Wednesday, January 3, 2018

FDA revokes draft compounding guidance
The new guidance will replace the draft document "Compounding Animal Drugs from Bulk Drug Substances," which was published in May 2015. It described FDA interpretations of the legality of compounding animal drugs from bulk pharmaceutical substances and indicated when the FDA would ...

Thursday, December 21, 2017

FDA Clarifies Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle

In January 2017, FDA and animal drug manufacturers completed the voluntary transition of antimicrobial drugs of medical importance used in animal feed to Veterinary Feed Directive (VFD) marketing status under Guidance for Industry (GFI) #213.

Since that time, the FDA has received questions from stakeholders relating to certain uses of free-choice medicated feeds (products that contain one or more animal drugs and are placed in feeding or grazing areas for animals to freely consume) for the control of active infection of anaplasmosis in cattle. Some of these questions involved uses of such feeds that are not in compliance with currently approved use conditions.

Read entire press release.

Friday, December 8, 2017

Pharmacy Board Releases Guidance on How to Issue a Valid ...

The National Law Review-21 hours ago
She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards. Sarah has a strong working knowledge of ...

New study funded by Morris Animal Foundation demonstrates loss of drug potency
DENVER/December 7, 2017 - Drugs work best when their potency remains stable or consistent, but a new study funded by Morris Animal Foundation shows a commonly compounded antimicrobial drug used in veterinary medicine may be losing potency over time. The study recently was published in ..

Loss of Drug Potency Found for Commonly Compounded Drug
Results showed that the compounded formulations of doxycycline lost potency within 21 days of receipt, with many dropping to sub-therapeutic content in that time, as defined by United States Pharmacopeia standards. The complete report was recently published in the Journal of the American Veterinary ...

US Compounding develops compound to manage equine ulcers
Adamis Pharmaceuticals Corp. announced that its subsidiary, US Compounding, has developed a compound to manage ulcers in horses. A study, utilizing US Compounding's drug formulation, was conducted in approximately 50 racehorses. Gastric endoscopy was performed at Day 0 and any time ..

Thursday, December 7, 2017

Animal Drugs at FDA Phase 3 Implementation

In our continued effort to improve transparency and public access to information about approved animal drugs, the U.S. Food and Drug Administration’s Center for Veterinary Medicine is launching Phase III of the redesigned Animal Drugs @ FDA website.

As before, the new Animal Drugs @ FDA website provides a searchable database for veterinarians, pet owners, animal producers and others to get information about approved animal drugs by application number, sponsor name, proprietary name, ingredient, application status, dosage form, route of administration, indication and species.

With the completion of Phase 3 on December 6, 2017, Animal Drugs @ FDA will now display animal drug information using the FDA Structured Product Labeling (SPL) style sheet.

Read entire press release.

Tuesday, December 5, 2017

Monday, December 4, 2017

U.S. Attorney’s Office
Western District of Virginia

Wednesday, November 29, 2017

Knoxville Man Sentenced for Conspiring to Defraud the FDA 

Billy Groce Illegally Shipped and Sold Veterinary Drugs 

Abingdon, VIRGINIA – A Tennessee man, who operated a business that unlawfully distributed prescription animal drugs to evade existing Food and Drug Administration laws, was sentenced today in the United States District Court for the Western District of Virginia in Abingdon to a federal felony conspiracy charge, United States Attorney Rick A. Mountcastle announced. 

Billy K. Groce, 65, of Knoxville, was sentenced today to imprisonment for a term of four months. Groce previously pleaded guilty to one count of conspiracy to defraud the United States by impeding, impairing obstructing and defeating the lawful functions of the Food and Drug Administration. 

Groce operated a business that was created for the purpose of illegally circumventing the FDA’s regulation of the interstate shipment and labeling of veterinary drugs. Groce’s business illegally obtained, stored, sold and caused to be shipped, drugs from veterinary drug manufacturers and distributers. Groce’s business was not a licensed wholesaler, a licensed pharmacy or a veterinary clinic. 

Federal regulation of prescription veterinary drugs are not primarily to protect animals from the potential harms of prescription drugs, but are to protect the human food supply from unsafe drug residues in the edible tissues of animals sold for slaughter.  Accordingly, veterinary prescription drugs must stay within the controlled chain of distribution to ensure the drugs’ safety and efficacy.  

Groce illegally sold the drugs throughout Tennessee and Southwest Virginia.  In addition, Groce shipped drugs to co-conspirator Marlin Webb, who was the store manager at a farm supply business in Carroll County, Virginia. Webb illegally sold the veterinary prescription drugs to customers in Southwest Virginia. Webb previously pleaded guilty to a felony charge of conspiracy to defraud the FDA and was sentenced to one year of probation.  He paid $125,000 in forfeiture and other payments at the time of his guilty plea. 

The investigation of the case was conducted by the U.S. Food and Drug Administration – Office of Criminal Investigations and the Virginia Department of Health Professions.  Assistant United States Attorney Randy Ramseyer prosecuted the case for the United States.