Archives for May 2018

Conatining Bloodstream Infections

 

DSM Montgomery ISO7 Sampling Room

 

 

Aseptic Enclosures were approached by DSM Montgomery, to design and develop an ISO 7 8×12 Sampling room. The sensitive instruments and procedures that are carried out, needed ISO 7 classification for particulate as well as protection from molecular, electromagnetic and magnetic contamination of the sampling procedure.

FDA Alters Course on Definition of Compounding “Facility” in Final Guidance

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA).

Mold Discovered in Injectable Antibiotic Prompts Nationwide Recall

AuroMedics Pharma announced a voluntary recall of 1 lot of Linezolid injection 600mg/300mL flexible bags at the hospital level after it was found to contain white particulate matter identified as mold.

New FDA recall guidance released

The FDA has released guidance to improve recall processes so the public are better equipped  to protect themselves from recalled medicines.

2018 saw the FDA release draft guidance that sheds light on the body’s policy on warnings and notifications regarding recalled products.

Drug, medicine, FDA, recall