"Detention Without Physical Examination of Drug Products Containing Adrenal Cortex Extract or Adrenal Cortex Injection"

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.

Districts may detain without physical examination all parenteral drugs for human use containing adrenal cortex extract, or adrenal cortex injection.

Adrenal cortex extract or products containing adrenal extract, and adrenal cortex injection.

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)]."

OASIS charge code - UNAPPROVED