IA #66-60 - 5/11/92, "Automatic Detention of Certain Steroid
Alternatives"
TYPE OF ALERT: Automatic Detention
PRODUCT: Foreign manufactured unapproved drugs
promoted as alternatives to certain anabolic
steroids i.e.,
- Yohimbe Bark or Yohimbe Bark Extract
- Cyclofenil
- Gamma Hydroxybutyrate (GHB)
- Diosgenin
- Clenbuterol
PRODUCT CODE: 66() () () ()
HARMONIZED CODE: N/A
PROBLEM: These products appear to be new drugs which are
being commercially distributed without an
approved New Drug Application.
COUNTRY: All
MANUFACTURER/
SHIPPER: N/A
MANUFACTURER/
SHIPPER ID#: 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
[Unapproved New Drug, Section 505(a)]."
RECOMMENDING
OFFICE: HFD-333
CDER/OC/DDQE/PSB
REASON FOR ALERT: Unapproved alternatives to anabolic steroids
have
commonly been found to present serious safety
and
effectiveness concerns. In February, 1991,
anabolic steroids became controlled substances.
This is one factor which has stimulated the
market for imported steroid alternatives.
INSTRUCTIONS: Automatically detain all shipments of finished
dosage forms (both commercial and personal) of
the cited unapproved products. Do not collect
samples for laboratory analysis. Districts
should determine whether the drugs are covered
by a current approved NDA or IND. Those
products covered by an approved NDA or IND
should be released.
Bulk forms of these drugs may be detained under
certain circumstances as misbranded drugs;
however, prior to initiating any action against
bulk pharmaceutical chemicals, contact
Donald L. Leggett, CDER HFD-316,(301)594-3150.
KEYWORDS: New Drug (NDA), Bulk Pharmaceutical Chemicals
(BPCs), Steroid Alternatives, Steroids
FOI: No purging necessary.
PREPARED BY: Rosa K. Forehand, HFC-131 (301) 443-6553
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