Revised 503B Guidance for Outsourcing Compounders

Mortar pharmacy

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.

Workplace Hazards that USP <800> could Prevent

The degree of danger that pharmacy workers are subject to depends on the kind of pharmacy they work in and its location. Pharmacists can be employed in community-, retail-, and hospital-based pharmacies, among others. Each of these workplace settings bring different hazards that need to be addressed to prevent harm.

1. Biological Hazards
Contact with patients and the public exposes pharmacy staff to biological hazards, as will contaminants found in food, water, and the ventilation system. The immunization of workers provides a first line of defense when interacting with patients.

Other measures should also be put into place, including the restriction of access to authorized personnel only, implementation of safe work procedures, and use of personal protective equipment, such as eye protection, gloves, and respiratory protection.

Care should not only be exercised on the medication contained within a pharmacy; the building itself should also be given attention, particularly the ventilation system. Regular maintenance reduces the risk of contamination.








Trends in USP <800> Compliance

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting some 800-compliant practices; for example, most facilities already segregate their HD inventory from non-HDs in storage. However, other recommended practices are far from widespread; for example, few hospital pharmacies conduct HD spill simulations and wipe analyses on a regular basis. As such, many facilities do not have a firm understanding of the impact of HD contamination in their facility, nor can they be assured that their staff will respond properly when an HD spill inevitably occurs.

Merry Christmas

Can an Isolator still be used without a Cleanroom

 

The answer is complicated.

Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions.  Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.

Cleanroom Training and Evaluation

As cleanroom experts, we also provide on-site clean room training.

This is the table of contents for our, joint commission evaluated, clean room training manual.

 

This on-site training can be implemented in several ways.

Exposure to Hazardous Materials during Shipping and Receiving

 

Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.

The first known, is actually outside of the clean room and is the pre-cleaning station.

Cleanrooms and Space Constraints

 

In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years.

Submit your Last Comments to USP 797 Revisions

 

Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018.

Complications Related to TPN and How to Prevent Them

 

There are many complications related to the administration of TPN. Total parenteral nutrition (TPN), also known as parenteral nutrition (PN) is a form of nutritional support given completely via the bloodstream, intravenously with an IV pump.