Do we need Safety Data Sheets for drugs in our pharmacy?

There seems to be a lot of misunderstanding about the applicability of OSHA’s Hazard Communication Standard (Title 29, Code of Federal Regulations, Section 1910.1200) to medicines and drugs. Many safety directors are confused by the “total exemption” of some products, but only the “partial exemption” of others. The good news is that OSHA has issued several directives and interpretation letters on this issue which can be found on their web site (www.osha.gov). They have been very consistent in their application and interpretation of this standard with regard to pharmaceuticals, so it makes it easier to apply the interpretation in the practice.

First, pharmaceuticals are NOT categorically exempt from this regulation. There are PARTS of the regulation that do not apply to them, but drugs, like all other chemicals are subject to the provisions of the HCS if they contain 1% or more of a substance considered hazardous.

Paragraph (b)(5)(ii) of the standard does exempt drugs regulated by the FDA ONLY from the labeling requirements set forth by OSHA. This section does not exempt the drug from the whole regulation.

Likewise, drugs that are packaged for resale to the public are only exempt from the SDS and labeling requirements if that drug is NEVER opened or used in the practice. If the staff is exposed to the drug, and it contains 1% or more of a hazardous substance, then the product is considered hazardous in the veterinary practice.

Paragraph (b)(6) of the regulation does exempt some categories of products from the entire regulation, including the need to maintain an SDS (click here for more information on exempt items.) Those exemptions include medications and drugs ONLY when they are in a solid tablet form. If a drug were otherwise considered hazardous, and it came in a liquid oral form, a tablet form and an injectable form, only the tablet form would be exempt. The other forms would have to be included in the hospital's HCS program. Capsules, powders and ointments generally do not fit OSHA’s definition of a tablet so they are NOT exempt from the rules.

Herbal remedies and nutritional products like diets, vitamins, dietary supplements and most IV fluids are also exempt from the HCS in that same section, so an SDS is not required for those products. However, just because a product is considered “all natural” does not automatically exempt it from the regulation since many “natural” products are hazardous to your health; just think about the number of poisonous plants, venoms and toxins that can be found in nature! A good rule of thumb to apply when evaluating one of these “all natural” products is to determine it’s intended use. If a “natural” product is intended to be taken internally, it is generally considered a nutritional product and therefore exempt. If a “natural product” is intended to be used externally, it is assumed to be hazardous unless proven otherwise using objective testing data.

The HCS requires the practice to maintain an SDS library. (click here for more information on maintaining your SDS library.) It further requires that the SDS specifically from the manufacturer of the current supply of the chemical be maintained. For drugs, this means that when “generics” are used, care must be taken to ensure the MSDS in the practice library is from the supplier of the current stock. If the manufacturer has simply changed names or merged with another company, but the formulation of the drug has not changed, it is not necessary to get a new MSDS, but new contact information for the company should be noted.

Although they are available from many sources, it’s best to get the SDSs for pharmaceuticals directly from the manufacturer or from the company that supplied the current hospital stock. Most manufacturers put them on their web sites.

In many practices, drugs are sometimes referred to by their trade names and sometimes known by their generic names. In these cases, it’s best to file the SDS under the trade name of the product that is currently being used (the name as it appears on the bottle). Then use a “place-holder” sheet in the SDS library where the generic drug’s name would be located. Written on the “place-holder” sheet would be a simple instruction directing the reader to the SDS for the trade named product. With this method, the SDS Coordinator for the practice can easily keep the SDSs current without the need to search for “duplicates.”

What about vaccines?

Even though some vaccines contain preservatives that technically meet the definition of a hazardous chemical, OSHA has generally allowed the practice to consider them “biologics” and not chemicals. Because of the extremely low risk these preservatives pose to the veterinary staff, it’s not usually necessary to obtain SDSs for vaccines.

In the end, although some drug forms like tablets are exempt from the regulations for SDSs, the safety officer must still make sure to include the drugs that are not exempt as well as continue to enforce proper handling techniques such as using pill counting trays, and good personal hygine practices like thorough hand washing.

 

 

Did You Know...?

The average veterinary practice has over 200 different drugs in the inventory at any given time that would be considered hazardous.