hours ago
Law360 (September 24, 2018, 8:07 PM EDT) -- Low-level pharmacists at the shuttered New England Compounding Center whose bosses have been convicted ...

'Blatant disregard for public safety'

Australian Journal of Pharmacy (blog)-6 hours ago
Isidoro “Rudy” Sanchez was the manager of the now-closed Marigold Compoundingand Natural Pharmacy in Courtney, British Columbia, Canada when he ...
09/11/2018Atlas Pharmaceuticals, LLCSan Francisco District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
03/06/2018Uckele Health & Nutrition, Inc.Chicago District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
08/31/2018Independent Nutrition, Inc.Seattle District OfficeUnapproved New Animal Drug/Adultered/Misbranded/MisleadingNot Issued *
09/11/2018Wilson Medicine CompanyCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
09/18/2018Rock Farm, LLC dba WholeFood FarmacyCincinnati District OfficeUnapproved New Drugs/MisbrandedNot Issued *
Congress keeps IMD provision in final opioids package
Congress finalized its deal on opioids legislation, including one longshot measure to free up Medicaid funds for inpatient addiction treatment in the package.  READ MORE

Monday, September 24, 2018

Queens pharmacy owner stole $7.9M through phony Medicare claims ...

QNS.com-2 hours ago
Prosecutors said Mohammed operated four Queens pharmacies, including Superdrugs I Inc., located at 127-04 Liberty Ave. in South Richmond Hill; and S&A

Pharmacy Owner Facing Federal Charges for Fraudulent ...

Pharmacy Times-3 hours ago
pharmacy owner facing an indictment charging her with submitting millions of dollars in fraudulent claims to Medicare and Medicaid is expected to be ...

PhRMA unlikely to get Part D changes in opioid bill

Politico-5 hours ago
The branded drug lobby also is not anticipated to succeed in using the opioid bill to .... Compounded medicine blamed for serious vision problems — At least 68 .

Connecticut sues for compound drug billing fraud

UConn Daily Campus-11 hours ago
The state of Connecticut has sued a Florida-based compound pharmacy for violations against the Connecticut False Claims Act. The lawsuit calls for civ

BC pharmacist loses licence after giving out drugs containing human ...

CBC.ca-2 hours ago
The penalty comes after a four-year investigation, which began with the closure of the Marigold Compounding and Natural Pharmacy over public safety ..

AP investigation: Drug prices going up despite Trump promise



Endo Agrees to Additional Stay of FDA Litigation Following FDA's Commitment to Use Best Efforts ...
In August 2018, an outsourcing facility announced it would commence bulk compounding of vasopressin and intervened in the litigation.
Endo once more agrees to delay FDA litigation
The lawsuit alleges the FDA's "interim policy" on compounding using bulk drug substances under Section 503 B of the Drug Quality and Security Act of ...


Sunday, September 23, 2018

2 days ago - What can you expect from the FDA's 2018 Compounding Priorities Plan? In this plan the FDA: Addresses quality standards for outsourcing facilities; Regulates ...

Saturday, September 22, 2018

A lot of Information Relating to Compounding in the September 2018 NABP Newsletter

Sep 1, 2018 - Pharmacies in US and ... Professional Affairs. Update ... Model Act Updates Address Veterinary Compounding, Long- .... As noted by the court, present pharmacy.
Sep 14, 2018 - PCCA. In this pleading, Plaintiff Anne Looney continues her ... Guardian had never madeTri-Moxi before, so Guardian turned to the PCCA for a.
Sep 14, 2018 - alleged purpose of Tri-Moxi is to prevent swelling, infection and dryness ... DefendantPCCA is not a pharmacy, compounding pharmacy, health ..

Markey, Hatch push for opioid warning

Boston Herald-17 hours ago
“Because of the confusing names and ingredients, many families may not know that they have just left the pharmacy with a bottle full of danger,” Markey said .

FDA to Veterinarians: Use Approved Mirtazapine Product


FDA to Veterinarians: Use Approved Mirtazapine Product
Compounded formulations, on the other hand, have not been reviewed by ... “As with many compoundedtransdermal drugs, the rate and degree of ...

