FDA Approves First Drug for Use in Wild Quail

Today the U.S. Food and Drug Administration issued a supplemental approval for Safe-Guard (fenbendazole) for the treatment and control of gastrointestinal worms (Aulonocephalus spp.) in wild quail. This approval provides a tool for wildlife managers to treat and control these parasites in wild quail populations. While there are currently FDA-approved drugs for use in farmed quail, this is the first animal drug approval for use in wild quail and for this indication.

 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability

May 23, 2024; 89 FR 45663

More CVM FR Notices

 

Is your compounding pharmacy pursuing best practices?

DVM360

https://www.dvm360.com › view › is-your-compoundin...

May 3, 2024 — The best compounding pharmacies hold themselves to a higher standard. They make sure each medication is safe and effective for your patients. Molly Price, DVM, ...

 

Government bans replicas of weight loss drug Ozempic, as ...

Australian Broadcasting Corporation

https://www.abc.net.au › news › compound-pharmacies...

1 day ago — The government will ban compounding pharmacists from making replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight ...

 

Department of Justice News: Covetrus Sentenced for Criminal Misbranding of Prescription Drugs

Ohio-based Company Will Pay More Than $23 Million in Fines and Forfeiture

ABINGDON, Va. – Covetrus North America LLC, a company based in Dublin, Ohio, which sells veterinary products to customers across the United States, was sentenced yesterday to one-year of probation for causing the introduction and delivery of misbranded veterinary prescription drugs into interstate commerce.

In addition, the court ordered Covetrus to pay over $23 million in criminal fines and forfeitures.

Covetrus will forfeit $21,534,091, pay $1,000,000 to the Virginia Department of Health Professions, as well as a fine of $1,000,000. In addition, Covetrus is obligated to keep in place appropriate compliance measures to prevent future violations.

 

FDA Announces Position on Use of Compounded GS-441524 to Treat FIP

Because no FDA approved drug is available to treat Feline Infectious Peritonitis in cats, the U.S. Food and Drug Administration does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

The FDA is aware of social media posts suggesting that compounded GS-441524 will be “legally” available in the United States starting June 1. The agency reminds compounding pharmacies, veterinarians and pet owners that animal drugs compounded from bulk drug substances are unapproved drugs and are not, in fact, legal. However, in GFI #256, the FDA has described certain conditions where the agency does not intend to take enforcement actions for compounded products for use in animals.

 

• On Friday, the FDA announced it had conditionally approved the first torsemide animal drug for dogs. UpCard-CA1 (torsemide oral solution) was conditionally approved for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary edema (fluid build-up in lungs) in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

 On Friday, the FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis, under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

 

Update: FDA extends comment period for new regulations for animal drug labeling

On May 21, 2024, the FDA announced it is extending the comment period for the proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs” by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Either electronic or written comments must be submitted by August 9, 2024.

 Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period

May 22, 2024; 89 FR 44944

 

5/14/2024

05/03/2024

Natuzen Co., Ltd.

Center for Drug Evaluation and Research | CDER

CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	03/27/2024	Vintage Chemical Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	04/15/2024	Cohere Beauty	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	04/30/2024	Grupo Quimico SRL	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	04/30/2024	Washington Fertility Center	Division of Biological Products Operations I	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

 

05/14/2024	04/17/2024	Westwood Laboratories LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	03/29/2024	Central Admixture Pharmacy Services, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Drug Products/Adulterated

 

05/21/2024	04/01/2024	Seatex, LLC	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
05/21/2024	04/30/2024	Akan Biosciences, Inc.	Office of Biological Products Operations – Division I	CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
05/21/2024	03/25/2024	Central Admixture Pharmacy Services, Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Drug Products/Adul

 

Specialty lab exec gets 10-year prison term for 11 deaths ...

WOWK 13 News

https://www.wowktv.com › news › u-s-world › ap-speci...

4 days ago — ... pharmacy executive Barry Cadden was sentenced to ... Compounding Center in Framingham, Massachusetts ... FBI, DOJ warn against threatening election workers .

PCCA's Motion to Dismiss for Want of Prosecution denied

 

in the united states district court

BrainJar.com

https://webservices.courthousenews.com › Data

PDF

May 3, 2024 — Compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an ...

Court denies PCCA's Motion for Summary Judgment

 

Case 5:14-cv-00212-XR Document 218 Filed 04/30/24 ...

GovInfo (.gov)

https://www.govinfo.gov › content › pkg › pdf

PDF

Apr 30, 2024 — The fraudulently reported ingredient prices were far more than the actual prices at which the Defendants sold ingredients to compounding pharmacies frequently ..

Maida Pharmacy, Inc. Agrees to Pay $25,000 to Resolve Allegations of Inadequate Recordkeeping

 BOSTON – The U.S. Attorney’s Office has reached a $25,000 settlement with the Arlington-based retail and compounding pharmacy Maida Pharmacy, Inc. (Maida) to resolve allegations that it failed to maintain adequate records of controlled substances and improperly disposed of controlled substances. 

 The Controlled Substances Act (the Act) regulates the manufacturing, purchasing, distribution and maintenance of certain controlled substances. Pursuant to the Act, Maida was required to keep records and follow security protocols for its controlled substances. 

As part of the settlement, Maida admitted that during an inspection, the Drug Enforcement Administration found that Maida did not have in place proper security protocols or maintain appropriate records for controlled substances. Maida also admitted that it had not conducted its mandatory inventory accountability audit and failed to maintain an appropriate security system for its controlled substances. Additionally, Maida admitted that, on several occasions, its employees disposed of Ketamine by placing it in the curbside trash, rather than properly destroying it in a manner consistent with the Act. 

Acting United States Attorney Joshua S. Levy and Brian D. Boyle, Special Agent in Charge of the Drug Enforcement Administration, Boston Field Division made the announcement today. Assistant U.S. Attorney Julien M. Mundele of the Affirmative Civil Enforcement Unit handled the case.

Updated May 1, 2024

 

Kentucky Board of Pharmacy

Kentucky Board of Pharmacy (.gov)

https://pharmacy.ky.gov › Pages

May 2, 2024 — Amendment filed April 15, 2024: This amendment creates a new type of pharmacist license for non-resident pharmacists. This is a limited license with a $50 ...

 

Compounded drug, not otherwise classified J7999 - HCPCS

AAPC

https://www.aapc.com › codes › hcpcs-codes

Apr 22, 2024 — HCPCS Code J7999 for Compounded drug, not otherwise classified as maintained by CMS falls under Drugs, Not Otherwise Classified.

 

FDA, doctors warn about compounded Ozempic. What we ...

WSB-TV

https://www.wsbtv.com › news › local › atlanta › fda-do...

Apr 25, 2024 — The FDA says improperly compounded versions of the drug can have serious consequences. Channel 2 Action News went to several weight loss clinics across metro