Question

What are some potential solutions to the issues discussed based on Sterile compound regulations (USP 797, 800)

Answer 1

USP Chapter 797 was released to the public in 2004 and has classified Sterile Compounding into 3 risk groups: Low, Medium and High Risk. For each risk level, the Chapter establishes staff responsibilities and training, quality control processes, competence assessment, environmental quality and control, and quality assurance program requirements.

Adopted by several states, USP 797 is currently under review by many others (check with your state Board of Pharmacy). States have the option to adopt 797 verbatim or to edit the standards into pharmacy regulations (Missouri and Texas have sterile compounding regulations, New Jersey’s requires that the buffer zone be ISO 6 / Class 1,000). Additionally, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is enforcing USP Chapter 797 within their standards. The JCAHO may require stricter compliance to 797 than the state Board of Pharmacy.

USP Chapter 797, as it applies to cleanrooms (Buffer Zones), is general in nature but refers to the International Standards Organization, ISO-14644 standard for cleanrooms. All Sterile compounding is to be performed in an ISO 5 (class 100) environment that is surrounded by an ISO 8 (Class 100,000) Buffer Zone (cleanroom), ISO 7 (Class 10,000) in 2006. A barrier isolator does not have to be contained in an ISO-rated space unless recommended by the manufacturer.

A “Buffer Zone” in the simplest form, is an environment that separates the compounding room from the surrounding ambient (unrated) area and is to be constructed from low-particle-generating materials that can withstand continuous cleaning. ISO standards require that the buffer zone be maintained under positive pressure and that airborne particles be limited in compliance with ISO 8 requirements. ISO 7 (Class 10,000) will be required in 2006.

You may be able to meet the specified standards with as little as a fresh coat of paint (water-based epoxy), the addition of 1, 2 or 3 new walls (fixed or modular), a new cleanroom ceiling, HEPA-filtered air, and a coved vinyl floor.

There are many ways to meet USP Chapter 797’s requirements for sterile compounding areas. Cleanrooms can be economical, installed in as little as 1-3 days (over a weekend), and designed to use your existing laminar flow hoods in a USP Chapter 797 compliant environment while conserving space. Evaluate all your options first. Modular Cleanrooms can provide preliminary cost estimates for a cleanroom within 1-3 days.When does USP <800> go into effect?

The “official date” for USP <800> compliance was December 1, 2019. After this date, all covered facilities in states that have adopted USP <800> standards were expected to be in compliance with the applicable requirements. Some states including California and Minnesota had adopted some or all of these requirements prior to the December 1, 2019, while others like Michigan and Washington have had their own separate, yet similar HD regulations in place prior to the publication of USP <800>.

There has been some confusion among stakeholders regarding the effective date for USP <800>. On June 1, 2019, USP published revisions to USP chapters <795> and <797>, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. After publication of the revised and new compounding standards, USP received appeals from stakeholders concerning specific provisions contained in <795>, <797>, and <825>. USP’s bylaws state that the official effective date of a standard under appeal must be postponed while an appeal is pending. Therefore, USP has postponed the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.

Because several of the requirements contained in USP <800> are directly related to provisions in USP <795> and <797>, there had been some speculation that the postponement and ongoing appeals to USP <795> and <797> would delay the December 1, 2019 deadline for USP <800> compliance. To address the concern over these delays, USP issued a news release on September 23, 2019 stating:

"General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health."

Let’s take a look at a few USP <800> requirements and discuss some best practices and technology tools that employers in the healthcare industry can use to better ensure the safety of their employees, and maintain compliance with USP <800>.

USP <800> Requirements for Maintaining an Inventory of Hazardous Drugs

USP <800> defines HDs according to the criteria established in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. 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. If the information available on a drug is not sufficient to make a determination as to whether it is considered an HD, (e.g. the SDS and/or label does not contain detailed information on the drug’s health effects) consider the drug hazardous until more information becomes available and add it to your internal list.

Compliance with this particular aspect of USP <800> relies almost entirely on maintaining a full and accurate inventory of the HDs used in your facility, and being able to update that inventory quickly as new HDs or dosage forms enter your workplace. MSDSonline chemical management software from VelocityEHS makes it easy to edit and update your physical inventory as HDs enter your workplace, map their locations and quantities on a virtual floor plan of your facility, and distribute inventory information in real-time to help healthcare workers better identify their risk of exposure to HDs in the workplace.

USP <800> Requirements for Hazard Communication

Maintaining a strong workplace hazard communication program is key to compliance with USP <800>. As with OSHA’s HazCom standard, USP <800> requirements for your workplace hazard communication program include:

A written plan that describes, in specific detail, how your HazCom program will be implemented at your facility [workplace specific]

All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings

Employers must have an SDS for each hazardous chemical they use and ensure that the SDSs for each hazardous chemical used are readily accessible to personnel in work areas during each work shift

Personnel who may be exposed to HDs must be provided information and training before the initial assignment to work with HDs, and also whenever new HDs are introduced or hazard information changes

Personnel must confirm in writing that they understand the reproductive risks of handling HDs

OSHA HazCom compliance is already significant challenge for employers, especially those in the healthcare industry who regularly handle large numbers of HDs and other chemicals. In fact, HazCom violations have ranked second on OSHA Top 10 List of Most Frequently Cited Standards for the past six years running, and changes to OSHA’s HazCom Standard that are slated to begin as early as 2020 are sure to add to the confusion. Considering all of the other USP <800> requirements you have to meet, it’s easy to understand how things can start to feel a little overwhelming.

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