"Methapyrilene and Drug Products Containing Methapyrilene"

Although the agency has never codified the prohibition on the use of methapyrilene in OTC drugs, there is sufficient documentation that this ingredient is not permitted in the United States.

In the February 14, 1989, Federal Register Final Rule covering "Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use" (54 FR 6816), the agency discussed the use of this ingredient.

Based on a National Cancer Institute study, the agency concluded that methapyrilene is a potent carcinogen. Since 1979 all oral and topical products containing methapyrilene have been considered to be misbranded under Section 502 of the Act (21 U.S.C. 352) and "new drugs" under Section 201(p) of the Act (21 U.S.C. 321(p)). The agency further concluded that methapyrilene fumarate and methapyrilene hydrochloride are non-monograph ingredients. Therefore any use of these ingredients makes the products unapproved new drugs and not permitted to be marketed unless covered by an Approved New Drug Application on file with FDA.

Disctricts may detain without physical examination all bulk and finished dosage products containing methapyrilene.

Methapyrilene and drug products containing Methapyrilene, including OTC and prescription systemic and topical preparations

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p), without an approved new drug application (NDA) [Unapproved New Drug, Section 505(a).]"

OASIS charge code - UNAPPROVED