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
Wednesday, October 30, 2013
It Shows that FDA is working Hard to Make its Website more user friendly, it is adding more and more information and keeping the Website Up to Date. For example, see the compounding page
News and Updates
For recent compliance actions, safety alerts, and related news releases, see Pharmacy Compounding: FDA Actions.
FDA Press/News Releases:
- FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy (10/22/2013)
- FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
- FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/11/2013)
- Federal judge enters consent decree with Med Prep Consulting (6/28/2013)
- FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (5/24/2013)
- FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (5/18/2013)
- FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (5/8/2013)
- FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy (4/21/2013)
- FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall (4/15/2013)
- Summary: 2013 FDA Pharmacy Inspection Assignment (4/11/2013)
- FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy (3/21/2013)
- FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (3/18/2013)
CDER Statements:
- FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
- FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
- FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (8/9/2013)
- Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (6/6/2013; updated 6/13/2013)
Firm Press Releases:
- Firm Press Release: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013)
- Firm Press Release: Leiter’s Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (9/10/2013)
- Firm Press Release: Park Compounding: Sterile Medication Recall – Concerns of Sterility Assurance at Testing Vendor (9/10/2013)
- Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (9/9/2013)
- Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/9/2013)
- Firm Press Release: University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns (9/6/2013)
- Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (9/4/2013)
- Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
- Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
- Firm Press Release: Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance (8/23/2013)
- Firm Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
- Firm Press Release: Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/15/2013)
- Firm Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/14/2013)
- Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/09/2013)
- Firm Press Release: Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
- Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (5/29/2013)
- Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (5/28/2013)
- Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (5/15/2013)
- Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (5/6/2013)
- Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/22/2013)
- Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/17/2013)
Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013) - Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)
- Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013)
- Firm Press Release: Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination (3/25/2013)
- Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (3/20/2013)
- Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/20/2013)
- Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/17/2013)
- Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (3/16/2013)
FDA Voice Blogs:
- Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding (4/11/2013)
- FDA Must Have New Authorities to Regulate Pharmacy Compounding (3/22/2013)
Recent Congressional Testimony:
- Reforming the Drug Compounding Regulatory Framework (7/16/2013)
- Examining Drug Compounding (5/23/2013)
- Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak (11/15/2012)
- The Fungal Meningitis Outbreak: Could It Have Been Prevented? (11/14/2012)
Public Meetings:
Related Information:
KUDOS to Alabama State Board of Pharmacy -Non-Resident Pharmacies:
APOTHECURE, INC., #113027
PERMANENTLY REVOKED, assessed monetary fine of $20,000.00
NEW ENGLAND COMPOUNDING CENTER, #112275/201114
REVOKED.
Alabama State Board of Pharmacy: Disciplines Citizen Express Pharmacy and Delmous Vance, III
DELMOUS VANCE, III, #12502
PROBATION 2 years; assessed monetary fine of $10,000.00 (order states both Vance and Citizen’s fined $10,000.00).
Pharmacies:
CITIZEN EXPRESS PHARMACY, #102380
Assessed monetary fine of $10,000.00 (order states both Vance and Citizen’s fined $10,000.00).
source Alabama State Board of Pharmacy
Subscribe to:
Posts (Atom)