USP 800

The United States Pharmacopeial Convention (USP) is looking into the establishment of safety standards to be used when handling drugs that are considered hazardous. While there are other organizations that have provided standards on handling hazardous drugs, USP 800 addresses in detail the storage, transportation, handling, compounding, administration as well as disposal of hazardous drugs. The following are the objectives USP 800 is seeking to meet.

-        Protect both the involved personnel as well as the general environment.

-        Proper handling of hazardous drugs.

-        Handling of both sterile and non-sterile product preparation.

-        Implementing all required standards.

To be more specific, USP 800 refers to the primary and secondary containment engineering controls which are in relation to the storage and compounding of HDs. It therefore addresses the guidelines on facility design, engineering controls, personal protective equipment as well as transportation of hazardous drugs.

Engineering Controls, Facility Design and Compounding

It identifies the primary and secondary containment engineering controls, Containment Primary Engineering Control (C-PEC) and Containment Secondary Engineering Control (C-SEC) which are in relation to the storage and compounding of HDs. The C-PECs are devices that are ventilated to reduce the risks of the workers and the environment from hazardous drugs. C-PECs there include equipment such as:

-        Biological Safety cabinets (BSC).

-        Compounding aseptic containment isolators (CASIs).

-        Containment ventilated enclosures (CVEs).

On the other hand, the C-SEC is the room in which the containment primary engineering control devices are kept. The rooms are negative pressure which are ventilated externally. The rooms may come with a refrigerator in case there are some hazardous drugs that require refrigeration. Depending on the drug, you will be pushed to controlling air changes per hour (ACPH). In this, it is evident that different hazardous drugs. There should be different areas designated for different drug conditions.

The different engineering controls fulfill the desired standards. The engineering controls for non-sterile HDs and those for sterile HD compounding are different. Therefore, you need a professional who understands the USP 800 chapter to put all the requirements in place. Every requirement must be fulfilled to the very last bit and you need to meet them.

Personal Protective Equipment and Personnel Training

It is not a compromise that all personnel must be in protective gear at all times when handling hazardous drugs. Every protective gear is outlined in the USP 800 and its use fully described to ensure that the company's personnel is safe.

In addition, each institution for this category is required to offer a training program that highlights what they are up against when handling hazardous drugs and their contents. All the procedures regarding storage, handling, as well as disposal must be well known to all personnel. After the training, the staff should be assessed of their competency from time to time to minimize on safety risks.

The above services cannot be complete and met without ensuring that all standards are met. In this, professionalism and a better understanding of this chapter must be looked into help implement the required requirements.