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Compounders who have read USP〈800〉carefully are aware that there is a mandate for a “Hazard Communication Program,” but few of them actually may understand the business risks of failing to create one. This post hopefully will help to clarify certain important and pertinent aspects of a Hazard Communications Program.

The Meaning and Definition of a Hazard Communications Program

Whereas USP〈800〉has literally no compliance impact unless enforced by a poorly-informed state pharmacy board, a Hazard Communication Program is a genuinely enforceable federal regulation you can (and should) read about at 29 CFR 1910.1200. The purpose of the regulation is to ensure that the hazards of all chemicals produced or imported are classified, and that the information concerning these classified hazards is transmitted to both the employers and employees. The rationale behind the program is that no one should labor in a workplace with known chemical hazards present without first being informed regarding those hazards. The regulation requires that the suppliers of products that contain hazardous chemicals must label those products in a very specific manner, plus provide Safety Data Sheets (formerly called Material Safety Data Sheets) to all of the purchasers. Employers must subsequently ensure this information is further transmitted to their employees by means of a comprehensive hazard communication program, which includes container labeling and other forms of warnings, safety data sheets and employee training information.

The Scope of a Hazard Communications Program

The requirement for Hazard Communication applies to all employers who have a workforce that spends time in their workplace. This obviously encompasses all pharmacies, physician offices, veterinary establishments, hospitals, surgery centers, and extended care facilities. Because most pharmacist’s thinking is centered first and primarily on medications and drugs, many are not focused at all on chemicals used for cleaning, disinfection, and the killing of spores, but our hazard program must cover those as well. Compounding pharmacies generally keep bulk quantities of active pharmaceutical ingredients and virtually all such API come with Safety Data Sheets.

A Hazard Communications Program Legal Basis and the Federal & State Entities That Enforce its Compliance

The requirement for employers to create and maintain a Hazard Communication Program is a mature federal regulation that has been in place since 1994, and the governing case law is now well established. OSHA can delegate the enforcement of the federal regulations to the various state governments if they successfully navigate the process of establishing an OSHA-Approved State Plan. Currently, twenty-two states have OSHA-Approved State Plans for private workers, as well as for workers employed by the state and local governments.

The states that currently have OSHA-Approved State Plans include:
North Carolina
New Mexico
South Carolina
Puerto Rico (although technically it’s not a state)

It’s sometimes important to note that these State Plans, once approved, may have the power to actually impose stiffer sanctions than those of OSHA itself. Note that virtually all states have a governmental arm that enforces STATE Occupational Safety and Health statutes and agencies, but which can enforce the FEDERAL statute only if they are OSHA-Approved State Plans.

Operational Requirements

So, to totally ensure that their operations comply with the Hazard Communication regulation, what must a company do? The answer is to develop and maintain a written hazard communication program for the workplace. This written program includes:
• A List of hazardous chemicals that are present.
• Documentation of accurate labeling of the containers of chemicals in the workplace, as well as of containers of chemicals being shipped
from your workplace to other workplaces.
• Demonstrable preparation and distribution of safety data sheets to employees and downstream employers.
• Development and implementation of employee training programs regarding hazards of chemicals and protective
measures to be taken.

To dive a little deeper:

– “List” means that if you keep a chemical in your workplace which is covered by a Safety Data Sheet you must have proof that you are tracking it in your Hazard Communication Program.

– “Labeling” means just what it says. If you buy a commercial product, it will have labeling in the fine print on the side of the container, but when you subdivide quantities into smaller containers, it could be construed that the smaller containers must each echo the cautionary labeling of the “parent” container.

– “Distribution” of SDS means you must demonstrate that your employees have ready access to any product included on your “List.” This can be a three-ring binder, a file cabinet or (since this is the electronic age) it can be accomplished by asubscr iption to a web-based SDS database. The last one I personally subscribed to many years ago was www.msds.com. I entered its domain (URL) into a web-browser and learned that their subscription costs $199 annually. A broader Google search yielded several competitive web-based services that I did not yet have the time to properly evaluate.

– “Training” means that you must ensure that all employees undergo training that informs them of the list of hazardous chemicals present, how to comprehend and interpret product labeling and how to locate and read the SDS for each substance on the list. This training should be successfully completed upon hire and before performing work activities. It should also be “refreshed” on a regular basis, the logical timing of which could coincide with your refresher training for HIPAA, Universal Precautions, etc. Training needs to ensure that employees comprehend and can competently execute the protocols for responding to exposures and spills, including location and use of spill remediation materials.

Likely Triggering Events For OSHA Inspections

Unlike the FDA, OSHA rarely makes random inspections. More than half of the OSHA drop-ins are complaint/event based. In my own personal experience, the triggering event for pharmacies and physician practices is most likely a complaint filed by a current or former employee. About 20% of such complaints result in an inspection, but the likelihood is higher in certain target industries or if the complaint touches on hot topics.

Optimal Compliance Strategies

For years, I have advised my healthcare clients that having a robust and deliberate Hazard Communication Program is tantamount to a “litmus test” for OSHA. It forms their impression of whether you “get it” or you don’t. Recently I learned that one of my business partners had an OSHA inspection at a pharmacy he formerly owned and could personally bear witness to the value of incorporating effective Hazard Communication into your SOPs. As soon as we can schedule it, we’re going to record a conversation about his remarkable OSHA experience which we will posting on 503qm.com.

Key Take Away Regarding Hazard Communication Programs

If OSHA “comes knocking on your door,” one of their first questions will be about your Hazard Communication Program. The correct answer is, “Let me boot up my computer and I will show you how to review our List, our training program, our attestation tracking, and how to log on to our SDS database. Or would you prefer that I print the list and we can walk around and look at our storage practices and spill resources? Either way we’re glad you’re here because we’re always eager to improve.” The WRONG ANSWER is, “What is a Hazard Communication Program?”

About 503 Quality Matters

503 Quality Matters, (503QM), is an advisory, consulting, and program management firm uniquely focused on the business of compounded medications.

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