Medical/Pharmaceutical

 

With the pharmaceutical industry being one of the fastest growing sectors in the medical world today, hazard-determination of pharmacological compounds has been increasingly significant. Often, formulations are generated without knowledge of the substance’s toxicity and possible reactions that may occur. Our team has expertise in determining some of these toxicities based on relevant chemical structure/family and comparison against like-molecules. However, we still recommend proper acute/chronic and ecological toxicology testing be performed to verify the actual hazard(s).

Using an SDS (Safety Data Sheet) with improper hazard information can lead to incorrect determination of carcinogens and mutagens. MSDS Authoring has a complete list of carcinogens that comply with the laws and organizations below:

  1. IARC (International Agency for Research for Cancer) – Group 1 to Group 4.
  2. The CDC (Center for Disease Control).
  3. California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm.

MSDS Authoring consistently stays up to date on new carcinogen and mutagen determinations. We also pride ourselves in recognizing exemptions (Limited Quantity, etc.) Few industries face the scrutiny of safety compliance as the medical world. MSDS Authoring offers analysis of formulation to offer a potential non-hazardous solution.

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS (Hazard Communication Standard). However, section (b)(6)(vii) of the HCS exempts FDA drugs when in solid final form, such as tablets or pills, for direct administration to the patient.

That section exempts any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is sold in the forms below:

  • in solid, final form for direct administration to the patient (e.g., tablets or pills).
  • drugs that are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs).
  • drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies).

Examples of those needing SDS’s for drugs would include pill manufacturing facilities and pharmacies (if the drug is compounded, crushed etc.).

Note: SDS’s are not meant for consumers. Given the likelihood of patient confusion, most drug companies do not make their SDS’s freely available to the general public. SDS’s for drugs are the most difficult to find on the Internet and usually require direct contact with the manufacturer.

 

 

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