Cleaning Validation for Medical Device Manufacturing

Why Get Cleaning Validation Support From Your Cleaner Supplier?

 

SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination.

Nurse practitioner indicted in compound pharmacy scheme

 

A nurse practitioner was indicted Oct. 18 for her alleged role in a compound pharmacy scheme with roots in Hattiesburg.

Susan Perry of Grand Bay, Alabama, who operated Immediate Family Clinic in Biloxi, was arraigned Wednesday in Gulfport before U.S. District Court Mississippi Southern District Magistrate John Gargiulo. She was released on a $25,000 unsecured bond.

Aseptic Enclosures BootieMatic XL

The BootieMatic XL is an automatic clean room Bootie dispenser. Holds approximately 200 booties. Many booting types available.

 

Features

  • More aseptic
  • More than 5X faster.
  • Significant cost savings.
  • Reduced risk of injury.
  • Reduced insurance costs.

Pharmacist In Meningitis Case Gambled With Lives, Prosecutor Says

Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center, departs federal court after attending the first day of his trial on Sept. 19. (Steven Senne/AP)

 

A pharmacist charged with murder in a meningitis outbreak that killed 76 people knew that mold and other bacteria were growing inside the filthy production rooms and that drugs shipped to customers were not sterile, but chose to do nothing, a federal prosecutor told jurors Friday.

FDA: Compounded Ocular Antibiotic May Cause Blindness

Compounded triamcinolone-moxifloxacin-vancomycin (TMV), a medication used for intraocular injection, may cause a rare, potentially blinding postoperative complication, according to the FDA.

 

Compounded bioidentical hormone therapy: Does the regulatory double standard harm women?

While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded bioidentical hormone therapy (cBHT) to combat hot flashes and other symptoms.

While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded bioidentical hormone therapy (cBHT) to combat hot flashes and other symptoms. Pharmacists polled last year, for example, estimated that 26 million–33 million cBHT prescriptions are filled each year. The problem, warn Cynthia A. Stuenkel, MD, of the University of California, San Diego, and JoAnn E. Manson, MD, DrPH, of Harvard Medical School, is that cBHT has been demonstrated neither as safe nor effective and, therefore, has not been sanctioned by FDA as such.

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

FDA Provides Guidance for Compounders

The FDA understands the importance of access to compounded drugs, and is committed to supporting access to these drugs under “high production standards,” according to a recently-released statement from FDA Commissioner Scott Gottlieb, MD.

Closed-System Transfer Devices: Important Considerations for Pharmacists

 

Closed-system transfer devices (CSTDs) mechanically prohibit the transfer of environmental contaminants into a system and the escape of hazardous drugs or vapor concentrations outside the system. Although the first CSTD was approved in the United States in 1998, several products are currently available, including those with widely varying design characteristics.1-3