https://www.dispatch.com/news/20190826/judge-orders-pharmacy-board-to-let-cannabis-dispensary-open-in-cleveland
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, August 30, 2019
Wednesday, August 28, 2019
Purdue offers up to $12B in opioid talks, reports say. Will that be enough?
Wednesday, August 28, 2019
Purdue Pharma has reportedly offered up to $12 billion to resolve thousands of opioid lawsuits. The company would hand over some cash and drug royalties and declare bankruptcy, while the Sackler family would pay $3 billion, media reports say.
Tuesday, August 27, 2019
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| 08/27/2019 | 08/15/2019 | H & A Walters Fulfillment Center | Center for Food Safety and Applied Nutrition | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| 08/27/2019 | 08/13/2019 | Ningbo Pulisi Daily Chemical Products Co., Ltd | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| 08/27/2019 | 07/12/2019 | CTX Lifesciences Private Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Monday, August 26, 2019
Thursday, August 22, 2019
Tuesday, August 20, 2019
4 hours ago - FDA Wins Court Case to Not Put Vasopressin on Compounding List. The US Food and Drug Administration (FDA) has won a case in the US District Court
Total Vein Pharmacy, LLC, (dba Total Vein Pharmacy), Houston, TX
- 483 Issued 05/09/2019 (PDF - 219KB)
The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN
- Referral Letter to the Tennessee Board of Pharmacy Issued 02/06/2019 (PDF - 54KB)
- FMD-145 Letter Issued 02/06/2019 (PDF - 47KB)
RXQ Compounding, LLC, Athens, OH
- Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)
Ranier’s Compounding Laboratory, Jeannette, PA
- FDA Press Release: Federal court enters consent decree against Ranier's Rx Laboratory and owner for manufacturing purportedly sterile drug products in unsanitary conditions (02/06/2019)
Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA
- 483 Issued 06/13/2019 (PDF - 1.27MB)
Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL
- Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)
Poulsbo Compounding Pharmacy, LLC, (dba Cascade Specialty Pharmacy), Poulsbo, WA
- 483 Issued 04/17/2019 (PDF - 710KB)
Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL
- Warning Letter CloseOut (04/22/2019)
Option Care Enterprises, Inc., (dba Option Care), Little Rock, AR
- 483 Issued 03/12/2019 (PDF - 354KB)
Millers of Wyckoff, Inc., Wyckoff, NJ
- Warning Letter CloseOut (02/26/2019)
- FMD-145 Letter Issued 02/26/2019
- State Referral Letter Issued 02/26/2019 (PDF - 218KB)
Guardian Pharmacy Services, Dallas, TX
- FDA Press Release: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (03/12/2019)
Buderer Drug Company Inc. Perrysburg, OH
- Warning Letter CloseOut (05/01/2019)
- 483 Issued 02/14/2019 (PDF - 268KB)
- Firm Press ReleaseExternal Link Disclaimer: Athenex Provides an Update Regarding the Vasopressin Case (08/02/2019)
Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI
- State Referral Letter Issued 02/11/2019 (PDF - 70KB)
CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD
- FMD-145 Letter Issued 02/19/2019 (PDF - 66KB)
| 08/20/2019 | 08/06/2019 | Let's Talk Health, Inc. | Division of Human and Animal Food Operations West V | Unapproved New Drugs/Misbranded |
| 08/20/2019 | 08/02/2019 | NingBo Huize Commodity Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| 08/20/2019 | 08/01/2019 | TG United, Inc. | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated |
| 08/20/2019 | 07/29/2019 | Promise Pharmacy, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
Monday, August 19, 2019
Jul 24, 2019 - Summary: Would require the compounding of drug preparations by a ... Summary
7 hours ago - Ruling Number: 19MDH59, Ruling Type: Medication/Drug Violation - Animal ...... Rule 7890.0110 Subpart 12 - Compounded Medications on Association Grounds ... Attorney at Law, in a Stewards' hearing at Delaware Park on July 26, 2019
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