FDAs 2018 Compounding Policy Priorities Plan

 

 

Choosing Engineering Controls Under USP 800

 

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these products.

Aseptic Enclosures is a Contracted Supplier of GPO Leader Premier, Inc.

 

With two in house agreements with Premier, Inc. Aseptic Enclosures now allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier. The base of the supplying contracts covers a wide range of Primary Engineering Control Devices (I.V. Hoods, Isolators, Bio-Chemical Hoods, and Laminar Work Benches) in addition to Pharmacy Planning and Design services in order to meet USP Chapters <797> and <800> compliance.

StageThru 800

 

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area.

XLTC800 for Tablet Pressing

 

Here in Aseptic Enclosures we have encountered a project where we were called upon to come up with a solution that will provide ISO class 5 conditions for compounding tablets. The issues we had successfully overcome were: increasing safety of the pharmacist, assuring sterility of the product, limit particulate emissions and avoid risks for potential cross contamination of products.

Pharmacy Planning and Design Projects

 

When it comes to clean room design, fabrication, installation, pricing, and customer service, we do clean rooms right.

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.