Proposed USP Chapter <800> for Hazardous Drugs

The rules and regulations swirling around acute care pharmacy clean rooms continues to grow. Recently I became aware of the United States Pharmacopeia and The National Formulary (USP–NF) General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, or simply USP <800>. I attended a webinar put on by Pharmacy Advisor that specifically addressed USP <797>, but briefly mentioned USP <800>. Then a colleague and friend mentioned it so I decided I better learn a little bit more about the proposed chapter.

USP <800> builds on existing USP chapters, namely <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations. The purpose of Chapter 800 is to pull together and make sense of hazardous drug guidelines from ASHP, NIOSH, OSHA.

The chapter is proposed to be added into the US Pharmacopeia in May/June 2014. Comments pertaining to the chapter are due by July 31, 2014. Additional information can be found at the U.S. Pharmacopeial Convention site here.

USP <800> adds specific elements for handling and containment of hazardous drugs (HDs). A HD is defined as any drug meeting at least one of the following criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, new drugs that mimic existing hazardous drugs in structure or toxicity. The list of HDs will start with the National Institute for Occupational Safety and Health (NIOSH) list and expand from there as items get added.

Much of the chapter focuses on the physical requirements for compounding areas, protection of personnel handling HDs, and how HDs will be handled from receipt to administration.

The chapter applies to all persons who compound HDs, and all places where HDs are prepared, including pharmacies, hospitals, other healthcare institutions patient treatment clinics, physicians’ practice facilities, and veterinarians’ offices.

All personnel that engage in HD compounding are required to be “competent in HD compounding and should continually expand their compounding knowledge by participating in seminars, training programs, and/or studying appropriate literature”. There are additional requirements for training in section 8 of the chapter. This will likely lead to additional documentation for continuing education for pharmacists and technicians.

Storage of antineoplastic HDs shall be separate from storage of non-HDs, and refrigerated items must be in a negative pressure room. This will likely lead to additional recordkeeping and better inventory management on the part of the pharmacy.

Here are some new things in USP <800> that you should be made aware:

  • Elimination of current allowance in <797> for facilities that prepare a low volume of hazardous drugs that permits placement of a Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI) in a non-negative pressure room.
  • All hazardous drug compounding shall be done in a separate area designated for hazardous drug compounding.

Major Differences between USP <797> and Proposed <800>

USP <797> Pharmaceutical Compounding Proposed USP <800> Hazardous Drugs
Applies to sterile compounding only Applies to sterile and nonsterile compounding
Applies from receipt of inventory up to drug administration Wider continuum of time – applies from receipt of inventory through drug administration
All HDs* must be stored separately Antineoplastic HDs must be stored separately from non-HDs
Exemption for low volume compounding No low volume exception
CSTD** recommended CSTD required (“shall be used”) during administration (as long as dosage permits)
Does not require environmental and medical surveillance Requires environmental and medical surveillance
Physical compounding areas for HDs are specifically defined

*HDs – Hazardous Drugs
**CSTD – closed-system transfer device

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2 Comments

  1. Tim Shannon says:

    It’s particularly discouraging to see under trained physician office staff (oncologists , urologists, etc) be almost oblivious to how much danger they are in.
    Nurses, 6 months pregnant mixing chemo, urology nurses mixing BCG and Mitomycin in shirt sleeves and no biological safety cabinet. Storeroom personnel unpacking the chemo vials contaminated from the manufacturer with bare hands!
    I have done testing in these offices all over the country for the last 6 years, and it’s rampant…sadly.

  2. Jerry Fahrni says:

    I had no idea that it was such an issue in physician offices. Thanks for sharing, Tim.

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