503B Audits and Services

 

 

 

 

Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements.

USP Compounding General Chapters Now Available for Public Comment

 

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.

Choosing Proper PPE for USP <800>

This article discusses appropriate hazardous drug (HD) personal protective equipment (PPE) for USP <800> compliance, including gloves, gowns, shoe covers, sleeve covers, donning and doffing, and PPE disposal. It also covers the appropriate respiratory protection, eye and face protection, and hair covers.

 

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.

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.

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).

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

Media Fill by Aseptic Enclosures

media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.