With USP <795> and <797> on Hiatus, Time to Focus on USP <800>

On September 23rd, USP announced they were postponing the official dates of the revised General Chapters <795> and <797> (and <825> – radiopharmaceuticals). Stakeholders submitted appeals and have now requested further review by an appointed panel. In question are Beyond Use Dating requirements and Alternate Technology Provisions. According to the USP Bylaws, the panel will meet within 90 days. If the standard is upheld, the date for conformance will be reestablished with at least a six-month notice.

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USP <800> is not subject to any pending appeals and will become official December 1st, 2019. Many facets of USP <800> are intertwined with compounding (<795>/<797>), so the General Chapter will be considered informational and not compendially applicable at this time.

With rare exception, all pharmacies will be responsible for meeting USP standards in General Chapter <800> Hazardous Drugs – Handling in the Healthcare Settings. If your pharmacy plans to prepare compounded prescriptions with Hazardous Drugs (HDs), then you must comply with all elements of the standard, including the extensive containment requirements. If your pharmacy does not plan to compound with HDs but has HDs in inventory (as all traditional pharmacies do), then your responsibilities are greatly reduced, but there are still aspects of USP <800> you must comply with.

USP developed General Chapter <800> to address a public health need to protect healthcare personnel from HDs. Both acute and chronic health issues can arise from improper handling or exposure to HDs. HD handling is not new. The National Institute of Occupational Safety and Health (NIOSH) first published a list of HDs in 2004 and the Occupational Safety and Health Administration (OSHA) first published guidelines for HD handling in 1986 (originally only cytotoxic [antineoplastic] drugs).

Various states have adopted USP <800> into law as they feel it’s the best practice to prevent employee, and public, harm. However, regardless of whether a state has specifically enacted USP <800>, all pharmacies should have robust policies and procedures to handle HDs. OSHA was established to ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.

The following statement was taken from OSHA’s website regarding HDs:

“Institutions should have formal written programs to manage hazards. Such programs should include training, exposure assessment, emergency procedures for spills, policies for managing staff with reproductive concerns, and most importantly, ways to ensure that the institution is adhering to critical national standards.

Although OSHA has no explicit standard, USP 800 focuses explicitly on protecting workers from exposures to hazardous drugs. It, and USP 797, represent professionally expected requirements in healthcare that incorporate national consensus standards on infrastructure maintenance (ASTM).

OSHA also makes available guidance on Controlling Occupational Exposure to Hazardous Drugs. They have the authority, and resources, to enforce USP <800> for the welfare and safety of pharmacy employees.

PAAS Tips:

  • Where to start (not all inclusive):
    • Review Applicable USP Chapters
    • Download NIOSH HD list
    • Establish a qualified/trained individual to be responsible for developing and implementing appropriate standard operating procedures
    • Complete an Assessment of Risk for all HDs that are dispensed in the pharmacy. NCPA has made a template available for consideration.
    • Obtain Safety Data Sheets for all Hazardous Chemicals
  • If you have HDs from the NIOSH list in your inventory that in are in final dosage forms and do not require further manipulation (other than counting or repackaging – unless specified by manufacturer) you may not need to follow all the containment requirements of USP <800>, but should consider the following
    • Tablets and capsules may not pose a significant risk of direct occupational exposure; however, dust from tablets/capsules may present a risk of exposure by skin contact or inhalation
    • If you do not perform an assessment of risk, all HDs must be handled with containment strategies defined in USP <800>
    • Counting or repackaging of HDs must be done carefully. Clean equipment (e.g. counting trays and spatulas) should be dedicated for use with HDs and should be decontaminated after every use.
    • Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.
    • Splitting HD tablets (e.g. Warfarin 1 mg) is considered manipulation and should only be done if a pharmacy is in full compliance with USP <800>
  • If you plan to compound under USP <795> or <797> using HDs, you must fully comply with USP <800>.