About This Database

This database of Material Safety Data Sheets (MSDS) for FDA-Approved drugs is maintained by DeLima Associates of McLean, Virginia for access by approved users including registered subscribers of select Lexicomp® Drug and Clinical Information products.

Background on Material Safety Data Sheets

Chemicals may pose a wide range of health hazards (such as irritation, sensitization, and carcinogenicity) and physical hazards (such as flammability, corrosion, and reactivity). The Occupational Safety & Health Administration of the U.S. Department of Labor developed the Hazard Communication Standard (HCS-1994) in 1994 in response to legislation. The HCS was designed to ensure that information about these hazards and associated protective measures is disseminated to affected parties. This is accomplished by requiring that chemical manufacturers and importers and the manufacturers of products that contain chemicals evaluate the hazards of the chemicals in products that they produce or import, and to provide information about them through various means including detailed information sheets called Material Safety Data sheets (MSDS). All employers that manufacture, stock or use products that contain hazardous chemicals in their workplaces must provide employee’s access to MSDS if they could potentially be exposed to hazardous chemicals contained in those products.

Contents of Material Safety Data Sheets (MSDS) as required by HCS-1994
(To be superseded by HCS-2014 on June 30, 2015)

Material Safety Data Sheets consist of 16 Major Sections:

Section 1: Identification

- Product identity same as on label and common names
- Name address and telephone number of the manufacturer, distributor, employer or other responsible party

Section 2: Hazard(s) Identification

- Physical Hazards
- Health Hazards

Section 3: Composition/Information on Ingredients

- Chemical and common name of ingredients contributing to known hazards
- For untested mixtures, the chemical and common name of ingredients at 1% or more that present a health hazard and those that present a physical hazard in the mixture
- Ingredients at 0.1% or greater, if listed carcinogens

Section 4: First-Aid Measures

- Emergency and first-aid procedures
- Signs and symptoms of exposure

Section 5: Fire-Fighting Measures

- Physical hazards (potential for fire, explosion)
- Emergency procedures

Section 6: Accidental Release Measures

- Procedures for cleanup of spills and leaks
- Protective measures during maintenance and repair of contaminated equipment

Section 7: Handling & Storage

                - Precautions for safe handling and use, including appropriate hygienic practices

Section 8: Exposure Controls/Personal Protection

- General applicable control measures, such as appropriate engineering controls, work practices, and personal protective equipment
- Protective measures during maintenance and repair of contaminated equipment
- Permissible exposure levels, threshold limit values, listed by OSHA, ACGIH, and other limit        recommended or used by the MSDS preparer

Section 9: Physical and Chemical Properties

                - Physical and chemical properties such as vapor pressure, flash point, etc.

Section 10: Stability and Reactivity

- Physical hazards (potential for fire, explosion, reactivity)
- Organic peroxides, pyrophoric, unstable(reactive), or water-reactive hazards

Section 11: Toxicological Information

- Health hazards, including signs and symptoms of exposure, and any medical conditions which are generally recognized as being aggravated by exposure to the chemical
- Primary routes of entry
- Whether the hazardous chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on       Cancer (IARC) Monographs (latest editions), or by OSHA

Section 12: Ecological information (Non-mandatory)

                - No specific requirements at Federal Level

Section 13: Disposal considerations (Non-mandatory)

                - No specific requirements at Federal Level

Section 14: Transport information (Non-mandatory)

                - No specific requirements at Federal Level

Section 15: Regulatory information (Non-mandatory)

- No specific requirements at Federal Level, however individual States may have specific requirements

Section 16: Other Information, including date of preparation or last revision

                - Date of preparation of MSDS or date of last change

 

NEW Recent Changes to the Hazard Communication Standard

The HCS-1994 was revised in 2012 (HCS-2012) to be consistent with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). While the HCS-1994 is a performance-oriented standard that provides guidance for defining hazards and for performing hazard determinations it does not specify an approach or format to follow. The GHS has certain aspects that are performance-oriented, but the key provisions are a uniformity-oriented approach for the classification and presentation, through labeling and safety data sheets, of hazard information. The term "Material Safety Data Sheet" has been changed to "Safety Data Sheet" (SDS). While the SDS contains the same 16 sections as in the old MSDS, the contents of some of the sections have changed as noted below. It is important to note that the deadline for manufacturers/importers to provide the new GHS-compliant Safety Data Sheets is June 15, 2015. We intend to retain all MSDS until manufacturers provide new SDS.

