Crucial Important Facts For USP 797 Guidelines for Hospitals

USP 797 Guidelines for Hospitals

Studies have shown that lack of compliance with the USP Standards by the health-care sector resulted in serious health issues. With cases of drug contamination often being reported it is extremely important for specialty pharmacists to abide by the USP 797 Guidelines for Hospitals for any forms of sterile preparations.

What Is USP?

USP is a non-profit organization or a scientific body that is solely responsible for setting down the standards of drug quality and its related practices.

What Is USP 797?

USP 797 is a chapter in the USP. It offers a set of requirements, procedures, and compliance requirements for the preparation of compounded drugs in a sterile environment. In other words, the purpose of USP 797 is to prevent causing harm and casualty to patients from microbial contamination and also from bacterial endotoxin.

To Whom Does This Standard Apply?

United States Pharmacopeia (USP) provides a set of standards that are applicable to all kind of settings and people who are involved in compounding sterile preparations (CSP) such as, clinics providing treatment to patients, pharmacies, healthcare institutions, etc.

A clinical pharmacy consulting firm can help pharmaceutical organizations to maintain their accreditation or get accredited by the accrediting agency. The firm helps pharmacies to get trained before the accreditation program or before any form of inspection by the pharmacy board.

Ways to Remain Compliance with USP 797

If you want your organization to remain compliant with USP 797 Guidelines for Hospitals, you will need to provide attention to many areas. USP 797 being mainly designed to protect patients as well as pharmacists, attention must be provided to these key areas. They are staff training, determining the risks, and implementation of policies and procedures.

Staff Training:

It is needed by everyone who is involved in sterile compounding practices. Pharmacists to nurses, pharmacy technicians to physicians need to be trained properly on the best practices available. For this, hands on training can be best.

Determining the Risks:

Microbial contamination can occur in three levels. For example, low level compounded sterile preparations can involve simple sterile compounding in an ISO 5 environments like restructuring of lyophilized powder. During medium risk level, compounded sterile preparations are more complicated. During sterile compounding in an ISO 5 environment multiple additives can get aggregated into the infusion device.

Policies and Procedures:

Compounded medicines must be produced in a sterile environment that contains the lowest possible risk of contamination. Monitoring the quality of the compounding room can be done on a monthly basis.

These steps can help CSPs to remain compliant with USP 797 standard with clinical pharmacy consulting and provide the best treatment to patients.

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