MSDSs for Active Pharmaceutical Ingredients

As I travel throughout the country, I often get asked the question, “Are material safety data sheets (MSDS)s required for discovery compounds, active pharmaceutical ingredients, or finished pharmaceutical products?” Well, the short answer is, “most likely, yes.” Let me explain in further detail. If any of the above compounds, active pharmaceutical ingredients, or products are sent to any laboratory, facility, or another location that is outside of the control of the facility that originally produced it, a MSDS is required. The only exception to this is when the drug is in solid, final form, and packaged for direct administration to a patient. This was explained in detail in the Occupational Safety and Health Administration’s Letter of Interpretation dated January 3, 1994. Several examples where MSDSs are required in the biotechnology and pharmaceutical industry include the transfer of:

  • Discovery compound(s) to a contract laboratory, another company-owned facility, or a collaborator for further testing or other type of work; or
  • API to a contract manufacturer; or
  • API from a fine chemicals manufacturer to a client; or
  • Bulk tablets, pills, capsules, liquids, creams, etc. to a contract packaging or other organization for further processing.

In addition, in recent years, there has been an emphasis on hazardous drugs in the healthcare setting. A key component of a hazardous drug program is accurate information and communication about the potential hazards of the drug products. A thorough and well-written MSDS is critical for this step in the program.

With the pending adoption of the Global Harmonized System for Hazard Communication by OSHA, now is the time to make adjustments and program improvements to your MSDS authoring process. Authoring a well-written MSDS is time-consuming job and hard work. It requires knowledge of basic toxicology, U.S. and International regulations, California’s Proposition 65 regulations, IATA requirements, and much more. You will also need to be aware that some excipient compounds do not have established OSHA PELs, but may have occupational exposure limits in other countries. In addition, your contract manufacturer or other organization may require that you place the compound into either a control band, categorization scheme, or provide an occupational exposure limit.

If you have any questions regarding MSDSs for pharmaceutical products please contact Dean M. Calhoun at Affygility Solutions.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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