Does USP 800 apply to physician offices?

Author: Wilhelmine Upton  |  Last update: Sunday, April 3, 2022

USP <800> applies to all facilities where hazardous drugs are prepared, stored, transported, or administered. This includes hospitals, pharmacies, clinics, physician's practices, and most acute care facilities.

Who does USP 800 apply to?

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.

What type of compounding does USP 800 apply to?

USP <800> is established in concert with USP General Chapters <795> for non-sterile compounding and USP <797> for sterile compounding. The purpose of the chapter is to provide standards and define processes to protect personnel, patients, and the environment when handling hazardous drugs in a healthcare setting.

Which healthcare personnel are required to use Cstds by USP 800?

Implementation began with training on CSTD use for the nurses, pharmacy technicians, and pharmacists who would be utilizing the device.

What is the difference between USP 797 and USP 800?

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 is USP 800?

Does USP 800 replace USP 797?

USP <800> section on storage presents a change from the guidance of USP <797>. ... Of note, USP <800> allows sterile and nonsterile hazardous drugs to be stored together, but only sterile hazardous drugs may be stored in a negative pressure buffer room.

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 ...

Why is USP 800 necessary?

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.

Why did it take USP 800 to implement?

Meanwhile, USP <800> will still take effect on December 1. The Healthcare Quality and Safety team at USP explained that it would only be “informational and not compendially applicable.” ... The delay was due to the number of appeals that USP received about certain provisions in <795>, <797>, and <825>.

How do I become compliant with USP 800?

USP Compliance

To remain compliant, manufacturers and healthcare facilities should identify the drugs they handle, get Safety Data Sheets (SDS), and segregate hazardous and non-hazardous drugs to prevent cross-contamination.

What is the scope of USP 800?

Scope. USP 800 describes practice and quality standards for the handling of HDs involving but not limited to the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products. This chapter applies to any personnel who may be exposed to HDs.

Which of the following is a new specific medical surveillance recommendation from the USP 800 requirements?

USP <800> states that a medical surveillance program should include the following: Completion of an exit examination when a worker' s employment ends, documenting the information on the employee' s exposure, medical, and reproductive history.

What is the status of USP 800?

The 2019 revision of USP 797 would have made USP 800 enforceable. Because the revision was remanded, USP 800 remains informational at this time. When a new revision of 797 becomes official, USP 800 will become enforceable, and organizations will need to become compliant with USP 800.

Who regulates 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.

Who does USP apply to?

USP standards may be adapted or adopted by any organization or government worldwide. USP has no role in enforcement; that is left to FDA and other government authorities in the U.S. and elsewhere. 2.

Which states adopted USP 800?

While the national implementation date will go into effect on December 1, 2019, some states have already adopted some or all of these guidelines and are currently implementing and enforcing, such as California, Kentucky, Indiana, Ohio, Pennsylvania, and Minnesota.

What is the effective date of USP 800?

The effective date for USP <800> implementation is Dec. 1, 2019. To help protect employees, patients and the environment, the United States Pharmacopeia (USP) has developed comprehensive standards for the safe handling of hazardous drugs—USP <800>.

Will USP 800 be delayed?

NCPA and six other national pharmacy organizations are asking state boards of pharmacy to postpone to 2021 the enforcement date for USP General Chapter <800>. The current enforcement implementation date is scheduled for July 1, 2018.

When did USP 800 go into effect?

Chapter 800 became official on December 1, 2019; however, as noted above, it remains informational and not compendially applicable until the revisions to Chapters 795 and 797 are fully resolved. The standards within Chapter 800 address the following matters: Identification of HDs.

What are the three steps taken to comply with USP 800?

What Are the Steps to Comply With USP <800>?
  • Identify Hazardous Drugs (HDs) for their final dosage form.
  • Designate a hazardous drugs point person in your store.
  • Complete an Assessment of Risk annually.
  • Ensure hazardous drugs are dispensed or returned a minimum of nine months prior to expiration.

How does USP 800 affect retail pharmacy?

USP <800> was designed to address the proper handling of hazardous drugs in the pharmacy setting, and its guidelines are plainly aimed at promoting patient and worker safety in and around sterile and non-sterile compounding. The first section of USP <800> covers compounding in its purest form.

What is the minimum PPE required when compounding hazardous drugs?

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.

Who enforces USP?

USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations.

Is USP 797 enforceable?

The new USP chapter 797, Pharmaceutical Compounding: Sterile Preparations, became enforceable by regulatory agencies on January 1, 2004. The provisions and requirements of USP 797 are designed to achieve compounding accuracy and sterility to ensure the safety of patients.

Is risperidone a hazardous drug?

NIOSH has determined it is unlikely that risperidone (Risperidal®) poses a carcinogenic, reproductive, or developmental hazard to workers in a healthcare setting and is no longer considered a hazardous drug by NIOSH.

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