What is the purpose of the USP 800 hazardous drug guidelines?
USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.
Who enforces compliance with USP 800?
Although USP is a scientific nonprofit organization, its standards—such as USP <800>—are enforced by a variety of local, state, and federal regulatory agencies and are also followed worldwide. Accrediting bodies such as The Joint Commission survey for compliance with USP compounding standards.
What are the USP 797 guidelines?
The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).
What are the requirements of compounding sterile HD drugs?
Sterile HD Compounding (USP-797 + USP-800)
- 30 ACPH minimum to reach an air quality of ISO 7 or better.
- Positive pressure of 0.02 inches of water relative to all adjacent unclassified areas.
- A cleanroom-specific sink at least 1 meter away from the entrance of the buffer room to avoid contamination of HD buffer room.
How do I comply with USP 800?
USP <800> requires covered workplaces to maintain an internal list of HDs used in their facilities, and review that list at least every 12 months. Whenever a new HD or dosage form is introduced in the workplace, it should be reviewed against your internal list using the NIOSH list criteria.
What does USP 800 stand for?
800 Hazardous Drugs – Handling in Healthcare Settings
From Wikipedia, the free encyclopedia. USP 800 Hazardous Drugs – Handling in Healthcare Settings is a chapter of a book which provides guidance about the handling of hazardous drugs (HDs) in the healthcare setting. It was created by the United States Pharmacopeia Convention.Why did USP 800 take so long to implement?
The delay was made “to provide a unified approach to quality compounding” by aligning USP <800> with the timeline of an earlier chapter already in force, USP <797>, the organization said in a statement announcing the postponement.
Is USP 800 enforceable?
The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make …
What is the difference between USP 797 and USP 800?
Difference Between USP 797 and USP 800 Cleanrooms The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
What qualifies as a high risk level compound?
High Risk Level Compounding: Sterile products compounded from non-sterile ingredients and/or compounded using any non-sterile devices, containers, or equipment. Products prepared from sterile ingredients, containers, devices, or equipment that are exposed to less than ISO Class 5 air.
What is the minimum PPE required when compounding hazardous drugs?
Reusable PPE must be decontaminated and cleaned after use. Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and nonsterile HDs. Two pairs of chemotherapy gloves are required for administering antineoplastic HDs.
Is USP 800 mandatory?
USP <800> applies to all healthcare personnel who handle HD preparations including pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.
When does the 800 rule come into effect?
on February 1, 2016 and will become official on December 1, 2019. The revisions to <795> and <797> published on June 1, 2019 and which make reference to <800>, have been postponed until further notice, pending resolution of appeals of those chapters. Although these revisions have been postponed, <800> will become official on December 1, 2019.
What does ITL Special Publication 800-series report on?
The Special Publication 800-series reports on ITL’s research, guidelines, and outreach efforts in information systems security and privacy and its collaborative activities with industry, government, and academic organizations.
Which is an appendix to NIST SP 800-53?
NIST SP 800-53 Appendix J Privacy Controls Security Center of Excellence (SCOE) March 20, 2014 Centers for Medicare & Medicaid Services Privacy Control Families (# of controls in each) 2 2 – Authority and Purpose (AP) 8 – Accountability, Audit, and Risk Management (AR) 5 – Data Quality and Integrity (DI)
What are the privacy controls in NIST 800-53?
Privacy Control Families (# of controls in each) 2 . 2 – Authority and Purpose (AP) 8 – Accountability, Audit, and Risk Management (AR) 5 – Data Quality and Integrity (DI) 6 – Data Minimization and Retention (DM) 6 – Individual Participation and Redress (IP) 2 – Security (SE) 5 – Transparency (TR) 2 – Use Limitation (UL) 36 total controls