IA#66-08, -------2/9/93 Revised
TYPE OF ALERT: Automatic Detention
PRODUCT : Adrenal cortex extract or products containing
adrenal extract, and adrenal cortex injection.
PRODUCT CODE : 66V--99
HARMONIZED
CODE : 3001
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 : For parenteral drugs for human use containing
adrenal cortex extract or adrenal cortex
injection, 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 : Division of Import Operations & Policy, HFC-170
REASON FOR
ALERT : Parenteral drugs containing adrenal cortex extract
or adrenal cortex injection have been marketed for
numerous years. There is however a lack of
substantial evidence of safety and effectiveness
of these drugs. The AMA Drug Evaluations, 1971
First Edition, stated that adrenal cortex
injection (adrenal cortex extract) is considered
"an obsolete preparation for treatment of adrenal
cortical insufficiency." The AMA Drug Evaluation,
1973 Second Edition, considers that "there is no
known medical use for this drug". FDA's medical
advisors concur that these drug products are not
generally recognized as safe and effective for
labeled indications for human use.
On March 2, 1989, adrenal cortex extract and
adrenal cortex injection from all sources and all
countries were included in the attachment to
Import Alert #66-41, "Unapproved New Drugs
Promoted in the United States" which instructs
automatic detention of these products.
INSTRUCTIONS : Automatically detain all parenteral drugs for
human use containing adrenal cortex extract, or
adrenal cortex injection.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required.
KEYWORDS : Adrenal Cortex Injection, Adrenal Cortex Extract,
New Drug
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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