“Approved by FDA” is mandatory on most labeling components for approved animal drugs-FDA says

 On Monday, the FDA put out an update to stakeholders and a separate letter to veterinarians informing them that the statement “Approved by FDA” is mandatory on most labeling components for approved animal drugs. As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the labeling statement is intended to help veterinarians, food animal producers, pet owners, and others clearly identify approved animal drugs and distinguish them from unapproved ones. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly labeled, and manufactured according to current good manufacturing practices for animal drugs.

 

03/26/2024	03/25/2024	Dermal Source, Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/26/2024	03/25/2024	Indelicare DBA INKEEZE	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/26/2024	03/25/2024	Tattoo Numbing Cream Co.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded

 

03/26/2024	03/18/2024	Deqing Jiarou Daily Chemical Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
03/26/2024	02/22/2024	Higley Industries, Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
03/26/2024	03/19/2024	Ammonia Sport Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/26/2024	03/25/2024	Sky Bank Media, LLC dba Painless Tattoo Cream Co.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/26/2024	03/25/2024	TKTX Company	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/26/2024	03/25/2024	SeeNext Venture, Ltd.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded

 

Authorities raid Como Compounding Pharmacy in ...

Lexology

https://www.lexology.com › library › detail

Mar 1, 2024 — The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized 'off-brand'…

 

TGA seizes compounded weight loss drugs from pharmacy

Medical Republic

https://www.medicalrepublic.com.au › tga-seizes-comp...

Mar 4, 2024 — TGA seizes compounded weight loss drugs from pharmacy. 4 minute read. Pharmacy ... compounding unlawfully, which includes mass-producing compounded

 

Search warrant executed on South Yarra pharmacy

Therapeutic Goods Administration

https://www.tga.gov.au › news › media-releases › searc...

Mar 1, 2024 — “Consumers need to understand that the safety of compounded medicines are ... drugs. 7 September 2020. Media releases. Criminal court proceedings have been ...

 

Kentucky Board of Pharmacy - Kentucky.gov

Kentucky Board of Pharmacy (.gov)

https://pharmacy.ky.gov › Pages

Mar 15, 2024 — ... drug product's total volume. • The dispensing of compounded preparations for veterinary use shall follow the requirements of 201 KAR 2:311. • Verification ...

 

Rule 4729:3-3-03 | Registered pharmacy technicians.

Ohio Laws (.gov)

https://codes.ohio.gov › ohio-administrative-code › rule...

Mar 7, 2024 — (9) Sterile drug compounding in accordance with the required training in ... (2) If preparing non-sterile hazardous compounded drugs in accordance with ...

Revised Proposed Regulation of the State Board of ...

Nevada Legislature

https://www.leg.state.nv.us › Register

PDF

Mar 6, 2024 — Existing regulations prohibit a pharmacy from selling or otherwise providing a compounded drug to a retail pharmacy or practitioner, except under certain ...

TELECONFERENCE/VIRTUAL PHARMACY RULES ...

Wisconsin (.gov)

https://dsps.wi.gov › BoardCouncils › PHM

PDF

Feb 29, 2024 — medications for adverse drug reactions to compounded sterile drugs. [Illinois. Administrative Code s. 1330.640]. In Illinois, the definition of “compounding ...

 

Regulator acts to close loophole enabling Australian ...

Australian Broadcasting Corporation

https://www.abc.net.au › news › compounding-pharma...

Feb 29, 2024 — ... compounded weight loss drugs were not being recorded. "Unlike for manufacturers and sponsors of TGA-approved medicines, there is no legal obligation for .

Section 535:15-10-8 - Drug compounding controls, Okla. ...

Casetext

https://casetext.com › regulation › chapter-15-pharmacies

Mar 1, 2024 — (5) Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing ...