Department of Justice News: NYC Mother and Son Charged with Interstate Shipment of Misbranded Animal Drugs

PHILADELPHIA – United States Jacqueline C. Romero announced that Bien King, 70, of Congers, NY and Khalil King, 36, of New York, NY were charged by indictment with conspiracy, distribution of unregistered and misbranded pesticides, and interstate shipment of misbranded animal drugs.

The indictment alleges that Bien King and her son, Khalil King, jointly operated a business called “Little City Dogs,” based in New York City. The defendants purchased unapproved animal drugs and pesticides, including ivermectin, nitenpyram, praziquantel, and fipronil, from various Chinese suppliers. The defendants’ Chinese suppliers routinely mislabeled the shipments to avoid inspection by United States Customs and Border Protection inspectors. According to the indictment, once the defendants received the shipments from China, they used various locations, including a Manhattan office, to mix and repackage these drugs and pesticides for resale to customers throughout the United States. According to the indictment, the defendants’ company received over $4,000,000 from the sale of these misbranded, unregistered, and unapproved pesticides and animal drugs.

 

04/18/2023	03/31/2023	Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy	Division of Pharmaceutical Quality Operations II	Compounding Pharmacy/Adulterated Drug Products
04/18/2023	04/04/2023	ByPro Nutrition LLC	Division of Human and Animal Food Operations West II	Unapproved New Drugs/Misbranded
04/18/2023	04/06/2023	SCS Direct, Inc.	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
04/18/2023	04/06/2023	Zermat International S.A. de C.V.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
04/18/2023	01/27/2023	La Aldea Distributors Inc	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
04/18/2023	04/05/2023	Chemical Services Group, Inc./Royal Chemical Company	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated

 

04/18/2023	11/08/2022	Abbott Point of Care Canada Limited	Center for Devices and Radiological Health	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
04/18/2023	12/27/2022	North American Diagnostics, LLC	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
04/18/2023	03/16/2023	Biloxi Freezing & Processing, Inc.	Division of Human and Animal Food Operations East V	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
04/18/2023	09/20/2022	Eco Lips, Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated

 

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject	Response Letter
04/27/2023	04/27/2023	Hot Grabba LLC d/b/a Buttas Hot Grabba	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/25/2023	04/20/2023	Accra-Pac, Inc. dba Voyant Beauty	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
04/25/2023	03/08/2023	Spartan Enterprises Inc. dba Watershed Wellness Center	Division of Human and Animal Food Operations East VI	Unapproved New Drugs/Misbranded
04/25/2023	03/28/2023	Pop Daddy Popcorn, LLC	Division of Human and Animal Food Operations East VI	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
04/25/2023	04/13/2023	Pharmaplast S.A.E.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
04/25/2023	03/29/2023	Five Star Trading IL, Inc.	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
04/25/2023	02/13/2023	Medivance Instruments Ltd.	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
04/25/2023	04/24/2023	Nose Slap LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
04/25/2023	04/19/2023	Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
04/20/2023	04/20/2023	FuZion Vapor LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Oklahoma Board of Pharmacy USP Chapter 795, 797 & 800 Changes

 USP Chapter 795, 797 & 800 Changes

 

The United States Pharmacopoeia (USP) published the final revised USP Compounding General Chapters <795> and <797> in USP-NF 2023 Issue 1 on November 1, 2022. The USP Compounding Expert Committee voted to extend the official date to November 1, 2023, to allow for implementation.

 

The Oklahoma State Board of Pharmacy (OSBP) is requesting input from pharmacists and pharmacy personnel regarding the upcoming changes that USP plans to make to chapters 795, 797 and 800.

 

The OSBP would like to know what impact these changes would have on the people, processes, technology and etc.

 

Please provide any comments, concerns or any foreseeable problems with these changes to the OSBP via email at pharmacy@pharmacy.ok.gov.

Over 80 Prescription and OTC Meds Recalled Due to Safety Concerns, FDA Warns

https://www.msn.com/en-us/health/medical/over-80-prescription-and-otc-meds-recalled-due-to-safety-concerns-fda-warns/ss-AA1aqGbM?ocid=msedgntp&cvid=266bfae88c944ba49f6501d8ab564b36&ei=43#image=5 

 

How FDA's latest compounding guidance affects ...

VIN

https://news.vin.com › doc

7 days ago — In addition to curtailing office-stock use of medications compounded from bulk drug substances, the FDA guidance calls for more documentation when such drugs ...

High Importance: Notice and Warning from Mississippi Board of Pharmacy regarding compounding Semaglutide

 

Semaglutide Compounding - Mississippi Board of Pharmacy

State of Mississippi (.gov)

https://www.mbp.ms.gov › files › inline-images

2 days ago — The FDA does not typically allow compounding of commercially available drugs unless the drug is not readily available and is listed on the FDA drug shortage .

 "But one word of caution Califf did issue was on use of compounded versions of the weight loss drugs provided online by unauthorized suppliers.

'Compounding is highly regulated,' Califf said. 'It should only be used in specific circumstances. Fraud use for weight loss is not one of those.'”

read entire article here

High Importance! Warning and Notice Regarding Semaglutide Compounding - Mississippi Board of Pharmacy

 

Semaglutide Compounding - Mississippi Board of Pharmacy

State of Mississippi (.gov)

https://www.mbp.ms.gov › files › inline-images

2 days ago — If such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary: Semaglutide.