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USP <800> FAQs

Tue, 03/19/2019
What is a hazardous drug?

­­A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.

Who must abide by USP 800 regulations?

Chapter <800> was written to protect all workers, patients, and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared. This includes but is not limited to pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. If any workers come in contact with HDs, they must receive HD training, and be assessed for an understanding of the training. All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.

Will I need a specialized area to work with hazardous drugs?

Yes, USP 800 regulations require special facility and engineering controls for working with hazardous drugs. A containment primary engineering control (C-PEC) is ventilated to minimize exposure while handling hazardous drugs. The C-PEC must be within a containment secondary engineering control (C-SEC). This C-SEC must be a separate room that is externally vented, have appropriate air exchange, and have negative pressure. For more specifics on engineering controls refer to USP 800 document.

What type of hoods can be used as containment primary engineering controls under USP 800?

USP 800 requires externally vented hoods as the preferred option, however, redundant-HEPA filtered in series hoods are also permitted. Nonsterile compounding of hazardous drugs can be performed in a Class I Biological Safety Cabinet (BSC), or a Containment Ventilated Enclosure (CVE). Aseptic compounding must be done in a Class II BSC, or a Compounding Aseptic Containment Isolator (CACI).

What type of personal protective equipment will I need?

Anyone involved in receiving, storing, transporting, compounding, administrating, deactivating/cleaning/disinfecting, spill control, or waste disposal must wear appropriate personal protective equipment (PPE). PPE includes chemotherapy gloves, resistant gowns (laminate materials such as polyethylene-coated polypropylene are recommended), head covers, hair covers, shoe covers, and sleeve covers, face and eye protection (face shields and goggles), and respiratory protection (such as N95 or better).

Is an entity required to have two sets of equipment, one set for compounding HDs and another second set for compounding non-HDs?

General Chapter <800> states that “disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs.”  This refers to equipment (or parts of equipment) that comes in direct contact with HDs.  Equipment that does not come in direct contact with HDs may be shared between HD and non-HD compounding areas provided it is deactivated, decontaminated and cleaned before it is removed from the HD area. Equipment used in HD compounding must be operated in the C-SEC unless it is operated as a closed system (e.g. certain mixers, terminal sterilization using an autoclave or convection oven).

During nonsterile compounding with HDs APIs, are all steps of the compounding process required to be performed in the C-PEC?

General Chapter <800> states that “bulk containers of liquid and API HD must be handled carefully to avoid spills. If used, APIs or other powdered HDs must be handled in a C-PEC to protect against occupational exposure, especially during particle-generating activities (such as crushing tablets, opening capsules, and weighing powder).” It is recognized that under some circumstances, it is not possible to perform all steps of the compounding process in the C-PEC (e.g. due to equipment size or function).  It is important for the safety of personnel that powdered HDs be weighed and mixed to the wet stage or made into capsules in the C-PEC.  Once nonvolatile, non-antineoplastic, powdered HDs are wet, an assessment of risk may be performed to determine alternative containment strategies and/or work practices. The NIOSH list of antineoplastic and other HDs provides general guidance on PPE for possible scenarios that may be encountered in healthcare settings including instances where a C-PEC cannot be used.

Can an assessment of risk be performed on concentrated solutions of HDs (i.e. hormone concentrates)?

No, concentrated solutions of HDs (i.e. hormone concentrates) is an HD API that is further manipulated into a final dosage form and is subject to the containment requirements in <800>. General Chapter <800> defines an API as “any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.

Do I have to store my final product (ex: compounded progesterone capsules) inside the C-SEC?

An assessment of risk may be performed on hazardous finished dosage forms that may not pose a risk of direct exposure due to their formation (such as in a solid dosage form like capsules or tablets) that will not undergo further modification. If an assessment of risk is not performed, then all hazardous drugs must be handled in a way that complies with USP 800 guidelines.

What type of standard operating procedure (SOP) documents will I need?

USP 800 requires a variety of SOP documents including those for the handling and disposal of hazardous materials. USP 800 specifically wants these SOPs:

  • Hazard communication program
  • Occupational safety program
  • Designation of HD areas
  • Receipt
  • Storage
  • Compounding
  • Use and maintenance of proper engineering controls (e.g., C-PECs, C-SECs, and CSTDs)
  • Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
  • Deactivation, decontamination, cleaning, and disinfection
  • Dispensing
  • Transport
  • Administering
  • Environmental monitoring (e.g., wipe sampling)
  • Disposal
  • Spill control
  • Medical surveillance

 

USP <800> Deconstructed Class

April 11-12, 2019 - Join industry experts and Fagron Academy for a two-day course on deconstructing and implementing the requirements for USP General Chapter <800>.  Learn techniques on SOP writing, standard operating procedure development, contamination control, and more.  Click below for more information.


Phone: (651) 219 5021    Email: info@fagronacademy.us