Contents of GHS-Compliant Safety Data Sheets (SDS) as required by HCS2012

Safety Data Sheets consist of 16 Major Sections:

Section 1: Identification

- Product identifier used on the label
- Other means of identification
- Recommended use of the chemical and restrictions on use
- Name, address, and telephone number of the manufacturer, importer, or other responsible party
- Emergency phone number

Section 2: Hazard(s) Identification

- Classification of the chemical in accordance with paragraph (d) of §1910.1200
- Signal word, hazard statement(s), symbol(s) and precautionary statement(s) in accordance with paragraph      (f) of §1910.1200. (Hazard symbols may be provided as graphical reproductions in black and white or the name        of the symbol, e.g., flame, skull and crossbones)
- Describe any hazards not otherwise classified that have been identified during the classification process|
- Where an ingredient with unknown acute toxicity is used in a mixture at a concentration = 1% and the mixture is not classified based on testing of the mixture as a whole, a statement that X% of the mixture    consists of ingredient(s) of unknown acute toxicity is required.

Section 3: Composition/Information on Ingredients

- Except as provided for in paragraph (i) of §1910.1200 on trade secrets:
-- For Substances            
-Chemical name
-Common name and synonyms
-CAS number and other unique identifiers
-Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance.

-- For Mixtures, in addition to the information required for substances:
-The chemical name and concentration (exact percentage) or concentration ranges of ingredients which are classified as health hazards in accordance with paragraph (d) of §1910.1200 and
-are present above their cut-off/concentration limits; or
-present a health risk below the cut-off/concentration limits.
-The concentration (exact percentage) shall be specified unless a trade secret claim is made  in accordance with §1910.1200(i), when there is batch-to-batch variability in the production of a mixture, or for a group of substantially similar mixtures (See A.0.5.1.2) with similar chemical composition. In these cases, concentration ranges may be used.

-- For All Chemicals Where a Trade Secret is Claimed
-Where a trade secret is claimed in accordance with paragraph (i) of §1910.1200, a statement that the specific chemical identity and/or exact percentage of composition (concentration) has been withheld as a trade secret is required.

Section 4: First-Aid Measures

- Description of necessary measures, subdivided according to the different routes of exposure, i.e., inhalation, skin and eye contact, and ingestion
- Most important symptoms/effects, acute and delayed
- Indication of immediate medical attention and special treatment needed, if necessary

Section 5: Fire-Fighting Measures

- Suitable (and unsuitable) extinguishing media.
- Specific hazards arising from the chemical (e.g., nature of any hazardous combustion products).

Section 6: Accidental Release Measures

- Personal precautions, protective equipment, and emergency procedures.
- Methods and materials for containment and cleaning up.

Section 7: Handling & Storage

                - Precautions for safe handling

Section 8: Exposure Controls/Personal Protection

- OSHA permissible exposure limit (PEL), American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet, where available.
- Appropriate engineering controls.

Section 9: Physical and Chemical Properties

- Appearance (physical state, color, etc.)
- Odor
- Odor threshold
- pH
- Melting point/freezing point
- Initial boiling point and boiling range
- Flash point
- Evaporation rate
- Flammability (solid, gas)
- Upper/lower flammability or explosive limits
- Vapor pressure
- Vapor density
- Relative density
- Solubility(ies)
- Partition coefficient: n-octanol/water
- Auto-ignition temperature
- Decomposition temperature
- Viscosity

Section 10: Stability and Reactivity

- Reactivity
- Chemical stability
- Possibility of hazardous reactions
- Conditions to avoid (e.g., static discharge, shock, or vibration)
- Incompatible materials
- Hazardous decomposition products

Section 11: Toxicological Information

- Description of the various toxicological (health) effects and the available data used to identify those  effects, including:

-- Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact)
-- Symptoms related to the physical, chemical and toxicological characteristics
-- Delayed and immediate effects and also chronic effects from short- and long-term exposure
-- Numerical measures of toxicity (such as acute toxicity estimates)
-- Whether the hazardous chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest editions), or by OSHA.

Section 12: Ecological information (Non-mandatory)

- Ecotoxicity (aquatic and terrestrial, where available)
- Persistence and degradability
- Bioaccumulative potential
- Mobility in soil

Section 13: Disposal considerations (Non-mandatory)

- Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging.

Section 14: Transport information (Non-mandatory)

- UN number
- UN proper shipping name
- Transport hazard class(es)
- Packing group, if applicable
- Environmental hazards (e.g., Marine pollutant (Yes/No))
- Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code)
- Special precautions, which a user needs to be aware of, or needs to comply with, in connection with transport or conveyance either within or outside their premises.

Section 15: Regulatory information (Non-mandatory)

                - Safety, health and environmental regulations specific for the product in question.

Section 16: Other Information, including date of preparation or last revision

                - The date of preparation of the SDS or the last change to it.

When is a Safety Data Sheet Not Required

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS and therefore require Safety Data Sheets. However, section (b)(6)(viii) of the HCS exempts FDA drugs when in solid final form, such as tablets or pills, for direct administration to the patient. However, tablets, capsules, or pills which are designed to be dissolved or crushed by employees prior to administration to a patient are not in "final form" and are covered by the HCS which means that these drugs are not exempt due to their method of administration and will require Safety Data Sheets.