IA #61-05 - Revised 10/5/92, "Automatic Detention of Methapyrilene and Drug
Products Containing Methapyrilene"
TYPE OF ALERT: Automatic Detention
PRODUCT : Methapyrilene and drug products containing Methapyrilene,
including OTC and prescription systemic and topical
preparations
PRODUCT CODE : 60 through 66-----
HARMONIZED
CODE : N/A
PROBLEM : New Drug Without an Approved New Drug Application (NDA)
(DNRD)
PAC FOR
COLLECTION : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "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).]"
RECOMMENDING
OFFICE : CDER/Office of Compliance, Division of Drug Labeling and
Compliance, HFD-311
REASON FOR
ALERT : 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 nonmonograph 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.
INSTRUCTIONS : Automatically detain all bulk and finished dosage products
containing methapyrilene.
PRIORITIZATION
GUIDANCE : Not applicable at this time
FOI : No purging is required
KEYWORDS : Methapyrilene Fumarate, Carcinogen, Unapproved New Drug,
Methapyrilene Hydrochloride.
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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