October 17, 2025

The Most Common Violations of §5194. Hazard Communication in Pharmaceutical Manufacturing

In the pharmaceutical manufacturing sector, adherence to safety regulations is critical. Yet, violations of §5194, the Hazard Communication Standard, are frequently encountered. These lapses can lead to serious safety hazards, compliance issues, and potential fines.

Inadequate Training and Information

One of the most common violations we see is a lack of comprehensive training. Employees must be fully versed in the hazards of the chemicals they work with. This includes understanding Safety Data Sheets (SDS), labels, and the company's specific hazard communication program. In my experience, many companies fall short here, leading to a workforce that's not fully equipped to handle hazardous materials safely.

Failure to Maintain Safety Data Sheets

Another frequent violation is the failure to maintain up-to-date Safety Data Sheets (SDS). These documents are essential for providing detailed information about the hazards of chemicals. They must be readily accessible to all employees during each work shift. I've seen cases where outdated SDS are used, or worse, where they're not available at all, which can significantly increase the risk of accidents.

Improper Labeling of Chemicals

Proper labeling of chemicals is another area where violations commonly occur. Each container of hazardous chemicals must be labeled, tagged, or marked with the identity of the hazardous chemical and appropriate hazard warnings. In pharmaceutical manufacturing, where multiple chemicals are often used, ensuring that every container is correctly labeled is crucial but often overlooked.

Lack of a Written Hazard Communication Program

Lastly, a written hazard communication program is a must under §5194. This program should detail how the standard is implemented in the workplace, including how labels and SDS are managed, and how employees are trained. Many companies fail to either develop this program or keep it updated, which is a clear violation of the standard.

Based on available research, addressing these common violations can significantly improve workplace safety. However, individual results may vary depending on the specific circumstances of each facility. For further guidance, resources from the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) can be invaluable.

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