Wednesday, July 11, 2018

Letter to Veterinarians - CYSTORELIN® (gonadorelin)

In June 2018, FDA approved the fourth gonadotropin releasing hormone (GnRH) product, CYSTORELIN® (gonadorelin), for estrous synchrony in lactating dairy cows. The drug is also the second GnRH product approved for estrous synchrony in beef cows.

CYSTORELIN (New Animal Drug Application 098-379) is a sterile injectable solution of gonadorelin diacetate tetrahydrate, and when used with cloprostenol sodium as part of a synchronization regimen, the drug can be used to synchronize estrous cycles to allow for fixed time artificial insemination in lactating dairy cows and beef cows. FDA wants to remind you of the benefits of using approved drugs in your practice.

Read the letter

Tuesday, July 10, 2018

FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier’s Compounding Laboratory

he U.S. Food and Drug Administration is alerting health care professionals and patients, as well as veterinarians and animal owners, not to use human and animal drug products intended to be sterile that are produced and distributed by Ranier’s Compounding Laboratory, also doing business as Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania, due to lack of sterility assurance.

Health care professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to assure the sterility of its drug products.

On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.

To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their health care professional.

FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:

For reporting animal adverse drug events, please see How to Report Animal Drug Side Effects and Product Problems.
U.S. District Judge Wilhelmina M. Wright for the District of Minnesota entered a consent decree of permanent injunction against Todd & Patty Meech Dairy Farm of Sebeka, Minn., and the farm’s owners, Todd Meech and Patty Meech, for introducing adulterated meat into interstate commerce and for failing to comply with federal requirements for administering drugs to food-producing animals.

The consent decree prohibits the defendants from delivering animals and meat from the animals into the food supply, and from administering animal drugs to their animals, unless they meet certain requirements. These requirements include, but are not limited to, establishing and implementing systems that prevent the sale or distribution of any animals whose edible tissues contain animal drugs in amounts above the levels permitted by law, and having systems in place for establishing and maintaining better drug inventory and animal identification records. The FDA must also inspect and certify in writing that Meech Dairy Farm is in compliance with all applicable regulations before it can resume business operations related to meat production. The permanent injunction, however, does not prohibit the farm from selling milk since there was no evidence that the farm’s milk was adulterated. 
05/24/2018Bimeda, Inc.Center for Veterinary MedicineFalse & Misleading Claims/MisbrandedNot Issued 

Tuesday, July 3, 2018

Statement from FDA Commissioner Scott Gottlieb, MD and FDA ... hours ago
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing ...

Thursday, June 28, 2018

The U.S. Food and Drug Administration today is releasing Guidance for Industry #252, entitled “Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.” This small entity compliance guide (SECG) is intended to help small businesses comply with the Antimicrobial Animal Drug Sales and Distribution final rule.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial animal drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those medically important antimicrobials that are used in human and veterinary medicine.

The FDA published a final rule in May 2016 to incorporate the annual reporting requirements for sponsors of antimicrobial drugs sold or distributed for use in food-producing animals that were established by ADUFA 105 into its existing records and reports regulations in 21 CFR part 514 and also added an additional reporting provision in order to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, turkeys).

The additional data collected as a result of this rulemaking and supporting guidance issued today will improve our understanding of how antimicrobial drugs are sold and/or distributed for use in major food-producing species.

Tuesday, May 29, 2018

Boulder County veterinarians use alternatives in face of nationwide ...

The Denver Post-8 hours ago
Diane Matt, CEO of Colorado Veterinary Medical Association, said the group is aware of the shortage and people are worried that the drugs won't be available to ...

FDA Approves Semintra, Animal Drug for the Control of High Blood ...

Pet Age-May 25, 2018
The U.S. Food and Drug Administration has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension ..