Section 8 Hazard Communications Program

Sections 1 through 7 of United States Pharmacopeia (USP) Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures with checks and balances for quality control and provision of direct protective measures on our road to compliance. Section 8 falls into requirements of facitilites and employers to include hazardous drug handling within their Hazard Communications Program for employee safety.

What is a Hazard Communication Program?

When you ‘Google’ the term the first hit is a listing by the United States Department of Labor (DOL). Basically, it requires employers to define workplace hazards and provide employees with education and a safe work environment with the proper tools to protect themselves. Under the DOL, employees are given rights and a formal process to file complaints to protect them in their workplace; this highlighted on the DOL banner for Hazard Communication ‘The standard that gave workers the right to know, now gives them the right to understand.’ Employers are required to post the rights of the employee in clear and visiable location for employees.

Example posting click here

Why would USP <800> use a term that falls under the jurisdiction of the DOL?

It starts with the Occupational Safety and Health (OSH) Act of 1970 which sets safety and health standards for United States workers which includes healthcare workers.The OSH is administered by Occupational Safety and Health Administration (OSHA), an agency of the Department of Labor (DOL).

All employers are subject to the OSH Act have a general duty to provide work and a workplace free from recognized, serious hazards. Since the publications 2004 NIOSH alert and proposed USP <800> are available in the public domain, handling certain drugs are considered as a ‘recognized’ hazard. As such, sites handling these products must include them in their Hazard Communications Program.

Although not listed within the USP section, sites are encouraged to read the three OSHA guides specific to Hazardous Drugs:

  1. Controlling Occupational Exposure to Hazardous Drugs.
    • In: OSHA Technical Manual, TED 1–0.15A, Sec VI, Chap II: 1995, 1999
  2. Hazard Communication Standard;
    • (29 CFR part 1910 – 1200) “Right to know”
  3. Hazardous Waste Operations and Emergency  Response (HAZWOPER)
    • Standard (29 CFR 1910.120)

USP does an excellent job of summarizing the three OSHA documents and gives light to the requirements under their term ‘must’. Sights must have a plan in place and a process for implementing and continuously updating their hazardous communication plan. Since manufacturers of drugs are not required to place a symbol or acknowledge a drug is a hazard, the burden of designing a list and adding placards is on each site. DOL mandates the use of the Global Harmonized System of Classification and Labeling of Chemicals (GHS) for classifying hazardous chemcials (drugs). Employers were required to train employees by December 1, 2013 on the new symbology, label elements and safety data sheet format and acknowledge an agreed upon understanding of the system.

Use this link to see common symbology used based on the defined hazard.

It is the responsibility of sites to have readily available current copies of the Safety Data Sheets (formally known as a Material Safety Data Sheet -MSDS); noting that readily available denotes staff (not supervisors) know where to get copies. The use of the GHS symbology should be mirrored on hazardous drugs and corresponding SDSs.

USP notes that sites are required to provide adequate training and employee safety programs and document compliance of the programs. This would include the use of Personal Protective Equipment compliance, engineering control utilization and other tools/devices used to protect the employee. Although not a line listed call-out in Section 8, it is implied throughout sections of USP <800>.

USP hightlights the OSHA requirement that personnel who may be exposed to hazardous chemicals (drugs) when working must be provided information and training before the initial assignment to work with a hazardous chemical (drugs). In addition, this must be modified whenever the hazard changes, such as the addition of a newly defined hazardous drug.

USP further specifices, based on the defined risks of certain drugs, that personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs. This statement is directed towards both female and males. It is in the best interest of sites to get a signed agreement on an annual basis confirming education and acknowledgment.

USP has done a great service by taking a multitude of standards and regualtions from differing state and federal agencies and placing them in an easy to read chapter; USP <800>. As the chapter evolves from Section 1 through to Section 18 we are provided with a logical roadmap to compliance.

As the NEW official implementation date of December 1, 2019 for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance allows time for compliance, the time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP <797>.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.


[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. Accessed May 10, 2017.

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