A change is coming: Proposed USP <800>
Specialty Pharmacy Section
The U.S. Pharmacopeial (USP) Convention is a nonprofit organization that sets legally recognized standards for drugs. USP’s mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” These standards are enforceable by FDA.
Recently, a new chapter was proposed for addition to The United States Pharmacopeia and the National Formulary (USP–NF), “USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings,” or simply “USP <800>.”
Guidelines for safe handling
The proposed chapter provides guidelines for the safe handling of hazardous drugs (HDs). According to the National Institute for Occupational Safety and Health (NIOSH), an HD exhibits one or more of the following six characteristics in humans or animals:
- Teratogenicity or other developmental toxicity
- Reproductive toxicity
- Organ toxicity at low doses
- Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria
Safe handling refers to various steps including, but not limited to, receiving and unpacking, storing, preparing, compounding, dispensing, and administering. It requires designating an individual who is responsible for compliance with all standards, from maintaining proper environmental controls to appropriate training of all personnel.
Public review, input
Whenever a new chapter to the USP–NF is proposed, there is a 90-day period of public review and comment. The statement that there is no acceptable level of exposure to HDs, originally included in the proposed chapter, was removed because this goal may be unattainable, even when all guidelines are followed.
Revised hazardous drugs list
In the summer of 2014, NIOSH revised its list of HDs. The revised list now includes three categories of HD: antineoplastic drugs, non–antineoplastic drugs that meet one or more NIOSH criteria for an HD, and non–antineoplastic drugs that have primarily adverse reproductive effects. The chapter was revised to allow entities to perform a risk assessment for nonneoplastic drugs and final dosage forms to determine alternative containment strategies and/or work practices.
Entities that do not compound may erroneously assume that this chapter does not apply to their practice. Any entity involved in the receipt, storage, labeling, transport, or dispensing of HDs must follow these new standards.
Per the proposed chapter, dispensing of final dosage forms will require clean equipment dedicated to use with these drugs. Counting or packaging machines may not be used with tablet or capsule forms of HDs. Physical stress could introduce powder contaminants into the work space, resulting in exposure to the HD.
Revisions allow for either external venting or redundant high-efficiency particulate air (HEPA) filtration of containment primary engineering controls used for nonsterile compounding.
Complement to <795>, <797>
USP <800> is designed to complement both USP <795> and USP <797>. Some facility requirements will necessitate a revision to USP <797>. It is no longer acceptable for facilities that prepare a low number of HDs to use a biologic safety cabinet (BSC) or a compounding aseptic containment isolator (CACI) in a nonnegative pressure room. HD compounding can be done only in an HD-designated area.
USP <800> allows a containment-segregated compounding area (C-SCA), a separate, negative pressure room with at least 12 air changes per hour for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or CACI located in an C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours.
New terminology is used in the revised chapter. The word “shall” has been replaced with “must,” indicating an enforceable guideline. The word “should” indicates a recommendation. All future revisions of USP standards will use this language.
Steps to prepare
Affected entities should take the following steps to prepare for deployment of the proposed standards:
- Review the NIOSH list and identify the HDs used in your establishment.
- Make any modifications to your facility to meet the new requirements.
- Establish appropriate training and monitoring of personnel.
- Use appropriate personal protective equipment.
- Document competencies.
- Follow designated cleaning procedures.
- Certify appropriate environmental quality and controls.
The current revision is being published on the USP website under Notices. Please provide the line numbers when submitting comments. The public comment period will end on May 31, 2015.
- www.usp.org/about-usp/legal-recognition/working-us-fda www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
- Department of Health and Human Services (NIOSH) Publication No. 2004-165