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy
"Global Compounding stole from insurance programs, including Medicare and TRICARE, by using a marketing scheme that increased the sales of ...

Athenex Gets FDA Compounding Policy Wrong, Amicus Says


Athenex Gets FDA Compounding Policy Wrong, Amicus Says
Chiming in through an amicus brief Thursday, PharMEDium Services LLC said the FDA only allows for drugs to be compounded in bulk under section ..

Friday, September 21, 2018

Very High Importance! 'Stuff floating' in compounded drugs prompts FDA to appeal for more funding STAT


'Stuff floating' in compounded drugs prompts FDA to appeal for more funding
ASHINGTON — The Food and Drug Administration doesn't have enough funding or staff to properly regulate pharmaceutical compounders, a top ...
Pharma push for Medicare donut hole change tangles opioid negotiations
A push by Big Pharma to claw back Medicare Part D donut hole money as part of the opioids package has hit against sharp Democratic opposition.  READ MORE

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats



In a Dear Veterinarian Letter issued today, the U.S. Food and Drug Administration reminded veterinarians of the differences between Mirataz (mirtazapine transdermal ointment), an animal drug that the FDA approved in May 2018 with demonstrated safety and effectiveness to manage undesired weight loss in cats, compared to the use of compounded formulations of transdermal mirtazapine, which some veterinarians started prescribing before there was an FDA-approved product available. FDA approval of this drug means that veterinarians have an approved mirtazapine product with known safety, efficacy, and quality to provide to their patients rather than relying on the only previously available products that are compounded from bulk drug substances that are unapproved animal drugs.

Unlike FDA-approved Mirataz, compounded formulations of transdermal mirtazapine have not been reviewed by the FDA for safety or effectiveness and may vary in quality and potency. With many compounded transdermal drugs, the rate and degree of absorption are unknown and may vary to deliver too little or too much of the active ingredient, making treatment outcomes unpredictable.

Manufactured for Kindred Biosciences Inc., Mirataz is a prescription animal drug that is intended to be applied topically on the inner surface of the cat’s ear once daily for 14 days. Mirataz must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose the cause of weight loss in cats and determine whether the drug is an appropriate treatment.

Press Release

Essential! High Importance! Must Read!! Blindsided:At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs Their tragedies expose a shadowy US industry that sells drugs with little government oversight. by Stephanie M. Lee

Thursday, September 20, 2018

Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products


The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.

Since these products have obtained their respective FDA approvals, data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures. Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products.

See more…

Is CBD illegal? Pharmacy board says yes, but dozens of stores sell it

WLWT Cincinnati-17 hours ago
The spokeswoman for the state's Board of Pharmacy told Dykes that the agency is not taking enforcement action at this point against stores selling CBD products ...

St. Louis pharmacist admits tax, conspiracy charges

STLtoday.com-18 hours ago
ST. LOUIS • A St. Louis pharmacist pleaded guilty Tuesday to federal charges in two separate cases and admitted a role in a kickback conspiracy and also ...

Wednesday, September 19, 2018

PharMEDium says compounder misinterpreting law to compete with Endo

PharMEDium says compounder misinterpreting law to compete with ...

Reuters-8 hours ago
PharMEDium, one of the largest U.S. compounding pharmacy companies, says a smaller firm making a compounded drug that competes with Endo International ...

Keeping pharmacy in pharmacy

Australian Journal of Pharmacy (blog)-1 hour ago
In it's latest communique, the Victorian Pharmacy Authority said it, and other state and territory pharmacy registering authorities have “intervened to stop a retail ...

Very High Importance!! Doctor disciplined by California medical board for menopause therapy: The therapy Dr Hall was prescribing is known as bio-identical hormones which are extolled as a ‘safer’ alternative to traditional hormone replacement therapy.

Doctor disciplined by California medical board for menopause therapy

Infosurhoy-22 hours ago
Bioidentical hormones are synthesized in a lab and either made by major drug companies or in a compounding pharmacy, which makes personalized .

Doctor Denies Charges in Cream Scheme

WorkCompCentral-17 hours ago
A Waxahachie anesthesiologist is rejecting federal charges that he received kickbacks as part of a two-state compounding medication scheme that defrauded ...