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2018 saw the FDA release draft guidance that sheds light on the body’s policy on warnings and notifications regarding recalled products.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

 

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

By Michael Sadick, Ph.D. and Dan Papa, Catalent Biologics

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

Get insights on how Octet-based Fc Receptor Panel test allows for rapidly adaptable assessment of monoclonal antibody therapeutics

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release

January 29, 2018

Contact

Consumers

Recall Department
recall@kareway.com
310-532-0009

 

Announcement

Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

Compounding Aseptic Containment Isolator from Aseptic Enclosures

We would like to start the New Year by introducing our Compounding Aseptic Containment Isolator. These close isolators provide a better physical barrier to protect the health of laboratory workers, maintain the sterility of experimental materials, and prevent the contamination of the environment. Closed containment cabinets are safer to use in research laboratories to provide a clean work environment, prevent exposure of laboratory personnel, prevent aerosol contamination, avoid pathogenic microorganisms to escape or enter the cabinet, prevent cross-contamination of experiments, and protect the environment.

FDA Announces Approval, CMS Proposes Coverage Of First Breakthrough-Designated Test To Detect Extensive Number Of Cancer Biomarkers

Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner

 

Cleaning Validation for Medical Device Manufacturing

Why Get Cleaning Validation Support From Your Cleaner Supplier?

 

USP 800: A Primer for Community Pharmacists

In the evolving world of pharmacy practice, many are asking what is included in the key provisions of the United States Pharmacopeial Convention (USP) 800 when it comes to transport, storage, preparation, and compounding.

PCAB Launches USP 800-based Distinction in Hazardous Drug Handling (HDH)

Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has released the compounding industry’s first Distinction in Hazardous Drug Handling (HDH).