An official website of the United States government.

Scope of FDA Exemption For Chemicals Used in Drugs

Section 311(e)(1) of EPCRA exempts from the definition of hazardous chemicals subject to EPCRA Section 311 and 312 reporting requirements any food, food additive, color additive, drug or cosmetic regulated by the Food and Drug Administration (FDA). Are all chemicals intended for use in drugs exempt from the EPCRA Section 311 material safety data sheet (MSDS) and EPCRA Section 312 Tier II inventory reporting?

Not all chemicals intended for use in drugs are exempt from MSDS and inventory reporting under the definition of hazardous chemical. The provision does not exempt all substances defined as drugs under the Federal Food, Drug, and Cosmetic Act in any form or use, but only those drugs that are regulated by FDA. FDA’s regulations pertaining to drugs are contained in 21 CFR.

The exemption contained in EPCRA Section 311(e)(1) applies only to those drugs that are being used in a manner consistent with current FDA regulations. Therefore, to qualify for the exemption, the drug must be in a use or form that is regulated by the FDA. Consequently, the exemption would not apply to unprocessed chemicals intended for eventual use in or as a drug, except to the extent that those unprocessed chemicals are regulated by FDA in their unprocessed state.