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, May 17, 2013
Products Produced by The Compounding Shop Should Be Quarantined Due to Lack of Sterility Assurance, Warns FDA
Medications produced and distributed by The Compounding Shop of St Petersburg, FL, should not be administered to patients and should be quarantined, warns FDA. The agency notes that preliminary findings from a recent inspection of the facility raise concerns about a lack of sterility assurance, and it is alerting hospital supply managers, pharmacists, and other health care providers that the products may potentially place patients at risk of serious infection. FDA has advised The Compounding Shop that action should be taken to remove all sterile products from the market to protect patient health, and the company has indicated that it is recalling all sterile products and is in the process of notifying customers.
“Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products,” indicates FDA in a news release. “Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.” The agency also encourages providers to report any adverse reactions or quality problems associated with these products to FDA’s MedWatchAdverse Event Reporting program.